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AC-DI-SOL

Croscarmellose Sodium USP/NF, EP, JP


Ac-Di-Sol is a crosslinked sodium CMC that facilitates rapid disintegration and drug dissolution
in tablets, capsules and other solid dosage forms. It performs dual functionality of water wicking
and rapid swelling resulting in it's superior disintegration characteristics.

Grade

Description

Application

Ac-Di-Sol SD711

Cross linked Sodium


CMC or Modified
Cellulose Gum

Highly effective in wet granulation & direct


compression products, independent of tablet
hardness with low use level and excellent stability.
Best known super disintegrant that is effective intra
and extra-granularly.

ALVEOSUCRE

Agglomerated Sucrose USP/NF, EP, JP


Alveosucre is obtained by wet granulation of pure icing sugar followed by subsequently drying
in a fluidized air bed and then sieved.

Grade

Description

Highly absorbent,
Alveosucre fine allows for structured
mixtures with
homogenetic
distribution of active
ingredients while
Alveosucre
avoiding sedimentation
with dextrin
or separation of
ingredients. Instant
cold dissolution

Application
Fast dissolution instant sugar for homogenous dry
mixes and sachet filling.
Designed for dry mixes formulae and direct
compression. Has high compaction rate.

SHIN-ETSU AQOAT (HPMCAS)

Hypromellose Acetate Succinate USP/NF, JPE


AQOAT is an enteric coating material which was first approved in Japan in 1987. Subsequently
the product was approved in Korea, Europe and USA.
Hypromellose acetate succinate is manufactured from highly purified pulp and involves
introduction of acetyl and succinoyl groups into the hydroxyl backbone of Hypromellose.
Various grades of AQOAT are available which differ in the particle size and chemical
substitution levels.
The polymer, Hypromellose acetate succinate, lends itself to use in different coating techniques aqueous, solvent based, ammonia neutralization and dry / deposition coating. It can also be
recommended in solid dispersions to enhance the bioavailability of poorly soluble drugs as well
as in the design of controlled release dosage forms for targeting drug release to specific
gastrointestinal sites.

Description
Grade

Dissolving
pH*
5.5

Acetyl (%) /
Succinoyl
(%)

Mean
particle size

Application

8 / 15

Aqoat AS-LF
Aqoat AS-MF

6.0

9 / 11

Aqoat AS-HF

6.5

12 / 7

Aqoat AS-LG

5.5

8 / 15

Aqoat AS-MG

6.0

9 / 11

Aqoat AS-HG

6.5

12 / 7

5 m

Micronized grades or aqueous


and dry coating.

1 mm

Granular grades for solventbased coating.

* In Mcllvaine's buffer (citric acidNa2HPO4) and USP Phosphate Buffer (NaOH


KH2PO4)

AQUACOAT CPD - 30

Cellulose Acetate Phthalate aqueous dispersion USP/NF, EP, JP


Aquacoat CPD is a 30 percent solid polymer aqueous dispersion of cellulose acetate phthalate
(CAP) for enteric coating. Enteric coatings allow acid sensitive drugs to pass through the
stomach unaffected or to keep stomach upsetting drugs like aspirin from releasing in the
stomach. Although CAP polymer is hydrophobic, the Aquacoat CPD process allows the product
to be delivered in a totally aqueous pseudo-latex form that is easy to use and clean up, almost
similar to that of solvent coating.

Grade

Description

Aquacoat CPD- A water based pseudo30


latex system
comprising of
Cellulose Acetate
Phthalate
No ammonia used

Application
Enteric coating of tablets and capsules (hard and soft
gelatin). Can also be coated onto beads for filling
into hard gelatin capsules.

AQUACOAT ECD - 30

Ethylcellulose aqueous dispersion USP/NF, EP, JP


Aquacoat ECD is a 30 percent solid polymer aqueous dispersion of ethylcellulose for film
coating of pharmaceutical dosage forms. It is designed for a variety of coating applications to
achieve sustained release, taste-masking and moisture-barrier/sealant coatings. As ethylcellulose
is a hydrophobic polymer, various kinds of release patterns can be achieved by use of suitable
plasticizers, pore formers, etc.

Grade

Description

Application

Aquacoat
ECD-30

A water based pseudolatex system

Sustained release beads for use in capsules / tablets,


moisture barrier / sealant coating and for taste

comprising of
Ethylcellulose, Cetyl
alcohol & sodium
lauryl sulphate. Allows
a wide choice of
plasticizer. No
ammonia used

masking of powders, granules, tablets and capsules.

CALCIUM PHOSPHATES

Calcium phosphates are widely used in pharmaceutical formulations as capsule or tablet diluents.
It has many positive characteristics as an excipient including good compressibility, excellent
stability and white colour. Due to their inherent property of good compatibility, they find use in
both direct compression and wet-granulation process. Two particle size grades of calcium
phosphate are available. The Milled or Powder grade is typically used in wet granulation
process or roller compaction while the Unmilled or Granular grade is used in direct
compression process due to its good flow properties.
Granular grades USP/NF, EP, JP

Grade

Description

Application

A-Tab

Dibasic calcium
phosphate Anhydrous

Tablet and capsule diluent / filler, used in direct


compression. Non-hygroscopic, stable at room
temperature adding to better product stability.
Source of calcium and phosphorous.

Di-Tab

Dibasic calcium
phosphate Dihydrate

Tablet and capsule diluent / filler, used in direct


compression. Flow agent, blend densifier, tablet
punch polishing agent, time release agent and carrier
of actives. Source of calcium and phosphorous.

Tri-Tab

Tribasic calcium
Phosphate Anhydrous

Tablet and capsule diluent / filler, used in direct


compression and as filler binder in vitamin
mineral formulations. Also used as a glidant due to

high surface area and carrier of actives. Higher


calcium and phosphorous content.
Tri-Cal WG

Tribasic calcium
phosphate Anhydrous

Special high density grade for use in wet


granulation. Benefits similar as Tri-Tab

CALCIUM PHOSPHATES

Calcium phosphates are widely used in pharmaceutical formulations as capsule or tablet diluents.
It has many positive characteristics as an excipient including good compressibility, excellent
stability and white colour. Due to their inherent property of good compatibility, they find use in
both direct compression and wet-granulation process. Two particle size grades of calcium
phosphate are available. The Milled or Powder grade is typically used in wet granulation
process or roller compaction while the Unmilled or Granular grade is used in direct
compression process due to its good flow properties.

Granular grades USP/NF, EP, JP

Grade

Description

Application

A-Tab

Dibasic calcium
phosphate Anhydrous

Tablet and capsule diluent / filler, used in direct


compression. Non-hygroscopic, stable at room
temperature adding to better product stability.
Source of calcium and phosphorous.

Di-Tab

Dibasic calcium
phosphate
Dihydrate

Tablet and capsule diluent / filler, used in


direct compression. Flow agent, blend
densifier, tablet punch polishing agent, time

release agent and carrier of actives. Source


of calcium and phosphorous.
Tri-Tab

Tribasic calcium
Phosphate
Anhydrous

Tablet and capsule diluent / filler, used in


direct compression and as filler binder in
vitamin mineral formulations. Also used as
a glidant due to high surface area and carrier
of actives. Higher calcium and phosphorous
content.

Tri-Cal WG

Tribasic calcium
phosphate
Anhydrous

Special high density grade for use in wet


granulation. Benefits similar as Tri-Tab.

AVICEL CE - 15
Microcrystalline Cellulose and Guar Gum

Avicel CE-15 is a patented combination of Microcrystalline cellulose and Guar gum specially
engineered to improve the organoleptic properties of chewable tablets by providing smoother and
creamier mouthfeel, less grittiness, minimum chalkiness and reduced tooth packing. It can be
used even in direct compression applications and yields softer tablets with reduced friability.
Avicel CE-15 in chewable tablets results in dramatic differences for end users, primarily in the
areas of overall sensory experience and perceived taste, when compared to other tablet binders. It
helps to improve overall patient compliance by improving the formulation palatability.

Grade

Description

Application

Avicel CE-15

Free flowing powder,


co-processed blend

Used for improved mouthfeel / superior sensory


characteristics in chewable tablets.

AVICEL DG
Spray dried compound of Microcrystalline Cellulose and Anhydrous Dibasic Calcium
Phosphate

Avicel DG is a synergistic combination of 75% of Microcrystalline Cellulose and 25% of


Anhydrous Dibasic Calcium Phosphate produced using spray dried, co-processing technology.
Avicel DG offers good flow characteristics, a high quality initial compactability, required for the
production of robust ribbons, and excellent recompactability, resulting in enhanced tabletting
performance and fewer rejected tablets.

Grade

Description

Application

Avicel DG

White, odourless
uniform particle size
powder

Dry granulation binder for roller compaction


process

AVICEL HFE - 102


Spray dried compound of Microcrystalline cellulose and Mannitol

Avicel HFE-102 is a novel, proprietary, co-spray dried Microcrystalline cellulose (MCC) and
Mannitol excipient for direct compression. The co-processing of MCC and Mannitol creates a
synergistic functionality, providing superior benefits compared to the use of individual or dryblended components.
Avicel HFE-102 is a highly compactible excipient and exhibits improved flow, superior
compactibility and better disintegration properties compared to traditional MCC grades. The
product also exhibits less sensitivity to lubrication.

Grade

Description

Application

Avicel HFE-

Medium particle size

High functionality excipient for direct compression

102

powder

of tablets, chewable tablets, fast dissolving tablets,


MUPS technology tablets etc. Helps accelerate
tablet development, reduces sensitivity to lubricant
thus enabling higher lubricant levels to reduce
sticking problems in full-scale production.

Avicel PH
Microcrystalline Cellulose USP/NF, EP, JP
Avicel PH is the innovators brand of microcrystalline cellulose. It is a purified, partially depolymerized alphacellulose made by acid hydrolysis of speciality wood pulp controlled to a stringent degree of polymerization than
required by global pharmacopeia.
The unique properties of Avicel PH makes it an indispensable formulation tool and excipient of choice in direct
compression applications on account of its superior compactibility, drug carrying capacity and rapid disintegration.
These properties also benefit dry granulation process such as roller compaction or slugging. When used in wet
granulation process, Avicel reduces the risk of over-granulation, avoids screen blockage and promotes uniform,
rapid drying. Avicel PH is an excellent extrusion-spheronization binder. The inclusion of Avicel PH in capsule
formulations improves flow, facilitates plug formation and aids capsule disintegration.
Avicel PH continues to set new standards with enhanced grades designed to boost productivity and meet any
formulation challenge.

Grade

Description

Application

Avicel PH
101

Fine particle size

For conventional applications, specially in


wet granulation and roller compaction.

Avicel PH
102

Medium particle size For improved flow in direct compression, dry


phase of wet granulation and dry
granulation.

Avicel PH
103

Low moisture with


fine particle size

Well suited for moisture sensitive actives.

Avicel PH
105

Extra fine particle


size

For use in direct compression of coarse or


hardtocompress materials.

Avicel PH
112

Very low moisture


with medium
particle size

Best for direct compression of moisture


sensitive actives with increased flow.

Avicel PH
113

Very low moisture


with fine particle
size

Improves product stability by extending the


shelf life, particularly of moisture sensitive
actives.

Avicel PH
200

Largest particle size

For best flow in direct compression and dry


granulation applications while maintaining
high levels of compressibility with minimum
weight variation and content uniformity
issues.

Avicel PH
200 LM

Very low moisture


with largest particle
size

Best for direct compression of moisture


sensitive actives with superior flow rate than
PH 112.

Avicel PH
301

High bulk density


with fine particle
size

For manufacture of small tablets. reduces


powder stratification and tablet weight
variation by efficient mixing.

Avicel PH
302

High bulk density


with medium
particle size

For manufacture of thin tablets despite high


API content. Prevents powder segregation
and gives good flow.

AVICEL RC/CL
Microcrystalline Cellulose and Carboxymethylcellulose Sodium USP/NF, BP, JPE
Avicel RC/CL are water dispersible, colloidal, spray dried blends of microcrystalline
cellulose and carboxymethylcellulose sodium used in pharmaceutical suspensions,
emulsions, nasal sprays and creams. Avicel RC / CL products produce highly
thixotropic, low viscosity, structured vehicles that yield desirable permanent
suspensions without settling or sedimentation. It also eliminates lengthy hydration
time while increasing formulation stability.

When used in reconstitutable suspensions, Avicel RC / CL facilitates hydration of the dry mix.

Avicel dispersions are stable to heat and freeze/thaw over a wide pH range. Avicel thixotropy
reduces the clearance of nasal spray formulations. It is an excellent stabilizer for oil-in-water
emulsions, reducing oil droplet movement and coalescence. The wide range of thixotropies,
viscosities, gel strengths, and dispersion characteristics of this product line provide unparalleled
suspension stability and functional versatility.

Grade

Description

Application

Avicel RC-581

Bulk dried powder


requiring high shear
mixing for dispersion

Conventional suspending agent and dispersion aid.

Avicel RC-591 Spray dried powder


requiring low shear
mixing for
dispersion

Used for oral suspensions, nasal sprays,


topical sprays, lotions, liquid and semi-solid
dosage forms. Provides a structured
dispersion vehicle, acts as a protective colloid
and facilitates dispersion.

Avicel CL-611 Spray dried powder


requiring low shear
mixing for
dispersion. Has
more CMC content

Recommended for reconstitutable / dry


suspensions. Also for oral suspensions.

BLANOSE
Sodium Carboxymethylcellulose USP/NF, EP, JP
BLANOSE, Carboxymethylcellulose Sodium is the sodium salt of
carboxymethylcellulose (CMC) which is an anionic, water-soluble polymer derived
from cellulose reacted with sodium monochloroacetate. BLANOSE is soluble in cold
or hot water, insoluble in organic solvents, compatible with water / alcohol systems
& imparts low water and oxygen transmission to coatings.

BLANOSE grades find application as thickeners, binders, stabilizers, suspending agents and
rheology modifiers. The grades designated P or PH are purified grades which meet
pharmaceutical standards. A wide range of substitution types are also available, based on number
of carboxymethyl groups present on the cellulose backbone. The low substitution grades (7
types) provide thixotropy whereas the higher substitution grades (9 and 12 types) provide smooth
solutions without thixotropy.
Grade

Viscosity in mPas
(% w/w)*

Application

Blanose 7H4F- 2500 - 4500 (1%)


PH

Tablet coatings - Film former

Blanose 7HFPH

Mucoadhesives - Absorbency

1500 - 2500 (1%)

Blanose 7MF- 400 - 600 (2%)


PH

Syrups & Suspensions - Thickener & suspending


agent

Blanose
7M1F-PH

50 - 100 (2%)

Sustained Release - Thickener, diffusion barrier

Blanose 7LFPH

25 - 50 (2%)

Blanose
9M31F-PH

1500 - 3100 (2%)

Blanose
9M8F-PH

400 - 800 (2%)

Blanose
12M8P

200 - 800 (2%)

Blanose
12M31P

1500 - 3100 (2%)

Bulk Laxative - Inert, high water binding agent

Ointments, Creams & Lotions - Stabilizer,


thickener, film former

*Also avaialbe in finely (X) ground grades.

*Viscosity in milli Pascal per second (mPas or cps) determined on aqueous solutions as per indicated weight %. at 250 C + 0.50 C
using a Brookfield SyncroLectric LVF viscometer.

DSType

Substitution
range

Sodium content, %

0,65 to 0,90 **

7,0 - 8,9

0,80 to 0,95

9,2 - 9,3

12 (for USP
grades)

1,15 to 1,45

10,4 - 12,0

12 (for EP
grades)

1,12 to 1,21

10,2 - 10,8

Cellulose Acetate
Non-enteric celluose ester

Cellulose Acetate is cellulose in which a portion or all of the hydroxyl groups are acetylated. It is
prepared from highly purified cellulose by treatment with acid catalysis and acetic anhydride. It
occurs as a white, odourless, tasteless, free-flowing powders. They are mainly used for sustained
release applications and taste masking.
Cellulose Acetate is used as a semi-permeable coating on tablets, especially on osmotic pumptype tablets and implants. This allows for controlled, extended release of actives. Cellulose
acetate films, in conjunction with other materials, also offer sustained release without the
necessity of drilling a hole in the coating as it is typical with osmotic pump systems. Cellulose
acetate and other cellulose esters have also been used to form drug-loaded microparticles with
controlled-release characteristics.
Grade

Description

CA-320-S

Water insoluble powder Used in controlled-release applications as water


with viscosity of 170 permeable membrane in osmotic systems; direct
280 cps in pyridine.
compression matrix component; barrier component
in taste masking.

CA-398-10

Water insoluble
powder of low
viscosity solution

CALCIUM PHOSPHATES

Application

Used for oral sustained release matrix drug


delivery and in film coating applications.

Calcium phosphates are widely used in pharmaceutical formulations as capsule or tablet diluents.
It has many positive characteristics as an excipient including good compressibility, excellent
stability and white colour. Due to their inherent property of good compatibility, they find use in
both direct compression and wet-granulation process. Two particle size grades of calcium
phosphate are available. The Milled or Powder grade is typically used in wet granulation
processes or roller compaction while the Unmilled or Granular grade is used in direct
compression processes due to its good flow properties.

Powder grades USP/NF, EP, JP

Grade

Description

Application

Calipharm A

Dibasic calcium
phosphate Anhydrous

Filler in wet granulation, multivitamin chewable


tablets and nutritional drinks.

Calipharm D Dibasic calcium


phosphate
Dihydrate.

Filler in wet granulation, vitamin premixes


and nutritional drinks.

Calipharm T

Filler in wet granulation, particularly antacid


formulations for its buffer action. Also used in
nutritional drinks and calcium / phosphorous
fortifications.

Tribasic calcium
phosphate
Anhydrous

STURCAL L & CALOPAKE Extra Light


(Precipitated) Calcium Carbonate USP/NF, EP, JP

Precipitated Calcium Carbonate (PCC), alternatively known as purified, refined or synthetic


calcium carbonate is produced by direct carbonation of hydrated lime by a simple process called
Milk of lime process. The process involves combining lime (CaO) with water to form slaked
lime, addition of carbon dioxide and precipitation of calcium carbonate in a very fine, white
form. The precipitated calcium carbonate is then washed, purified, dried and packaged.
Specialty Minerals Inc. uses high quality limestone sources for its PCC products, including some
from the 150 year old SMI limestone mine in Adams, Massachusetts. Although a number of
different calcite crystal forms are possible, Sturcal L & Calopake Extra Light consist of
agglomerates of scalenohedral calcite crystals. The two grades differ in particle size and apparent
densities and are compliant as per USP/NF, EP & JP.

Grade

Description

Media
n
Partic
le size
(m)

Application

Sturcal L

Heavy grade, apparent


density: 0.78 0.96

75

Used mainly in antacid tablets and


liquids, in dentifrices &
therapeutically as calcium
supplement in pharmaceuticals &
fortified foods.

Calopake
Extra Light

Extra light grade,


apparent density: 0.42
0.50

45

Used as abrasive in dentifrice


products, for calcium
supplementation in nutritional
and pharma products, also as
antacid, pH modulator and
flocculent.

CASTER SUGAR
Screened Sucrose USP/NF, EP, JP

Sieved sucrose or screened sucrose is obtained by purification and crystallization of juice


extracted from sugar beet and subsequently screening it continuously. It is a highly pure
crystalline powder recommended for applications requiring high quality clear solutions or for
coatings.
Grade

Description

Application

Caster Sugar
250

Extremely pure,
Ideal for dry syrups, suspensions, granulation and
crystalline powder with coating. Facilitates dissolution and ensures
low dispersion particle homogenous mixture.
size. Dust free and free
flowing

Caster Sugar
400

Highly pure, fine


grain crystalline
powder. Dust free
and free flowing

Facilitates preparation of dry syrups, liquid


syrups due to higher dissolution rate than
crystal sugar. Also used for coating.

CELLULOSE ACETATE PHTHALATE (C-A-P)


Cellacefate USP / NF, EP, JP

C-A-P is a cellulose in which about half the hydroxyl groups are acetylated, and about a quarter
are esterified with one of two acid groups being phthalic acid, where the remaining acid group is
free. It is a pH-sensitive cellulose derivative designed for enteric coating of pharmaceutical
dosage forms like tablets or granules. It can also be used for matrix drug delivery.
C-A-P can withstand prolonged contact with acidic gastric fluids while being able to dissolve
readily in the mildly acidic to neutral environment of the small intestine. C-A-P is commonly
applied to solid-dosage forms either by coating from organic or aqueous solvent systems or by
direct compression. C-A-P is compatible with many plasticizers and the addition of plasticizers
improves the water resistance of this coating material thus making the formulations more
effective.

Grade

Form

Application

C-A-P Pellets

White pellets

C-A-P Powder

White powder

Used as enteric film coating material for solid


dosage forms like tablets, pellets and capsules. Also
used as a matrix binder.

CELPHERE
Microcrystalline Cellulose USP/NF, EP, JP, JPE

Celphere represents 100% pure microcrystalline cellulose (MCC) spheres or seed cores and is a
product of cellulose particle research, development and process technology at Asahi Kasei. It is
used in manufacturing of granules for sustained / controlled release, taste masked and other
special properties.
Celphere enables greater accuracy and consistency in drug layering and coating as it is highly
spherical, has narrow particle size distribution and exhibits optimum water absorption. It has low
chemical reactivity and hence can be freely used to layer high dose, moisture sensitive & potent
actives. Its high mechanical strength and low friability allows it to withstand the rigors of
fluidized bed or wurster coating process. It is conveniently available in various particle size
grades ranging from 75 to 850 m.

Grade

Particle size
range (m)

Application

Celphere SCP100

75 - 212

Celphere CP102

106 - 212

Used as spherical seed cores for drug layering &


film coating. Also used in manufacture of granules /
beads with sustained / controlled release, taste
masking & other special properties.

Celphere CP203

150 - 300

Celphere CP305

300 - 500

Celphere CP507

500 - 710

Celphere CP708

710 - 850

CEOLUS KG / UF
Microcrystalline Cellulose USP/NF, EP, JP

Ceolus KG / UF are super-compactibility Microcrystalline Cellulose (MCC) powder grades. The


unparalleled compactibility is attributed to its distinctive rod-form particle configuration. Ceolus
KG / UF grades thus enable lowest friability, reduced compression force, low addition rate and
reduced tablet size. Even at 5% addition, they are very effective.
Ceolus KG / UF finds use in direct compression, wet granulation, roller compaction as well as
for adsorption of oily actives for direct compression. They occupy a unique position among dry
binders in its combination of three salient performance characteristics far higher
compactibility, together with an optimum balance of powder flowability and tablet
disintegration.

Grade

Particle size (m) Application

CEOLUS KG
802

Effective in tableting of high dose actives, poorly


compressible actives, pressure -sensitive actives,
coated granules / pellets and orally disintegrating
tablets. It is ideal in formulations based on MUPS
(Multiple unit particulate systems) technology.
50

CEOLUS KG
1000
CEOLUS UF
711

Similar applications like KG grades. However,


flow is more superior compared to KG types.

COMPRESSUC
Spray Dried Sugars USP/NF, EP, JP

Compressuc represents a new generation of sugar for direct compression, produced from an
innovative and patented spray drying process. Anhydrous, fully soluble in water with a sweet
taste; Compressuc is probably one of the most efficient excipient available on the market for
direct compression tabletting.

Grade

Description

Application

Compressuc
MS

Directly compressible
sucrose with
maltodextrins /
inverted sugar.

Excellent diluents, binder for direct compression of


chewable, effervescent and orodispersible tablets.
Has remarkable free-flow, mixing, compaction
properties.
Also used in sachet fillings and dry syrups.

Compressuc
PS

Directly
compressible pure
sucrose (without
additives)

CREMOPHOR
Non-ionic solubilizers / Emulsifiers

Cremophor RH 40 is a non-ionic solubilizer and emulsifying agent obtained by reacting 45


moles of ethylene oxide with one mole of hydrogenated castor oil.
Cremophor EL is a non ionic solubiliser and emulsifier made by reacting castor oil with ethylene
oxide in a molar ratio of 1:35. Cremophor ELP is a purified grade of Cremophor EL specially
developed to give stable formulations of sensitive APIs, especially in injectable form.
The Cremophor A types are prepared by reacting higher saturated fatty alcohols with ethylene
oxide, with the degree of ethoxylation being indicated by the numeral in the name.

Grade

Pharmacopo
eial Name

Appearance

Cremophor RH Polyoxyl-40
White to yellowish,
Hydrogenated nearly odourless,
40
Castor Oil
tasteless, paste

Application

Used to solubilize vitamins,


hydrophobic actives, and
essential oil-in-water or
hydroalcoholic
mixtures, to improve
bioavailability in solid
dosage forms and as solubilizer
in oral / topical liquid and semiliquid dosage forms.

Cremophor
EL

Polyoxyl-35
Castor Oil
(Standard
grade)

Pale yellow oily liquid

Cremophor
ELP

Polyoxyl-35
Castor Oil
(Extra pure
grade of EL).

White to yellowish
paste or cloudy liquid

Used as solubilizer and


emulsifier in
liquid formulation for oral,
topical and parenteral use.

Cremophor A
6

Macrogol-6cetostearyl
ether

Whitish waxy
substance

Cremophor A
25

Macrogol-25cetostearyl
ether

Free flowing,
nondusting micro
beads

Non-ionic emulsifiers used


for production of ointments,
creams, gels based on oil-in
water
emulsions / water-in-oil
emulsions. Also used
for emulsification of
hydrophobic APIs to
form very stable oilinwater
emulsions.

CRYSMEB
Methyl Betacyclodextrin

Kleptose Crysmeb is a new generation, low metylated betacyclodextrin which is a purified


polydisperse product resulting from the controlled reaction of a methylation agent and native
betacyclodextrin. This unique patented product of Roquette has good water solubility, enhanced
stability to form inclusion compounds and a good potential for biological tolerance.

Grade

Description

Application

Crysmeb

Methyl
Betacyclodextrin with
low molar substitution

Suitable for encapsulation of low solubility, volatile


or unstable active ingredients. Used for injectables,
syrups, solutions and oral suspensions.

GLUCOSE
Dextrose USP/NF, EP, JP

Glucose or Dextrose is the monomer of natural starch polymer. It is white,


odourless, sweet, in crystalline or granular powder form and freely soluble in water.
This monomer is also the natural physiological sugar in the human body. In its
crystalline form this doubly natural sugar has long been used both as a filler for oral
dosage forms and as a sweetener. It also helps in improving the stability of API
sensitive to oxidation due to its slight reducing properties. Therapeutically it is used
as a preferred source of carbohydrate in parenteral nutrition.
Roquette has a range of dextrose products wide enough to meet any of
manufacturers different requirements.

Grade

Description

Application

Lycadex PF

Pyrogen free dextrose


monohydrate

Osmotic agent in injectables and dialysis solutions,


for parenteral nutrition and treatment of
hypoglycemia.

Dextrose
Pyrogen free
Anhydrous PF dextrose anhydrous
Dextrose GC

Agglomerated
dextrose
monohydrate

Direct compression diluent with excellent


compressibility and flowability for use in
tablets, sachets and capsule formulations.

Roferose

Dextrose
Monohydrate

Diluent for tablets, capsules and sachets.

Dextrose

Crystalline dextrose

Anhydrous C

anhydrous

Roclys

Dextrose syrup
without extensive
hydrolysis

Flolys

Dextrose syrup with


extensive hydrolysis

For inhibiting sucrose crystallization as


texturizer and bulk sweetener in syrups,
lozenges, pastilles and pharmaceutical
chewing gums.

CALCIUM PHOSPHATES

Calcium phosphates are widely used in pharmaceutical formulations as capsule or tablet


diluents. It has many positive characteristics as an excipient including good compressibility,
excellent stability and white colour. Due to their inherent property of good compatibility, they
find use in both direct compression and wet-granulation process. Two particle size grades of
calcium phosphate are available. The Milled or Powder grade is typically used in wet
granulation process or roller compaction while the Unmilled or Granular grade is used in
direct compression process due to its good flow properties.

Granular grades USP/NF, EP, JP

Grade

Description

Application

A-Tab

Dibasic calcium
phosphate Anhydrous

Tablet and capsule diluent / filler, used in direct


compression. Non-hygroscopic, stable at room
temperature adding to better product stability.
Source of calcium and phosphorous.

Di-Tab

Dibasic calcium
phosphate
Dihydrate

Tablet and capsule diluent / filler, used in


direct compression. Flow agent, blend
densifier, tablet punch polishing agent, time
release agent and carrier of actives. Source
of calcium and phosphorous.

Tri-Tab

Tribasic calcium

Tablet and capsule diluent / filler, used in

Tri-Cal WG

Phosphate
Anhydrous

direct compression and as filler binder in


vitamin mineral formulations. Also used as
a glidant due to high surface area and carrier
of actives. Higher calcium and phosphorous
content.

Tribasic calcium
phosphate
Anhydrous

Special high density grade for use in wet


granulation. Benefits similar as Tri-Tab.

DOCUSATE SODIUM USP/NF, EP


Dioctyl Ester of Sodium Sulfosuccinate (DSS)

Docusate Sodium (DSS) enjoys the reputation of being one of the most versatile and
effective anionic surfactants (surface active agents) used by the Industry. It has
excellent wetting, solubilizing, dispersing and emulsifying properties allowing it to
be used in a multiplicity of applications in pharmaceutical formulations especially in
oral dosage forms. Cytecs DSS is of exceptionally high purity and has a valid Drug
Master File no. with the USFDA.
DSS is virtually free from adverse reactions, non habit-forming and causes the least
possible disturbance of normal body physiology. It is effective alone or in
combination with peristaltic stimulants and bulking agents in the treatment of
constipation. It is also an effective wetting agent in topically applied medical
preparations like creams, lotions and ointments.

Grade

Description

Application

Docusate Sodium
(100 %)

Rolls of white wax- Aids the granulation process, improves tablet


disintegration and dissolution, facilitates
like plastic sheets

Docusate
Sodium (85%)
with Sodium
Benzoate (15%)

White crystalline
powder

Docusate

White to yellow,

tablet coating, emulsifies gels & suspensions.

Also used in laxatives and stool softeners,


prenatal and geriatric vitamin preparations,
colon cleansing aids (used before Xray or
surgery) and in ear wax removal formulations.

Sodium (50%) in
Polyethylene
glycol (50 %)

clear viscous
liquid

DUB DBHG
Glyceryl Dibehenate EP

Glyceryl Behenate is prepared by the esterification of glycerin by behenic acid


without the use of catalysts. It is a mixture of diacylglycerols, mainly
dibehenoylglycerol, together with variable quantities of mono and triacylglycerols. It
is generally regarded as a relatively non-irritant and non-toxic material.

Grade

Description

Application

DUB DBHG

Fine, micronized
powder with a faint
odour

Used as lubricant for tablets. Also can be used as


lipidic matrix for sustained release.

DUB DBS
Dibutyl Sebacate USP/NF

Dibutyl Sebacate is manufactured by the esterification of n-butanol and sebacic


acid in the presence of a suitable catalyst, and by the distillation of sebacic acid
with n-butanol in the presence of concentrated acid. DUB DBS is stable and is not
reactive with water and thus hazardous polymerization does not occur. However it
is incompatible with strong oxidizing materials and strong alkalis.

Grade

Description

Application

DUB DBS

Clear, colorless, oily

Used in oral pharmaceutical formulations as a

liquid with a bland to


slight butyl odour.

plasticizer for film coatings on tablets, beads and


granules, in controlled-release tablets and
microcapsule preparations.

DUB MCT
Medium Chain Triglycerides USP/NF, EP

Medium chain triglycerides are a class of fatty acids obtained by esterification of


glycerol with mixtures of caprylic and capric fatty acids which are fractionated from
coconut or palm kernel oils. They are specially processed to achieve superior
oxidative stability and low colour and then are further refined to remove residual
fatty acids resulting in a product with no odour or flavor.
Their chemical composition is of a shorter length than the long-chain fatty acids
present in most other fats and oils. They are also different from other fats as they
have a slightly lower calorie content and are more rapidly absorbed and
metabolized as energy resembling a carbohydrate more than fat. The unique
metabolic and functional properties, a consequence of their chemical structure
make them versatile ingredients in a number of pharmaceutical and food
formulations.

Grade

Description

Application

DUB MCT
5545

Oily liquid

Energy source for patients with fat


malabsorption syndrome. Used as plasticizer,
tablet lubricant and as a liquid base for
parenterals. Also used as low calorie fats in
diet preparations and in capsule filling.

DUB MCT
7030
DUB MCT
6535

DUB MICROLUB
Stearic Acid USP/NF, EP

Stearin or Stearic acid is a mixture of stearic acid and palmitic acid derived from an
edible source. The content of stearic acid is not less than 40% while that of palmitic
acid is also not less than 40% and the sum of the two not less than 90%. It occurs
as a hard, white or faintly yellowish, somewhat glossy, crystalline solid or as white
or yellowish white powder, with a faint odor and taste, suggesting tallow.

Grade

Description

Application

DUB
MICROLUB
70

Stearic Acid 70% Micronised powder

Used as a tablet lubricant. Micronized grade


imparts a smooth, shiny surface to film
coated tablets. Also used as emulsifying and
solubilizing agent in topical formulations like
ointments and creams.

DUB
Stearic Acid 50% MICROLUB 50 Micronised powder

Also available is STEARIC ACID 95% (in flakes form) and STEARIC ACID 50% (in pellets or powder form)

DUB PP
Hemi-synthetic Glycerides USP/NF, EP

DUB PP are hard fat suppository bases and are a mixture of triglycerides,
diglycerides and monodiglycerides which may be obtained either by esterification of
natural fatty acids with glycerol or by inter-esterification of natural fats. Each type of
hard fat is characterised by its melting point, its saponification value and its
hydroxyl value. These suppository bases, DUB PP, are made from vegetable fatty
acids. They are presented in non-toxic, neutral pellet form allowing for easier use.
Moreover, they do not contain any oxidizing or stabilizing agent.

Grade

DUB PP C 3

Saponificatio
n
Value

Melting Point
(C)

Hydroxyl
Value

Applicatio
n

230 240

33 35

20 30

Multipurpo
se

DUB PP CDL 1

225 245

33.5 35.5

15

DUB PP D 1

234 247

34 36

10

DUB PP E 1

235 245

35 36.5

10

DUB PP E 3

235 245

35 36.5

20 30

DUB PP F 1

235 245

36 37.5

10

DUB PP H 1

230 240

38 40

10

DUB PP M 1

223 233

42 44

10

DUB PP KC 3

225 240

33.5 35.5

20 30

DUB PP KCD 1

235 245

33.5 35.5

15

DUB PP KD 3

225 240

34 36

20 30

DUB PP KE 3

215 236

Ac-Di-Sol SD711

20 30

DUB PP KF 1

235 250

35.5 37.5

15

Suppositor
y Bases

Specific
Suppositor
y Bases

DUB SE
Sucrose Esters USP/NF, EP

Sucrose esters are natural surfactant materials obtained by the esterification of one
or more of the hydroxyl groups of the sucrose molecule with vegetable fatty acids.
These compounds are non-ionic and have excellent emulsifying, wetting and
dispersing properties. By modifying the esterfication degree of the sucrose, it is
possible to obtain a range of different emulsifiers with HLB from 3 to 16.
Sucrose esters are tasteless, odorless and non-toxic. They are non-irritant, mild to
the skin and find use in pharmaceuticals, cosmetics and foods.

Grade

Description

Application

DUB SE 3S

Sucrose Tristearate

DUB SE 5S

Sucrose Distearate

DUB SE 11S

Sucrose Stearate

Low HLB grades used as tablet / capsule lubricant


while high HLB grades are used to make easy
dispersible tablets. Also used as a solubilizer, foam
enhancer and as an emulsifier - stabilizer in oil-inwater emulsions. Their nonionic nature makes them
co-emulsifiers as well.

DUB SE 15P

Sucrose Palmitate

DUB SE 16P

Sucrose Palmitate

AQUALON ETHYL CELLULOSE PHARM


Ethylcellulose USP/NF, EP, JP

AQUALON EC is a non-ionic ethyl ether of cellulose, soluble in a wide range of


organic solvents. Typically, ethylcellulose is used as a non-swellable, insoluble
component in matrix or coating systems. When water soluble binders cannot be
used in dosage processing because of water sensitivity of the active ingredient,
ethylcellulose is often chosen.
Ethylcellulose can be used to coat one or more active ingredients of a tablet to
prevent them from reacting with other materials or with one another. It can prevent
discoloration of easily oxidizable substances such as ascorbic acid, allowing
granulations for easily compressed tablets and other dosage forms. Ethylcellulose
can be used on its own or in combination with water-soluble polymers to prepare
sustained release film coatings that are frequently used for the coating of microparticles, pellets and tablets.

Grade

Viscosity in mPas
(% w/w)*

Application

EC N 7 Pharm

6 to 8

Microencapsulation - Stabilizes against active

EC N 10
Pharm

8 to 11

EC N 14
Pharm

12 to 16

EC N 22
Pharm

18 to 24

EC N 50
Pharm

18 to 24

EC N 100
Pharm

80 to 105

EC T 10
Pharm

8 to 11

interactions, hydrolysis and oxidation.


Tablet coating Film coating for sustained release.
Tablet Binder - Plastic flow, suitable for direct
compression, injection molding and melt extrusion.
Taste Masking - improved taste through suppression
of bitter taste & strong odours of actives.

Directly compressible, micronized grade with


high ethoxyl content and low viscosity for
optimum compactibility and good powder
flow. Eliminates the need for solvents in
direct compression controlled release
matrices.

* Determined using 5% ethyl cellulose solution (by weight) in 80 parts toluene & 20 parts ethanol

GLUCOSE
Dextrose USP/NF, EP, JP

Glucose or Dextrose is the monomer of natural starch polymer. It is white,


odourless, sweet, in crystalline or granular powder form and freely soluble in water.
This monomer is also the natural physiological sugar in the human body. In its
crystalline form this doubly natural sugar has long been used both as a filler for oral
dosage forms and as a sweetener. It also helps in improving the stability of API
sensitive to oxidation due to its slight reducing properties. Therapeutically it is
used as a preferred source of carbohydrate in parenteral nutrition.
Roquette has a range of dextrose products wide enough to meet any of
manufacturers different requirements.

Grade

Description

Application

Lycadex PF

Pyrogen free dextrose


monohydrate

Osmotic agent in injectables and dialysis solutions,


for parenteral nutrition and treatment of
hypoglycemia.

Dextrose
Pyrogen free
Anhydrous PF dextrose anhydrous
Dextrose GC

Agglomerated
dextrose
monohydrate

Direct compression diluent with excellent


compressibility and flowability for use in
tablets, sachets and capsule formulations.

Roferose

Dextrose
Monohydrate

Diluent for tablets, capsules and sachets.

Dextrose
Anhydrous C

Crystalline dextrose
anhydrous

Roclys

Dextrose syrup
without extensive
hydrolysis

Flolys

Dextrose syrup with


extensive hydrolysis

For inhibiting sucrose crystallization as


texturizer and bulk sweetener in syrups,
lozenges, pastilles and pharmaceutical
chewing gums.

Marine Colloids Carrageenan


Carrageenan USP/NF

Carrageenan is a family of naturally-occurring high molecular weight


polysaccharides extracted from red seaweed. The main seaweed types include
Eucheuma, Chondrus and Gigartina which yields kappa, iota and lambda
carrageenan.
The carrageenan structure is made up of repeating galactose and 3,6
anhydrogalactose units, both sulfated and non-sulfated joined by alternating alpha
1-3 and beta 1-4 glycosidic linkages.
The kappa, iota and lambda carrageenans differ in properties mainly due to the
number and position of ester sulphate groups on the galactose units. While kappa
forms a brittle gel, iota forms an elastic gel and lambda does not form a gel. Based
on their properties, they find use as stabilizers, thickeners, suspending agents,
gelling agents and flow regulators in pharmaceutical dosage forms.

Description
Grade

Application

Carrageen
an Type

Viscosity

Gel Type

Gelcarin GP-379

Iota

High
thixotropic

Elastic,
Medium
strength

Creams and
suspensions. Is polyol
and protein reactive.
Promotes freeze thaw.

Gelcarin GP-812

Kappa

Low

Brittle,
Strong

Gives stronger gels


than GP 911 with
higher syneresis.

Gelcarin GP-911

Kappa

Low

Brittle, Firm

Used in encapsulation /
delivery systems. Is
polyol and protein
reactive.

Viscarin GP-109

Lambda

Medium

Nongelling

Used in creams and


lotions. Is polyol and
protein reactive.

Viscarin GP-209

Lambda

High

Nongelling

Used in creams and


lotions. Is polyol and
protein reactive.

SeaSpen PF

Iota

Medium
thixotropic

Elastic,
Weak

Used in suspensions,
reconstitutables, topical
lotions and creams.

GLUCIDEX

GLUCIDEX is a large family of maltodextrins and dried glucose syrups, obtained


from starch by hydrolysis, followed by purification and spray drying. Glucidex
grades exhibit good stability and range from slightly sweet-to-sweet products.
Depending on the grade used, GLUCIDEX products can help adjust and control the
properties of viscosity and texture, sweetness, anti-crystallizing power, browning
reactions, fermentability and freezing point depression.

GLUCIDEX Maltodextrins
Maltodextrin USP/NF, EP
Maltodextrins are dried starch hydrolysis products with a dextrose equivalent (D.E.)
lower than 20. These are fine white, neutral or slightly sweet tasting powders,
soluble in water and with a high standard of organic, mineral and bacteriological
purity.
Grade

Description

Application

Glucidex 2 D

Maltodextrin with
dextrose
equivalent of
maximum 5

Diluent for tablets, capsules, sachets, carrier for


spraydrying, carbohydrate source in infant and
enteral foods. Can also be used for DC formulations
of vitamins or
mineral supplements.

Glucidex 6 D

Maltodextrin with
dextrose
equivalent of 5 to 8

Glucidex 9 D

Maltodextrin with
dextrose
equivalent of 8 to
10

Glucidex 12 D Maltodextrin with


dextrose
equivalent of 11 to
14
Glucidex 17 D Maltodextrin with
dextrose
equivalent of 15 to
18
Glucidex 19 D Maltodextrin with
dextrose
equivalent of 18 to
20

Note: Also available in IT grades with free flow properties and better solubilization due to its particular physical structure.

GLUCIDEX Dried glucose syrups


Corn syrup solids USP/NF, EP

Corn syrup solids (earlier known as dried glucose syrups) are dried starch hydrolysis
products with a Dextrose equivalent (DE) greater than 20. They have greater
sweetness as compared to maltodextrins. These are fine white, neutral or slightly
sweet tasting powders, soluble in water and with a high standard of organic, mineral
and bacteriological purity.
Grade

Description

Application

Glucidex 21 D

Dried glucose syrup


with dextrose
equivalent of 20 to 23

Diluent for tablets, capsules, sachets, carrier in


spraydrying, carbohydrate source in infant and
enteral foods.

Glucidex 33 D Dried glucose syrup


with dextrose
equivalent of 31 to
34
Glucidex 47 D Dried glucose syrup
with dextrose
equivalent of 43 to
47
Note: Also available in IT grades with free flow properties and better solubilization due to its particular physical structure.

GLYCOLYS
Sodium Starch Glycolate USP/NF, EP, JPE

Sodium Starch Glycolate is the sodium salt of cross-linked carboxymethyl ether of


starch. It is a white-to-off-white, odourless, tasteless, free flowing powder which is
sparingly soluble in 95% ethanol and practically insoluble in water. GLYCOLYS is
potato starch based and has the capacity to swell upto 300 times its original
volume in water, a property that attributes to its use as a superdisintegrant.

Roquette has been producing SSG for more than 20 years now and has developed
different grades of GLYCOLYS to meet the specific needs of viscosity, moisture, pH or
solvent-free properties.

Grade

Description

Application

Glycolys

Standard grade SSG Type A

Super disintegrant for solid dosage forms. Used in


both wet granulation and direct
compression processes.

Glycolys LV

Low viscosity grade


SSG - Type A

Designed to withstand high shear in wet


granulation processes.

Glycolys LM

Low moisture grade


SSG - Type A

For moisture sensitive actives.

Glycolys Low
pH

Acid stable grade


SSG - Type B

Designed to resist acidic pH and stabilize


products containing strongly acidic drugs.

HI-SWEET
High Fructose Corn Syrup (HFCS)

High Fructose Corn Syrups (HFCS) products are sweet, clear, clean-tasting, odorless
liquids manufactured by controlled hydrolysis of starch polymers thus resulting in
high fructose compositions with valuable bulk sweetening profiles. Roquette offers
two grades of HFCS differing in sweetness and viscosity.

Grade

Description

Hi-Sweet 55

Used as a bulk sweetener and viscosity


Solid content of
minimum 55% fructose enhancer in medicated syrups and
suspensions. Provides high sweetness and
on dry basis.

Hi-Sweet 42

Solid content of

Application

clean mouth feel compared to sucrose and


invert sugar.

minimum 42%
fructose on dry
basis.

HPMCP
Hypromellose Phthalate USP/NF, EP, JP

Hypromellose Phthalate (Hydroxypropyl Methylcellulose Phthalate) is a phthalic half


ester of Hypromellose and the threshold pH value for rapid disintegration of HPMCP
can be controlled by varying the phthalyl content.
HPMCP is a solvent based enteric coating agent used to protect drugs from gastric
degradation or to protect the gastric mucosa from irritant drugs.
Two types of HPMCP are available based on the pH solubility, HP-50 and HP-55.
Additionally, there is a special type viz, HP-55S which has a higher molecular weight
and gives films of greater strength and gastric resistance.

Grade

Description
Dissolving pH*

HPMCP HP50

Viscosity (cst)
40

HPMCP HP55
HPMCP HP
55S

Application

5.5

5.0

170

55

* In Mcllvaine's buffer solution (citric acidNa2HPO4) and Clark-Lubs buffer solution

ICING SUGAR
Milled Sucrose USP/NF, EP, JP

Regular grade
Greater film strength

Soluble at low pH

Icing Sugar is obtained by continuous grinding of sugar crystals. The range of icing
sugar is particularly adapted to any use requiring a finely milled and high purity
sugar.

Grade

Description

Application

Icing Sugar
Pure

Very fine powder,


impalpable (100%
sucrose)

Used for granulation, coating and in sachets.


Easily compressible and dissolves quickly in
water than regular sugar.

Icing Sugar
with Starch

Very fine powder,


impalpable (with
maize starch added
as an anti-caking
agent)

ALGINATES and ALGINIC ACIDS USP/NF, EP, JP

Alginates are natural hydrocolloids of vegetable origin that occur as a structural


component in marine brown algae, where they give strength and flexibility to the
plant. In contrast to most other polysaccharide gels, alginate gels can develop
instantaneously in the presence of divalent cations into acid gels at low pH and
constant temperature. The gelling gives rise to a three dimensional network which
determines the gel strength. Alginates with high content of G-blocks give stronger
gels & M-rich alginates give softer and more fragile gels. The molecular weight
determines the viscosity of alginate solutions while the ratio of mannuronic acid
guluronic acid (M/G) determines the relative strength of the gel.
FMC range of alginates and alginic acids offer unique gel-forming, film-forming,
thickening and stabilizing properties.

Grade

Description
Alginate Type

Protacid F 120
NM

Alginic Acid

Application

Viscosity (mPas)
-

Used in antireflux and


effervescent tablets. Also as a

Kelacid

Alginic Acid

Alginic Acid
DC

Alginic Acid,
Directly
Compressible

Protanal LFR
5/60

Sodium

Protanal LF
Mg 5/60*

Magnesium

Manugel LBA

Sodium

300-700 (10%)

Manugel LBB

Sodium

8000 (10%)

Protanal LF
240 D

Sodium

70 200 (1%)

Protanal LF
120 M

Sodium

70 150 (1%)

Keltone LVCR

Sodium

35 (1%)

Keltone HVCR Sodium

300 700 (10%)

AntiReflux Suspensions (Raft


formation).

1000 - 1800 (7.5%)

Controlled release.

400 (1%)

Manucol LKX

Sodium

60-170 (1%)

Kelcosol

Sodium

1000-1500 (1%)

Manugel LBA

Sodium

500 (10%)

Manucol LB

Sodium

4 (1%)

Kelcoloid S

Propylene Glycol

Manucol DH

Sodium

Gelling.

Viscosity enhancer.

25 (1%)
40-90 (5%)

Manucol DMF Sodium

300 (1%)

Kelvis *

760 (1%)

Sodium

natural disintegrant in wet and


direct compression granulation.

Thickener and stabilizer for


syrups, emulsions.

Protanal Ester Propylene Glycol


SD-LB
Kelcoloid
K3B426

700 - 1800 (2%)

Propylene Glycol

120 (1%)

Kelcoloid HVF Propylene Glycol


*

400 (1%)

Kelcoloid LVF
*

Propylene Glycol

120 (1%)

Manucol
Ester E/RK *

Propylene Glycol

125 (1%)

Manucol
Ester M *

Propylene Glycol

200 (1%)

Protanal KF
200 *

Potassium

200 400 (1%)

Protanal TA
250 *

Triethanolamine

200 400 (1%)

Kelmar *

Potassium

400 (1%)

Manucol SS /
LL

Sodium

200 (1%)

Kelset

Sodium-Calcium

Keltose *

AmmoniumCalcium

Semi-gel (1%)

Protanal LF
200 M

Sodium

200 400 (1%)

Protanal LF
10/60

Sodium

20 - 70 (1%)

Manucol LF

Sodium

25 (1%)

* Non-pharmacopeial grades

500 1000 (0.5%)

Dental Impression
materials.

Dental Fixtures.

Selfgelling polymers for


controlled release.

Wound Healing.

KLEPTOSE
Betadex USP/NF, EP, JPE

The complexes formed with betacyclodextrin are of monomolecular type leading to


the concept of molecular encapsulation. Betacyclodextrins can improve the
solubility of poorly soluble compounds and finds use as encapsulating agents,
solubility and stability enhancers for tablets, capsules, sachets and oral
suspensions. They are also used for taste masking of bitter or unpleasant active
ingredients.

Grade

Description

Application

Kleptose STD

Standard grade

For inclusion in liquid phase.

Kleptose DC

Granular grade

For direct compression.

Kleptose 10

Micronized grade

For aerosols.

Kleptose 7PC

Low moisture grade

For inclusion in dry phase.

KLEPTOSE HPB / HP
Hydroxypropyl Betadex (HPBCD) USP/NF, EP, JPE

Hydroxypropyl Betadex (HPBCD) are purified polydisperse products resulting from


controlled reaction of propylene oxide and native betadex under base catalysis. By
virtue of its amorphous polydisperse composition, it overcomes the low solubility
and inadequate biological tolerance of the native betacyclodextrin. Kleptose HPB is
produced in a purpose built, state-of-the-art manufacturing plant following USFDA
type GMP quality guidelines for API and is perhaps the only brand supported by
toxicology data.

Grade

Description

Application

Kleptose HPB

HPBCD with medium


molar substitution
(Endotoxin controlled)

Kleptose HP

HPBCD with high


molar substitution
(Oral grade)

Increases water solubility of poorly soluble


drugs by encapsulation. Suitable for
parenteral solutions, syrups, oral suspensions
and dry formulation. Increases bioavailability
and improves organoleptic properties of
bitter and unpleasant actives.

KLUCEL
Hydroxypropyl Cellulose USP/NF, EP, JP

KLUCEL HPC is non-ionic water-soluble cellulose ether, formed by reaction of


cellulose with propylene oxide. KLUCEL provides a remarkable set of physical
properties for tablet binding, modified release and film coating. It combines organic
solvent or aqueous solubility, thermoplasticity and surface activity with aqueous
thickening and stabilizing properties.

Grade

Viscosity in mPas
(% w/w)*

Application

Klucel LF
Pharm

75 - 150 (5%)

Tablet binding for immediate release - Yields


unmatched tablet hardness and friability in wet
granulation and direct compression or dry
granulation.

Klucel LXF
Pharm
(extra fine)
Klucel GF
Pharm

Modified release - Provides effective diffusion


limiting matrix systems.
150 - 400 (2%)

Tablet coating - Imparts good flexibility and


adhesion to films while providing a good barrier to
water and oxygen transmission.

Klucel GXF
Pharm
(extra fine)
Klucel JF
Pharm

150 - 400 (5%)

Klucel JXF
Pharm
(extra fine)
Klucel EF
Pharm

300 - 600 (10%)

Klucel EXF
Pharm
(extra fine)
Klucel HF
Pharm

1500 - 3000 (1%)

Klucel HXF
Pharm
(extra Fine)
Klucel MF
Pharm

4000 - 6500 (2%)

Klucel MXF
Pharm
(extra fine)
*Viscosity in milli Pascal per second (mPas or cps) determined on aqueous solutions as per indicated weight %. at 250 C + 0.50 C using a
Brookfield - Syncro-Lectric LVF viscometer.

KOLLICOAT IR
PVA-PEG graft copolymer

A breakthrough in instant release film coating, Kollicoat IR is an innovative new


coating polymer derived from BASFs extensive polymer research. They are
basically polyvinyl alcohol-polyethylene glycol graft copolymers slightly modified to
render different application values. All the grades are in powder form and give an
extremely flexible film without addition of any plasticizer and offer pH independent
release. Kollicoat IR grades are white to faintly yellow free-flowing powder that is
very rapidly soluble in acidic, neutral and alkaline aqueous media. Such aqueous
solutions have low viscosity.

Grade

Description

Application

Kollicoat IR

Graft copolymer of
75% polyvinyl alcohol
units and 25%
polyethylene glycol
units

Used for instant release coating of tablets, pellets


and particulate matter, as a pore former in sustainedrelease coatings, as a binder using a binding solution
for wet granulation.

Kollicoat IR
White

Graft copolymer of
75% polyvinyl
alcohol units and
25% polyethylene
glycol units with
white pigments

Ready-to-use, white colour coating system.


Instantaneous dispersion due to a patented
manufacturing process.

Kollicoat
Protect

Co-processed
product of Kollicoat
IR and Polyvinyl
alcohol

Ready-to-use moisture barrier system for use


in combination with pigments.

KOLLICOAT MAE
Methacrylic acid / Ethyl acrylate copolymer USP/NF, EP, JPE

Kollicoat MAE 30 DP and Kollicoat MAE 100P are anionic polymers based on
methacrylic acid and methacrylic acid esters and are used as film-formers for the
production of enteric coatings for solid dosage forms. The ratio of carboxyl groups to
ester units is about 1:1. The films are insoluble below pH 5 and thus resistant to
gastric fluid. By salt formation in the neutral to weakly alkaline medium of intestinal
fluid, the films dissolve step-wise at pH values above 5.5.

Grade

Description

Kollicoat MAE Aqueous, milky white,


30 DP
low viscosity
dispersion with solid

Application

For enteric film coating of tablets, pellets, capsules,


crystals, soft gelatin capsules and other solid dosage
forms. . Also used as a moisture barrier, taste odour

Kollicoat MAE
100 P

content of 30% and a


faint characteristic
odour

masking and as a barrier between incompatible


actives.

White, partially
neutralized,
redispersible
powder with a faint
characteristic odour

For the production of an aqueous dispersion


for coating or a solution in organic solvents
for enteric coatings on tablets, pellets,
capsules, crystals, soft gelatin capsules and
other solid dosage forms.

KOLLICOAT SR 30 D
Polyvinyl acetate dispersion EP

Kollicoat SR 30 D is a an aqueous dispersion consisting of 27% polyvinyl acetate


stabilized with 2.7% povidone and 0.3% sodum lauryl sulfate. This dispersion is
suitable for the manufacture of pH independent sustained release formulations.
Very effective control of drug release is achieved by coating pellets, granules and
crystals. This dispersion can also be used for taste masking.

Grade

Description

Application

Kollicoat SR
30 D

Low viscosity, milky


white or slightly
yellowish dispersion
with solid content of
30% and a weak
characteristic odour

Used for sustained release coating of pellets,


granules, etc; for sustained release matrix tablets; for
taste and odour masking and protective coatings of
interacting ingredients.

KOLLIDON
Povidone USP/NF, EP, JP

The Kollidon range consists of soluble polyvinyl pyrrolidone which is obtained by


radical polymerization of N-vinylpyrrolidone in water or isopropanol under cGMP
conditions to yield the chain structure constituting polyvinylpyrrolidone (PVP). By
virtue of its solubility in water and many organic solvents, its high binding power
and ability to form complexes, soluble PVP occupies a special position among the
synthetic colloids.
Kollidon is available in different grades on the basis of their K-value and molecular
weight. All grades are supplied as almost white, free flowing, tasteless powders with
a slight characteristic odour in pharmaceutically pure form.

Description
Grade

Kvalue

Kollidon 12 PF 10.2 - 13.8

Molecular
weight (Mw)

Application

Low (2000-3000) Pyrogen free grade, used as

solubilizing, stabilizing agents,


dispersants and crystallization
inhibitors particularly for injectables;
especially antibiotics in solution or
lyophylisate form.
Kollidon 17
PF

15.3 - 18.0

Low (700011000)

Kollidon 25

22.5 - 27.0

Kollidon 30

27.0 - 32.4

Medium (28000 - Versatile and widely used as


34000)
binders in tablets, capsules and
granules, stabilizers in oral
Medium (44000 - suspensions, film formers,
dispersants for pigments,
54000)
thickeners and bioavailability
enhancers

Kollidon 90 F

81.0 - 96.3

High (1000000 1500000)

Same as Kollidon 12 PF. Can be


additionally used as solubilizer,
film former or thickener in
ophthalmic preparations.

Highly effective binder for wet


and dry granulation; stabilizer
and thickener for oral and
topical solutions including

ophthalmic preparations.

KOLLIDON CL
Crospovidone USP/NF, EP, JPE

Crospovidone grades are the insoluble grades of Povidone manufactured by a


polymerization process that yields crosslinked insoluble polyvinylpyrrolidone in the
form of a popcorn polymer. The polymerisation is performed using an aqueous
system.
Crospovidones are Super Disintegrants completely insoluble in solvents. In
contrast to many other disintegrants they are also non-water soluble. As a
consequence, there is no influence on the disintegration of a tablet and the
dissolution of the active due to the increased viscosity. The crosspovidones act as
disintegrants by absorbing water and subsequently swelling. This gain in volume is
responsible for the subsequent disintegration of the tablet. The different Kollidon CL
are distinguished by their different particle sizes.

Grade

Description

Application

Kollidon CL

Standard grade

Used as a tablet disintegrant and for improving the


release of active substances from tablets, capsules
and granules.

Kollidon CL-F

Fine particle size


grade

Used as disintegrant in tablets, especially in


formulations for small tablets and in wet
granulation (less content uniformity
problems).

Kollidon CLSF

Superfine particle
size grade

Used as disintegrant in fast dispersible


tablets for a smooth mouth-feel.

Kollidon CL-M

Micronized grade

Used as a stabilizer for oral and topical


suspensions and for improving the release of
active substances from tablets, capsules and
granules.

KOLLIDON SR
Blend of Polyvinyl Acetate and Povidone

Kollidon SR is a blend of polyvinyl acetate and povidone for use as a matrix-forming


agent in directly compressible sustained release tablets. It consists of 80%
polyvinyl acetate and 19% povidone alongwith small quantities of sodium lauryl
sulfate and silica as stabilizers.
Polyvinyl acetate is a very plastic material that produces a coherent matrix under
low compression forces. When the tablets formulated using Kollidon SR are
introduced into gastric or intestinal fluid, the water soluble povidone is leached out
to form pores through which the active ingredient slowly diffuses out through these
pores to give sustained action. Kollidon SR contains no ionic groups and is therefore
inert to drug substances. The sustained-release properties are unaffected by ions or
salts.

Grade

Kollidon SR

Description
Kvalue

Characteristics

60.0 - 65.0

White or slightly
yellowish, freeflowing powder,
insoluble in water
(only povidone
part is soluble)
and very soluble
in NMP

KOLLIDON VA 64
Copovidone USP/NF, EP, JPE

Application

Used in formulation of pH
independent sustained release
matrix dosage forms tablets,
pellets and granules by either
direct compression, roller
compaction, wet granulation or
extrusion.

Kollidon VA 64 grades are excellent dry binders. Basically they are vinylpyrrolidone
- vinyl acetate copolymers which are soluble in both water and alcohols. It is white
or slightly yellowish powder with a faint characteristic odour and practically no
taste. An important property of Kollidon VA 64 is its plasticity which distinguishes
it from Povidone (eg. Kollidon). This property often gives granules and mixtures that
are less susceptible to capping during tabletting and results in tablets that are less
brittle.

Grade

Description
Kvalue

Kollidon VA 64 25.2 - 30.8

Kollidon VA
64 Fine

Application

Characteristics
Copolymer of
vinylpyrrolidone
and vinyl acetate
in a ratio of 6:4 by
mass

Dry binder for direct


compression and roller
compaction; as a binder for wet
granulation in tablets, capsules
and granules; as a film forming
agent in tablet coating / subcoating and in topical sprays.
Fine particle size grade for
increased tablet hardness
resulting in less friability and
better mechanical stability.

KRONOS 1171
Titanium Dioxide USP/NF, EP, JP

KRONOS 1171 Titanium dioxide is an amorphous, fine, superwhite powder produced


by the sulphate process. It is a special anatase grade of exceptionally high purity
specifically manufactured for the pharmaceutical industry. Due to its high refractive
index, Kronos 1171 Titanium Dioxide has unique light scattering properties and thus
widely used as a white pigment and opacifier.
Kronos 1171 Titanium Dioxide complies to the latest monographs of USP/NF, EP, JP
etc as well as to several purity regulations of the EU and USFDA.

Grade

Description

Application

Kronos 1171

Anatase grade, super


Used as a white pigment and opacifier in film
white, fine particle size coating mixes for tablets, gelatin capsules, sugar
and bacteria controlled coated tablets, films and dermatological
preparations. Can also be admixed with other
pigments to lend different colour tones to tablets and
coatings.

LACTOCHEM
Lactose Monohydrate USP/NF, EP, JP

Lactochem is a white, crystalline powder. It is the alpha-isomer of lactose and in


crystalline form it is present as alpha monohydrate lactose. The water of
crystallization is tightly bound and shows no chemical activity while bound. Moisture
sorption is extremely low even at high relative humidity. Lactochem is available in
sieved and milled forms of different particle size distributions, ranging from coarse
to very fine material.
Milled Lactochem products are all characterized by small particles and high
specific surface area, resulting in good binding properties. Therefore these products
are especially useful in wet granulation tabletting, pelletization as well as
spheronization.

Grade

Description

Application

Lactochem Powder

Milled Lactose

Widely used as fillers in wet granulation processes.


Also used for capsule filling and in powder mixtures
filled into sachets.

Lactochem Coarse
Powder
Lactochem Regular
Powder
Lactochem Fine
Powder

Lactochem Extra
Fine Powder
Lactochem Super
Fine Powder

Sieved Lactochem products are all characterized by a low Carrs index, implying
good flowability and are therefore ideal for filling of capsules and sachets where
excellent flowability is needed. These products are also successfully applied as
diluents for direct compression. The finer crystal types are suitable for pelletization
as well.

Grade

Description

Application

Lactochem Crystals

Sieved Lactose

Prevents segregation in capsule based formulations


and sachets. Used as filler - binder in directly
compressible formulations.

Lactochem Coarse
Crystals
Lactochem Fine
Crystals
Lactochem Extra
Fine Crystals

LACTOPRESS
Directly Compressible Lactose USP/NF, EP, JP

Lactopress is a white, free flowing directly compressible Lactose powder. It is


available in two forms; spray dried and anhydrous with different particle sizes
distributions. The good flowability of these powders in combination with excellent
compactibility characteristics make them ideal for direct compression tabletting.
These products are also suitable for applications that require only excellent
flowability.
Lactopress Anhydrous is characterized by superior dissolution and excellent

binding properties. It consists mainly of the beta-isomer of lactose, which contains


no water of crystallization and the free moisture content is low. Lactopress
anhydrous does not absorb water even at high relative humidity which makes it the
best choice for use in direct compression of moisture sensitive actives.
Grade

Description

Application

Lactopress Anhydrous Roller dried DC As low moisture DC binder and filler in tablets and
250
Lactose, Coarse capsules. Improves stability of
particle size
moisture sensitive actives as well as their dissolution
due to its high intrinsic solubility.
Lactopress
Anhydrous Fine
Powder

Roller dried
DC Lactose,
Fine particle
size

Lactopress spray-dried is produced by spray-drying a suspension of small


crystals of lactose monohydrate. It consists mainly of spherical particles resulting in
excellent flowability and binding. Lactopress spray-dried contains up to 15%
amorphous lactose, which ensures low friction with the die wall, preventing capping
behavior. It is therefore highly effective in modern, high-speed tabletting machines.

Grade

Description

Application

Lactopress
Spray Dried
250

DC Lactose, Fine
particle size

As binder, fillerbinder, and flow aid in direct


compression due to its excellent flow and high
compressibility. Ensures good content uniformity.

Lactopress
Spray Dried
260

DC Lactose, Coarse
particle size

Lactopress
Spray Dried

DC Lactose, Coarse
particle size

LACTOPRESS GRANULATED
Lactose monohydrate, modified USP/NF, EP, JP

Lactopress granulated is a highly stable excipient having excellent flow, low density,
low hygroscopicity and good compaction properties. It has low lubricant sensitivity
and offers short disintegration time on use in formulations. The short disintegration
time together with the sweet taste, makes it and ideal excipient for use in
orodispersible tablets.
Grade

Description

Lactochem Granulated Granulated


Lactose
monohydrate

Application

Direct compression formulations


Orodispersible tablets
Low dose applications
Capsules and sachets filling

LACTOPRESS
Directly Compressible Lactose USP/NF, EP, JP

Lactopress is a white, free flowing directly compressible Lactose powder. It is


available in two forms; spray dried and anhydrous with different particle sizes
distributions. The good flowability of these powders in combination with excellent
compactibility characteristics make them ideal for direct compression tabletting.
These products are also suitable for applications that require only excellent
flowability.
Lactopress Anhydrous is characterized by superior dissolution and excellent
binding properties. It consists mainly of the beta-isomer of lactose, which contains
no water of crystallization and the free moisture content is low. Lactopress
anhydrous does not absorb water even at high relative humidity which makes it the
best choice for use in direct compression of moisture sensitive actives.
Grade

Description

Application

Lactopress Anhydrous Roller dried DC As low moisture DC binder and filler in tablets and
250
Lactose, Coarse capsules. Improves stability of
particle size
moisture sensitive actives as well as their dissolution
due to its high intrinsic solubility.
Lactopress

Roller dried

Anhydrous Fine
Powder

DC Lactose,
Fine particle
size

Lactopress spray-dried is produced by spray-drying a suspension of small


crystals of lactose monohydrate. It consists mainly of spherical particles resulting in
excellent flowability and binding. Lactopress spray-dried contains up to 15%
amorphous lactose, which ensures low friction with the die wall, preventing capping
behavior. It is therefore highly effective in modern, high-speed tabletting machines.

Grade

Description

Application

Lactopress
Spray Dried
250

DC Lactose, Fine
particle size

As binder, fillerbinder, and flow aid in direct


compression due to its excellent flow and high
compressibility. Ensures good content uniformity.

Lactopress
Spray Dried
260

DC Lactose, Coarse
particle size

Lactopress
Spray Dried

DC Lactose, Coarse
particle size

LACTOPRESS GRANULATED
Lactose monohydrate, modified USP/NF, EP, JP

Lactopress granulated is a highly stable excipient having excellent flow, low density,
low hygroscopicity and good compaction properties. It has low lubricant sensitivity
and offers short disintegration time on use in formulations. The short disintegration
time together with the sweet taste, makes it and ideal excipient for use in
orodispersible tablets.
Grade

Description

Lactochem Granulated Granulated


Lactose

Application

Direct compression formulations


Orodispersible tablets

monohydrate

Low dose applications


Capsules and sachets filling

LACTOPRESS
Directly Compressible Lactose USP/NF, EP, JP

Lactopress is a white, free flowing directly compressible Lactose powder. It is


available in two forms; spray dried and anhydrous with different particle sizes
distributions. The good flowability of these powders in combination with excellent
compactibility characteristics make them ideal for direct compression tabletting.
These products are also suitable for applications that require only excellent
flowability.
Lactopress Anhydrous is characterized by superior dissolution and excellent
binding properties. It consists mainly of the beta-isomer of lactose, which contains
no water of crystallization and the free moisture content is low. Lactopress
anhydrous does not absorb water even at high relative humidity which makes it the
best choice for use in direct compression of moisture sensitive actives.
Grade

Description

Application

Lactopress Anhydrous Roller dried DC As low moisture DC binder and filler in tablets and
250
Lactose, Coarse capsules. Improves stability of
particle size
moisture sensitive actives as well as their
dissolution due to its high intrinsic solubility.
Lactopress
Anhydrous Fine
Powder

Roller dried
DC Lactose,
Fine particle
size

Lactopress spray-dried is produced by spray-drying a suspension of small


crystals of lactose monohydrate. It consists mainly of spherical particles resulting in
excellent flowability and binding. Lactopress spray-dried contains up to 15%
amorphous lactose, which ensures low friction with the die wall, preventing capping
behavior. It is therefore highly effective in modern, high-speed tabletting machines.

Grade

Description

Application

Lactopress
Spray Dried
250

DC Lactose, Fine
particle size

As binder, fillerbinder, and flow aid in direct


compression due to its excellent flow and high
compressibility. Ensures good content uniformity.

Lactopress
Spray Dried
260

DC Lactose, Coarse
particle size

Lactopress
Spray Dried

DC Lactose, Coarse
particle size

L-HPC
Low substituted Hydroxypropyl Cellulose USP/NF, JP

L-HPC is a low-substituted hydroxypropyl ether of cellulose. It is non-ionic and less


reactive to active ingredients. It is insoluble in water and alcohols but swells in
water. It causes changes in the binding and disintegrating characteristics as a result
of subtle changes in its physical properties like particle size and substituent content.
Hence, it is widely used as a dual-functional excipient (disintegrant / binder) for
tablets, granules or other pharmaceutical solid dosage forms.

Description
Grade

Mean particle
size (m)

Particle type

Application

LHPC LH11

50

Highly fibrous

Direct Compression
(anticapping).

LHPC LH-21

40

Moderately fibrous

Regular grade (dry mixing,


wet granulation).

LHPC LH-22

40

Moderately fibrous

Lower hydroxypropoxy
content (sometimes better

disintegration).
LHPC LH-31

20

LHPC LH-32

20

LHPC LH-B1

50

Micronized

Micronized grade (Pellet


extrusion, layering).
Micronized grade with lower
hydroxypropoxy content
(Pellet extrusion, layering).

Non fibrous

High density grade suitable


for direct compression with
good flowability and high
loading capability.

* Laser diffraction method

LUDIFLASH
Compound of Mannitol, Crospovidone and Polyvinyl Acetate

Ludiflash is an innovative, unique co-processed blend of mannitol (95%),


crospovidone (5%) and polyvinyl acetate (5%) manufactured in a validated patented
process. Ludiflash is practically in a league of its own when it comes to excipients
for direct compression tablets that rapidly disintegrate in the mouth to form a
smooth and creamy texture.
Thanks to its unique composition, Ludiflash produces tablets with an excellent
compression / hardness curve, very low friability and very high content uniformity
even at high tabletting speed. The oro-dispersible tablets made with Ludiflash can
be taken without water, anytime, anywhere and have extremely rapid disintegration
(within seconds) and fast release rates.

Grade

Description

Application

Ludiflash

All-in-one system with Excellent excipient for direct compression of fasta mild sweet taste and disintegrating solid oral dosage forms (mouth-melts)
cooling effect in the
for rapid release.
mouth. White to offwhite powder with
superior flowability

and low
hygroscopicity. Does
not dissolve completely
in water or organic
solvents

LUDIPRESS
Compoud of Lactose Monohydrate and Povidone

Ludipress is the result of an intensive research and development effort by BASF to


produce an advanced excipient for the manufacture of tablets by the direct
compression process. Ludipress is white, free-flowing, tasteless and odourless
granules of lactose monohydrate (93%), povidone (3.5%) and crospovidone (3.5%)
and combines the three functionalities of a filler, binder and disintegrant into a
single, ready-to-use excipient for direct compression. The versatility of Ludipress
allows very simple formulations resulting in rapidly disintegrating tablets of
excellent hardness and low friability
Ludipress LCE, on the other hand, is a directly compressible compound of lactose
monohydrate (96.5%) and povidone (3.5%). Due to the absence of a disintegrant,
Ludipress LCE is completely soluble in water and particularly suitable for cost
saving production of lozenges, chewables, effervescent tablets etc.

Grade

Description

Ludipress

Granules of lactose
Direct compression tabletting (disintegrating tablets)
monohydrate, povidone and as a filler in hard gelatin capsules.
and crospovidone

Ludipress LCE Granular compound


of lactose
monohydrate and
povidone

LUSTRECLEAR LC - 103

Application

Directly compressible production of lozenges,


sublingual, chewable tablets particularly, in
effervescent tablets. Also used as a bulking
agent for modified release formulations.

Microcrystalline Cellulose and Carrageenan based film coating system

LustreClear LC-103 is a highly effective, proprietary all-in-one aqueous film coating


system. This unique film coating technology combines microcrystalline cellulose
(MCC) and carrageenan to provide a distinctive, smooth, satin finish on solid dosage
forms. It is clearly an innovative, cost-effective, aesthetic coating system opening
new possibilities in aqueous film coating for a wide variety of tablets and other solid
dosage forms. This advanced technology platform, makes processing easier and
offers distinctive sensory attributes. Its added advantages of taste masking and
ease of swallowing of the coated dosage forms add to the patients appeal and
compliance.

Grade

Description

Application

LustreClear
LC-103

All-in-one, aqueous,
Used for film coating of tablets and other solid
clear, conventional
dosage forms into elegant, easy to swallow and taste
film coating system
masked products.
comprising of
microcrystalline
cellulose, carrageenan
and polyethylene glycol

LUTROL E
Polyethylene Glycol (Macrogol) USP/NF, EP

Lutrol E types are liquid polyethylene glycols manufactured by alkali-catalysed


polymerisation of ethylene oxide with subsequent neutralisation of the catalyst.
Lutrol E grades are readily soluble in water, ethanol, acetone, glycols and
chloroform. The number in the name of the product is indicative of the average
molecular weight. The higher the molecular weight of the product; the less
hygroscopic it is and lower its solubility in water.
Lutrol E 300 and Lutrol E 400 are colourless, almost odourless and tasteless liquids
at room temperature; while Lutrol E 600 can be either liquid or pasty at room
temperature.

Grade

Description

Application

Lutrol E 300

Molecular weight : 285 - 315


Viscosity : 5.4 - 6.4 mPa.s

Lutrol E 400

Molecular weight : 380 - 420


Viscosity : 6.8 - 8.0 mPa.s

Lutrol E 600

Molecular weight : 570 - 630


Viscosity : 9.9 11.3 mPa.s

Used as solvents and


solubilizing agents for oral,
parenteral, topical, ophthalmic
and rectal preparations.
Carriers for dissolved or
suspended drug in soft gelatin
capsules. Widely used as an
ointment base.

LUTROL F
Poloxamer USP/NF, EP, JPE

The Lutrol F grades or Poloxamers are block copolymer of polyoxyethylene


polyoxypropylene (Pluronics). While Lutrol F 68 (Poloxamer 188) is a white to
slightly yellowish, waxy substance in the form of microbeads with a faint odour,
Lutrol F 127 (Poloxamer 407) is a white, coarse-grained powder with a waxy
consistency. Both grades are soluble in ethanol and water.
The Ltrol micro grades - Ltrol F micro 68 and Ltrol F micro 127 are white,
micronized Poloxamer powders of average particle size of ~50 m. with a weak
odour.

Grade

Description

Application

Lutrol F 68

Poloxamer 188 (Block


polymer of 81%
polyethylene glycol
and 19%
polypropylene glycol)
with an average
molecular weight of
8600

Emulsifier, solubilizer and suspension stabilizer in


liquid, oral, topical and parenteral dosage forms, as
a plasticizer and bioavailability enhancer in solid
preparations. Also as coemulsifier in creams and
emulsions and as a tablet lubricant.

Ltrol Micro

Micronized

Dissolution enhancer for actives in solid oral

68

Poloxamer 188 with dosage forms; water soluble lubricant for


a mean particle size effervescent tablets and for actives
of 50 m for
incompatible with stearates.
homogenous mixing

Lutrol F 127

Poloxamer 407
(Block polymer of
73% polyethylene
glycol and 27%
polypropylene
glycol with an
average molecular
weight of 12,000

Gel former, thickening agent and solubilizer


in oral and topical solutions and as a
stabilizer in topical suspensions.

Ltrol Micro
127

Micronized
Poloxamer 407 with
a mean particle size
of 50 m for
homogenous mixing

Dissolution enhancer for actives in solid oral


dosage forms; water soluble lubricant for
effervescent tablets and for actives
incompatible with stearates.

MAGNABRITE

Magnesium Aluminum Silicate USP/NF, BP


Magnabrite product range are highly refined, naturally occurring, complex colloidal white
smectite clays i.e. Magnesium Aluminum Silicates manufactured to meet the specifications of the
USP/NF and BP. Chemically Magnesium Aluminum Silicate is a blend of colloidal
montmorillonite and saponite that has been processed to remove grit and non- swellable ore

components. The plate-like structure and colloidal nature of Magnabrite contributes to a wide
range of applications for stabilization of emulsions, as a suspending agent, thickener, rheology
modifier, binder, and as a tablet disintegrant. Magnabrite is available in different particle sizes
and varying viscosity to suit the end-user.

Grade

Description
Type

Application

Viscosity at 5%
solids (cPs)
800 - 2200

Magnabrite HV High viscosity


grade, Small
flakes,

Excellent suspension and emulsification


properties, delivers high viscosity with
excellent rheology in low solid
formulations.

Magnabrite K

Acid stable
grade, Small
flakes,

100 - 300

Low acid demand and high acid


compatibility, used to reduce thickening
and flocculation in acidic preparations /
suspensions.

Magnabrite S

Standard
grade, Small
flakes,

225 - 600

Excellent emulsification and thickening


abilities, used in formulations requiring
medium viscosity, high brightness and
ease of dispersion.

Magnabrite F

Micro fine
150 - 450
powder grade,
Free flowing

Used as an inert low-bulk disintegrant in


large tablets. Also used as a suspending
agent.

MAGNABRITE HS

Purified Bentonite USP/NF, BP

Magnabrite HS is an absorbent aluminium phyllosilicate, highly refined, naturally occurring


complex colloidal white smectite clay. Chemically it is colloidal montmorillonite which has been
processed to remove grit and non-swellable ores. The properties of Magnabrite HS are similar to
that of the other Magnabrite grades.
Grade

Description
Type

Viscosity at 5%

Application

solids (cPs)
40 - 200
Magnabrite HS High
electrolyte
stability grade,
Small flakes

Easily hydrates in hot or cold water, used


as suspending, thickening agent and
binder.

MAGNESIUM CARBONATE USP/NF, EP, BP

Magnesium carbonate is a basic hydrated magnesium carbonate or a normal hydrated magnesium


carbonate. DSPs magnesium carbonates are manufactured by an unique process which ensures
freedom from the impurities generated by the commonly used precipitation processes grades.
Their product is thus of exceptionally high purity and characterized by particularly low levels of
impurities such as lead and other minerals.
They are offered in two grades Basic and Heavy.
Grade

Description

Application

Basic
Magnesium
Carbonate

Light grade
For use in the manufacture of antacid preparations
(Tapped BD: 0.35-0.55 and mineral supplements, Also used in microsphere
g/cc)
formulations for the purpose of stabilizing
encapsulated proteins or to absorb flavors, in
tableting processes.

Heavy
Magnesium
Carbonate

Heavy grade
(Tapped BD : NLT
0.50 g/cc)

To produce tablets with high crushing strength, low


friability, and good disintegration properties.

MAGNESIUM CARBONATE LIGHT USP/NF, EP, BP

Magnesium carbonate is a basic hydrated magnesium carbonate or a normal hydrated magnesium


carbonate. Scoras magnesium carbonate is manufactured by the Pattinson process which
ensures freedom from the impurities generated by the commonly used precipitation processes
grades. The product is thus of high purity and exceptional quality.
Grade

Description

Application

Basic
Magnesium
Carbonate

Heavy grade, free


flowing

Viscosity regulator, anti-caking and free flow aid.


Used in antacid preparations / tablets, laxatives and
in production of pharmaceutical magnesium
derivatives. Also used in mineral supplements &
food additives.

MAGNESIUM HYDROXIDE USP/NF, EP, BP

Magnesium hydroxide is an inorganic compound, not very soluble in water. While the solubility
of magnesium hydroxide is low, all of the magnesium hydroxide that does dissolve in the water
does dissociate. DSPs magnesium hydroxides are manufactured by an unique process which
ensures freedom from the impurities generated by the commonly used precipitation processes
grades. Their product is thus of exceptionally high purity and characterized by particularly low
levels of impurities such as lead and other minerals. They are available as spray dried powders
with different bulk densities thus offering a wide choice of compounding possibilities for tablet
and powder dosage systems.
Grade

Description

Application

Magnesium
Hydroxide
HD5

Lowest bulk density


grade

Spray dried, directly compressible powders for use


in the manufacture of antacid preparations and
mineral supplements.

Magnesium
Hydroxide
HD7

Low bulk density grade

Magnesium
Hydroxide
HD9

Medium bulk density


grade

Magnesium
Hydroxide
HD12

High bulk density


grade

MAGNESIUM OXIDE USP/NF, EP, BP

Magnesium oxide is a free flowing white powder, insoluble in alcohol and almost insoluble in
water. It is a source of magnesium and formed by an ionic bond between one magnesium and one
oxygen atom. DSPs magnesium oxides are manufactured by an unique process which ensures
freedom from the impurities generated by the commonly used precipitation processes grades.
Their product is thus of exceptionally high purity and characterized by particularly low levels of
impurities such as lead and other minerals. They are available in a variety of grades to meet the
requirements of the formulator.
Grade

Description

Magnesium
Oxide Light

Low bulk density grade For use in the manufacture of tablet-form antacid
preparations, pH modifier, mineral supplements and
in the production of pharmaceutical grade
magnesium derivatives.
Heavy grade

Magnesium
Oxide PHRA
50
Magnesium
Oxide DC

Application

Directly compressible
grade, Granular

MAGNESIUM OXIDE LIGHT USP/NF, EP, BP

Magnesium oxide is a free flowing white powder, insoluble in alcohol and almost insoluble in
water. It is a source of magnesium and formed by an ionic bond between one magnesium and
one oxygen atom. Scoras magnesium oxides are manufactured by the Pattinson process which
ensures freedom from the impurities generated by the commonly used precipitation processes
grades. The product is thus of high purity and exceptional quality.
Grade

Description

Magnesium
Oxide Light

Low bulk density grade Used as precursor of magnesium hydroxide, pH


modifier and viscosity regulator in antacid
preparations. Also used in mineral supplements,
food additives and in production of pharmaceutical
grade magnesium stearates.

MALIC ACID

Application

D, L Malic Acid USP/NF, EP

Malic Acid is widely found in nature and is the predominant organic acid in many fruits and
berries. Commercially, Malic Acid is manufactured by hydration of Maleic Anhydride, at high
temperature and pressure. The Malic Acid crystallizes out from aqueous solutions as white,
translucent, anhydrous, non-hygroscopic and non-volatile crystals. It's properties allow it to be
stored under normal conditions for a very long time without any caking & contribute to its long
shelf life.
Malic Acid works by blending with flavours and essences. Its acid taste building up slowly at
the beginning, but persists for a long period. The final effect gives a stronger taste and a
pronounced flavor note. It works synergistically with most sweetners and has the ability to
enhance the effect of the aromas used to mask the undesirable tastes and smell of medicinals.
Polynt offers malic acid in both powder & granule forms.
Grade

Description

Malic acid
granular

White crystalline
powder or granules
with a distinct acidic
taste. Extremely
Malic acid fine
soluble in water
granular

Application
Used in throat lozenges, cough syrups, effervescent
powders and tablets. Masks undesired taste and
odour of medicinals. Also used in health / sports
drinks and anti-wrinkle creams.

Malic acid
special fine
granular
Malic acid
powder

MALTISORB & LYCASIN

Maltitol USP/NF, EP

Maltitol is a white crystalline powder of high purity obtained by the catalytical hydrogenation of
D-maltose using a process patented by Roquette. It is a dimeric polyol with a cool mouthfeel and
sweetness close to that of Sucrose. Maltitol is a stable polyhydric non-cariogenic sugar alcohol
with low glycemic index and low calorific value.
Maltilol solution is obtained by the hydrogenation of maltose syrup and is constituted by D-

sorbitol, hydrogenated disaccharides and polysaccharides. It is supplied as a pure, odourless


liquid with a pleasant sweet taste. Roquette offers Maltitol solution in different compositions to
generate very little acid production when in contact with the plague bacteria; which means they
are guaranteed not to induce caries. It has high sweetening power with good solubility and is
used to totally replace sugar in syrups, lozenges and jellies for specific patient groups.
Grade
Maltisorb P 90

Description
Fine particle size

Maltisorb P 200 Coarse particle size

Application
Diluent for tablets and sachets, excipient for coating
as well as for candying of lozenges, sweetener for
pharmaceutical chewing gums. Used for chewable,
suckable and effervescent tablets.

Maltisorb 75/75 Dry maltitol syrup


(72% - 76%)

Bulk sweetener for pastilles and lozenges.

Lycasin 80/55

Dry maltitol syrup


(50% - 55%)

Liquid sweetener for sugarless syrups, suspensions,


lozenges, oral ampoules, and pharmaceutical
chewing gums.

Lycasin HBC

Dry maltitol syrup


Sweetener for hard boiled candies, pastilles and
(50% - 55%) with high lozenges.
viscosity

GUM BASE

Non-nutritive masticatory substance

Gum base, especially the medicated chewing gum represents the novel and alternative drug
delivery system. It is an inert, insoluble, non-nutritive product designed to deliver flavours,
minerals, vitamins, sweetners and active pharmaceutical ingredients. Once formulated, it is
designed to release the active on chewing without having to swallow or consume the base. The
product can be administered anywhere, anytime and does not require a liquid medium to
swallow or consume the base.
Unique formulations have been designed with gum base for smoking reduction, weight
management, heartburn relief, dry mouth relief, stress reduction, memory and concentration
improvement etc. Various formulations for nicotine delivery, motion sickness and pain relief are
already commercialized. While MedGumBase is ideal for formulating medicated chewing
gums, the Compressed Powder Gum (CPG) forms the basis for a new delivery vehicle for
functional products, with an exceptional chew. CPG, made by a unique process, can be
compressed using cold and dry processes on tablet presses and is ideal for sensitive actives.
CPG offers greater flexibility over conventional chewing gum technology in terms of shape, size
and flavours.

Grade

Description

Application

MedGumBase Specific gum base


developed for
medicated chewing
gums
CPG
(Compressed
Powder Gum)

Absorption through oral mucosa, Good distribution


of active principles, Bypasses hepatic first pass, No
degradation of actives, Easy and pleasant
administration for better patient compliance and
emergency dosage, Efficient delivery of large doses.

Directly compressible
chewing gum base
powder for sensitive
actives

* Available with & without flavours. Conventional chewing gum base and Bubble gum base can also be provided on demand

METOLOSE

Hypromellose (HPMC) USP/NF, EP, JP


Methylcellulose (MC) USP/NF, EP, JP

Metolose is a non-ionic water-soluble cellulose ether derived from highly purified natural pulp
by an initial treatment with caustic soda to obtain alkali-cellulose, followed by etherification
with methyl chloride or with the combination of methyl chloride and propylene oxide. Metolose
consists of Methylcellulose and three substitution types of Hypromellose (Hydroxypropyl
methylcellulose) each available in several grades differing in viscosity.
Metolose can be used as a binder for solid dosage forms such as tablets and granules. It also
provides a variety of functions such as water retention, thickening, protective colloid, surface
activity, sustained release, film formation etc. Shin-Etsu also manufactures specific Metolose SR
grades for use in hydrophilic sustained release matrix systems.
Description
Grade

Viscosity (cPs)

USP Substitution
Type

Application

2910
Metolose 60SH-50

50

Metolose 60SH-4000

4000

2910

Metolose 60SH-10000

10000

2910

As sustained release agent,


thickener, suspending agent
and binder for tablets and
granules. Also used for

Metolose 65SH-50

50

2906

Metolose 65SH-4000

4000

2906

Metolose 90SH-4000

4000

2208

Metolose 90SH-15000

15000

2208

Metolose 90SH100000

100000

2208

Metolose 90SH100SR

100

2208

Metolose 90SH4000SR

4000

2208

Metolose 90SH15000SR

15000

2208

Metolose 90SH100000SR

100000

2208

Metolose SM-4

Low viscosity
Methylcellulose for granule
coating.

Metolose SM-15

15

Metolose SM-400

400

Metolose SM-4000

4000

Methylcellulose for use as


granulating agent,
emulsifying agent, thickener
and bulk laxative.

ophthalmic formulations.

In hydrophilic sustained
release matrix systems and
direct compression
applications. Gives more
controllable and reproducible
drug release alongwith good
product consistency.

METOLOSE

Hypromellose (HPMC) USP/NF, EP, JP


Methylcellulose (MC) USP/NF, EP, JP

Metolose is a non-ionic water-soluble cellulose ether derived from highly purified natural pulp
by an initial treatment with caustic soda to obtain alkali-cellulose, followed by etherification with
methyl chloride or with the combination of methyl chloride and propylene oxide. Metolose
consists of Methylcellulose and three substitution types of Hypromellose (Hydroxypropyl
methylcellulose) each available in several grades differing in viscosity.
Metolose can be used as a binder for solid dosage forms such as tablets and granules. It also
provides a variety of functions such as water retention, thickening, protective colloid, surface
activity, sustained release, film formation etc. Shin-Etsu also manufactures specific Metolose SR
grades for use in hydrophilic sustained release matrix systems.

Description
Grade

Viscosity (cPs)

USP Substitution
Type

Application

2910
Metolose 60SH-50

50

As sustained release agent,


thickener, suspending agent
and binder for tablets and
granules. Also used for
ophthalmic formulations.

Metolose 60SH-4000

4000

2910

Metolose 60SH-10000

10000

2910

50

2906

Metolose 65SH-4000

4000

2906

Metolose 90SH-4000

4000

2208

Metolose 90SH-15000

15000

2208

Metolose 90SH100000

100000

2208

Metolose 90SH100SR

100

2208

Metolose 90SH4000SR

4000

2208

Metolose 90SH15000SR

15000

2208

Metolose 90SH100000SR

100000

2208

Metolose SM-4

Low viscosity
Methylcellulose for granule
coating.

Metolose SM-15

15

Metolose SM-400

400

Metolose SM-4000

4000

Methylcellulose for use as


granulating agent,
emulsifying agent, thickener
and bulk laxative.

Metolose 65SH-50

\
NATROSOL

Hydroxyethyl Cellulose USP/NF, EP

In hydrophilic sustained
release matrix systems and
direct compression
applications. Gives more
controllable and reproducible
drug release alongwith good
product consistency.

NATROSOL HEC is a non-ionic water-soluble cellulose ether, formed by reaction of cellulose


with ethylene oxide. It is used as a modified release tablet matrix, film former and thickener,
stabilizer and suspending agent for oral and topical applications when a non-ionic material is
desired. NATROSOL is easily dispersed in cold or hot water to give solutions of varying
viscosities and desired properties, yet it is insoluble in organic solvents.
Grade

Viscosity in mPas (%
w/w)*

Application

Natrosol HHX
Pharm

3500 - 5500 (1%)

Modified release - Provides effective diffusion


limiting matrix systems; most suited for actives with
low water solubility.

Natrosol HX
Pharm

1500 - 2500 (1%)

Natrosol M
Pharm

4500 - 6500 (2%)

Natrosol G
Pharm

250 - 400 (2%)

Natrosol L
Pharm

75 - 150 (5%)

Tablet coating - Imparts flexibility to films while


providing a good barrier to water and oxygen
transmission.
Solutions, gels & emulsions - Controls rheology,
provides thickening and pseudoplasticity, and
stabilizes emulsions with high salt tolerance and
surfactant compatibility.

NUTRIOSE

Soluble Fibre

Nutriose are specialty dextrins developed as innovative soluble dietary fibres with valuable
technological advantages. They are made by dextrinification of wheat or corn starch followed by
refining, purification and drying. The result is an agglomerated water soluble dextrin with high
dietary fibre and very low sugar content. These free flowing micro-granulated powders have
high digestive tolerance and exhibit good stability to both pH and heat.
Nutriose offers other unique benefits like low glycaemic and insulinaemic response, quick
dissolution, high stability, quick dispersion, low osmolality, non-cariogenic, low caloric value,
neutral taste etc. These properties alongwith the simplicity of use makes Nutriose the fibre of
choice for clinical nutrition and for all nutraceutical forms.
Grade

Description

Application

Nutriose FB

Nutriose FM

Speciality dextrin from Fibres for gut regulation, moderation of glucidic and
wheat
lipid metabolism, obesity prevention etc. Also used
for low calorie formulations, direct compression /
granulated formulations and enteral nutrition.
Speciality dextrin from
maize

PC-10

Pregelatinized Starch USP/NF, EP, JPE

PC-10 is a partially pregelatinized starch grade manufactured by controlled thermal gelation of


raw corn starch. It is inert without any starch odour, high in water-absorbing and has pHindependent disintegrating properties. With a far lower soluble content; its particles swell in
contact with water rather than dissolve thereby serving as an excellent disintegrant to effect
active-ingredient release. This mechanism makes possible higher performance levels and new
application parameters for solid dosage formulations.
As compared to conventional pregelatinized starch; PC-10 has higher whiteness, better texture
and superior flow properties. With these and few of its other unique properties it is considered as
an ideal excipient for many unstable actives (API).
Grade

Particle size (m)

Application

PC-10

70

Disintegrant, granulation aid and dissolution


enhancer. Also a stabilizer for moisture-sensitive
actives and carrier for hygroscopic substances like
herbal extracts.

PEARLITOL

Mannitol USP/NF, EP, JP

Mannitol is a polyol manufactured by catalytic hydrogenation of starch, a natural raw material of


vegetable origin. It occurs as a slightly sweet, white crystalline powder that gives a cooling
sensation on dissolution in the mouth. It has excellent stability, low hygroscopicity and good
solubility in different solvents. It forms an ideal excipient for dry formulations (granules, pellets,
tablets) and as a cryoprotective agent in freeze drying applications. It is low-calorie, non-

cariogenic and ideal for sugar-free formulations. These exceptional properties and the excellent
chemical stability make Pearlitol the best choice in excipients for stable formulations.
Crystalline Mannitol

Grade

Description

Application

Pearlitol PF
Pyrogen free grade
(Mannitol PFG)

Diureticosmotic for injectable solutions.

Pearlitol 25 C
(Mannitol 25)

Extra fine particle size

Pearlitol 50 C
(Mannitol 35)

Medium particle size

Diluent for unstable or moisture sensitive actives


and flash release, as freeze drying carrier and
sweetener with cooling effect for ODTs and
pharmaceutical chewing gums.

Pearlitol 160 C
(Mannitol 60)

Coarse particle size

Granular Mannitol

Grade

Description

Pearlitol 100
SD

Spray dried, fine


particle size

Pearlitol 200
SD

Spray dried, medium


particle size

Pearlitol 300
DC

Granulated, fine
particle size

Pearlitol 400
DC

Granulated, medium
particle size

Pearlitol 500
DC

Granulated, coarse
particle size

Application
Excellent fillerbinder for direct compression of
chewable, effervescent and fast dissolving tablets.
Ideal for formulation of unstable or moisture
sensitive actives, sugar free diluent for capsules and
sachets. Also used as neutral carrier base for loading
of actives.

PEARLITOL FLASH

Compound of Mannitol and Maize starch

Pearlitol Flash is a compound produced by granulation of 80% mannitol and 20% extra white
maize starch. The intrinsic composition of Pearlitol flash enables successful formulation of ODTs
even at low lubricant levels. The mannitol imparts the sweet and pleasant taste while the starch
aids in instant disintegration.
ODTs formulated with Pearlitol Flash melt in the mouth with a creamy, smooth texture and a
uniquely pleasing taste. Pearlitol Flash helps in the formulating robust tablets of good hardness
capable of disintegrating within stipulated time.

Grade

Description

Application

Pearlitol Flash

Coarse particle size


(200 m)

Direct compression of orodispersible tablets.

PHARMACOAT

Hypromellose USP/NF, EP, JP

Pharmacoat is low viscosity Hypromellose (Hydroxypropyl Methylcellulose) based film coating


polymer. It is easy to use, versatile and gives an excellent finish to the tablet. It is also effective
as a binder since it does not interact with drugs, has superior stability and is non-ionic in
character. It is available in various viscosity grades to suit the end user.
Description
Grade

Viscosity (cPs)

USP Substitution
Type

Application
Binder in wet granulation.

Pharmacoat
603

2910

Pharmacoat
645

4.5

2910

Pharmacoat
606

2910

Pharmacoat
615

15

2910

Film coating, greater film


strength.

Pharmacoat
904

2208

Binder for sugar coating.

Regular film coating.

PHARM-A-SPHERESTM

Sugar Spheres (Non-Pareil seeds) USP/NF, EP

Pharm-a-spheres (Sugar Spheres) are inert, neutral pellets of nearly spherical form, usually of
diameter below one millimeter. They have a slight sweet taste and are composed of sucrose and
corn starch. Sugar Spheres are modern day excipients used in capsule and tablet formulations
particularly in multiparticulate formulations. They are the core upon which a drug is coated by a
classic coating pan process or a fluidised bed coating process; usually for controlled or sustained
release applications.
Werners Pharm-a-spheres are of superior quality in terms of its greater mechanical strength,
low friability and high sphericity which allows precise calculation of drug quantity to be loaded.
Its narrow particle size distribution coupled with its superior flow characteristics and total
regulatory support makes it today the brand of choice for a majority of the pharmaceutical
formulators. Werners Pharm-a-spheres are available in a variety of particle diameters ranging
from 100 m to 2000 m.
Particle size
range
(Mesh ASTM)

Particle size range


(m)

120 140

106 125

100 120

125 150

80 100

150 180

70 80

180 212

60 70

212 250

50 60

250 300

45 50

300 355

45 60

250 355

40 60

250 425

40 50

300 425

40 45

355 425

35 55

355 500

Application

Used as drugfree cores for controlled or sustained


release systems.

35 50

300 500

35 45

400 450

35 40

425 500

30 35

500 600

25 30

600 710

20 25

710 850

18 20

850 1000

16 20

850 1180

16 18

1000 1180

14 16

1180 1400

12 16

1400 1700

12 14

1400 1700

10 12

1700 2000

* Special sizes and mixtures are also possible.

POLYSORB

Anhydrized Liquid Sorbitol USP/NF, EP

Polysorb 85/70/00 is a partially dehydrated liquid sorbitol presented as a clear, colorless, syrupy
liquid, partially miscible with water but practically insoluble in oil.
It was developed as an additive for manufacture of soft gels. Its remarkable plasticizer
properties helps to form soft gelatin capsules without surface crystallization or graining and
prevents leaching into the filler media within the soft gel. Its high dry solid content of almost
83% makes it the most efficient soft gel plasticizer.

Grade

Description

Application

Polysorb
85/70/00

Aqueous solution of
D-Sorbitol and
Sorbitans

Optimal plasticizer for gelatin shell of soft gel


capsules. Enables good stability with the filler soft
gels.

PRONOVA UP

Ultra Pure Sodium Alginates USP / NF, EP

Pronova UP sodium alginates are a family of highly purified and well-characterized alginates
with ultra low levels of endotoxins and proteins developed for use in biomedical and
pharmaceutical applications. They are available in different viscosities and C-5 epimer a-Lguluronate (G) content. These products are manufactured in a specially designed production
facility in compliance with cGMP (21 CFR 210, 211), ISO 9001:2000 and ISO 13485 standards.
The safety and toxicology profile of ultrapure PRONOVA sodium alginate are covered in a Drug
Master File on file at the US FDA.
Alginates are linear copolymers with homopolymeric blocks of (14)-linked b-D-mannuronate
(M) and its C-5 epimer a-L-guluronate (G) residues, respectively, covalently linked together in
different sequences or blocks. Alternating M and G blocks form the most flexible chains which
exhibit excellent solubility at lower pH. In contrast to most other polysaccharide gels, alginate
gels can develop and set at constant temperature lending them useful in pharma applications
involving temperature sensitive molecules.

Grade

Viscosity (mPas)

Mannuronic / Guluronic acid content

Pronova UP
VLVG

< 20

GA content > 60%

Pronova UP
LVG

20 -200

GA content > 60%

Pronova UP
MVG

> 200

GA content > 60%

Pronova UP
VLVM

< 20

MA content > 50%

Pronova UP
LVM

20 -200

MA content > 50%

Pronova UP
MVM

> 200

MA content > 50%

Pronova UP (Sodium Alginate ) Test Kit containing approx. 2 gm of Pronova UP LVM, MVM, LVG and MVG grades available

PROTASAN UP

Ultra pure Chitosan salts

PROTASAN UP chitosans are ultra-purified and well-characterized water-soluble chitosan


chloride and glutamate salts and chitosan bases, for use in biomedical and pharmaceutical
applications such as wound healing, tissue engineering / repair, local delivery of cells, drugs,
proteins, genes, nasal drug delivery and non-viral gene delivery systems. PROTASAN UP
chitosans are manufactured in compliance with cGMP guidelines, ISO 9001:2000 and ISO
13485:2003 standards. Drug Master Files covering the chitosan salts and bases have also been
submitted to the US FDA.
Chitosan is a linear polysaccharide composed of randomly distributed b-(1,4)-linked Dglucosamine and N-acetyl-D-glucosamine It is produced commercially by deacetylation of
chitin, the structural element in the exoskeleton of crustaceans, with its viscosity primarily
dependent on the average molecular weight. Chitosan is positively charged, soluble in acidic to
neutral solutions, bioadhesive, biocompatible and biodegradable. It readily binds to negatively
charged surfaces such as mucosal membranes and enhances the transport of polar drugs across
epithelial surfaces.
Grade

Description

Viscosity (mPas)

Protasan UP B
80 20

Chitosan Base

20 - 199

Protasan UP B
80 200

Chitosan Base

200 - 499

Protasan UP B
80 500

Chitosan Base

500 - 999

Protasan UP B
90 20

Chitosan Base

20 - 199

Protasan UP B
90 500

Chitosan Base

500 - 999

Protasan UP B
90 1000

Chitosan Base

1000 - 2000

Protasan UP
CL 113

Chitosan Chloride EP

< 20

Protasan UP
CL 213

Chitosan Chloride EP

20 - 200

Protasan UP
CL 214

Chitosan Chloride EP

20 - 200

Protasan UP G

Chitosan Glutamate

< 20

113
Protasan UP G
213

Chitosan Glutamate

20 - 200

Protasan UP G
214

Chitosan Glutamate

20 - 200

Protasan UP Chitosan Test Kit Contains approx 2 gm of Protasan UP CL 113, CL 213, G 113 & G 213 grades also available

PVP-Iodine

Povidone - Iodine USP/NF, EP, JP

Iodine has been used for a long time in the form of tincture of iodine or Lugols solution for the
topical antiseptic treatment of minor wounds. Despite its high efficiency, limits were imposed on
a wider application, because these two formulations initiated a number of side-effects, i.e. gastric
irritation, allergy, etc.
In 1950s, Povidone-Iodine, a complex of Iodine with Povidone was first reported in literature &
forms the basis for the PVP Iodine range of topical antiseptics offered by BASF. PVP-Iodine
30/06 is the standard grade, preferred for preparations for application to the intact skin. PVPIodine 30/06 M 10 is a micronized grade, intended for use in suppositories and powder sprays.

Grade

Description

PVP-Iodine
30/06

Brown, pourable
powder soluble in
water, ethanol and
propanol.

PVP-Iodine
30/06 M10

Pale brown-orange,
micronized powder
soluble in water,
ethanol and propanol.

LYCOAT

Aqueous Film Coating System

Application
Used as a disinfectant in topical formulations such
as ointments, solutions, creams, suppositories,
sprays, etc. Also find use in gargles, mouth washes,,
surgical scrubs and soaps.

LYCOAT is a major breakthrough in aqueous film coating for immediate release, solid oral
dosage forms. It is modified peas starch presented as a stable, patent protected powder, instantly
dispersible in cold water at room temperature using traditional mixing equipment with no foam /
lump formation. LYCOAT suspensions are absolutely neutral and its coating does not impair
either the flavor or colour of the tablets. Coating time with LYCOAT is dramatically faster with
no production stops fro gun cleaning and even at high solids content, spraying is uniform. Tablets
coated with LYCOAT has a very attractive, glossy finish, smooth surface and uniform colour
tone. LYCOAT is available in two viscosities as well as in different colours to suit customer
needs.
Another interesting application where LYCOAT is used, is for the production of oro-dispersible
films.

Grade

Description

Application

Lycoat RS 780

Low viscosity grade

For immediate release, aqueous film coating of


tablets.

Lycoat RS 720

High viscosity grade

ReadiLYCOAT Ready-to-use film


coating system based
on LYCOAT

Used for aesthetic and functional benefits in tablets


with improved organoleptic properties, ease of
solubilization and process efficiency.

Lycoat NG 73

Used in the manufacture of orally disintegrating


films or mouth wafers.

Modified peas starch


film former

`GLUCOSE

Dextrose USP/NF, EP, JP

Glucose or Dextrose is the monomer of natural starch polymer. It is white, odourless, sweet, in
crystalline or granular powder form and freely soluble in water. This monomer is also the natural
physiological sugar in the human body. In its crystalline form this doubly natural sugar has long
been used both as a filler for oral dosage forms and as a sweetener. It also helps in improving the
stability of API sensitive to oxidation due to its slight reducing properties. Therapeutically it is
used as a preferred source of carbohydrate in parenteral nutrition.
Roquette has a range of dextrose products wide enough to meet any of manufacturers different
requirements.
Grade

Description

Application

Lycadex PF

Pyrogen free dextrose


monohydrate

Dextrose
Anhydrous PF

Pyrogen free dextrose


anhydrous

Dextrose GC

Agglomerated dextrose Direct compression diluent with excellent


monohydrate
compressibility and flowability for use in tablets,
sachets and capsule formulations.

Roferose

Dextrose Monohydrate Diluent for tablets, capsules and sachets.

Dextrose
Anhydrous C

Crystalline dextrose
anhydrous

Roclys

Dextrose syrup without For inhibiting sucrose crystallization as texturizer


extensive hydrolysis
and bulk sweetener in syrups, lozenges, pastilles and
pharmaceutical chewing gums.
Dextrose syrup with
extensive hydrolysis

Flolys

Osmotic agent in injectables and dialysis solutions,


for parenteral nutrition and treatment of
hypoglycemia.

GLUCOSE

Dextrose USP/NF, EP, JP

Glucose or Dextrose is the monomer of natural starch polymer. It is white, odourless, sweet, in
crystalline or granular powder form and freely soluble in water. This monomer is also the natural
physiological sugar in the human body. In its crystalline form this doubly natural sugar has long
been used both as a filler for oral dosage forms and as a sweetener. It also helps in improving the
stability of API sensitive to oxidation due to its slight reducing properties. Therapeutically it is
used as a preferred source of carbohydrate in parenteral nutrition.
Roquette has a range of dextrose products wide enough to meet any of manufacturers different
requirements.
Grade

Description

Application

Lycadex PF

Pyrogen free dextrose


monohydrate

Osmotic agent in injectables and dialysis solutions,


for parenteral nutrition and treatment of
hypoglycemia.

Dextrose
Anhydrous PF

Pyrogen free dextrose


anhydrous

Dextrose GC

Agglomerated dextrose Direct compression diluent with excellent

monohydrate

compressibility and flowability for use in tablets,


sachets and capsule formulations.

Roferose

Dextrose Monohydrate Diluent for tablets, capsules and sachets.

Dextrose
Anhydrous C

Crystalline dextrose
anhydrous

Roclys

Dextrose syrup without For inhibiting sucrose crystallization as texturizer


extensive hydrolysis
and bulk sweetener in syrups, lozenges, pastilles and
pharmaceutical chewing gums.
Dextrose syrup with
extensive hydrolysis

Flolys

SCORALITE

Calcium Carbonate USP/NF, EP, JP, BP

Scoralite is a very pure, highly free flowing synthetic calcium carbonate manufactured by using a
unique synthesis process. It possesses exceptional properties particularly valued in the
pharmaceutical industry. Production of Scoralite is carried out according to GMP guidelines and
is supplied under a C-O-S from the European Pharmacopeia.
Grade

Description

Application

Heavy grade

Inert filler and calcium source. Used in antacid


preparations, osteoporosis treatment tablets
alongwith Vitamin D3, mineral supplements, food
additives and in production of pharmaceutical grade
calcium derivatives.

Scoralite

Scoralite LL

Heavy grade with low


lead content

SICOVIT

Iron Oxide USP/NF, EP

The Sicovit product line comprises of insoluble iron oxide pigments powders of high purity for
use in the pharmaceutical and food industry. Sicovit Iron oxide colours are an useful tool to help
identify a product in its manufacturing and distribution stages. Patients often rely on color to be
able to recognize the prescribed medication. Also use of insoluble pigments like iron oxides,
titanium dioxide, etc in tablet coatings or gelatin shells provides good opacity and protection to

light sensitive actives.


The Sicovit product line is available in different colour shades to suit the end-user.
Grade

Description

Application

Sicovit Red

Red powder pigment

Stable colourant in pigment form, approved for use


in various dosage forms.

Sicovit Yellow

Yellow powder
pigment

Sicovit Black

Black powder pigment

Sicovit Brown

Brown powder pigment

SODIUM GLUCONATE PHARMA USP/NF

Sodium Gluconate Pharma is a pharmaceutical-grade of sodium gluconate with a low endotoxin


content. It is a pyrogen-free organic salts manufactured by natural starch through a fermentation
process.
Grade

Description

Application

Sodium
Gluconate
Pharma

White powder form,


low endotoxin content

Electrolyte for injectables and dialysis solutions, pH


regulation agent, emollient in cosmetics

Sodium Hyaluronate

Ultra pure Sodium Hyaluronate EP

Sodium Hyaluronate Pharma Grade consists of highly purified and well-characterized sodium
hyaluronate with controlled endotoxin content (Max 2.5 EU/g), )developed for use in biomedical
and pharmaceutical applications. Sodium Hyaluronate Pharma Grade is manufactured at a stateof-the-art ISO approved production facility in Japan by a fermentation process involving
Streptococcus zooepidemicus.
Sodium Hyaluronate is a linear copolymer composed of (-1,4)-linked D-glucuronate and (1,3)-N-acetyl-D-glucosamine. It is the only non-sulfated glycosaminoglycan and forms highly

viscous aqueous solutions as a direct result of trapping of approximately 1000 times its weight of
water by its expanded random coil structure. The ultra-pure sodium hyaluronates are clear
solutions and are described in a Drug Master File submitted to the US FDA. They forms an
attractive building block for new biocompatible and bio-interactive materials in drug delivery, in
tissue engineering and for visco-supplementation.
Grade

Intrinsic Viscosity (m3/kg)

Sodium Hyaluronate Pharma grade 80

1.2 2.0

Sodium Hyaluronate Pharma grade 150

2.1 2.8

Sodium Hyaluronate Pharma grade 200

2.9 3.5

SODIUM LACTATE PHARMA USP/NF, EP

Sodium Lactate Pharma is a highly purified single isomer and pyrogen free solution presented as
a clear, colourless, slightly syrupy liquid solution with neutral pH. It has low endotoxin content,
is heat stable and exhibits improved organoleptic properties. They are pyrogen-free organic salts
manufactured by natural starch through a fermentation process.
Grade

Description

Application

Sodium
Gluconate
Pharma 60%

Dry Sodium lactate


content (60%)

Electrolyte for injectables and dialysis solutions,


buffering agent in IV, pH regulation agent,
emollient, bacteriostatic agent.

Sodium
Gluconate
Pharma 50%

Dry Sodium lactate


content (50%)

SOLULYS

Corn-steep powder
Solulys is a spray- dried free flowing corn-steep powder produced by the industrial processing of
corn. It is rich in soluble proteins, vitamins and lactic acid making it useful as a culture medium
in the production of a variety of fermentation products- antibiotics, Vitamin B12, etc.

Grade

Description

Application

Spray dried corn-steep


powder

For seed culture as well as in main fermentation


process

Solulys AST

SOLUPHOR P

2-Pyrrolidone, Distilled

Soluphor P is available as a solidified excipient which is soluble in water and a number of


organic solvents, e.g. ethanol, isopropyl alcohol and aromatic hydrocarbons. The solutions of
Soluphor P in water of up to 50% have a viscosity of not more than 4 mPa.s, lending it useful in
injectable formulations.
Grade

Description

Application

Colourless or slightly
coloured liquid which
solidifies at room
temperature and has a
characteristic odour.

Used mainly as a solvent for veterinary injections.


Also indicated as absorption enhancer for topical
formulations using the transdermal or transmucosal
route.

Soluphor P

SOLUTOL HS 15

Macrogol-15-Hydroxystearate EP

Solutol HS 15 is a nonionic solubilizer and emulsifying agent obtained by reacting 15 moles of


ethylene oxide with 1 mole of 12-hydroxy stearic acid. It is soluble in water, ethanol and 2propanol to form clear solutions. Its solubility in water decreases with increasing temperature. It
is insoluble in liquid paraffin.
Solutol HS 15 has high chemical stability and is tolerated extremely well as several toxicological
tests have shown; especially a low histamine release after application of Solutol HS 15 is
observed.
Grade

Description

Application

Solutol HS 15

Yellowish white paste


Used as a non-ionic solubilizer in aqueous
at room temperature
parenteral preparations containing vitamins an
which transforms into a
liquid at approx.30C

STARCH USP/NF, EP, JP

Starch occurs as an odourless, tasteless, fine, white-to-off white coloured powder and has been
used for decades as one of the best known excipient in various pharmaceutical formulations.
Since the beginning of industrial pharmaceutical formulation, Starch has been used as a reliable
excipient in the form of fillers for tablets and capsules, as a powder for sachets and also as a
disintegrant.
Native Starches

Roquette supplies a variety of quality starches from different sources like maize (corn), wheat
and potato for pharmaceutical use. All the starch grades are GMO free and microbiologically
compliant.
Grade

Description

Application

Maize Starch 5
%

Low moisture grade

Used for moisture sensitive drug formulations.

Maize Starch B Standard grade


Extra White
Maize Starch

Extra-white grade

Corn Starch
400 L

Super-white grade,
highly refined.

Wheat Starch
TB

Standard grade

Potato Starch B Standard grade

Modified Starches

Pregelatinized Starch USP/NF, EP

Diluent for tablets and capsules, powder for sachets


and a disintegrant.

To overcome the drawbacks of native starch viz. cooking step, high viscosity, poor flow,
agglomeration etc; the modified range of starch products were introduced by Roquette. The
range consists of pre-cooked starches, partially-cooked starches, partially hydrolyzed starches as
well as compounded starches using special production processes. These modified starches
brought in a lot of reliability, flexibility and advantages for wet granulation as well as direct
compression tabletting.
Grade

Description

Application

Lycatab PGS

Fully
pregelatinize
d maize
starch

Excellent binder for wet granulation.

Lycatab C

Partially
pregelatinize
d maize
starch with
good flow
and
controlled
cohesive
power

Versatile excipient, filler-disintegrant


for hard gelatin capsules, binderdisintegrant for direct compression
and binder for wet granulation
applications. Also used as a flow-aid
in powder blends.

Lycatab D

Partially
hydrolyzed
maize starch
with good
flow, aqueous
solubility and
wettability

Cost effective binder for wet


granulation with high wettability.
Used to granulate mixtures for
capsule/sachet filling and densifying
mixtures for compression.

STARLAC

Spray-dried compound of Maize


Starch and Lactose Monohydrate

StarLac is an innovative, spray dried


compound of native maize starch and
alpha lactose monohydrate in a free
flowing powder form designed for
direct compression. It was developed
by Roquette in collaboration with
Meggle company as a part of its
ongoing drive towards innovation.
Starlac shows technical improvement
and added value for the tablet producer
as it easies tabletting process with an
outstanding combination of high

compactibility, superior flowability, fast


disintegration and excellent tablet
hardness.
Grade Benefits

Application

Starlac
Optimized
disintegration,
excellent
tablet
hardness,
superior
flowability,
high shear
force
resistancy,
higher storage
stability

Direct
compression
filler, lowdosage
formulations,
fast
dissolving
tablets,
capsule
filling, and
cores for
coating.

SH
Lycatab Mineral

Compound of Direct compressible filler / binder


Precipitated with an excellent mouth-feel. Also a
calcium
source of calcium.
carbonate and
maize starch

STEPANOL WA 100

Sodium Lauryl Sulfate USP/NF, EP, JP, BP

STEPANOL WA-100 is sodium lauryl sulfate which is a mixture of sodium alkyl sulfates mainly
consisting the lauryls. It is an anionic surfactant in white to off-white powder form with faint
characteristic odour of fatty substances.
Stepanol WA-100 is produced from the sulfation of fatty alcohol via Stepan's SO3 process. The
product is then spray dried to produce a highly active powder of exceptional quality for
pharmaceutical applications. It is characterized by a very high active substance matter and a very
low content of inorganic salts and unsulfated fatty alcohol.

Grade
Stepanol WA100

Description

Application

White spray-dried
powder with a smooth
feel and soapy, bitter
taste

Tablet and capsule lubricant, wetting agent, anionic


surfactant, emulsifying agent, skin penetrant and
skin cleanser in topical applications.

STURCAL L & CALOPAKE Extra Light

(Precipitated) Calcium Carbonate USP/NF, EP, JP


Precipitated Calcium Carbonate (PCC), alternatively known as purified, refined or synthetic
calcium carbonate is produced by direct carbonation of hydrated lime by a simple process called
Milk of lime process. The process involves combining lime (CaO) with water to form slaked
lime, addition of carbon dioxide and precipitation of calcium carbonate in a very fine, white
form. The precipitated calcium carbonate is then washed, purified, dried and packaged.
Specialty Minerals Inc. uses high quality limestone sources for its PCC products, including some
from the 150 year old SMI limestone mine in Adams, Massachusetts. Although a number of
different calcite crystal forms are possible, Sturcal L & Calopake Extra Light consist of
agglomerates of scalenohedral calcite crystals. The two grades differ in particle size and apparent
densities and are compliant as per USP/NF, EP & JP.

Grade

Sturcal L

Description
Heavy grade, apparent
density: 0.78 0.96

Calopake Extra Extra light grade, apparent


Light
density: 0.42 0.50

Median
Particl
e size
(m)

Application

75

Used mainly in antacid tablets and


liquids, in dentifrices &
therapeutically as calcium
supplement in pharmaceuticals &
fortified foods.

45

Used as abrasive in dentifrice


products, for calcium
supplementation in nutritional and
pharma products, also as antacid, pH
modulator and flocculent.

SUCROSE S-124

Ultra-Pure, Low-Endotoxin Sucrose USP/NF, EP, JP

Ferro Pfanstiehls ultra-pure, low-endotoxin sucrose grades are manufactured from highest purity
cane sugar or beet sugar. These base sugars are generally obtained from non-genetically modified
sources of sugar cane grass or sugar beet. Where commercial sources are not available, the
carbohydrates are either isolated from botanical sources or are manufactured via fermentation.
The ultra-pure, low-endotoxin sucrose grades are further purified through a combination of
various techniques including chromatography, deionization, ultrafiltration, nanofiltration,
activated carbon treatment and dissolution / re-crystallization under cGMP conditions. The end
product of high purity is thus suitable for the manufacture of regulated injectable formulation
grade ingredients or for use in injectable formulations.
Grade

Description

Sucrose S-124- White to-off-white


1
solid with endotoxin
content < 1,5 EU/g

Application
Used in parenteral drug formulations, particularly
intravenous and intramuscular injectables.

Sucrose S-124- White to-off-white


2-MC
powder with endotoxin
content < 0.6 EU/g

SYNPRO STEARATES

Stearates USP/NF, EP, JP

Synpro Stearates are special grade alkali stearates of vegetable origin refined for the
pharmaceutical industry. They are alkali salts (Magnesium, Zinc & Calcium) manufactured from
special grades of vegetable fatty acids with a particular emphasis put on sensory properties
ensuring absence of colour, odour, taste and favorable tactile qualities to get a superior endproduct.
Synpro Stearates are offered in a fine, consistent particle size, white powder form which ensures
consistent performance from batch to batch. They comply to all major international
pharmacopeias viz. USP/NF, EP and BP monographs and are well supported by all regulatory
documents like TSE/BSE, GMO, Residual solvents, Gluten free, Kosher etc. Synpro Stearates
are widely used as lubricants and mould release agents in the pharmaceutical and cosmetic
industry.

Grade

Application

Synpro Magnesium Stearate VG

Used as lubricant to improve granule flow during


tablet compression.

Synpro Zinc Stearate VG

Used as lubricant during tablet compression and as a


protective in formulations for treatment of skin
ailments.

Synpro Calcium Stearate VG

Used as lubricant to improve flow during tablet


compression and capsule filling.

TACKIDEX

Dextrin USP/NF, EP

Dextrins are starch polymers derived through solid-state heating from partially hydrolysed starch
of maize, tapioca or potato. It is partially or completely soluble in cold water with low viscosity.
Grade

Description

Tackidex B 167 White dextrin from


potato starch

Application
Tablet and capsule filler, binder for tablet
granulation, component in sugar coating solution,
thickening agent for suspensions.

TALC LUZENAC PHARMA

Talc USP/NF, EP, JP

Talc is a hydrated magnesium silicate and is the softest mineral in the world. It is a natural
material of white to grayish white colour and generally occurs in two morphologies, either in
macro or microcrystalline. Most talc deposits are mined, extracted, sorted depending on the talc
content and brightness and milled to obtain the right particle size. Talc is odorless, impalpable,
inert, water repellent, platy mineral and shows an affinity for organic substances.
Luzenac Talc products are purified, bacteria controlled grades and are manufactured according to

the IPEC GMP guide for bulk pharmaceutical excipients. They are heat-treated (sterilized) to
decontaminate them before being packaged. Additionally it is extra-white.
Grade

Description

Application

Talc Luzenac
Pharma

Standard grade

Flow regulator (glidant), reduces fluctuations in


tablet weight, enhances tablet homogeneity &
quality and increases productivity.

Talc Luzenac
Pharma M

Micronized grade

Anti-tack agent for tablet coating, eliminates


stickiness during drying, prevents agglomerations in
the coater, reduces coating time and produces
flawless coated products.

Talc Luzenac
Pharma UM

Ultra-micronized grade Lubricant for easier tablet pressing, reduces friction,


prevents binding during compression & ejection and
guarantees smooth crack-free results.

TREHALOSE

Non-reducing Di-Saccharide

Trehalose is a naturally occurring disaccharide present in plants like seaweeds, mushrooms,


yeast etc. It is odorless, moderately sweet and is supplied in form of either powder or crystalline
granules. It has distinctive characteristics like low reactivity to basic drugs, high stability to
moisture / heat & pH, high compactibility and faster disintegration than sugar alcohols. It is
digestible, has low laxative effect and is similar to sucrose in viscosity, osmotic pressure and
water reactivity.
Grade

Description

Application

Trehalose P

Powder

Filler & taste masking agent in solid & liquid


dosage forms.

Trehalose G

Granular

CALCIUM PHOSPHATES

Calcium phosphates are widely used in pharmaceutical formulations as capsule or tablet diluents.

It has many positive characteristics as an excipient including good compressibility, excellent


stability and white colour. Due to their inherent property of good compatibility, they find use in
both direct compression and wet-granulation process. Two particle size grades of calcium
phosphate are available. The Milled or Powder grade is typically used in wet granulation
process or roller compaction while the Unmilled or Granular grade is used in direct
compression process due to its good flow properties.
Granular grades USP/NF, EP, JP

Grade

Description

Application

A-Tab

Dibasic calcium
phosphate Anhydrous

Tablet and capsule diluent / filler, used in direct


compression. Non-hygroscopic, stable at room
temperature adding to better product stability.
Source of calcium and phosphorous.

Di-Tab

Dibasic calcium
phosphate Dihydrate

Tablet and capsule diluent / filler, used in direct


compression. Flow agent, blend densifier, tablet
punch polishing agent, time release agent and carrier
of actives. Source of calcium and phosphorous.

Tri-Tab

Tribasic calcium
Phosphate Anhydrous

Tablet and capsule diluent / filler, used in direct


compression and as filler binder in vitamin
mineral formulations. Also used as a glidant due to
high surface area and carrier of actives. Higher
calcium and phosphorous content.

Tri-Cal WG

Tribasic calcium
phosphate Anhydrous

Special high density grade for use in wet


granulation. Benefits similar as Tri-Tab.

CALCIUM PHOSPHATES

Calcium phosphates are widely used in pharmaceutical formulations as capsule or tablet diluents.
It has many positive characteristics as an excipient including good compressibility, excellent
stability and white colour. Due to their inherent property of good compatibility, they find use in
both direct compression and wet-granulation process. Two particle size grades of calcium
phosphate are available. The Milled or Powder grade is typically used in wet granulation
process or roller compaction while the Unmilled or Granular grade is used in direct
compression process due to its good flow properties.
Granular grades USP/NF, EP, JP

Grade

Description

Application

A-Tab

Dibasic calcium
phosphate Anhydrous

Tablet and capsule diluent / filler, used in direct


compression. Non-hygroscopic, stable at room
temperature adding to better product stability.
Source of calcium and phosphorous.

Di-Tab

Dibasic calcium
phosphate Dihydrate

Tablet and capsule diluent / filler, used in direct


compression. Flow agent, blend densifier, tablet
punch polishing agent, time release agent and carrier
of actives. Source of calcium and phosphorous.

Tri-Tab

Tribasic calcium
Phosphate Anhydrous

Tablet and capsule diluent / filler, used in direct


compression and as filler binder in vitamin
mineral formulations. Also used as a glidant due to
high surface area and carrier of actives. Higher
calcium and phosphorous content.

Tri-Cal WG

Tribasic calcium
phosphate Anhydrous

Special high density grade for use in wet


granulation. Benefits similar as Tri-Tab.

XANTURAL

Xanthan Gum USP/NF, EP, JP

Xantural is a exocellular polysaccharide produced by fermentation of a pure culture,


Xanthomonas campestris, with protein, carbohydrate source and other nutrients. Xantural gives
clear and transparent gel exhibiting pseudoplastic behaviour; the shear thinning being directly
proportional to the shear rate. The viscosity returns to normal immediately on release of shear
stress. It is nontoxic, compatible with most other pharmaceutical ingredients and has good
stability and viscosity properties over a wide pH and temperature range.
Xantural is widely used as a suspending and stabilizing agent, thickener and emulsifier.
Additionally, xanthan gums swell in gastric fluid to produce a highly viscous layer around the
tablet through which the drug must diffuse. This property makes Xantural a useful ingredient for
controlled and sustained release applications as well.
Grade

Description

Application

Xantural 75

Fine mesh grade with


particle size ~ 200

Reconstitutable oral suspensions & hydrophilic

mesh.

matrix / sustained release tablets.

Xantural 180

Coarse mesh grade


with particle size ~ 80
mesh.

Oral suspensions and syrups.

Xantural 11K

Agglomerated grade
with particle size ~ 14
mesh.

Oral suspensions and syrups. Disperses easily and


hydrates effectively.

XYLISORB

Xylitol USP/NF, EP, JP

Xylitol is a five-carbon polyol with a characteristic crystalline shape. It occurs as a white, sweet
tasting, odorless, granular solid comprising crystalline, equi-dimensional particles which are
stable to heat and marginally hygroscopic. Its sweetening power is identical to that of sucrose
and when combined with its distinct cooling effect in the mouth; it becomes highly effective in
enhancing the flavor of tablets and syrups and masking the unpleasant or bitter flavors associated
with some pharmaceutical actives.
Xylitol is used as a non-cariogenic sweetening agent and an alternative to sucrose in a variety of
pharmaceutical dosage forms, including tablets, syrups and coatings. It also finds increasing
application in chewing gum, mouth rinses and toothpastes as an agent that decreases dental
plaque and tooth decay (dental caries).

Grade

Description

Application

Xylisorb 90

Fine particle size

Diluent for sachets, chewable and suckable tablets.


Sugar free coating (non-cariogenic).

Xylisorb 300

Medium particle size

Xylisorb 700

Coarse particle size

Xylisorb PF

Pyrogen free grade

Parenteral nutrition; used in combination with amino


acids.