Brochure Meggle Lactoses

MEGGLE worldwide
Regional Offices
MEGGLE Group Wasserburg

BG Excipients & Technology
Megglestrae 6 12
83512 Wasserburg
Germany
Phone +49-(0)80 71-73-4 76
Fax
+49-(0)80 71-73-3 20
service.pharma@meggle.de
www.meggle-pharma.com
MEGGLE USA Inc.

50 Main Street, 10th Floor
White Plains, NY, 10606
USA
MEGGLE Prishtina
Prishtina
Kosovo
UNMIK
MEGGLE Group Shanghai

Room 301, Block 6
Lane 289 Bisheng Road
Zhangjiang Hi-Tech Park
Pudong New Area
201204 Shanghai
China
MEGGLE Japan Co.,
Ltd Ginza 1- Chome Bldg., 11 F
15 - 4, Ginza 1- Chome/Chuo-Ku
Tokyo 104 - 0061
Japan
MEGGLE Singapore
45 Jalan Pemimpin #06 - 00
Foo Wah Industrial Building
577197
Singapore
Presented by
GB 03/09 Pe 15 Sai
Headquarters
Lactose Excipients
Excipients for Direct Compression, Granulation,
Capsules, Sachets, Pellets, Powder Blends,
Dry Powder Inhaler
To the best of our knowledge,

the information contained herein is
accurate. However nothing herein
contained shall be construed to
imply any warrantee or guarantee.
MEGGLE Excipients & Technology

Megglestrae 6 12
83512 Wasserburg
Germany
Phone +49-(0)80 71-73-4 76
Fax
+49-(0)80 71-73-3 20
www.meggle-pharma.de
www.meggle-pharma.cn
www.jp.meggle-pharma.com
Know-how
Our Mission
MEGGLE achieved through excellent product

quality and intelligent innovations a
leading position globally in excipients. In
more than 50 years market presence we
developed a broad, unparalleled product
portfolio. It comprises besides excipients
for wet granulation and capsule filling also
state of the art specialties for direct compression and dry powder inhalers. Our
customers are mainly producers of
pharmaceutical products and nutritional
supplements. However the functionality of
our products is also appreciated by the
cosmetic and detergent industry.
As a leading manufacturer of lactose it is

our endeavor to offer our customers worldwide always the optimal product for their
respective application. Already today our
products exceed internationally accepted
quality standards. In terms of maximal
customer orientation we are constantly
improving our service.
Innovation and Service

For our customers a team of experts is
constantly available in all questions
concerning development, production,
application and refinement of excipients.
Regardless of custom manufacturing or
development cooperation: we committed
ourselves to share our experience with our
partners. We are bound to innovation
and are therefore in constant contact with
various scientific institutions all over the
globe.
Our Vision
Our long term targets are:
To maximize the benefit of our customer
through development of innovative
highly sophisticated products, also for
new application forms
To expand our independent leading
position in development and improvement
of excipients
To support our customers in the development of new formulations
To expand our global network of competent representations and subsidiaries
Wherever your are:

we are at your side
The products of MEGGLE are enjoying an
excellent reputation around the globe and
are used in more than 100 countries of the
world. A worldwide network of representations and subsidiaries guarantees, that
distribution, consultation and service are
always of the quality you rightly expect
from us.
MEGGLE worldwide
Headquarters
Wasserburg
Regional Offices
New York
Prishtina
Shanghai
Singapore
Tokyo
For contact details see page 36
Agencies
Please visit our homepage:

Our literature data base is now open for
you around the clock. On the MEGGLE
homepage you will find all relevant facts
about our products and their respective
applications. Of course also as download.
MEGGLE headquarters in
Wasserburg/Germany
55
MEGGLE Excipients
-lactose-monohydrate Ph. Eur. USP-NF JP
crystalline
powder blends, capsule/sachet filling, pellets,
dry powder inhaler, wet granulation, premixes
sieved
modified
Compounds
direct compression
direct compression
milled
agglomerated
spray-dried
spray-dried
PrismaLac 40
InhaLac 70
GranuLac 70
Tablettose 70
FlowLac 90
Cellactose 80
CapsuLac 60
InhaLac 120
GranuLac 140
Tablettose 80
FlowLac 100
MicroceLac 100
SacheLac 80
InhaLac 230
GranuLac 200
Tablettose 100
SpheroLac 100
GranuLac 230
SorboLac 400
66
StarLac
Sieved Lactose
Sieved Lactose for Dry Powder Inhaler
Milled Lactose
Sieved Lactose
3
4
6
7
Product
Product
Product
Product
overview
description
overview
description
8
10
12
14
Product overview
Product description
16
18
Information for Direct Compression
20
Agglomerated Lactose [DC]
Product overview
Product description
22
24
Spray-dried Lactose [DC]
Product overview
Product description
26
26
Compounds [DC]
Cellactose 80
MicroceLac 100
StarLac
28
30
32
34
35
Compounds [DC]
General Specification
Contact
Milled Lactose
Excipients & Technology

MEGGLE worldwide
Grades/product
roduct overview
Content
Conte
Content
77
PrismaLac 40
CapsuLac 60
SacheLac 80
SpheroLac 100
Sieved La
actose
Ph. Eur. USP-NF JP
88
Sieved Lactose
Product description
Application
Coarse lactose is fractionated into products

with a narrow particle size distribution by
sieving.
Sieved lactose consists of mono crystals

and agglomerates. The variety
riety of the
products allows
llows for an optimal selection
for the iintended application.
Product features
Due to its good blending properties and

excellent flowability these products are
most suitable for capsule/sachet filling
and powder blends. Compactibility of
sieved lactoses is moderate.
Flowability
Sieved Lactose
Leaked mass [g]
50
45
40
35
30
25
20
15
10
5
0
0 10 20
Capsule filling
Sachet filling
Powder blends
Triturations
Excellent flowability
Narrow particle size distribution
Good blending properties
High storage stability
Sieve data
Lactose type
Particle size distribution < 63 m

Method:
< 100 m
Mechanical sieve shaker < 150 m
< 200 m
< 250 m
< 400 m
< 500 m
< 630 m
< 800 m
30 40 50
Time [s]
60
70
80
PrismaLac 40
CapsuLac 60
SacheLac 80
SpheroLac 100
specified/typical
specified/typical
specified/typical
specified/typical
20 %/ 9 %
10 %/ 5 %
20 %/ 5 %
/ 15 %
/ 78 %
10 %/ 4 %
75 %/ 98 %
40 70 %/ 60 %
/ 63 %
90 %/ 99 %
98 %/100 %
/ 99.5 %
/ 65 %
/ 90.5 %
97 %/100 %
97 %/100 %
Density poured
[g/l]
/470
/590
/600
/690
Density tapped
[g/l]
/540
/700
/710
/840
PrismaLac 40
CapsuLac 60
SacheLac 80
Erichsen funnel mod. 321, orifice: 4 mm
99
Typical histogram
PrismaLac 40
Mass [%]
100
90
80
70
60
50
40
30
20
10
0
0 100 200 300 400 500 600 700 800 900 1000
Particle size [m]
500 m
PrismaLac 40
Application:
Powder blends
Sieved Lactose
Ph. Eur. USP-NF JP
CapsuLac 60
Application:
Capsule filling
Sachet filling
Powder blends
Triturations
500 m
10
10
Typical histogram
CapsuLac 60
Mass [%]
100
90
80
70
60
50
40
30
20
10
0
0 100 200 300 400 500 600 700 800 900 1000
Particle size [m]
Sieved Lactose
SacheLac 80
Application:
Capsule filling
Sachet filling
Powder blends
Triturations
Typical histogram
SacheLac 80
Mass [%]
100
90
80
70
60
50
40
30
20
10
0
0 100 200 300 400 500
Particle size [m]
5 0 m
500
SpheroLac 100
Application:
Pellets
Triturations
Powder blends
500 m
Typical histogram
SpheroLac 100
Mass [%]
100
90
80
70
60
50
40
30
20
10
0
0 100 200 300 400 500
Particle size [m]
11
11
InhaLac 70
InhaLac 120
InhaLac 230
Sieved Lactose
actose for Dry Powder Inhal
Inhaler
Ph. Eur. USP-NF JP
12
12
Product description
InhaLac stands for sieved lactose in
crystalline form, which is in particular
suitable for use in Dry Powder Inhalers.
InhaLac attributes its unique performance

to the extremely narrow particle size
distribution. InhaLac is practically free of
amorphous lactose.
InhaLac is available in a broad spectrum

of sieve cuts. Excellent flowability,
wability,
preeminently
tly defined particle
p
surface
definition and physical-chemical stability
definitio
are the requirements for excipients for
Dry Powder Inhalers.
Flowability
Leaked mass [g]
50
45
40
35
30
25
20
15
10
5
0
0 10 20 30 40 50 60
Time [s]
InhaLac 120
InhaLac 230
typical
typical
typical
Lactose type
Particle size distribution

Method:
Laserdiffraction
d10
d50
d90
110 m
90 m
45 m
200 m
130 m
90 m
300 m
190 m
135 m
Density poured
[g/l]
590
700
710
Density tapped
[g/l]
660
790
820
1.1
1.13
1.15
Hausner ratio
70
InhaLac 70
Sieve data
80
InhaLac 70 [1]
InhaLac 120 [1]
InhaLac 230 [2]

Erichsen funnel mod. 321, orifice: [1] 4 mm, [2] 6 mm
13
13
500 m
InhaLac 70
Particle size distribution [Laser diffraction]

InhaLac 70
Distribution density [%]
Cumulative distribution [%]
100
20
90
18
80
16
70
14
60
12
50
10
40
8
30
6
20
4
10
2
0
0
0
10
100
1000
Particle size [m]

Ph. Eur. USP-NF JP
14
14

500 m
InhaLac 120

InhaLac 120
100
30
90
25
80
70
20
60
50
15
40
10
30
20
5
10
0
0
0
10
100
1000
Particle size [m]
InhaLac 230

InhaLac 230
100
25
90
80
20
70
60
15
50
40
10
30
20
5
10
0
0
0
10
100
1000
Particle size [m]
500 m
15
15
GranuLac 70
GranuLac 140
GranuLac 200
GranuLac 230
SorboLac 400
Milled Lacctose
Ph. Eur. USP-NF JP
16
16
Product description
Application
GranuLac types and SorboLac 400

consist of fine lactose particles.
Milled la
lactose has a limited flowability
and therefore has to be granulated before
the production of tablets.
Milled Lactose
Due to its good compressibility and

blending properties lactose is the most
frequently used filler for wet
et granulation.
Wet granulation
Premixes
Triturations
Media for fermentation
n
Enhancement of flavors
Enhancemen
Product features
Good compressibility
Good blending properties
Narrow particle size distribution
High storage stability
High batch to batch consistency
Sieve data
Lactose type

Method:
Air-jet sieving
< 32 m
< 63 m
< 100 m
< 400 m
< 630 m
GranuLac 70
GranuLac 140
specified/typical
specified/typical
40 %/ 30 %
40 60 %/ 50 %
80 %/ 90 %
GranuLac 200
GranuLac 230
SorboLac 400
specified/typical
specified/typical
specified/typical
45 75 %/ 55 %
90 %/ 98.4 %
/ 75 %
90 %/ 97.5 %
90 %/ 96 %
/ 99.5 %
/ 99.5 %
95 %/ 99.5 %
/100%
Density poured
[g/l]
/715
/660
/535
/465
/390
Density tapped
[g/l]
/900
/890
/800
/760
/630
1717
200 m
GranuLac 140
100 m
GranuLac 70
Typical histogram
GranuLac 70
Mass [%]
100
90
80
70
60
50
40
30
20
10
0
0
100
200
300
400
Particle size [m]
500
600
Typical histogram
GranuLac 140
Mass [%]
100
90
80
70
60
50
40
30
20
10
0
0
100
200
300
Particle size [m]
400
500
200
300
Particle size [m]
400
500
700
Milled Lactose
Ph. Eur. USP-NF JP
GranuLac 200
200 m
1818
Typical histogram
GranuLac 200
Mass [%]
100
90
80
70
60
50
40
30
20
10
0
0
100
SorboLac 400
Milled Lactose
GranuLac 230
Typical histogram
GranuLac 230
Mass [%]
100
90
80
70
60
50
40
30
20
10
0
0
100
2000 m
200
300
Particle size [m]
400
Typical histogram
SorboLac 400
Mass [%]
100
90
80
70
60
50
40
30
20
10
0
0
100
500
100 m
m
200
300
Particle size [m]
400
500
1919
Direct Compression [DC]
History
Tablets are the most frequently used form

in pharmaceutical applications. They are
convenient, easy to administer and
production is relatively cheap. Moreover
the prescribed and required dose is
applied with a high degree of precision.
Until the early sixties tablets have been

produced in a complicated multistep
procedure. The development of modified
lactose and microcrystalline cellulose as
well as improvement of tablet presses
revolutionized the technology of compaction
and made a simple three step compaction,
the so called direct compression, possible.
sible.
Direct Compression [DC]
Economical advantages
Technological advantages
The most obvious advantage of direct

compression compared to the traditional
wet granulation is the economy, due to
reduction of costs for equipment, operating
and validation.
The technological advantage of direct

compression compared to wet granulation
is the improved stability of the active
ingredient through:
No exposure to heat
No exposure to humidity
In addition direct compression allows for a
simplified optimization of disintegration.
Equipment:
Less production machinery necessary
Less production area necessary
Less production equipment necessary
Costs for development and production:
Improvement of total variable cost of production
Reduction of production time for one batch
Reduction of labor cost
Improvement of effectiveness per work space
Reduction of validation cost
2020
Excipients
The right choice of excipients for direct
compression is more critical than for wet
granulation. None of the traditional
excipients provides the required good
flowability and excellent compactability
required for direct compression. Therefore
traditional excipients have to be modified.
Production
The MEGGLE production process
combines efficiency with a high
degree of quality and absolute
cleanliness.
DC-Compounds
The ideal filler-binder for direct compression
gives high compressibility, good binding
properties, high adhesion capacity and a
low sensitivity to lubricants.. All these
desired characteristic
aracteristics can be achieved
by co-p
co-processing. The MEGGLE Group
was one of the first manufacturers who
introduced a co-processed excipient,
consisting of two traditional excipients,
in the market.
DC compounds have been developed to:

achieve a synergistic
stic effect
achieve an op
optimal functionality
eliminate undesired weaknesses
Particle structure
The MEGGLE DC-excipients contain
the know-how of 20 years of
research and development your
guarantee for optimal functionality.
Flowability
The excellent flowability of
MEGGLE DC-excipients provides for
trouble free processing.
Blending
Blending is the crucial step in
direct compression.
MEGGLE DC-excipients demonstrate
excellent blending properties.
Compaction
You can rely on the functionality
of MEGGLE DC-excipients
also with high output ratios
in modern rotary presses.
It is generally accepted, that the spherical

shape of the spray-dried particles is
responsible for the excellent flowability
and that the composition of the co-processed products accounts for the good
compressibility. All co-processed MEGGLE
products consist of a major fraction of a
brittle material [-lactose-monohydrate]
and a minor fraction of a plastic material
[powdered cellulose, microcrystalline
cellulose or corn starch]. The plastic
deforming material improves the
compressibility.
With Cellactose 80 and MicroceLac 100

a higher hardness yield could be achieved
compared to the physical mixture of the
respective ingredients.
Direct Compression
Direct compression reduces
compaction to three
uncomplicated, economical
production steps.
Direct Compression:
Dispensing/Screening
Blending/Lubrication
Tablet Compression
With StarLac the disintegration of the

direct compression compound is faster
compared to the physical mixture.
Research and Development

MEGGLE DC-excipients undergo a
sequence of tough quality tests
before marketing.
Advisory Service
A team of cordial industry
pharmacists assists you in all
questions concerning
compaction.
21
21
Tablettose 70
Tablettose 80
Tablettose 100
Direct Compression
Ph. Eur. USP-NF JP
Flowability
Leaked mass [g]
60
55
50
45
40
35
30
25
20
15
10
5
0
0 10 20 30 40 50
Time [s]
60
70
Tablettose 70
Tablettose 80
Tablettose 100
22
22
80
Product description
Application
Product features
Tablettose 70/80/100 are trade

names for agglomerated lactose
[-lactose-monohydrate according
to Ph. Eur. USP-NF JP].
Conventional compaction
Filling of capsules/sachets [in particular
Tablettose 70]
Effervescent tablets
Artificial swe
sweetener tablets
Tablettose 70/80/100 are stable and

non-hygroscopic
Fast
ast disintegration through the high total
surface area of the excipient
A structured surface and pure white
appearance are ideal for table top
sweetener formulations
Good flowability guarantees trouble free
and economical filling of capsules and
sachets
High and stable degree of whiteness
Tablettose was especially developed for

direct compression.
pression. It combines
c
the good
flowability of a coarse lactose ideally with
flowabi
the good compactibility of a fine milled
lactose.
Sieve data
Method:
Mechanical sieve shaker
Lactose type
< 63 m
< 150 m
< 180 m
< 200 m
< 250 m
< 400 m
< 500 m
< 630 m
Tablettose 70
Tablettose 80
Tablettose 100
specified/typical
specified/typical
specified/typical
6 %/ 3 %
20 %/ 13 %
/ 25 %
25 %/ 12 %
/ 42 %
Compactibility
Crushing force [N]
250
40 75 %/ 53 %
200
30 70 %/ 56 %
60 90 %/ 77 %
/ 93 %
150
85 %/ 93 %
98 %/100 %
96 %/100 %
100
97 %/100 %
Density poured
[g/l]
/548
/610
/570
50
Density tapped
[g/l]
/670
/738
/690
0
0
50
100
150
200
Compaction pressure [MPa]
250
300
Tablettose 70
Tablettose 80
Tablettose 100
Press: Korsch EK 0, tablets: 8 mm, weight: 240 mg
23
23
Tablettose 70
Typical histogram
Tablettose 70
Mass [%]
100
90
80
70
60
50
40
30
20
10
0
0
100
500 m
200
300
400
Particle size [m]

Ph. Eur. USP-NF JP
24
24
500
600
700
Tablettose 80
Tablettose 100
Typical histogram
Tablettose 100
Mass [%]
100
90
80
70
60
50
40
30
20
10
0
0
100
200
300
400
Particle size [m]
500
600
700
200 m
200
300
400
Particle size [m]
500
600
700
25
25
Typical histogram
Tablettose 80
Mass [%]
100
90
80
70
60
50
40
30
20
10
0
0
100
500 m
FlowLac 90
FlowLac 100
Product description
FlowLac 90
FlowLac 90 is the trade name of a spraydried -lactose-monohydrate [modified]
according to Ph. Eur. USP-NF JP.
Due to its unique production process
FlowLac 90 does have almost no fines,
has an outstanding hardness yield and
a fast disintegration. FlowLac 90 can
be used therefore basically for all direct
compression formulations. This makes a
virtually dust-free production with an
optimum output possible.
Sieve data
Direct Compression

Ph. Eur. USP-NF JP

Method:
Air-jet sieving
26
26
As FlowLac 100 demonstrates an excellent

flowability and an extraordinary
compactibility it is in particular suitable for
direct compression.
Lactose type
< 32 m
< 100 m
< 200 m
< 250 m
FlowLac 90
FlowLac 100
specified/typical
specified/typical
5 %/ 2 %
10 %/ 5 %
25 40 %/ 30 %
20 45 %/ 34 %
85 %/ 92 %
80 %/ 88 %
/ 99 %
/ 98 %
Density poured
[g/l]
/600
/620
Density tapped
[g/l]
/660
/710
Application
FlowLac 90
Low to high dosage formulations
Formulations with poorly flowing active
ingredients
Chewable tablets
Capsule/sachet filling
FlowLac 100
FlowLac 100 is a spray-dried -lactosemonohydrate [Ph. Eur. USP-NF JP].
Product features
FlowLac 100
Low dosage formulations
Chewable tablets
Capsule/sachet filling
FlowLac 90
An excellent compressible excipient with
outstanding compaction profile
extraordinary for a spray-dried lactose
Fast disintegration profile extraordinary
for a spray-dried lactose
Almost no fines therefore virtually
dust free
Ideal for capsule/sachet filling due to
its excellent flowability
Typical histogram
FlowLac 90
Mass [%]
100
90
80
70
60
50
40
30
20
10
0
0
100
FlowLac 90
300 m
Flowability
Leaked mass [g]
200
300
Particle size [m]
400
500
200
300
Particle size [m]
400
500
Compactibility
Crushing force [N]
300
55
50
45
40
35
30
25
20
15
10
5
0
250
200
150
100
50
0
10
20
30 40 50
Time [s]
60
70
80
FlowLac 90
FlowLac 100
50
100
150
200
300
FlowLac 90
FlowLac 100
FlowLac 100
FlowLac 100
The spray-drying process leads to an
excellent compressible excipient
Fast disintegration through rapid
dissolution in water
Very good content uniformity of low
dosage tablets trough adhesion of active
ingredients on the porous surface
Pleasant taste and mouth feeling of
chewable tablets
Ideal features for capsule/sachet filling
by excellent flowability
250
500 m
Typical histogram
FlowLac 100
Mass [%]
100
90
80
70
60
50
40
30
20
10
0
0
100
27
27
Cellactose 80
Product description
Application
Cellactose 80 is a spray-dried compound,

consisting of 75 % -lactose-monohydrate
[Ph. Eur. USP-NF JP] and 25 % powdered
cellulose [Ph. Eur. USP-NF].
Herbal extract tablets

Chewable tablets
Mineral salt tablets
Cores for coating
Oblong tablets
This product was developed in particular

for direct compression, as it combines filler
and binder properties of its two ingredients
ideally, which allows for a simplified and
economical compaction.
LoA for DMF and MEGGLE monograph
available on request
Direct Compression
Compounds [DC
C]
Flowability
Cellactose 80
Leaked mass [g]
40
35
30
25
20
15
10
5
0
0 10 20
Sieve data
Cellactose 80
Method:
< 160 m
Air-jet sieving
< 250 m
30 40 50
Time [s]
Cellactose 80
28
28
60
70
80
specified/typical
20 %/ 9 %
35 65 %/ 56 %
80 %/ 95 %
Density poured
[g/l]
/380
Density tapped
[g/l]
/500
Product features
Good content uniformity through low
segregation tendency of the active
ingredient
Smooth surface of the resulting cores for
easy and economical coating
oating
Compaction
tion of delicate
delica active
ingredients through excellent
ingre
compressibility
Consistent tablet hardness through
constant lactose/cellulose ratio
High weight consistency at all compaction
speeds through good flowability
High degree of whiteness of tablets
200 m
Compactibility
Cellactose 80
Crushing force [N]
250
200
150
100
50
0
200
300
Particle size [m]
400
500
50
100
150
200
250
300
Compounds [DC]
Typical histogram
Cellactose 80
Mass [%]
100
90
80
70
60
50
40
30
20
10
0
0
100
Cellactose 80
Cellactose 80
29
29
MicroceLac 100
Product description
Application
MicroceLac 100 is a spray-dried

compound consisting of 75 % -lactosemonohydrate [Ph. Eur. USP-NF JP]
and 25 % microcrystalline cellulose
[Ph. Eur. USP-NF JP].
Production of small tablets

Formulations containing minerals
Oblong tablets
Formulations with high content of active
ingredients
Formulations with poor flowable,
micronized active ingredients
MicroceLac 100 is the synergistic

combination of the filler lactose and the
dry binder MCC.
LoA for DMF and MEGGLE monograph
available on request
Direct Compression
Compounds [DC
C]
Flowability
MicroceLac 100
Leaked mass [g]
45
40
35
30
25
20
15
10
5
0
0 10 20
Sieve data
MicroceLac 100
Method:
< 160 m
Air-jet sieving
< 250 m
30 40 50
Time [s]
MicroceLac 100
Erichsen funnel Mod. 321, orifice: 4 mm
30
30
60
70
80
specified/typical
15 %/ 9 %
45 70 %/ 56 %
90 %/ 96 %
Density poured
[g/l]
/500
Density tapped
[g/l]
/588
Product features
Excellent compressibility for high dosage
formulations
Low aggregation tendency guarantees
consistent flowability
Constant tablet hardnesss through fixed
ratio of lactose/MCC
actose/MCC
High weight consistency at various
compaction speeds
MicroceLac 100
200 m
Compactibility
MicroceLac 100
Crushing force [N]
250
200
150
100
50
0
200
300
Particle size [m]
400
500
50
100
150
200
250
300
Compounds [DC]
Typical histogram
MicroceLac 100
Mass [%]
100
90
80
70
60
50
40
30
20
10
0
0
100
MicroceLac 100
31
31
StarLac
Product description
StarLac is a spray-dried
compound consisting of 85 %
-lactose-monohydrate
[Ph. Eur. USP-NF JP] and
15 % GMO free white corn
starch [Ph. Eur. USP-NF].
Disintegration
StarLac
Disintegration time [s]
180
150
120
90
60
30
0
80
100
120 140
160
180
LoA for DMF and MEGGLE

monograph available on
request
StarLac was developed in
particular for direct compression. It combines a superior
flowability and compressibility
ibility
with extraordinary
ry disintegradisin
tion properties
erties.
200
220
StarLac
Physical blend
Press: Kilian types, tablets: 10 mm, weight: 320 mg,
Mg-stearate 0.5 %
Direct Compression
Compounds [DC
C]
Flowability
StarLac
Leaked mass [g]
50
45
40
35
30
25
20
15
10
5
0
0 10 20
Sieve data
StarLac
Method:
< 63 m
Air-jet sieving
< 100 m
< 160 m
< 250 m
< 315 m
30 40 50
Time [s]
60
70
specified/typical
15 %/ 7 %
/ 14 %
/ 21 %
35 65 %/ 50 %
80 %/ 90 %
/100 %
Density poured
[g/l]
/600
Density tapped
[g/l]
/680
80
StarLac
StarLac is a product co-marketed by

MEGGLE and Roquette. For further
information and availability in your
32
32
geographic region please contact your

local Roquette or MEGGLE partner.
Application
Low dosage formulations
Cores for coating
Homeopathic formulations
Product features
atures
Optimized disintegration properties
Excellent hardness yield by spray-drying
process
Excellent flowability leads to high tablet
weight uniformity
High shear stability
Excellent storage stability
Compactibility
StarLac
Crushing force [N]
250
200
150
100
50
0
200
300
Particle size [m]
400
500
50
100
150
200
250
300
Compounds [DC]
Typical histogram
StarLac
Mass [%]
100
90
80
70
60
50
40
30
20
10
0
0
100
StarLac
200 m
StarLac
33
Definition
All MEGGLE lactose complies with the corresponding
monograph -lactose-monohydrate of the European
Pharmacopoeia [Ph. Eur.]
This monograph is harmonized between Ph. Eur., USP-NF
and JP.
Characteristics
White or almost white, odorless and sweet-tasting powder.
It is free but slowly soluble in water, practically insoluble in
ether and absolute alcohol.
General Specification Lacto

ose Monohydrate
Method
Specification
Identity
Ph. Eur.
conforms
Purity
Appearance of solution
Acidity or alkalinity
Specific optical rotation
Absorbance
Ph. Eur.
Ph. Eur.
Ph. Eur.
Ph. Eur.
Heavy metals
Water
Loss on drying -lactose-monohydrate
modified -lactose-monohydrate
Sulphated ash
Ph. Eur.
conforms
< 0.4 ml: 0.1 N NaOH
54.4 55.9
400 nm: < 0.04
270 300 nm: < 0.07
200 220 nm: < 0.25
< 5 ppm
4.5 5.5 %
< 0.5 %
< 1.0 %
< 0.1 %
Microbial contamination
Total viable aerobic count
Moulds
Yeasts
Escherichia coli
Pseudomonas aeruginosa
Staphylococcus aureus
Salmonella spp.
Ph. Eur.
Ph. Eur.
Ph. Eur.
Ph. Eur.
Ph. Eur.
Ph. Eur.
Ph. Eur.
NMT 100/g
NMT 10/g
NMT 10/g
neg./10 g
neg./10 g
neg./10 g
neg./10 g
Storage
34
Ph. Eur.
Ph. Eur.
USP-NF
at room temperature in tightly

closed containers under dry and
odourfree conditions
MEGGLE worldwide
Regional Offices

Megglestrae 6 12
83512 Wasserburg
Germany
Phone +49-(0)80 71-73-4 76
Fax
+49-(0)80 71-73-3 20
MEGGLE USA Inc.

50 Main Street, 10th Floor
White Plains, NY, 10606
USA
MEGGLE Prishtina
Prishtina
Kosovo
UNMIK
MEGGLE Group Shanghai

Room 301, Block 6
Lane 289 Bisheng Road
Zhangjiang Hi-Tech Park
Pudong New Area
201204 Shanghai
China
MEGGLE Japan Co.,
Ltd Ginza 1- Chome Bldg., 11 F
15 - 4, Ginza 1- Chome/Chuo-Ku
Tokyo 104 - 0061
Japan
MEGGLE Singapore
45 Jalan Pemimpin #06 - 00
Foo Wah Industrial Building
577197
Singapore
Presented by
GB 03/09 Pe 15 Sai
Headquarters
Lactose Excipients
Excipients for Direct Compression, Granulation,
Capsules, Sachets, Pellets, Powder Blends,
Dry Powder Inhaler

Brochure Meggle Lactoses

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MEGGLE worldwide

MEGGLE Group Wasserburg

MEGGLE USA Inc.

MEGGLE Group Shanghai

To the best of our knowledge,

MEGGLE Excipients & Technology

MEGGLE Group Wasserburg

MEGGLE achieved through excellent product

As a leading manufacturer of lactose it is

Innovation and Service

Wherever your are:

Please visit our homepage:

-lactose-monohydrate Ph. Eur. USP-NF JP

Information for Direct Compression

Agglomerated Lactose [DC]

Spray-dried Lactose [DC]

Spray-dried Lactose [DC]

Excipients & Technology

Agglomerated Lactose [DC]

Coarse lactose is fractionated into products

Sieved lactose consists of mono crystals

Due to its good blending properties and

Particle size distribution < 63 m

Sieved Lactose for Dry Powder Inhaler

InhaLac attributes its unique performance

InhaLac is available in a broad spectrum

Particle size distribution

InhaLac 230 [2]

Particle size distribution [Laser diffraction]

Sieved Lactose for Dry Powder Inhaler

Sieved Lactose for Dry Powder Inhaler

Particle size distribution [Laser diffraction]

Particle size distribution [Laser diffraction]

GranuLac types and SorboLac 400

Due to its good compressibility and

Particle size distribution

Direct Compression [DC]

Tablets are the most frequently used form

Until the early sixties tablets have been

Direct Compression [DC]

The most obvious advantage of direct

The technological advantage of direct

DC compounds have been developed to:

It is generally accepted, that the spherical

With Cellactose 80 and MicroceLac 100

With StarLac the disintegration of the

Research and Development

Tablettose 70/80/100 are trade

Tablettose 70/80/100 are stable and

Agglomerated Lactose [DC]

Tablettose was especially developed for

Agglomerated Lactose [DC]

Agglomerated Lactose [DC]

Spray-dried Lactose [DC]

Particle size distribution

As FlowLac 100 demonstrates an excellent

Spray-dried Lactose [DC]

Cellactose 80 is a spray-dried compound,

Herbal extract tablets

This product was developed in particular

MicroceLac 100 is a spray-dried

Production of small tablets

MicroceLac 100 is the synergistic

LoA for DMF and MEGGLE