International Journal of Pharma Sciences

Vol. 5, No. 4 (2015): 1144-1154

Review Article
Open Access

ISSN: 2320-6810

Recent advances in Granulation technologies

Vanya Vashisht, Keerti Jain, Sumandeep Kaur and Neelesh Kumar Mehra*
Pharmaceutical Nanotechnology Research Laboratory, ISF College of Pharmacy, Moga- 142001 INDIA.

* Corresponding author: Neelesh Kumar Mehra, e-mail: neelesh81mph@gmail.com

Received: 22 May 2015

Accepted: 02 July 2015

Online: 06 July 2015

ABSTRACT

Granulation is a key unit opration in the production of pharmaceutical dosage forms like tablets and capsules.
Granulation process improves flow, compressibility and content uniformity of the powders. It prevents the
separation of blend components and eliminates excessive amount of fine particles. The technique helps to achieve
improved yields with less tablet defects, high productivity alongwith reduced down time. Pharmaceutical granules
usually range from 0.2 and 4.00 mm in size, depending on their use. Particle size depends on the quantity and
feeding rate of the granulating liquid. Selecting a method requires comprehensive study of each ingredient in the
formula, the combination of ingredients and their compatibility with each other is checked after, which
appropriate granulation process can be applied. The recent technologies used for granulation include steam
granulation, moisture activated dry granulation (MADG), moist granulation technique (MGT), thermal adhesion
granulation process (TAGP) and foam granulation etc. have their own advantages and overcome the disadvantages
of conventional granulation process such as dust generation or deteriorating effect of heat as drying step. The
objective of present work is to focus on the novel granulation technologies.

Keywords: Granulation, tablets, spheronization, flow properties, content uniformity.

1. INTRODUCTION

Granules is defined as primary powder particles get

adhere and form larger multi-particles entities having
size range from 0.2 and 4.0 nm and mainly depend
upon the use of granules.
Mostly during the production of tablets and capsules,
when the granules will be made as an intermediate
product and have a typical size range between 0.2 to
0.5 mm, whereas larger granules are used as a dosage
form in their own right. Granulation generally
commences after initial dry mixing of the necessary
powdered ingredients so that a uniform distribution of
each ingredient through the mix is achieved [1].
1.1 Reasons for granulation:
1. To prevent segregation of the constituents of the
powder mix: Segregation or de-mixing is due to the
differences in the size or density of the components
of the mix, the smaller particles or denser particles
concentrating at the base of a container with the
large particle or more dense particles above them. In
order to have an ideal granulation all the
constituents of the mix are in correct proportion in
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each granule and segregation of the ingredients will

not occur. It is necessary to control the particle size
distribution of the granules because although the
individual components might not segregate
themselves, if there is a wide size distribution, the
granules will get segregated by themselves. If this
occurs in the hoppers of machines like sachet-filling,
capsule- filling or tablet machines, products
obtained will have large weight variations. The
reason behind this is that these machines fill by
volume rather than weight and if different regions in
the hopper contain granules of different sizes
(thereby bulk density), a given volume in each
region will have variation in weight of granules. This
leads to an unacceptable distribution of the drug
content within the batch of finished product even if
the drug has been evenly distributed, weight by
weight, through the granules [2].
2. To improve the flow properties of the mix: Large
number of powders, because of their small size and
irregular shape or surface characters, are cohesive
and do not flow well. Poor flow often results in a
wide weight variation within the final product due to
variable fill of tablet dies, etc. The granules will be
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larger and more diametric when produced from

such a cohesive system [2].
3. Improvisation of the compaction characters of
the mix: The primary powder particles are difficult
to compress even though a readily compactable
adhesive has been included in the mix but granules
of the same formulation are often more easily
compacted and produce stronger tablets. Mostly the
solute migration which occurs during the post
granulation drying stage results in a binder rich
outer layer to the granules. This leads to the direct
binder-binder bonding that helps in the
consolidation of the weak bonding materials [2].
4. Other reasons:
Granulation process is helpful to minimizing the
hazards associated with toxic dust particles during
handling, transporting of powders, thus precaution
should be taken.
Granules are generally occupy less volume per unit
weight and more denser than the powder mix, thus
more convenient for storage and shipment.
Granulation technique helps adhesion and cake
formation of hygroscopic materials. This occurs
because the granules will be able to absorb some
moisture and still retain the flow-ability because of
their size [2].
1.2 Methods of granulation:
1. Dry Granulation or Compression Granulation:
This technique involves the compaction of the
components of a tablet formulation by means of a
tablet press or with the help of specially designed
machinery which is followed by milling and
screening before the final compression into a
tablet. This process is used for drugs which are
sensitive to heat, moisture or both of which
precludes wet granulation. In this dry method, the
primary particles are aggregated at high pressure
as is shown in the figure given below.
It is done by two processes; either a heavy duty
tabletting press produces a large tablet or the powder
is squeezed between the two rollers and a sheet of
material is produced. In both the cases these
intermediate products are broken using a suitable
milling technique to produce a granular material which
is usually sieved in order to separate the desired size
fraction [3-5].
2. Wet Granulation Method: This technique involves
the massing of dry primary powder particles using
a granulating fluid. This fluid consists of a solvent
which must be volatile so that it can easily vaporize
and should be non toxic. If the powder is wetted
during the initial stage, liquid films will be formed
on their surface which might combine to produce
liquid bridges at the point of contact. The surface
tension and negative capillary pressure in such
bridges provide a cohesive force and result in a
condition called the pendular state, which has low
mechanical strength. As the liquid content
increases it leads to funicular state; further
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capillary state and droplet state. Typical liquids

which are used as granulating liquid can be water,
ethanol or isopropanol either alone or in
combination. The granulating fluid might be used
alone or more usually as a solvent containing a
dissolved adhesive which is used to ensure particle
adhesion once the granules are dry [4-5].
Water is usually used for the economical and ecological
reasons. The drawback of using it is that it might
adversely affect the drug stability thereby leading to
hydrolysis of susceptible products and it needs a longer
drying time than organic solvents. The long drying time
also increases the length of the process and therefore
might affect stability because of the extended exposure
to heat.
The advantage of using water is that it is nonflammable which means that there is no need of using
expensive safety precautions such as the use of flame
proof equipment.
1.3 Important steps which have been involved in
the wet granulation include:
1. Mixing of the drug(s) and excipients
2. Preparation of binder solution
3. Mixing of binder solution with powder mixture
to form wet mass
4. Coarse screening of wet mass using a suitable
sieve (6-12 # screens)
5. Drying of moist granules
6. Screening of dry granules through a suitable
sieve (14-20 # screen)
7. Mixing of screened granules with help of
disintegrant and glidant.
1.4 Ideal characteristics of the granules:
These include spherical shape, smaller particle size
distribution with sufficient fines to fill void spaces
between granules, adequate moisture (between 1-2%)
good flow, good compressibility and sufficient
hardness.
1.5 The granulation effectiveness depends on the
following properties [7].
Particle size of the drug as well as excipients
Type of the binder (strong or weak)
Volume of binder (less or more)
Wet massing time (less or more)
Amount of shear applied
Drying rate (hydrate formation and polymorphism)
1.6 Types of Wet Granulation:
i.
High shear mixture granulation
ii.
Fluid bed granulation
iii.
Extrusion- Spheronization
iv.
Spray drying
i.
High Shear Mixture Granulation: It has been
widely used in various pharmaceutical industries for
blending and granulation (Figure 2) [5,6,8,9].
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Wet aggregation in a high shear mixer involves 3

stages:
Dry powder mixing (for 2-5 minutes)
Liquid binder addition(1-2 minutes)

Compound(1)
MCC (internal phase)
Crosspovidon

Wet massing
Advantage of this technique is that even very highly
cohesive material can also be granulated.

Pre- blended

Roll- compaction
Crosspovidon
Acrosil 200 pH
MCC (external
phase)

Sieving
Blend

Magnesium
stearate
Color
coating

Sieve
(20
mesh)
Compaction

Blend
30 revolutions

Final blend

Final color coated compound (1)

Figure.1: Flow diagram of dry granulation.

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Figure 2: High Shear Granulator.

ii.
Fluid bed Granulation: it is a process with the
help of which granules can be produced by spraying
a binder solution onto a fluidized powder bed .The
figure depicting it is given below. The materials that
are processes by using this technique are free
flowing and homogeneous [9].

Advantages:
It helps to reduce the product loss.
It also is helpful in improving worker safety.
Disadvantages:
The cleaning process is labor intensive and
time consuming.
Difficulty in assuring reproducibility.

Figure 3: Processing of Fluidized Bed Granulator.

iii.
Extrusion- Spheronization: This is used as a
method to produce multi-particulates for controlled
release application. A multiple step process which
involves 5 steps those are capable of making
uniform sized spherical particles. The equipment
used for spheronization is given in the figure 4.
Steps
Dry mixing of materials of achieves
homogeneous dispersion.
Wet granulation of the resulting mixture to
form wet mass.
The extrusion of wet mass to form rod
shaped particles.
The rounding of the particles in
spheronizer.
Drying of the round particles.

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These dried particles are then screened I order to

achieve a targeted mean size distribution [5, 10].
Advantages:
More than two active agents can be easily
combined in any ratio in the same unit.
Various physical characteristics of the
ingredients and excipients can also be
modified but using this technique.
It helps in producing the particles with
high bulk density, low hygroscopicity, high
spherocity, dust free, narrow particle size
distribution and smoother surface.
Disadvantages:
This process is more laborious and time
consuming as compared to other
granulation techniques [11].

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Figure 4: Spheronization (Pellet formation) technique and Spheronizer

iv.
Spray Drying: (Figure 5)
This process has been divided in three stages:
o Atomization of a liquid feed into fine
droplets.
o The mixing of spray droplets with a heated
gas streams allows the liquid to evaporate
and leave behind the dried solids.
o The dried powder is separated from the
gas stream [5].
Advantages:

It is a very rapid and continuous

process.
It helps in the overall cost reduction
by avoiding the labour intensive
drying and the granulation steps.
It helps in minimal product handling
and operator exposure to dust.
It is suitable for heat sensitive product.

Figure 5: Method for spray drying of granules.

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1.7
Novel Granulation Technologies [5]:
Pneumatic Dry Granulation: This is a novel
drug method for automatic or semi-automatic
production of granules. It enables the flexible
modification
of
drug
load
alongwith
disintegration time and tablet hardness [4].
The PDG Technology enables the production of
porous granules having excellent compressibility
and flow ability characteristics.
The pneumatic dry granulation process is
capable
of
granulating
virtually
any
pharmaceutical solid dosage ingredient.
The granulated material produced has good
flow-ability and compressibility properties.
PDG Technology has been used with superior
results in development of tablets having fastrelease, controlled release along with fixed-dose,
and orally disintegrating tablets.
The technology can be used for practically any
solid dosage pharmaceutical product.
PDG technology can achieve:
o High drug loading, even with difficult APIs
and combinations
o Taste masking
o Excellent stability
Nowadays, wet granulation is the most commonly used.
This
process
can
granulate
virtually
any
pharmaceutical solid dosage ingredient. Granulated
materials possess exceptionally good flow-ability and
compressibility properties. This technology is used for
the development of tablets with fast and controlledrelease along-with fixed dose and orally disintegrating
tablets. PDG has replaced wet granulation technique.
The comparison between the PDG technology and wet
granulation is given in figure 6.

PDG
Technology

Mixing

Pneumatic
Dry
Granulation
Compression

Issues with wet granulation:

It is unsuitable for various moisture and heat
sensitive drugs.
It is more expensive and requires intense labor
and therefore can take a long time.
This process requires a large number of
process steps and each step requires
qualification, cleaning and cleaning validation,
high material losses which can be incurred
because of the transfer between stages,
thereby leading to long drying times.
Advantages of PDG Technology:
It is helpful in good granulation even at high
loading with materials that have been known
to be difficult to handle.
The speed of the manufacturing is faster than
the wet granulation technique.
The cost of the manufactured product is less
than the cost of product manufactured by wet
granulation.
The system used is closed which offers safety
advantages due to low dust levels and provides
potential for sterile production or handling of
toxic materials.
The end products formed by using this
technique are very stable and their shelf life
can be enhanced.
There is little or no waste of material; scale up
is straight forward.
Tablets and granules that have been produced
by this technique are disintegrated rapidly,
offering fast releasing dosage forms.
The release time can be controlled as per the
requirements.

Wet
Granula
tion

Mixing
Wet
Granulation

Wet Milling
Drying
Mixing
Compression

Figure 6: Comparison between Pneumatic Dry Granulation and Wet granulation.

Freeze Granulation Technology: This

technique has been adopted by Swedish Ceramic
Institute (SCI) which enables preservation of the
homogeneity from suspension to dry granules. A
powder suspension is sprayed into liquid nitrogen,
the granules are frozen instantaneously. In a
subsequent freeze-drying the granules are dried by
using sublimation of the ice without any segregation
effects as in case of conventional drying in air. The
resulting granules will be spherical and free flowing
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with optimal homogeneity (Figure.7).

This
technique helps in easy crushing to homogeneous
and dense powder compacts in processing operation
[5].
Advantages:
Control of granule density by the solid content of
the suspension.
Serious oxidation of non-oxides and metals is
prevented by mild drying.
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Granules have no cavities.

There is low material waste (high yield)
Small (50-100 ml suspension) as well as large
granule quantities can be produced to equal
quality.
The equipment is easily cleaned and latex binder
can be used for cleaning.

Recycling of the organic solvents is possible.

Typical ceramic powders: Oxides (aluminium oxides,

silicon oxide), nitrides (Si3N4) and carbides (SiC), but
also nano powders, diamonds and pharmaceuticals like
proteins and enzymes.

Figure 7: Freeze drying Granulation.

Foamed Binder Technologies (FBT): FBT

from the Dow Chemical company helps in achieving
faster, simpler and safer wet granulation. This
technique uses METHOCEL polymers and greatly
improves binder distribution in the formulation mix
and yields a remarkable array of processing
advantages. It helps in reducing water
requirements, improves reproducibility. It helps in
eliminating spray nozzles and their many variables
in granulation processing equipment.
One can very easily use it with familiar high shear, low
shear, or fluid bed granulation equipment, in both
laboratory and production scale settings. Our
evaluation also shows it yields familiar metrics for
particle size distributions, solid dose physical
properties and dissolution profiles.
Working: It gives advantage of tremendous increase in
the liquid surface area and volume of polymeric binder
foams to improve the distribution of the water or

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binder system throughout the powder bed of

pharmaceutical formulation of solid dose (Figure. 8)
A simple foam generation apparatus is generally used
in order to incorporate air into conventional water soluble polymeric excipients binders such as
METHOCEL hypromellose (hydroxyl propyl methyl
cellulose). This results in foam which has a consistency
like shaving cream. The ideal candidates for this
technology are hypromellose polymers because they
are excellent film formers and create exceptionally
stable foams. The foam generator can also be directly
connected to high shear, low shear or fluid bed
granulation equipment. Extremely efficient binder
delivery and particle coverage: Foamed binders offers
much bigger surface area, they spread very rapidly and
evenly over powder surface. The binder has a low soak:
spread ratio, so the particle surfaces are quickly and
completely covered. Spraying is a cumulative process
which begins with dappling particle surfaces until
enough binder liquid accumulates to initiate particle
agglomeration [5, 10, 12].
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Figure 8: Foamed Binder.

Melt Granulation Technology: This is technique

with the help of which granules are obtained
through the addition of either a molten binder or a
solid binder which melts during the process. This
method is also called melt agglomeration and
thermoplastic granulation [5,14-15].
Principles of melt granulation:
This granulation process consists of three different
phases:
Wetting and nucleation
Coalescence step
Attrition and breakage
Wetting and nucleation stage:
In this stage, the binder comes in contact with the
powder bed and liquid bridges are formed which leads
to the formation of small agglomerates.
Two nucleation mechanisms used are:

Immersion
Distribution

Immersion:
When the size of molten binder droplets is
greater than that of fine solid particles, it leads
to nucleation.
This process proceeds by depositing fine solid
particles onto the surfaces of molten binder
droplets.
Distribution:
The molten binding liquid is distributed onto
the surfaces of fine solid particles.
The collision of the wetted particles leads to
nuclei formation.
Smaller the binder droplet size, low binder
viscosity and high shearing forces are favorable
conditions for nucleation by distribution
method.

Figure 9: Modes of distribution.

Coalescence steps:
It involves the nuclei that have residual surface
liquid to promote successful fusion of nuclei.
Plasticity to the nuclei is imparted to the surface
liquid which is necessary for the deformation of
nuclei surface for coalescence as well as
promoting the rounding of granulation.
Attrition- breakage step:
This is the phenomenon of granulation
fragmentation in that are solidified by tray
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cooling to ambient temperature without the

need for drying by a tumbling process.
Breakage plays an essential role by affecting the
properties of melt granulation during the
granulation phase.

Requirements of melt granulation:

10-30% w/w of meltable binder with respect to
that of fine particles is generally used.
Meltable binder used in this has a melting point
within a range of 50-100C.
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For immediate release dosage forms, hydrophilic

molecules are used while for prolonged release
dosage forms, hydrophobic molecules are used.
Melting point of fine particles used should be at
least 20C higher than that of the maximum
processing temperature.

Meltable binders:
1. Meltable binders should be solid at room
temperature and the melting point should lie
between 40 to 60 C.
2. The HLB value of the binder should ensure
correct release of the active ingredient.

Requirements for meltable binders:

It should be solid at room temperature and has
melting point ranging from 10 and 80 degree
Celsius.
These binders should be physically and
chemically stable.
HLB should ensure the correct release of active
substance.
There are two types of meltable binders:
Hydrophilic meltable binders
Hydrophobic meltable binders

Advantages:
No solvent is used and the processing steps
needed are fewer thereby eliminating the time
consuming drying steps.
There is uniform dispersion of fine particles and
it offers good stability at varying pH and
moisture.
They can be applied safely in humans due to
their non swellable and water insoluble nature
[5].

Table 1: List of Binders.

Hydrophilic meltable binders generally used in
the melt granulation technique

Hydrophilic Meltable Binder Typical Melting Range

(C)

Gelucire 50/13
Poloxamer 188
Polyethylene glycols :
PEG 2000
PEG 3000
PEG 6000
PEG 8000

44 50
50.9
42 53
48 63
49 63
54 63

Figure 10: Steam Granulation Technology

Steam Granulation Technology: This technique

is a modification of wet granulation. We use steam
as binder instead of water. Pure steam is a
transparent gas. At a standard temperature and
pressure (mixed with air, but in equilibrium with
liquid water) it occupies about 1600 times volume
of an equal mass of liquid water. The granulation
of particles involves the injection of appropriate
amount of liquid in the form of steam.
This steam injection method employs the use of
steam at 150 degree Celsius and tends to produce
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local overheating and excessive wetting of

particles in the vicinity of steam nozzles, thereby
causing the formation of lumps in the granulated
product.
Advantages:
1. Higher distribution uniformity and
diffusion rate into powders.
2. The granules are more spherical and have
large surface area which increases the
dissolution rate of drug from the granules.
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3.
4.
5.
6.

Short processing time and use of water

vapor makes it an environmental friendly
technique.
It maintains sterility and can control the
total microorganism count.
Regulatory compliance.
No health hazards to the operator.

Disadvantages [5,10]
1. Special equipment is needed for steam
generation.
2. High energy output is needed.
3. It is not suitable for thermolabile
materials.
4. More safety measures are required in this
technology.
5. It is not suitable for all types of binders.
Moisture Activated by Dry Granulation
(MADG): This technology is also called Single pot
granulation.
1. Moisture is used in order to activate the granules
formation but the granule drying process is not
necessary due to moisture absorbing material
such as microcrystalline cellulose.
2. This method consists of two steps, wet
agglomeration of powder mixture followed by
moisture absorption stages.
3. 1-4% water is added first in order to agglomerate
the mixture of API, a binder and excipients.
Moisture absorbing material such as MCC along
with potato starch is added to absorb the excess
amount of moisture.
4. After the lubricant has been mixed, the mixture
obtained can be compressed directly into the
tablets. Hence, this process offers several
advantages of wet granulation.
FMC Biopolymer has introduced two new excipients to
the pharma market:
1. Avicel HFE- 102
2. Avicel PH- 200LM
These products have been generated to produce a
different entity with improved benefits.
Avicel PH-200LM, based on MCC is used to ensure the
removal of excess amount of moisture during
granulation process.
Advantages:
1. Very little granulating fluid is used.
2. Drying time is reduced and the granules
produced have good flow ability.
3. Single production equipment such as high shear
granulator is used.
4. No equipment change and lower tablet capping.
5. No over and under granulation.
6. It is applicable for developing a controlled
released formulation.
Disadvantages:
1. Moisture sensitive materials and high moisture
absorbing API cannot be used.
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2.

The formulations with high drug loading are

very difficult to develop [5].

Thermal Adhesion Granulation Process

(TAGP): It is helpful in preparing tabletting
formulations. This process is performed under low
moisture
content
or
low
content
of
pharmaceutically acceptable solvent by subjecting
a mixture containing one or more diluents and
active ingredients; a binder; optionally a disintegrant to heat at a temperature ranging from 30
degree to 130C in a closed system under mixing
by tumble rotation until the formation of the
granules takes place.
It uses less water than the wet granulation method. It
provides granules with very good flow properties and
binding capacity to form tablets which have low
friability with adequate hardness and have a high
uptake capacity for active substances whose tabletting
is poor. Drying and milling to form desired granules are
unnecessary in the present invention due to low
amount of moisture introduced to the tabletting
mixture. After cooling and screening, granules of
required particle size can be obtained. It also helps to
minimize the generation of dust particles during the
processing. This technique serves to contain finepowder active ingredients whose spread or loss from
system is not desirable due to their cost or biological
activity [8,16].
TOPO Technology: HERMES PHARMA has
developed a unique technology for carrying out
single pot granulation. This process requires a
very small quantity of liquid to start the chain
reaction. Pure water or water-ethanol mixtures
are used.
TOPO Technology produces granules for tablets which
at least contains one solid crystalline, an organic acid
and one alkaline or alkaline earth metal carbonate that
reacts with the organic acid in aqueous solution to form
carbon dioxide. As a result there are no solvent
residues in the finished products; granules have
excellent hardness and stability. TOPO Granulator was
employed for producing effervescent tablets following
TOPO vacuum granulation technology, patented by
Hermes Pharma. It involves granulation under vacuum
to prevent uncontrolled chain reaction [8].
Continuous Flow Technology: This method
does not require any liquid to start the chain
reaction. In this case granulation is carried out in
an inclined drum into which powder is fed at one
end and granulate is removed at the other. The
process produces granule with surface protected
by inactive component that do not harm the
sensitive API. CF technology can produce upto 12
tons of granules every day.
Advantages:
1. Sensitive APIs are protected.
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2.
3.
4.

Granules and effervescent become less sensitive

to humidity and high temperature.
Granules form extremely stable products.
No solvent residues in the final products [5].

Granulex Technology: This method performs

both coating and powder layering process.
Multiple coating and powder layers indicate the
accuracy and control of a granulex rotor process,
including the creation of non-pareil.
Key-Features: Unique, Efficient granulation processes.
Granules produced are dense and spherical in shape.
One Pot Processing: It has the ability of drying the
product in the same processing chamber. This method
in combination with 12 bar construction provides a
true one pot system which is ideal for manufacturing of
highly potent and expensive pharmaceutical
compounds.
Increased batch capacities: The patented conical rotor
plate increases batch capacities when compared to
traditional rotor processes. The precision machined
gap contains the product within the processing area
and peripheral spray guns are embedded inside the
product and this
provides accurate coating with
minimal spraying defects.
Maximum Process Flexibility: Using micronized
acetaminophen as the base material, the granurex
produced both a 100m and a 200m spherical bead.

2.
3.

5.
6.
7.
8.
9.

10.
11.
12.

13.
14.
15.
16.

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