WJPPS 23519

WORLD JOURNAL OF PHARMACY AND PHARMACEUTICAL SCIENCES
Phoke et al. World Journal of Pharmacy and Pharmaceutical Sciences

SJIF Impact Factor 7.632
Volume 11, Issue 11, XXX-XXX Research Article ISSN 2278 – 4357
EXTRUSION- SPHERONIZATION TECHNOLOGY USED IN PELLET

FORMULATION
Phoke S. V.*1, Etther D. S.1, Ramteke C. R.1, Jaybhaye S. S.1 and Hatkar A. D.1
1
Department of Pharmaceutics, Institute of Pharmacy Badnapur, DBATU University, Jalna-
431203 (MS), India.
2
Department of Pharmacognosy, Bajiraoji Karanjekar College of Pharmacy, Sakoli Dist-
Bhandara 441802.
Article Received on ABSTRACT

09 September 2022, Pellets have been used in pharmaceutical industry for more than four
Revised on 30 Sept. 2022,
Accepted on 20 Oct. 2022 decades with beginning of controlled release technology that full
DOI: 10.20959/wjpps202211-23519 impact of inherent advantages of pellets over single dosage form has
been realized. Now day’s pelletization technology represents an
*Corresponding Author efficient pathway for manufacture of drug delivery system. There is
Phoke S. V. different pelletization and granulation techniques available to prepare
Department of drug loaded spherical particles or granules. Extrusion spheronization is
Pharmaceutics, Institute of
one of pelletization techniques and utilized in formulation of beads and
Pharmacy Badnapur,
pellets. Limitations related to bioavailability and site specific drug
DBATU University, Jalna-
431203 (MS), India. delivery can be overcome by this technique. Today this technology has
phokesandip@gmail.com gained attention because of its simple and fast processing. Compared
to single-unit dosage forms, oral multiparticulate drug-delivery
systems (e.g. pellets) offer biopharmaceutical advantages in terms of a more even and
predictable distribution and transportation in the gastro-intestinal tract. Extrusion
spheronization is widely utilized in formulation of sustained release controlled release
delivery system or modified release delivery systems. Present reviews outline manufacturing
and evaluation of pellets. Manufacturing techniques includes extrusion-spheronization have
been discussed. Characterization of pellets is discussed with reference to the particle size
distribution, surface area, porosity, density, hardness, friability and tensile strength of pellets.
KEYWORD: Pellets, Extrusion, Spheronization.
www.wjpps.com │ Vol 11, Issue 11, 2022. │ ISO 9001:2015 Certified Journal │
INTRODUCTION
Extrusion is a process used to create objects of a fixed cross-sectional profile. A material is
pushed or drawn through a die of the desired cross-section.[1] The two main advantages of
this process over other manufacturing processes are its ability to create very complex cross-
sections and work materials that are brittle, because the material only encounters compressive
and shear stresses. It also forms finished parts with an excellent surface finish. Extrusion may
be continuous (theoretically producing indefinitely long material) or semi-continuous
(producing many pieces).[1,2] The extrusion process can be done with the material hot or cold.
Hollow cavities within extruded material cannot be produced using a simple flat extrusion
die, because there would be no way to support the center barrier of the die. Instead, the die
assumes the shape of a block with depth, beginning first with a shape profile that supports the
center section. The die shape then internally changes along its length into the final shape.[1,4]
Spheronization or Marumerization is a rapid and flexible process where pharmaceutical
products are made into small spheres or spheroids. Spheronized products are relatively dense,
of a uniform in size and shape and have defined surface characteristics. The flow
characteristics of spheres make them suitable for transportation by most systems found in the
pharmaceutical industry. Spheres provide the lowest surface area to volume ratio and thus
pharmaceutical compounds can be coated with a minimum of coating material.[3,4] The
Extrusion Process is useful in several ways; it can improve the product; simplify
manufacturing processes and help to reduce costs.[2] It is well known and widely used in the
pharmaceutical industry but spheronization is becoming increasing recognized in other areas
of industrial materials handling.[2,3]
The extrusion of the product is a required step prior to spheronization. The size of the spheres
is determined by diameter of the extrudate used for the spheronization process. For e.g, in
order to obtain spheres with a diameter of 1 mm, a 1 mm screen is used on the extruder,
although spheres with a slighter bigger diameter will sometimes be obtained. In a
spheronizer, it is possible to obtain spheres with a diameter ranging from about 0.5 to 10 mm
but in practical terms the range 0.7 to 3 mm is considered normal. Larger sizes would have a
poor product appearance (not round) and a low yield of product and smaller sizes would be
difficult to extrude.[1,2,4] Extrusion & Spheronization (ES) is commonly used for the
production of pharmaceutical pellets. This four steps process consists of wet mixing,
extrusion, Spheronization, and drying/coating. The pellets are then encapsulated, tabeleted, or
dosed into sachets. Pharmaceutical pellets range in size from 0.6 to 1.2 mm. Spheronization,
also known as Marumerization (Japanese origin), is the third step in the ES process. During
this step, cylindrical extrudates (from the previous step) are converted into spheres unspended
center pieces supported from the back of the die.[3, 5, 6]
HISTORY
In 1797s, Joseph Bramah patented the first extrusion process for making lead pipe. It
involved preheating the metal and then forcing it through a die via a hand driven plunger. The
process wasn't developed until 1820s when Thomas Burr constructed the first hydraulic
powered press. At this time the process was called squirting. In 1894s, Alexander Dick
expanded the extrusion process to copper and brass alloys. Extrusion spheronization was
developed in the early 1960s as a pelletization technique. The extrusion-Spheronization
process is commonly used in the pharmaceutical industry to make uniformly sized spheroids.
It is especially useful for making dense granules with high drug loading for controlled-release
oral solid dosage forms with a minimum amount of excipients.[2, 4, 5]
PELLET FORMULATION BY EXTRUSION SPHERONIZATION TECHNIQUES[4,

6,7]
Pellets
Historically, the word pellet has been used by a number of industries to describe a variety of
agglomerates produced from diverse raw materials. In the pharmaceutical industry, pellets
can be defined as agglomerates of fine powders or granules of bulk drugs and excipients.
They consist of small, free-flowing, spherical or semi-spherical solid units, typically from
about 0.5 to 1.5 mm, and are intended usually for oral administration. The pelletized products
can improve the safety and efficacy of the active agents. These multiple-unit doses are
usually formulated in the form of suspensions, capsules or disintegrating tablets, showing a
number of advantages over the single-unit dosage system.
Pellets are small particles typically created by compressing an original material. Specific
items often termed 'pellet' include.[3]
a) Pelletizing is the industrial process used to create pellets, using a pellet mill or equipment
for extrusion and spheronization (also called marumerization)
b) Spheroids are the process for the manufacture of round and regularly sized pellets by the
process of spheronization.
THERAPEUTIC ADVANTAGES OF PELLETS MADE BY THE E.S. PROCESS[7, 8, 9]

 Easy to coat
 Separation of incompatible drugs
 Ability to mix pellets with different release rates
 Reduced risk of dose dumping
 Reduced risk of local irritation in the gastro-intestinal tract
 Less variable bio-availability
 Particles of 1mm or less behave more like liquids in terms of gastric emptying
 Even distribution over the gastro-intestinal tract
 Easy formulation and mixing of otherwise incompatible drugs.
PHYSICAL ADVANTAGES OF PELLETS MADE BY THE E.S. PROCESS[7, 8, 9]

 Improved flow characteristics
 Narrow particle size distribution (PSD)
 Uniform packing characteristics
 Dust free
 Low friability
Steps in Pellets Production by E.S. Techniques

Mixing
↓
Extrusion
↓
Spheronization
↓
Drying
Figure 1: Flowchart for production of pellets.
The extrusion-spheronization process is commonly used in the pharmaceutical industry to

make uniformly sized spheroids. It is especially useful for making dense granules with high
drug loading for controlled-release oral solid dosage forms with a minimum amount of
excipients. Steps in ES techniques as follows.
Step 1: Mixing
The ingredients are generally mixed (or granulated - the process is called granulation) in
either a high-shear granulator or a more simple planetary mixer. Mix of all ingredients is
done to get homogeneous powder dispersion or mixer using different types of mixers like
twin shell blender, high shear mixer, tumbler mixer and planetary mixer.
Step 2: Extrusion
The wet mass (or granulation) is extruded on low pressure extruders (such as Dome, Radial,
or basket extruders) to form cylindrical extrudates of a constant diameter (0.6 - 1.2 mm). The
wet mass is wiped through the screen forming soft, pliable extrudates (similar to pasta) which
break by their own weight into shorter unit. The size of the final pellets (spheres) is primarily
determined by the hole diameter of the screen (or die) used in the extrusion step. For example
in order to obtain spheres with a diameter of 1mm, a 1mm screen is used on the extruder,
although spheres with a distribution of 0.8 - 2.5 mm may sometimes be obtained.
Step 3: Spheronization
Spheronization is a batch process. Extrudates are charged to the spheronizer and falls on the
spinning plate. During the first contact of the cylindrical granules with the friction plate, the
extrudates are cut into segments with a length ranging from 1 to 1.2 times their diameter.
These segments then collide with the bowl wall and they are thrown back to the inside of the
friction plate. Centrifugal force sends the material to the outside of the disc. The action of the
material being moved causes the extrudate to be broken down into pieces of approximately
equal length related to the diameter of the extrudate. These cylindrical segments are gradually
rounded by the collisions with the bowl wall and the plate and each other. The ongoing action
of particles colliding with the wall and being thrown back to the inside of the plate creates a
“twisting rope movement” of product along the bowl wall. The continuous collision of the
particles with the wall and with the friction plate gradually converts the cylindrical segments
into spheres, provided that the extrudates are plastic (pliable) enough to allow the
deformation without being destroyed or sticking together. It is essential that this rope
movement is present for an optimal Spheronization. When the particles have reached the
desired level of sphericity, they are then discharged from the spheronizer.[10, 11]
The basic steps in converting a pharmaceutical formulation into a spheronized product:

1. The Powder Mix
2. The Plastic Mass
3. Wet Sphere
4. Coated Sphere
The Advantages of Spheronization Are Described Further Below[10, 11]


Optimum Flow and Handling Characteristics
The flow characteristics of spheres make them suitable for transportation by most systems
found in the pharmaceutical industry, including vacuum transfer.

More Reproducible Packing into Small Containers
The packing of small sphere into small containers, such as hard gelatin capsules, or larger
packages is much more convenient than other dry forms such as powders or granules.
Eliminate quality problems with variable dosage due to packaging problems with powder.

Minimum Surface Area/Volume Ratio
Spheres provide the lowest surface area to volume ratio and thus pharmaceutical compounds
can be coated with a minimum of coating material. Spheres are a dense material that can
easily be coated with a minimum of coating material.[13]

Optimum Shape for Coating and for Controlled Release
Coating can provide controlled, targeted release at different locations within the body.
Spheres are a dense material that can easily be coated with a minimum of coating material.

Easy mixing of non-compatible products
Spherical particles are easily mixed. Smooth spheres are an ideal base on which to apply a
coating.

Elimination of Dust
The elimination of dust removes the hazards and problems associated with material in this
form. Contamination is reduced. The amount of fines and dust will be reduced during
transport and handling.

Improved Hardness and Friability
Spheronization increases the hardness and reduces friability of granules.

Improved Packing of Beds and Columns
In some chemical processes porous beds or packed columns are used as chemicals reactors
and catalysts. Spherical surfaces allow the reproduction of beds with always the same volume
of void spaces. Modeling and calculations are easier when the products flow around
symmetrical bodies.
Step 4: Drying/Coating
Wet pellets are collected and dried in a vertical fluid bed drier (FBD). The FBD can also be
used to coat the pellets (using a Wurster insert) if so desired.
EXTRUSION- SPHERONIZATION EQUIPMENT[13, 14]

Extrusion Equipment
In the pharmaceutical industry, extrusion is the necessary first step in the extrusion-
spheronization process. However, extrusion is often used to eliminate dust in formulations
even when spheronization is not the final objective. The choice between gear and screen
extruders depends on the formulation characteristics and the required density of the extrudate.
Therefore, the right equipment would depend on the specific needs of application.
There are three main types of extruders

 Screw Extruders
 Screen (or Basket) Extruders
 Gear Extruders
Screw Extruders
 Commonly used in industrial applications
 Higher pressure and heat can degrade pharmaceutical products
Screen, or Basket, Extruders

 Commonly used in pharmaceutical industry
 Lower density extrudate
 Relatively high through put
Gear Extruders
 Commonly used in pharmaceutical industry
 Produces a relatively higher density extrudate
 Gentler on product
 Gears are robust and and last longer
OTHER TYPES OF EXTRUDERS [8, 13.15]

Cylinder Extruder
The cylinder type consists of two contra-rotating cylinders, one of which is solid. The second
cylinder is hollow and has a series of holes drilled through it. The material to be extruded is
fed into the area above the two cylinders and is extruded into the bore of the larger perforated
cylinder where it is cut into lengths by an adjustable cutter blade.
Radial Extruder
The radial and axial type of extruders consists of one or two feed screws that force the
material either through a circumferential screen in the radial type.
Table 1: Summarizing the Different Types of Extruders for Pharmaceutical Production

and Development.
Equipment Description Main Uses
MTR Extruder Laboratory: small quantity (10g)
MTR option
Head development use
Laboratory experimental / small scale
Extruder 20 Bench top screen extruder
production (30 g 25 kg /hr)
Lab/ Production. Low cost-high output
Extruder 35 Production screen extruder
(2kg /min) of less dense extrudate
Extruder 40 Production gear extruder Quality Extrudate Output 40-100 kg/hr
Extruder 100 Production gear extruder Quality Extrudate Output 100-500 kg/hr
Extruder 20 Models
Features
 Bench top extruder for laboratory use
 Designed for experimental work using small quantities of product
 Standard screen 1mm aperture. Other sizes available
 All contact parts in 316 stainless steel, PTFE or HDPE
 Cabinet in 304 stainless steel
 Can be quickly dismantled for easy cleaning
 Ideal extruder to use with the Multi Bowl Spheronizer
Extruder 35 Models
Features
 A flexible floor standing pharmaceutical production machine that can easily be moved.
Allows flexibility for both development and production.
 Extrusion mechanism interchangeable with the bench top Extruder 20.

 Allows confidence in Pharma process scale-up Easy to dismantle and clear allowing
efficient and flexible use.
 A cost effective solution for your various extrusion needs.
 Interchangeable screen sizes for the production of extrudate with different diameters.
 Designed for laboratory and production use
 All contact parts in 316 stainless steel, Perspex, HDPE
 Cabinet in brushed 304 stainless steel
 All product contact parts are easily removed for rapid cleaning
 GMP design
 Simple control structure requiring low operator training
 Screens with apertures of 1.5 mm, 2.5mm and customer-specific apertures available
Extruder 40 Models
Features
 All contact parts in 316 stainless steel
 Detachable extrusion gears with replaceable extrusion dies for ease of cleaning
 Suitable for most low pressure wet extrusion processes
 GMP design
 Product working capacity is suited to the Spheronizer Model 380
 Drive shafts mounted in substantial tapered roller bearings, eliminating the need for
bearings at forward end of processing area.
 Feeding manually or by auger feed.
 Applications in the pharmaceutical, chemical, agricultural, and a wide variety of other
industries.
 Special features to meet individual requirements
Extruder 100 Models

Features
 All contact parts in 316 stainless steel
 Detachable extrusion gears with replaceable extrusion dies for ease of cleaning
 Suitable for most low pressure wet extrusion processes
 GMP design
 Product working capacity is suited to the Spheronizer Model 700
 Drive shafts mounted in substantial tapered roller bearings, eliminating the need for
bearings at forward end of processing area.
 Feeding manually or by auger feed.
industries.
SPHERONIZATION EQUIPMENT[8,13.15]
Table 2: Summarizing the Different Types of Spheronizer for Pharmaceutical
Production and Development.
Equipment Description Main uses
Laboratory: small quantity
Micro Spheronizer ----
development use
Bench top Bench Top Laboratory experimental /
Spheronizer 120
Spheronizer small scale production
Lab scale bench top Lab/Production Low cost -
Spheronizer 250
Spheronizer high output
Spheronizer 380 --- Quality Spheroids Output
Spheronizer 500 --- Quality Spheroids Output
Multi Bowl Spheronizer 250 Models

Features
 Bench-top spheronizer for laboratory use designed for experimental work using small
quantities of product, or small scale production using a larger bowl.
 Select the most appropriate sized bowl for the batch you are spheronizing.
 It will easily fit on your bench-top
 Possibility of Spheronizing batches as large as 1kg down to 1g.
 Great for experimental work when only small amounts of material are available.
 Can be used for small-scale clinical trial production with 250mm bowl.
 Buy components as you need them.
 Easy clean design features
 Contact parts in 316 stainless steel and FDA approved plastics.

 Cabinet in 304 stainless steel.
 Designed for the pharmaceutical industry.
 60mm and 85mm diameter inserts made of 316 stainless steel and FDA approved plastics
are available.
 Other types of disks, such as discs with a "radial” pattern (for a gentler spheronizing
action) and disks with special coatings are available.
applications.
 The Multi-Bowl Spheronizer is designed to work in conjunction with the Screen Extruder
20 and the Mini-Screw Extruder.
Spheronizer 380 Models

Features
 Designed for the production of smooth, regular spheroids.
 A robust production machine small enough for development work.
 Compact size that is easily transportable between locations.
 Convenient batch size from 0.5kg to 4kg.
 Spheroid or pellet production can be greater than 40kg per hour.
 A full range of options available including fully automatic operation.
 Suitable for the pharmaceutical industry.
 Main seal area fitted with compressed air inlet to minimize ingress of dust
 Quickly detachable main product discharge chute.
 GMP design
Spheronizer 500 Models

Features
 Designed for the production of smooth, regular spheroids.
 A robust production machine small enough for development work.
 Compact size that is easily transportable between locations.
 Convenient batch size from 1kg to 11kg.
 Spheroid or pellet production can be greater than 40 kg per hour.
 A full range of options available including fully automatic operation.

 Contact parts in 316 stainless steel, Cabinet in 304 Stainless Steel.
 Suitable for the pharmaceutical industry.
 Main seal area fitted with compressed air inlet to minimize ingress of dust
 Quickly detachable main product discharge chute.
 GMP design
KEY FACTORS
Machine Parameters
In principle the basic machine consists of a round disc with rotating drive shaft, spinning at
high speed at the bottom of a cylindrical bowl. The spinning friction plate has a carefully
designed groove pattern to the base. This is most often cross-hatched, several sizes and other
types available. These discs are designed to increase the friction with the product.
Spheronisation equipment is available from several manufacturers.[5, 17, 16]
Friction plate pattern

The most common groove pattern used for spheroniser discs is the “waffle-iron” or cross-
hatch design, where the friction plate is like a chessboard of chopped-off pyramids.[17] The
choice of which disc type and size to use is rather empirical. Discs with a radial design are
also used, as these are considered gentler on the material being spheronised.[5, 13, 17]
Friction plate speed

The typical rotation speed of a 700 mm diameter disc ranges from 400 to 500 rpm. The
higher the speed, the more energy is put into the particle during a collision. The optimum
speed depends on the characteristics of the product being used and the particle size. In
general, smaller discs require a high speed while bigger discs require lower speeds. In
practice the optimum speed can be determined from experience and systematic testing. For
some products it might be recommendable to start at a high speed and to lower the speed in
the final stage of the process. But again this can be determined by simple practical tests. The
process allows a high degree of flexibility for most materials.[13, 17, 18]
Retention Time
Typical Spheronization retention times to obtain spheres range from 2 to 6 minutes. As with
speed this is relatively easy to determine and best obtained by simple trials with specific
products. For some products, the strong cohesive forces in the extrudate prevent the extrudate
from breaking up into smaller pieces. If the objective is to reduce dust and not necessarily
obtain perfect spheres than the short contact with the friction plate is sufficient to break the
long extrudate into small segments and round the edges. The edges of cylindrical granules are
the most fragile part and they will generate dust during handling and transportation.
Spheronisation with a short retention time can help to reduce this amount of dust
significantly.[3, 7, 13, 18]
The charge volume

The optimum level depends upon the machine size and the product characteristics; there is an
optimum quantity of product to be charged per batch into the spheroniser chamber that will
produce the most narrow particle distribution and the best spheres. Increasing the load per
batch increases the hardness of the spheres and smooths the granule surface.[13, 18]
Product parameters[20]
The result obtained in the spheroniser depends on the rheology of the product. The particles
must have enough plasticity to allow deformation under the impact they receive during the
spheronization process, but also must be strong enough to withstand the collisions with the
friction plate, each other and bowl wall without being broken up and destroyed.
 The rheology of the product can be changed by varying the formulation (excipients, API
level, moisture), or physically (mixing time, type of mixer, intensity of mxing).
 Binders can be used to increase the strength of the granules and reduce the amount of
fines generated during the spheronisation. If too much binder is added and the granules
can become too hard, it will be difficult to obtain good spheres.
 Lubricants will increase the plasticity but may also increase the amount of fines generated
during spheronisation.
 Water can also be used as a lubricant. If too much water is used, sticking can occur on the
friction plate and bowl wall. It can also happen that the granules will
 Stick together, forming big lumps. If the extrudate are too dry, a high amount of fines will
be generated. The optimum moisture content for spheronisation is slightly less than for
extrusion only.
AUXILIARY EQUIPMENT[20]
Water jacket
Warm or cooling water can be introduced in a jacket. Warm water can be particularly useful
on the chamber wall to drive off moisture that would cause product sticking on that wall.
Cooling the wall will avoid temperature rises in heat sensitive products, although, the average
temperature rise in a spheroniser is generally rather small (normally about 4°C).
Air introduction (Fines air)

A slight flow of air can be introduced in the chamber from under the friction plate this not
only prevents dust from getting between the rotating plate and the wall of the chamber but
also can help to remove moisture from the granule’s surface, improving the friction forces
and the process efficiency.
Non-Stick Coatings
For some products, the chamber wall and the spheronisation plate can be coated with non-
stick materials if this is necessary for ease of use with sticky materials or cleaning.
CHARACTERIZATION OF PELLETS
Particle size distribution
Particle size distribution should be as narrow as possible. That will ensure minimum variation
in coating thickness; facilitate blending process if blending of different types of pellets is
required. Sieve analysis using sieve shaker is the most widely used method for measuring
particle size distribution.[6] Microscopy is direct method for determining particle size
distribution. Optical microscopy and scanning electron microscope are used to measure the
diameter of pellets.[7, 8]
Surface area
The characteristics of pellets, those controlling the surface area, are mainly size, shape,
porosity and surface roughness.[4] There are three methods of measuring the surface area of
pellets. It can be calculated from the particle-size distribution by measuring/using the mean
diameter, since the surface area is equal to πd2. However, this calculation does not account
for the contributions of the surface area arising from other morphologic characteristics, such
as porosity, surface roughness and shape of the pellets. Therefore, two techniques, i.e. gas
adsorption and air permeability, permit direct calculation of surface area. Air permeability
methods are widely used pharmaceutically for specific surface measurement, especially to
control batch to batch variations.[5] The principle resistance to the flow of a Fluid such as air
through a plug of compacted material is the surface area of the material. The gas adsorption
method (commonly known as the BET method) was developed by Brunauer, Emmett and
Teller (1937).[6] In this method the volume of nitrogen that is absorbed by the substrate
contained in an evacuated glass bulb is measured at different pressures, and the results are
plotted as P/V (p0-p) versus p/p0 to generate a linear plot where V is the volume of gas in
cm3 adsorbed per gram of substrate at pressure p and p0 is the saturation vapour pressure of
liquefied nitrogen at the temperature of the experiment. The slope and intercept of the plot
yield the values b and Vm. The specific surface (sw) of the pellets is then obtained by using
the following equation.
SW = 4.35 * Vm
Porosity
The porosity of pellets influences the rate of release of drugs from the pellets by affecting the
capillary action of the dissolved drug. The porosity of the pellets can be measured
qualitatively by scanning electron microscopy (SEM) and quantitatively by mercury
porosimetry.[7] The porosity of pellets can be determined quantitatively also by using optical
microscopy and scanning electron microscopy together with image.[8]
Density
The density of pellets can be affected by changes in the formulation and/or process, which
may affects other processes or factors, such as capsule filling, coating, and mixing. The bulk
density of the pellets can be measured by an automated tapper. True density indicates the
extent of densification or compactness of substances. The true density Allenki et al. /
Pelletization Techniques for Oral Drug Delivery of pellets can be determined by an air-
comparison pycnometer, a helium pycnometer or by the solvent displacement method.
Hardness and Friability

Hardness and friability determination of pellets is necessary because the pellets have to
withstand during handling, shipping, storage and other processing such as coating. The
instrument such as the Kaul pellet hardness tester provide relative harness values and
friability of pellets are determined by using Erkewa type tablet friabilator or turbula mixer for
a fixed period of time combined with glass beads of certain diameter in order to generate
abrasion. Friability can also be determined using fluidized bed with Wurster insert by using
stream of air.[20]
Tensile Strength
The tensile strength of the pellets is determined by using tensile apparatus with a 5 kg load
cell, the pellets are strained until failure occurs. The load is recorded and the tensile strength
is calculated applying the value for the failure load and the radius of the pellets.
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WORLD JOURNAL OF PHARMACY AND PHARMACEUTICAL SCIENCES

Phoke et al. World Journal of Pharmacy and Pharmaceutical Sciences

EXTRUSION- SPHERONIZATION TECHNOLOGY USED IN PELLET

Article Received on ABSTRACT

KEYWORD: Pellets, Extrusion, Spheronization.

PELLET FORMULATION BY EXTRUSION SPHERONIZATION TECHNIQUES[4,

THERAPEUTIC ADVANTAGES OF PELLETS MADE BY THE E.S. PROCESS[7, 8, 9]

PHYSICAL ADVANTAGES OF PELLETS MADE BY THE E.S. PROCESS[7, 8, 9]

Steps in Pellets Production by E.S. Techniques

The extrusion-spheronization process is commonly used in the pharmaceutical industry to

The basic steps in converting a pharmaceutical formulation into a spheronized product:

The Advantages of Spheronization Are Described Further Below[10, 11]

EXTRUSION- SPHERONIZATION EQUIPMENT[13, 14]

There are three main types of extruders

Screen, or Basket, Extruders

OTHER TYPES OF EXTRUDERS [8, 13.15]

Table 1: Summarizing the Different Types of Extruders for Pharmaceutical Production

 Extrusion mechanism interchangeable with the bench top Extruder 20.

Extruder 100 Models

Multi Bowl Spheronizer 250 Models

 Contact parts in 316 stainless steel and FDA approved plastics.

Spheronizer 380 Models

Spheronizer 500 Models

 A full range of options available including fully automatic operation.

Friction plate pattern

Friction plate speed

The charge volume

Air introduction (Fines air)

Hardness and Friability

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