Theory Industrial Pharmacy-I [PY3CO19T]

Odd Semester (Aug-Dec 2021)

Unit –III (Pellets)

Sourabh Billore
Faculty of Pharmacy
E mail: Sourabh.Billore@medicaps.ac.in
Introduction
Pelletization can be defined as an agglomeration (size-enlargment) process that converts
fi ne powders or particles of bulk drugs and excipients into small, free-fl owing, more
or less spherical units, called pellets .

Granulation is also known as pelletization, agglomeration or spheronization, and the

units obtained are referred to as granules, pellets, agglomerates or spheroids

Sourabh Billore Sourabh.billore@medicaps.ac.in

Sourabh.billore@medicaps.ac.in Medi-Caps University, Indore
Sourabh.billore@medicaps.ac.in Medi-Caps University, Indore
Generally, if a size-enlargement process produces agglomerates of a size distribution
within the range of 0.1 to 2.0 mm and a high porosity (about 20-50%), the process may
be called “granulation”, and the resulting agglomerates are called “granulates”.

“Pelletization” is often referred to as a size-enlargement process that involves the

manufacture of agglomerates with a relatively narrow size range, usually with mean
size from 0.5 to 2.0 mm, named “pellets”. Pellets have free-fl owing properties and a
low porosity (about 10 %).

Sourabh.billore@medicaps.ac.in Medi-Caps University, Indore

Currently, pellets containing the active ingredients are administered in the form
of suspensions, capsules or tablets,

Also, pelletization is used in various industries, such as agriculture (fertilizers

and herbicides), mineral processing (iron ore pelletization), food and detergent
industry.

Sourabh.billore@medicaps.ac.in Medi-Caps University, Indore

REƒSONS FOR PELLETIZATION
1. prevention of segregation of co-agglomerated components, resulting in an
improvement of the uniformity of the content.

2. prevention of dust formation

3. increasing bulk density and decreasing bulk volume

4. improves the appearance of the product

5. improvement of the handling properties, due to the free-flowing properties

6. controlled release application of pellets due to the ideal low surface area-to-volume
ratio that provides an ideal shape for the application of film coatings
Sourabh.billore@medicaps.ac.in Medi-Caps University, Indore
Disadvantages:
1. often pellets can not be pressed into tablets because they are too rigid. In that case,
pellets have to be encapsulated into capsules

2. the production of pellets is often an expensive process and / or requires highly

specialized equipment.

3. the control of the production process is diffi - cult (e.g. the amount of water to be
added is critical for the quality of the pellets and overwetting can occur very
easily).

Sourabh.billore@medicaps.ac.in Medi-Caps University, Indore

Theory of pellet formation & growth
The following steps were proposed:
 nucleation,

 coalescence,

 layering

 abrasion transfer

Sourabh.billore@medicaps.ac.in Medi-Caps University, Indore

Sourabh.billore@medicaps.ac.in Medi-Caps University, Indore
1. AGITATION

It is a pelletization process in which powders, on addition of an appropriate quantity of liquid or

when subjected to high temperatures, are converted to spherical particles by a continuous rolling or
tumbling action.

A. BALLING/SPHERICAL AGGLOMERATION

The finely divided partiocles of powder converted to spherical shape by the addition of liquid prior
or during the agitation stage by continous rolling or tumbling action. If the liquid is used to form
spherical shape called liquid induced agglomeration or subjecting it to high temperature called melt
induced agglomeration.
Sourabh.billore@medicaps.ac.in Medi-Caps University, Indore
Sourabh.billore@medicaps.ac.in Medi-Caps University, Indore
B. DIRECT PELLETIZATION

In this system, the uniform sized dense pellets are formed from the spherical
agglomeration which is formed by subjecting the blended material and solvent (organic,
any other) into centrifugal motion. The pellets are formed from agglomerates due to
random collisions.

Sourabh.billore@medicaps.ac.in Medi-Caps University, Indore

2. COMPACTION

the pellets of defined shape and size are formed by subjecting the blend of powder or
granules are forced together under pressure.

A. COMPRESSION

It is one type of compaction technique in which pellets are produced by subjecting the
material to the mechanical pressure. The formulation and process variables are similar
to that of the tablet manufacturing. [32] In fact pellets produced compression is nothing
but small tablets that are approximately spheroidal in shape.

Sourabh.billore@medicaps.ac.in Medi-Caps University, Indore

 B. EXTRUSION SPHERONIZATION

Sourabh.billore@medicaps.ac.in Medi-Caps University, Indore

Sourabh.billore@medicaps.ac.in Medi-Caps University, Indore
 EXTRUDERS
Wet mass forced through the dies to produce small cylindrical uniform size
particles. This shaping of wet mass into uniform size is known as “Extrusion”
and long roads are known as “Extrudates”

Sourabh.billore@medicaps.ac.in Medi-Caps University, Indore

Sourabh.billore@medicaps.ac.in Medi-Caps University, Indore
Sourabh.billore@medicaps.ac.in Medi-Caps University, Indore
III. LAYERING

A. SUSPENSION / SOLUTION LAYERING TECHNIQUE

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 B. POWDER LAYERING TECHNIQUE

Sourabh.billore@medicaps.ac.in Medi-Caps University, Indore

IV. GLOBULATION / DROPLET FORMATION

Spray Drying and Spray Congealing, also known as globulation process, involve
atomization of hot melts, solutions, or suspensions to generate spherical particles
or pellets.

Sourabh.billore@medicaps.ac.in Medi-Caps University, Indore

A. SPRAY DRYING The drug entities in solution or suspension are sprayed,
with or without excipients, into a hot air stream to generate dry and highly
spherical particles.

Sourabh.billore@medicaps.ac.in Medi-Caps University, Indore

A. SPRAY CONGEALING / SPRAY CHILLING

The transition of a melt from a soft or fluid state to a rigid or solid state by cooling is
called congealing. [51] In this technique the drug is allowed to melt, suspend or
dissolve in hot melt of gum, fatty acid, waxes and other solid then sprayed into air or
steam chamber with temperature below the melting point of formulation components
under appropriate processing conditionto obtained spherical congealed pellets.

Sourabh.billore@medicaps.ac.in Medi-Caps University, Indore

V. CRYOPELLETIZATION

In cryopelletization the pellets can be produced by allowing droplets of liquid

formulation such as solution, suspension or emulsion to come in contact with
liquid nitrogen at -160°C in which liquid nitrogen used as solidifying medium.

VI. FREEZE PELLETIZATION

In this technique a molten solid carrier along with a dispersed active ingredient is
introduced as droplets into an inert and immiscible column of liquid.

Sourabh.billore@medicaps.ac.in Medi-Caps University, Indore