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Introduction
Traditionally, the word “pellet” had been used to
describe a variety of systematically produced,
geometrically defined agglomerates obtained from diverse
starting materials utilizing different processing
conditions. Pellets are of great interest to the
pharmaceutical industry for a variety of reasons and
these products not only offers flexibility in dosage
form design and development but also utilized to improve
the safety and efficacy of bioactive agents. Pellets are
a multi-particulate, solid form of medication. The
individual pellets are almost spherical with diameter
ranges 100-2000 micrometer.1 Pelletization is an
agglomeration process that converts fine powders or
granules of bulk drugs and excipients in to small, free
flowing, spherical or semi-spherical units (referred to
as pellets) using appropriate processing equipment.
These agglomerates include fertilizers, animal feeds,
iron ores, and pharmaceutical dosage units and thus do
not only differ in composition but also encompass
different sizes and shapes. Pellets are also used to
provide the pharmaceutical scientist with tremendous
flexibility during the development of oral dosage forms.
Pellets composed of different drug entities can be
blended and formulated in a single dosage form. This
approach has numerous advantages. Pellets can be divided
into desired dosage strength without formulation or
process changes and also can be blended to deliver
incompatible bioactive agents simultaneously and/or to
provide different release profiles at the same or
different sites in gastrointestinal (GI) tract. In
addition, pellets, taken orally, disperse freely in the
GI tract, maximize drug absorption, minimize local
irritant drugs and reduce intra- and inter patient
variability of plasma profiles, which are common with
single unit regimens. When formulated as modified
release dosage forms, pellets are less susceptible to
dose dumping than the reservoir-type single unit
formulations. In addition, pellets have an enough
surface area-to-volume ratio and hence provide an ideal
shape for the application of film coatings.2 As pellets
flow and pack freely, it is not difficult to obtain
uniform and reproducible fill weights in capsules,
provided that the size and densities are favorable.
Pellets can also be made attractive due to the various
shades of color that can easily be imparted to them
during manufacturing process. As the application of
pellets in the development of oral dosage forms
increases, basic principles governing pellet formation
and growth should be studied thoroughly. Due to their
unique properties and flexibility of manufacturing
involved, pellets are expected to continue to play a
major role in the fabrication of solid dosage forms.
Many generic companies have already shown an interest in
pellets for the development of superior line extensions
of existing products that suffer from taste-masking
problems. The antibiotic market also provides a target
for this technology. E.g. Macrolide antibiotic was
recently introduced into the market as pellet
formulation. The purpose of this chapter is to study the
importance of pharmaceutical development and production
of drug pellets, possible formulation variables during
the pellets formulation; technologies and equipment
involved in the fabrication of pellets and various
applications of the pellets.
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