Abstract :

The process of Pelletization first came into*existence back*in early 1950s, when the product was
first introduced to the market. These pelletized dosage form has gathered considerable

popularity because of their diverse features such as relieve in capsule filling as they promise
better flow properties of the spherical pellets, intensification of drug dissolution; easy coating
options; succored, restricted and site-specific drug release from the pellets; incessant packing;
regular distribution in the GI tract; and mitigated GI irritation. Techniques for preparing
Pelletization dosage forms includes drug layering on non-peril sugar or microcrystalline
cellulose beads, spray congealing, spray drying, roto-granulation, hot-melt extrusion, and
spheronization process on low melting materials. The present review outlines the recent findings
on the manufacturing and evaluation of spherical pellets. The techniques namely extrusion-
spheronization, freeze-pelletization, hot melt extrusion, cryo-pelletization* have been discussed
along with formulation requirements for the process, parameters affecting pelletization*.
Evaluation of quality of the pellets is discussed with reference to the size surface morphology,
distribution, shape, friability, specific surface and tensile strength.

Introduction:

Since Ages, oral drugs have been one of the most commonly used techniques for delivery of
most therapeutic agents. Traditionally, oral dosages form is established as both single and
multiple unit dosage forms. Multi-particulate dosages forms are receiving immense attention as
an alternative oral drug delivery system though single unit dosage form has been primarily used
for quite a time now. The most prevalently consumed pharmaceutical solid dosage forms
comprise of granules, tablets and capsules, of which tablets are the most popular dosage,
accounting for about 70% of all the whole set .

It was soon realized that a few of the formulating and clinical problems (free flowing property,
dose dumping etc.) that it brings along with the single dose formulations. Not before long it led
to the division of monolithic dosage forms into multiples. Multiple unit dosage forms (MUDFs),
are formulated as granules, pellets, or mini tablets 3, 4. The idea of this multiple unit dosage forms
speaks to many formulating problems and is a general strategy to manage the release of drug as
screening the reproducible release profiles when compared to SUDFs. These MUDFs, can either
be filled in to hard capsules or compacted in to bigger tablets or can be dispensed in a dose
pouches or packets.

The most increasingly appealing area in the expansion of MUDF’S is amalgamation into tablets
instead of solid gelatin capsules in order to create it more reasonably priced to the consumers and
gaining more interest currently. The present assessment focuses on the pelletized form of several
units, they are prepared by process called Pelletization which is referred to as a size extension
process and the ultimate product produced is called pellets.

Therefore, being a consumer-friendly substitute, over the single unit dosage forms many of the
pharmaceutical companies are switching their item for consumption franchise to improve the
technology. This technology alternative can also provide a good platform for patent non-
infringing product development. This drug delivery platform shows business potential promise
for future in pharmaceuticals.

Pellets:

Pellets are produced systematically; they are typically defined as agglomerate attained from a
variety of starting materials using varied processing methods. These are freely-flowing, semi-
spherical or spherical solid units with their size ranging between about 0.5 mm to 1.5 mm and
that are anticipated mostly for oral management.

Ideal properties of the pellets

 Smooth surface and perfectly spherical shape.

 The pellet size should range between 600-1000μm.
 Amount of active ingredient in pellets is maximum zed in to maintain size of pellet

Advantages:

In most of the cases the prime reason for using of pellets in manufacturing is with controlled
release properties. Though these multiple unit dosages offers a much superior therapeutic effect
even when modified release is not the primary objective.

 Superior appearance of the product having fine and far more pharmaceutical elegance.
 Flexibility in the dosage form design and development.
 It improves the flow properties.
 Free flow and easier packing eradicating major difficulties (resulting in regular and
reproducible fill weight of capsules).
 Lesser susceptibility to dose dumping.
 It reduces accumulation of drugs especially proven advantageous in the case of irritating
drugs 11.
 It paves a a great deal more expedient way for the severance of irreconcilable drugs.
 It improves safety and efficacy of a drug.
 Pellets offer reduced divergence in gastric emptying rate and intestinal transit time.
 It resolves the problem of taste-masking.
 Coating of pellets can be done with different drugs to enable a pellets release rate.
 The most imperative cause for the wide recognition of multiple unit products is the quick
increase in recognition of oral pellets dosage forms, Pellets oral solid dosage forms are
 generally anticipated either for delivery of the drug at a precise site contained by the
gastrointestinal tract or to uphold the stroke of drugs over an unmitigated period of time.
 The coating material may be colored with a dye material so that the beads of dissimilar
coating thickness will be darker and discernible from those having smaller quantity coats.
 Products that are chemically irreconcilable can be encapsulated into pellets & delivered
in a single dosage.
 An immediate release product in case of larger surface area facilitates improved
distribution.
 It is used in the chemical industries for avoiding powder dusting.

Thus Pellets have attracted more attention due to their unit clinical and technical advantages.

Citation : Article on PELLETIZATION TECHNOLOGY by Kammili Lavanya*, V.

Senthil and Varun Rathi

(Department of Pharmaceutics, JSS College of Pharmacy, (A Constituent College of JSS

University, Mysore), Ooty, The Nilgiris, Tamil Nadu, India).

Pellet formation and growth theory:

Previous to selection and optimization of any Pelletization/granulation procedure, it is

imperative to understand the elementary mechanisms of pellet development and growth. Diverse
theories have been postulated connected to the mechanism of formation and growth of pellets. A
few of these theories are derived from experimental consequences while others are derived by
visual annotations. Of all these hypothetical conjectures the most convincing categorization of
Pelletization method, involves three successive regions: nucleation, transition and ball
development However, based on the experiments on the mechanism of pellet formation and
growth, the following steps were proposed: nucleation, coalescence, layering and abrasion
relocation .

Nucleation is a phase of Pelletization process that takes place when powder is wetted with
solvent method. The primal particles are pinched together to form three-phase air, water, liquid
nuclei system which are apprehended mutually by liquid bridges that are wintered in nature. The
diminution of particle size will picks up the bonding potency amid them. Further the size, the
pace and the degree of nuclear development depends upon the amount of the particles, the
moisture content, the viscosity of the binding particles, the wet ability of the substrate in addition
to the dispensation conditions, such as tumbling and drying rates.

Following the Nucleation process is a transition phase where the augmentation mechanisms
affecting are coalescence and layering. Coalescence is defined as the development of bulky
particles by unsystematic impact of well-formed nuclei, this mechanism necessitate slightly
surplus moisture on the surface of the nuclei even though the amount of nuclei are progressively
abridged even though the entirety of mass of the system remains unaffected during this
operation. Layering is a slow growth mechanism and with the successive addition of fragments
and fines on an already formed nuclei. In the layering step, the number of particles remains
unvarying while the totality of mass of the system increases owing to increasing particle size
with time. The fragments or fine particles can be produced by particle size diminution.

FIG. 1: PELLET GROWTH MECHANISM

The fines and the fragments created in the course of size diminution are taken up by superior
pellets. Production of fines and succeeding coalescence and layering continues in anticipation of
the number of collisions declines quickly, thus resulting in reduction in the rate of growth of the
pellets. This is the point where the third phase of the ball growth region, is reached.

The major mechanism in the ball growth phase is the abrasion transfer that involves the
elicitation of materials from one granule formed to another with no predilection in any direction.
This phase does not result in any alteration in the whole number or mass of the particles.
Although, the particles undergo a constant change in their sizes as long as the conditions that
results in the transfer of material exist.

Citation: Asian Journal of Pharmaceutical Sciences

Volume 11, Issue 6, December 2016, Pages 684-699