The document discusses pelletization, an agglomeration process that transforms fine powders and granules into small, free-flowing pellets, enhancing drug absorption and minimizing side effects. It outlines the significance of formulation excipients such as fillers, binders, lubricants, and disintegrants, and mentions existing pelletization methods including coating pans and fluid bed equipment. Additionally, it describes the role of various additives like pH adjusters and glidants in improving the properties of the pellets.

1. Dr. Mohammad Aijaz Sheikh
Associate professor
Anuradha College of Pharmacy, Chikhli
Pelletization
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2.  Pelletization is an agglomeration process that
converts
fine powder or granules of bulk drugs and
excipients
into small, free flowing, spherical or semi-
spherical
units, referred to as pellets.
 Pellets range in size between 0.5 to 1.5 mm.
Definition
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3.  Pelletized products offer flexibility in dosage form
design and development.
 Pellets disperse freely in the gastrointestinal tract,
they invariably maximize drug absorption and
minimize potential side effects.
 Reduced variations in gastric emptying rates and
overall transit time.
 High local concentration of bioactive agent can be
avoided.
 Pellets are less susceptible to dose dumping.
 Provide an ideal shape for application of film coating.
Significance
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4. FORMULATION EXCIPIENTS FORPELLETS
 Fillers are water soluble or insoluble substances that
are incorporated in to pellet formulations, mainly to
add bulk.
 Selection of filler should be based on the intended
overall properties of the pellets as these fillers
contribute largely to the rate and extend of drug
availability from pellets.
 Physicochemical and pharmacological inertness are
two factors that impact heavily on the selection of the
fillers, and are used in concentration range, as high
as 99% or as low as 1%.
Fillers
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5. Binders
 Binders are adhesive materials that are added
in pellet formulation to bind powder and to
maintain the pellet integrity.
 Binders may be added as a solution or in the
dry form, although application via solution is
more efficient than dry mixing.
 Gelatin, sucrose and HPMC are the examples
of binders.
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6. Lubricants
 These are the substances that are incorporated
in pellet formulation to reduce the coefficient of
the friction between individual particles or
between the particle and the surfaces of the
processing equipment.
 Examples: Glycerine, mineral oil, magnesium
stearate and propylene glycol.
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7. Disintegrants
 Disintegrants are substances, which in the
presence of liquid promote the disruption of solid
dosage forms.
 The purpose is to enhance the dissolution of drug
by providing a larger surface area to the dissolving
fluid.
 Thus, the function of disintegrants is to overcome
the effect of binder.
 Examples: Crospovidone, Alginates.
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8. pHAdjusters
 These are the substances which are incorporated
in pellets formulation to influence the micro
environment of drug molecules.
 These are incorporated in the preparation for
keeping the pH in most favorable condition and
which help in stability of drug.
 Buffers are incorporated for improving the rate of
dissolution of drugs whose solubility is affected by
alteration in the pH.
 Phosphates and citrates are the examples of the
pH adjusters. 8

9. Surfactants
 These are added to improve the wettability
and enhance the dissolution rates of poorly
soluble drugs.
 Example: Sodium lauryl sulfate
Polysorbate
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10. Spheronization Enhancers
 These are used to facilitate the production of
spherical pellets mainly during spheronization
and balling.
 Example: Microcrystalline cellulose
Carboxymethyl cellulose
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11. Glidants
 Glidants improves the flow property of the
cohesive powder by reducing inter particulate
friction and may be hydrophilic or
hydrophobic in nature.
 Hydrophobic glidants are incorporated to
improve the flow of hydrophilic powders, while
hydrophobic glidants are more effective for
hydrophilic glidants.
 Starch, talc and magnesium stearate
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12. Separating Agents
 Separating agents are materials that adsorb on
the surface and promote the separation of pellets
in to distinct units during a pelletization process.
 There is development of surface charges on the
surface of pellets during the manufacturing, may
cause agglomeration.
 The degree of wetness of the surface of the
pellet, coupled with the local concentration of the
binding agent may also lead to agglomeration.
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13. EXISTING METHODS OF PELELTIZATION
 Since the early 19th
century, coating pans have been
used in pharmaceutical coating operation.
 Less expensive
 Higher labor cost
 Longer processing time
 Lack of process control
 Lower yield
Coating Pan
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14. Fluid Bed Equipment
 In pharmaceutical industry the
batch type fluid bed processor
have been
used for some 30 years.
 Provides high degree of
assurance for
reproducibility.
 Too much sophisticated to handle
and maintain which increase the
cost of the equipment.
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15. Extrusions Equipment
 Process of applying pressure to a mass until it
flows through the orifice, which have defined
opening diameter.
 The extrudate length may vary depending on
the physical characteristics of the material to be
extruded and the method of the extrusion.
 Various types of extrusion devices are

Screw extruder

Sieve and basket

Roll and ram
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16. Spheronizer
 This is an instrument, which is used to round up
the material.
 It consist of hollow cylindrical (bowl) with a
rotating disk (friction plate) located inside.
 The extruded, cylindrically shaped particles are
broken in to uniform length by collision with the
particles, by the collision with the wall and by
contact with the friction plate.
 Further processing will cause the extrudate to
deform gradually in to a spherical shape.
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17. References
1.Isaac Ghebre-Sellassie (1989), Pharmaceutical pelletization
technology,
Marcel dekker inc, 37, 1-14.
2.Douglas C. Hicks, Howard L, Isaac Ghebre-Sellassie (1989),
Pharmaceutical pelletization technology, Marcel dekker inc, 37, 71-
100.
3.Bankers G S, Rhodes CT (1995), Modern Pharmaceutical, Marcel
dekker inc., 3, 575- 576.
4.Aulton M E, John Staniforth (2002), Pharmaceutics the science of
dosage form design, Churchill livingston, 2, 198-210. 17

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