pellets can be defined as multi particulate system or multiunit system
They are spherical particulates manufactured by agglomeration of the powder granules containing drug substance and excipients.
Pellets can be prepared by a special technique called Pelletization.
This technique is referred to an agglomeration process that convert fine powder or granules of bulk drug or excipient in to small , free flowing , spherical or semi spherical pellets .
Multi particular drug delivery system especially suitable for achieving controlled delay released oral formulation with low risk of dose dumping, flexibility of blending to attain different release patterns as well as reproducible and short gastric residence time.
Multi particulate drug delivery system are mainly oral dosage form consisting of a multiplicity of small discrete units each exhibiting some desire characteristics.
Pulmonary drug delivery system M.pharm -2nd sem P'ceutics
Pelletization
1. Presented and Prepared by :Ms. Kajal A. Pradhan
Assistant professor
B. Pharm. , M. Pharm. (Pharmaceutics)
2. What is pellets?
Mechanism of pellets
Multi unit dosage system
Pelletization techniques
Advantages of pellets
Disadvantages of pellets
Pelletization techniques
Factors affecting of pellets
Evaluation parameters
Application of pellets
Current products of pellets
Reference
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3. Pellets can be defined as multi unit particulate system these are free
flowing, spherical particulates manufactured by agglomeration of fine
powders granules of drug substances and excipients by using
appropriate processing equipment.
Size – 0.5-1.5mm.
Due to it size and shape it is used as injections and oral drug delivery
system.
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4. An innovative use of pellet in pharmaceutical
field:
Improve aesthetic appearance of products.
Achieve control release rate of drugs when coated with polymers.
Improve flow properties and flexibility in formulation
development and manufacturing.
It has less variance in transient time through the gastro intestinal
tract (GIT) than a single unit dosage form like tablet.
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5. Pellets can be prepared by a special technique called
Pelletization.
This technique is referred to an agglomeration process that
convert fine powder or granules of bulk drug or excipient in
to small , free flowing , spherical or semi spherical pellets .
This technique is needed to produce pellets of uniform size
with high drug loading capacity and also prevent segregation
and dust.
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6. Before Selection and optimization of any Pelletization/granulation
process, it is important to understand the fundamental mechanisms of
pellet formation and growth:
I. Nucleation phase
II. Coalescence phase
III. Layering phase
IV. Abrasion transfer phase
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8. Multi particular drug delivery system especially suitable for achieving
controlled delay released oral formulation with low risk of dose
dumping, flexibility of blending to attain different release patterns as
well as reproducible and short gastric residence time.
Multi particulate drug delivery system are mainly oral dosage form
consisting of a multiplicity of small discrete units each exhibiting some
desire characteristics
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10. Multi particulate less dependent on gastric emptying , resulting in less
inter and intra subject variability in gastrointestinal transit time also
better distributed and likely to cause local irritation
Benefits of multi particulate dosage form such as:
increases bioavailability
reduce risk of system toxicity
reduce risk of local irritation
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11. Many reason of multi particulate system eg : to facilitate disintegration
in stomach or to provide a convenient fast disintegration tablet that
dissolves in water before swallowing which can aid compliance in
older patient and children
After disintegration which occurs with in few minutes often within few
seconds , the individual subunits particulate pass rapidly through the
GIT .
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If this subunit have diameter less than 2mm they are able to leave
the stomach continuously even if the pylorus is closed.
These result in lower intra and inter individual variability in plasma
levels and bioavailability.
12. Mechanism of multi particulate
dosage system are as follow:
Diffusion
Erosion
osmosis
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13. Preheating of core particle was done.
The drug solution was loaded over core particle and dried.
Drug loaded pellets was sifted through the sieve.
The enteric sustain or controlled released polymer was
dissolved in a solvent to prepare a coating solution.
Solution was sprayed over drug loaded pellets and dried.
This coated pellets was then compressed along with other
excipients to prepare the MUPS tablets.
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15. Improve appearance of product.
Pellets are of small size and have good flow ability compare
to powder form.
Ease of handling, such as filling into capsules.
Different release profiles at different sites in the
Gastrointestinal tract.
Protection against degradation of active ingredients by
oxidation or moisture by providing film coating
High degree of patient acceptance when filled in capsules
due to their elegance as compared to tablets.
High drug loading capacity without producing large
particles.
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16. Pellets filling involve capsule filling which can increase the
costs.
Tableting of pellets destroy film coating on the pellets.
The size of the pellets may vary formulation to formulation
but usually is in range of 0.05 mm and 2 mm.
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19. Balling:Liquid in required amount is added prior to or during agitation stage to
finely divided particles and this mass under continuous rolling or tumbling
motion results in spherical particles. Equipment used is pans, discs, drums, or
mixers.
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Compression :Pelletization process in which mixtures or blends of active
ingredients and excipients are compacted under pressure to obtain pellets of
definite shape and size . These pellets are of narrow size distribution and can
be filled into capsules.
20. Dry mixing
• All ingredients are mixed in order to form
homogenous mixture
Wet mixing
• The powder are wet mixed to form sufficiently
plastic mask
Extrusion stage
• Wet mass is shaped into cylindrical segments with a
uniform diameter
Spheronization stage
• Small cylinders are rolled into spheres(spheroids)
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24. A process droplets of liquid formulation are converted in
solid spherical particles or pellets by using liquid nitrogen as
the fixing medium at 160⁰C.
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26. 1. Moisture content
2. Rheological characteristics
3. Solubility of excipients and drugs in granulating fluid
4. Composition of granulation fluids
5. Physical properties of starting materials
6. Speed of Spheronizer
7. Extrusion screen
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27. 1. Particle size distribution
2. Surface area
3. Porosity
4. Density
5. Hardness and friability
6. Tensile strength
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28. Taste masking.
Immediate release.
Sustained release.
Chemically incompatible products.
Varying dosage without reformulation.
As a self emulsifying pellets.
Pectin film coated based pellets for site specific target delivery .
Gastro retentive floating pellets.
Fast meting pellets in mouth.
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29. A. “PELLETS FOR CAPSULE/TABLET DOSAGE FORMS”
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I. Enteric Coated/Delayed Release Pellets
1. Aspirin
2. Diclofenac sodium
II. Extended Release/Time Release/Sustained Release and Controlled Release
Pellets
1. Diclofenac Sodium
2. Diclofenac Potassium
3. Venlafaxine HCl