novel pellets for oral dosage forms

1. This Presentation is submitted to
BCDA COLLEGE OF PHARMACY AND TECHNOLOGY
Under the guidance of
Mr. Seemanchala Rath, Assistant Professor
M. Pharm. (Utkal Univ.)
By
Nilanjan Bhattacharya B. Pharm. 7th Sem.
University Roll No. - 20101911022
&
Prosenjit Chakraborty B. Pharm. 7th Sem.
University Roll No. - 20101911026 1

2.  Pelletization can be defined as an agglomeration
(size-enlargement) process that converts fine powders
or particles of bulk drugs and excipients into small,
free-flowing, spherical units called pellets.
 Pellets size ranges from 0.5 to 2.0 mm, having free-
flowing properties and a low porosity of about 10 %.
 The term “spheronization” implies spherical units
formed by a size-enlargement process that includes a
spheronization step where extrudates or agglomerates
are rounded as they tumble on a rotating frictional
base plate, being named “spheroids”. 2

3.  Spherical shape and smooth
surface is considered as
desired characteristics for
uniform film coating.
 The particle size of pellets
should be in range of 0.5 to
2.0 mm.
 The quantity of the active
ingredient in pellets should
be maximum in order to
maintain size of pellet. 3

4.  They can be divided in to desired dosage strength
without process or formulation changes.
 They can be blended to deliver incompatible bioactive
agents.
 They can be used to provide different release profile at
the same or different sites in the gastrointestinal tract.
 When pellets containing the active ingredient are in
the form of suspension, capsules, or disintegrating
tablets, they offer significant therapeutic advantages
over single unit dosage forms. 4

5. 5

6.  Agitation can be further classified under
Balling, which is –
 A technique is not popular in the
pharmaceutical industry as a Pelletization
process.
 This is because due to the constraints of
particle size distribution and content
uniformity.
 Work in this area is expected to continue.
6

7.  Compaction is a form of pressure agglomeration, in
which drug particles or granules are forced
together with or without formulation aids by a
mechanical force to generate pellets of well
defined shapes and sizes.
 The Pelletization process can be subdivided into
compression and extrusion.
7

8.  In this process, drug is layered onto seed materials
(generally, a coarse material) in powder, solution or
suspension form and leads to heterogeneous pellets,
which consist of an inner core region and an outer
shell region of a different composition.
This process is classified into three categories namely :
1. Direct Pelletization
2. Solution or Suspension Layering
3. Powder Layering
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12.  It is a process where hot melts, solutions, or
suspensions are atomized to generate
spherical particles or pellets.
 In globulation, atomization produces solid
particles directly from the liquid phase through
evaporation or cooling and subsequent
solidification of hot melts, solution and
suspension.
12

13. It is an approach that has come into existence
which combines the features of both controlled
release tablets and modified release capsules
in one dosage form, such a system is known as
MUPS tablets or Multiple-Unit Pellet System.
13

14. When taken orally, multiple unit dosage forms-
 Disperse freely in the gastro intestinal tract.
 Offer reduced variation in gastric emptying rate
and transit time which is less dependent on the
state of nutrition.
 Reduces localized concentration of irritative
drugs.
 Improves safety and efficacy of a drug. 14

15.  Should maintain all the tablet properties.
 Pellets should not show any interaction like
developing electrostatic charges during compression.
 The drug release should not be affected by the
compaction process.
 Like tablets, MUPS should have ease to withstand
physical parameters, stability, packing storage and
transportation.
 The dosage form must disintegrate rapidly into
individual pellets in gastrointestinal fluids.
15

16. MUPS formulations are
broadly classified into two
types :
A. MUPS with matrix
pellets
B. MUPS with pellets
coated
16

17.  Pellets which inherently
contain excipients that slows
down the drug release by
being contained within the
matrix of pellet structure
commonly referred as MUPS
with matrix pellets .
 For example matrix pellets of
swellable polymers or waxes,
retain their controlled
release characteristics to a
larger extent.
 Fusion of matrix pellets as a
result of compaction can be
avoided by application of film
coating or by excessive
blending with a hydrophobic
agent.
17

18. There are several types of coating, they are followed by :
18

19. PRODUCT COMPANY DRUG THERAPUTIC
CATEGORY
FORMULATIO
N
TYPE
Losec MUPS Astra Zeneca Omeprazole
magnesium
Antiulcer Antiulcer
Esomeprazole Astra Zeneca Esomepraz
ole
magnesium
Antiulcer Antiulcer
Toprol XL Astra Zeneca Metoprolol
tartrate
Antihypertensi
ve
Extended
release
Prevacid
SoluTab
Takeda Lansoprazo
le
Antiulcer Delayed
release
orodispersible
tablet
Theodur key Theophyllin
e
Antihistaminic Extended
release
19

20. Thus we see that the present scenario of MUPS find
a greater advantage due to its flexible design in variable
release properties, stability, patient compliance and
economic compared to other dosage forms.
For the pharmaceutical industry, not only the
innovation of new products and techniques, creation of
line extension, expansion of patent protection, achieving
globalized product and thereby overcome competition are
also key strategies with respect to profit perspective.
MUPS meet all these with medical, health care, and
business benefits.
20

21. Reddy S ,Das P, Das H, Das,
Ghosh A, MUPS (Multiple Unit
Pellet System) Tablets – A Brief
Review, JOURNAL OF
PHARMACEUTICAL AND
BIOMEDICAL SCIENCES, 2011,
Vol 12 (02)
N.Jawahar, Patel H.A, Multi Unit
Particulates Systems (MUPS): A
Novel Pellets for Oral Dosage
Forms Journal Of Pharmaceutical
Science and Research,
2012,Vol.4(9)
S.Ramu*, G.Ramakrishna,
M.Balaji, Rao K.K, Reddy S.H,
Kumar D.P, Multiple Unit Drug
Delivery System: Pelletization
Techniques, American Journal of
Advanced DrugDelivery,2013,Vol:
1[1]
Hirjau M, Nicoara A.C, Hirjau V,
Lupuleasa D, PELLETIZATION
TECHNIQUES USED IN
PHARMACEUTICAL FIELDS.
Practica Farmaceutică, 2011, Vol.
4
VR Sirisha K, K Vijaya sri, K
Suresh, G Kamalakar Reddy,
MULTIPLE UNIT PELLET
SYSTEMS: A REVIEW , Int J
Pharm 2012; 2(2)
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