A study on the plasticization of sustained
release coatings for their ability to withstand the
damaging effects of compaction on coated
pellets
Chan Pui Sheon
a
, Sivaram Nallamolu
a,
*, Paul Wan Sia Heng
b
a
Department of Pharmaceutical Technology, International Medical University, 57000 Malaysia
b
Department of Pharmacy, National University of Singapore, 117543 Singapore
ARTICLE INFO
Article history:
Available online 24 November 2015
Keywords:
MUPS
Tableting
Plasticizer (TEC)
Pellets
Pharmaceutical solid dosage forms are commonly coated to
modify the release of drugs. Due to the disadvantages of coated
single-unit dosage forms, such as occurrences of dose dumping
and local irritation, coated multi-particulates are preferred.
Coated multi-particulates can eventually be filled into cap-
sules or compressed into tablets. The latter is more desirable
as unit production costs of tablets are considerably lower and
machinery is more easily available. However, compression forces
can result in structural changes to the coat, affecting its func-
tion. Hence, it is important to understand the factors affecting
coat damage during compression [1–3].
The objective of this project is to examine how plasticiza-
tion of coatings mitigate the level of pellet coat damage in
tableted multi-unit pellet system (MUPS). The method in-
volves coating of sustained release coats of different levels of
plasticizer triethyl citrate (TEC) by film casting method.The com-
pacts were made with the coated pellets. The casted films were
studied for their mechanical properties and the coated pellets
for their dissolution study.The model drug chlorpheniramine
maleate was loaded onto sugar coated pellets of 500–600 μm
in size using HPMC, povidone and de-ionized water. The drug
loaded pellets were film coated with aqueous ethyl cellulose
dispersion with varying levels of TEC using precision coating
unit. The coated pellets were formulated with lactose,
crospovidone and magnesium stearate into compact masses,
by using 15 mm flat face punches with a compression force of
10 kN. These compacted tablets of MUPS were studied for in-
vitro tests like hardness, disintegration and dissolution rate.
The surface morphology of the pellets was assessed by using
SEM and the results were statistically analyzed by ANOVA.
The results of hardness, disintegration and dissolution were
shown in Fig. 1. When the amount of TEC increased, the tablet
hardness decreased which comparably produced soft and easily
breakable tablets.The disintegration test shows increase in dis-
integration time with increased TEC concentration. A significant
sustain action was observed in 2% weight gain, rather than 10%
weight gain pellets. This was found to be the same in all the
varying concentrations of TEC (10%, 20% and 30%) signifying
* E-mail address: sivaram_nallamolu@imu.edu.my.
Peer review under responsibility of Shenyang Pharmaceutical University.
http://dx.doi.org/10.1016/j.ajps.2015.11.032
1818-0876/© 2016 Production and hosting by Elsevier B.V. on behalf of Shenyang Pharmaceutical University.This is an open access
article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
asian journal of pharmaceutical sciences 11 (2016) 209–210
Available online at www.sciencedirect.com
journal homepage: www.elsevier.com/locate/ajps
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