Affiliation:
1. Department of Pharmaceutics, Anand Pharmacy College, Anand-388 001, Gujarat, India
Abstract
Objective:
The prime objective was to formulate pellet formulation incorporating
a newer extrusion- pelletisation aid, Pregelatinised Starch (PGS) and to scrutinise the
factors that can affect the quality of the pellets and to overcome the slower disintegration
of Microcrystaline Cellulose (MCC).
Methods:
Pellets were prepared initially using PGS, MCC, water, ethanol, HPMC K 4 M
and Febuxostat was employed as model drug. Optimisation of formulation was done by
employing Quality by design (QbD) and Design of experiment (DoE) approach. Ratio of
PGS and MCC, ratio of binder and spheronisation speed were selected as independent
variables and disintegration time and % cumulative drug release as dependent variables.
In vitro in vivo correlation of the optimised batch was carried out using Wagner nelson
method. Incompatibility studies have indicated compatibility of drug and excipients.
Results:
From the experiments, it was proved that the batch comprising 3:1 ratio of PGS
and MCC, 1:1 binder solution and 1500 speed yielded good pellets with decreased disintegration
time and improved dissolution rate as compared to pure Febuxostat. IVIVC
studies indicated one to one correlation between in vitro and in vivo parameters.
Conclusion:
Pellets with good quality, minimum disintegration time and improved dissolution
of model drug were successfully prepared with maximum amount of PGS. Optimisation
using QbD approach was worth fruitful that affected the quality of pellets.
Publisher
Bentham Science Publishers Ltd.
Subject
Pharmacology (medical),General Pharmacology, Toxicology and Pharmaceutics
Cited by
1 articles.
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