Design, Fabrication and Evaluation of Drug Release Kinetics from Aceclofenac Matrix Tablets using Hydroxypropyl Methyl Cellulose

Abstract

The objective of this study was to develop a sustained release matrix tablet of aceclofenac using
hydroxypropyl methylcellulose (HPMC K15M and HPMC K100M CR) in various proportions as release controlling
factor by direct compression method. The powders for tableting were evaluated for angle of repose, loose bulk
density, tapped bulk density, compressibility index, total porosity and drug content etc. The tablets were subjected to
thickness, weight variation test, drug content, hardness, friability and in vitro release studies. The in vitro dissolution
study was carried out for 24 hours using United States Pharmacopoeia (USP) 22 paddle-type dissolution apparatus in
phosphate buffer (pH 7.4). The granules showed satisfactory flow properties, compressibility index and drug content
etc. All the tablets complied with pharmacopoeial specifications. The results of dissolution studies indicated that the
formulations F-2 and F-3 could extend the drug release up to 24 hours. By comparing the dissolution profiles with the
marketed product, it revealed that the formulations exhibited similar drug release profile. From this study, a decrease
in release kinetics of the drug was observed when the polymer concentration was increased. Kinetic modeling of in
vitro dissolution profiles revealed the drug release mechanism ranges from diffusion controlled or Fickian transport to
anomalous type or non-Fickian transport, which was only dependent on the type and amount of polymer used. The
drug release followed both diffusion and erosion mechanism in all cases. The drug release from these formulations
was satisfactory after 3 months storage in 400C and 75% RH. Besides, this study explored the optimum concentration
and effect of polymer(s) on acelofenac release pattern from the tablet matrix for 24 hour period.