Abstract

DEVELOPMENT AND STABILITY STUDIES OF DICLOFENAC SODIUM CONTROLLED RELEASE DOSAGE FORMS USING VARIOUS POLYMERS

Divvela Hema Naga Durga*, Duppala Lohithasu and Kolapalli Venkata Ramana Murthy

ABSTRACT

The objective of the present study is to develop the controlled release dosage form of diclofenac using hydrophilic polymers (Araucaria heterophylla gum and xanthan gum from natural origin, hydroxy propyl methyl cellulose K 100M from semisynthetic origin) and hydrophobic polymer (compritol 888 ATO from synthetic origin). Diclofenac sodium matrix tablets were prepared by Araucaria heterophylla gum, xanthan gum and hydroxy propyl methyl cellulose by wet granulation method. Hot melt granulation method was used for compritol as it was insoluble polymer. AHD2, XGD4, HPD4 and CD2 formulations were considered as optimum formulations for oral controlled release of diclofenac sodium. Stability studies can be concluded that aging has no adverse effect on the tabletting characters and dissolution profile of optimised tablets. FTIR studies also showed that there was no significance difference. Stability testing was carried Out for a period of six months and there was no significant change in initial and six months old sample, so it was not tested for further period. All the optimized formulations of diclofenac sodium were considered stable as per ICH guidelines.

Keywords: Stability studies, Araucaria heterophylla gum, Xanthan gum, HPMC K 100 M, compritol 888 ATO.