Stability Studies of Formulated Controlled Release Aceclofenac Tablets

Author(s): V. L. Narasaiah, T. Karthik Kumar, D. Srinivas, K. Sowmya, P. L. Pravallika and Sk. Md. Mobeen

Stability studies were performed on various formulations of aceclofenac tablets prepared by wet granulation method and solid dispersions using Eudragit RS 100 as a rate controlling polymer. The in vitro drug release was found to be 89% for aceclofenac from solid dispersion formulation (B7) compared with 83% from wet granulation formulation (B1). Selected formulation (B7) was packed and stored at 40 ± 2oC with 75 ± 5% RH for a period of six months and 25 ± 2oC with 60 ± 5% RH for a period of 9 months. At every 1, 2, 3, 6 and 9 months, samples were evaluated for appearance, hardness, friability, weight variation, drug content and drug release studies. A slight variation occurred in above parameters periodically in aceclofenac content. Drug release rate was good, when stored under accelerated conditions.

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