FORMULATION AND OPTIMIZATION OF TOPICAL GEL CONTAINING SOLID DISPERSION OF ACECLOFENAC USING QUALITY BY DESIGN APPROACH

Abstract

The objective of this research was to develop and optimize topical gel containing Aceclofenac using quality by design QbD based on a 23 factorial design. Aceclofenac is a non-steroidal anti-inflammatory drug used for the treatment of pain and inflammation. Aceclofenac is insoluble in water and may cause gastrointestinal side effects being a BCS class II drug. In order to decrease gastric ulcerogenic effects, gels have been developed. The optimized gel showed improved saturation solubility of (0.091+0.009) to the corresponding physical mixture of pure Aceclofenac