Formulation and Development of Aceclofenac loaded Microsponges Topical Drug Delivery System using quality by Design Approach

Abstract

The proposed study is focussed at developing Aceclofenacmicrosponges for topic drug delivery systems. QbD was applied for better understanding of the process and to generate design space, using quality target product profile, critical quality attributes, and risk assessment. The aim of the experiment was to prepare a safe, efficacious, stable and patient compliant microsponge dosage form of Aceclofenac. Materials and methods: Pre-formulation studies were carried out which helped in developing an accurate dosage form. UV, FTIR, DSC, and SEM studies were done for pre-formulation and post-formulation evaluations. These study deals with the design and optimization of Aceclofenacmicrosponges loaded topical drug delivery system to the controlled release of active drug into the skin in order to minimize the systemic exposure and minimize local cutaneous reactions to active drugs by DoE method of QbD Approach. AceclofenacMicrosponges were prepared by quasi emulsion solvent diffusion method using Eudragit-RS100 as a polymer, polyvinyl alcohol, Ethanol as Internal phase volume and Liquid paraffin as External phase volume. In this study, we found that the controlled release of aceclofenac microsponges.