Abstract

DEVELOPMENT OF GENERIC DAPSONE GEL 5% USING QBD TECHNIQUE

*Mangesh R. Bhalekar, Ashwini R. Madgulkar and Shraddha K. Pardeshi

Abstract

Dapsone is used as an anti acne agent for the treatment of acne vulgaris which is a most common skin disorder. In the present work an attempt has been made to formulate and evaluate generic dapsone gel 5% using Quality by Design technique so as to ensure the generic drug product has similar desired quality attributes to the reference-listed drug (RLD). The concept of reverse-engineering is used to copy the RLD as a strategy during development of generic product to ensure qualitative (Q1, same components) and quantitative formulation similarity (Q2, same components with same concentration), as well as similarity in formulation microstructure (Q3). The formulations were characterized for various physiochemical properties such as, physical appearance, viscosity, hardness (spreadability), in vitro drug release and microparticulate to dissolved drug ratio. The present study employes in vitro skin permeation studies as a tool to justify formulation similarities between the test generic product and the RLD to ensure a successful bioequivalence study.

Keywords: Dapsone gel, generic product, RLD, Quality by Design, Orange book.