Design Expert Assisted Formulation of Topical Bioadhesive Gel of Sertaconazole Nitrate

Abstract

Purpose: The objective of this work was to develop a bioadhesive topical gel of sertaconazole nitrate with the help of response-surface approach. Methods: Experiments were performed according to a 3-level factorial design to evaluate the effects of two independent variables [amount of Carbapol 934 = X1) and Sodium carboxymethylcellulose (NaCMC) = X2)] on the bioadhesive character of gel, rheological property of gel (consistency index), and in-vitro drug release. The best model was selected to fit the data. Results: Mathematical equation was generated by Design Expert® software for the model which assists in determining the effect of independent variables. Response surface plots were also generated by the software for analyzing effect of the independent variables on the response. The effect of formulation variables on the product characteristics can be easily predicted and precisely interpreted by using a 3-level factorial design and generated quadratic mathematical equations. Conclusion: On the basis of product characteristics viscosity, bioadhesiveness, permeation study, in-vitro release, in-vivo studies, TPA and spreadability it can be concluded that the best batch of topical bioadhesive gel of Sertaconazole nitrate would be with 1% Carbopol 934 and 1% NaCMC.

Keywords: Topical bioadhesive gel, Sertaconazole nitrate, Three-level factorial design, Carbapol, NaCMC