Abstract

FORMULATION AND EVALUATION OF GELRITE BASED PHASE CHANGE OPHTHALMIC SOLUTION OF NEPAFENAC- As QBD APPROACH

Deepak G. Wagh* and Dr. Sadhana R. Shahi

Abstract

The present investigation was focused on application of QbD approach to seethe effect of formulation variables on in situ ophthalmic gel containing a newer NSAID drug, nepafenac. Riskassessment of critical material and process parameters are linked to criticalquality attributes (CQAs) of the product with respect to obtain target qualityproduct profile (TQPP). The effects of critical parameters (concentration of Gelrite, Hypromellose METHOCEL E 15 LV) were investigated by executing design ofexperimentation (DoE) using 32 factorial designs. Drug release, viscosity at non physiological condition (NP) and viscosity at physiological condition (P) were considered critical quality attributes(CQAs). Gelrite based ophthalmic Nepafenacin situ gels were prepared and evaluated. Multiple regression analysis and ANOVA were employed to identify andestimate the effect of important parameters and establish their relationshipwith CQAs and to obtain design space for optimization purpose. The best in vitrodrug release profile, viscosity at non physiological condition (NP), viscosity at physiological condition (P) anddesired product quality was achieved with the formulation prepared in theregion of design space.3D response graph and overlay plots were successfullyimplemented to interpret effects and selection of significant parameters onCQAs. Formulation parameters which affect the nepafenac in situ ophthalmic gel can be successfully optimized.

Keywords: In situ ophthalmic gel, Nepafenac, Gelrite, Ion sensitive gelling system, HPMC E 15LV.