Abstract

FORMULATION, EVALUATION AND DEVELOPMENT OF FAST RELEASE TABLETS OF ROSUVASTATIN CALCIUM USING SUBLIMATION METHOD

Dr. Yamini D. Shah*, Susmita Rajbongshi and Neel Dave

ABSTRACT

Aim: The aim of the present work was to prepare Drug-β Cyclodextrin complex to increase solubility and prepared complex was used to formulate Fast Release Tablets (FRT). Increase in drug solubility by β- Cyclodextrin was evaluated by Higuchi connor‟s phase solubility studies. Methods: FRTs were prepared by direct compression, wet granulation and sublimation methods using Sodium starch glycolate, Croscarmellose sodium and Crospovidone as a superdisintegrants. Method giving satisfactory result was further studied and a 32 full factorial design was applied to optimize the formulation. The concentrations of two Superdisintegrants showing best results were selected as independent variables. Disintegration time (Y1) and % Drug release at 5minute (Y2) were selected as dependent variables. The prepared tablets were evaluated for hardness, friability, disintegration time and in vitro drug release. Results: Rosuvastatin calcium FRTs prepared were found to be fulfilled all the requirements for tablets. The tablets prepared by sublimation method showed better results compared to direct compression and wet granulation and among all superdisintegrants, Sodium starch gycolate (X1) and Croscarmellose sodium (X2) significantly affected the disintegration time (Y1) and % drug release at 5 minutes (Y2). Regression analysis and numerical optimization were performed to identify the best formulation. Formulation F10 prepared with Sodium starch glycolate (6.88mg) and Croscarmellose sodium (7.35 mg) was found to be the best formulation with disintegration time 11 sec and % drug release at 5minute of 93.68%. Conclusion: Fast release tablets of Rosuvastatin calcium were successfully formulated by sublimation technique with improved patient compliance and immediate onset of action.

Keywords: Rosuvastatin calcium, Fast Release Tablets, Complexation, Sublimation Technique.