Abstract

FORMULATION DEVELOPMENT AND IN VITRO EVALUATION OF PULSATILE DRUG DELIVERY SYSTEM USING NOVEL NATURAL SUPERDISINTEGRANT

Ganesh D. Basarkar*, Ajinkya S. Thorat and Rakesh G. Shinde

Abstract

The present study was an attempt to develop and evaluate an oral pulsatile drug delivery system using dried mucilage of Hibiscus Rosa sinensis linn as a novel superdisintegrant. The rapid release tableted core contained a model drug (Diclofenac sodium) and novel superdisintegrant (Hibiscus Rosa sinensis linn) and controlled release effect was achieved with a combination of coating material (Eudragit S100). A 32 full factorial design was employed for the optimization of developed formulation considering concentration of superdisintegrant and coating ratio as independent variables with lag time and drug release as dependent variables. The developed formulations showed uniform appearance, average weight, drug content and adequate hardness. The increase in lag time was observed with an increase in Eudragit S100 concentration and decreased concentration of novel superdisintegrant. Design expert software® was used to give the solution for optimized formulation based on the evaluation of the developed formulations. Further comparison of Hibiscus Rosa sinensis linn in concentration suggested in the optimized formulation with pharmaceutically acceptable superdisintegrants in same concentration showed almost similar drug release behavior. It can be concluded from the outcome of the present research that dried mucilage of Hibiscus Rosa sinensis linn, a natural superdisintegrant, can prove to be best alternative to the existing semisynthetic or synthetic superdisintegrant.

Keywords: superdisintegrant, Hibiscus Rosa sinensis linn, Chronopharmaceutics.