Formulation and Evaluation of Extended Release Gastroretentive Microspheres for Anti-Hyperlipidemic Drug

Abstract

controlled release in the stomach. Simvastatin is an important for treatment for hyperlipidemi as (hypercholesterolemia). To overcome inherent drawbacks associated with conventional dosage forms of simvastatin, an attempt is being made to develop an alternative drug delivery system in the form of mucoadhesive microspheres. The objective of the present study was to formulate and evaluate mucoadhesive microspheres of Simvastatin. In the present study, 27 Formulations with variable Drug: polymer ratio, concentrations of polymers (ethylcellulose, Carbopol) and variable speed of stirring (rpm) were prepared and evaluated for percentage yield, particle size, percentage entrapment efficiency, In vitro release studies, mucoadhesion, SEM and Stability study. Compatibility studies by FTIR proved that there was no interaction between simvastatin and the polymers used. The mean particle size of microspheres was obtained in the range between 318.52 to 412.19μm. The percentage drug entrapment efficiency of all formulations was found between 12.76% to 99.21%. Prepared batches were subjected to in vitro release studies which had shown prolonged release of the drug for 8 hrs. Amongst all prepared formulations, B26 shows the more prolonged release up to 8 hrs and much higher entrapment as compared to other batches. Henceforth, it was subjected to in vitro mucoadhesion, SEM and stability study. It shows satisfactory mucoadhesion, along with good spherical shape which was confirmed from SEM study. It also shows maximum stability at room temperature storage condition.