Formulation and evaluation of rapid dissolving films of Pravastatin sodium

Abstract

The concept of Fast dissolving drug delivery system offers a solution for those patients having difficulty in swallowing tablets/capsules etc. This work investigated the possibility of developing Pravastatin sodium rapid dissolving films allowing fast, reproducible drug dissolution in the oral cavity, decreases the hyperlipidemia effect in patients in less time and enhances the patient compliance The fast-dissolving oral films of Pravastatin Sodium prepared using different film-forming materials HPMC E5 and Polyvinyl alcohol by the solvent-casting method which is simple and cost effective. The prepared films were subjected to different evaluation parameters like morphological properties, film thickness, folding Endurance, Surface pH, content uniformity, in vitro disintegration time and in vitro dissolution studies. The optimized formulation was subjected to stability studies, revealed that no significant changes occur after 1 month of test period. Results of FTIR data of optimized formulation (F10) revealed that there was no incompatibility observed between the drug and excipients used in the formulation. These findings suggest that the fast dissolving oral film containing Pravastatin sodium is considered to be potentially useful for the treatment of hyperlipedemia where quick onset of action is desirable.