COMPARATIVE STUDY OF NATURAL SUPERDISINTEGRATING AGENTS IN THE FORMULATION OF ROSUVASTATIN MOUTH DISSOLVING TABLETS

Abstract

The present work concerned with formulation and evaluation of Mouth dissolving tabletsof Rosuvastatin by using natural superdisintegrants like dehydrated banana powder, plantago ovata mucilage powder and orange peel powder. Rosuvastatin is an anti-hyperlipidemic drug a BCS-II drug. The solubility of the dug was increased by complexation. Inclusion complexes of Rosuvastatin with $\bete$-cyclodextrin have been prepared in the ratio of 1:1, 1:3 and 1:5. Preformulation studies like solubility, Melting point, drug- excipient interaction studies (FTIR) were conducted. Dissolution study with $\bete$-cyclodextrin- Rosuvastatin complex (1:3), has shown faster drug release. Hence 1:3 ratio was selected for formulating Rosuvastatin mouth dissolving tablets. Nine formulations were prepared using different concentrations of superdisintegrants by direct compression method. FTIR studies revealed that no interaction between drug and carrier. All the formulations were evaluated for precompression parameters and all the parameters were found to be within the pharmacopoeial limits. Post compression parameters like hardness, thickness, disintegration time, water absorption ratio, Dispersion time, Swelling Index and in-vitro drug release studies were performed. The formulation F6 containing 7.5% w/w of plantago ovata mucilage shown disintegration time of 15 sec and 97% of drug release within 30 minutes.Rapid disintegration of the Plantago ovata is due to its mucilaginous swelling activity (85.1%v/v) that creates enough hydrodynamic pressure for quick and complete disintegration of the tablet. An accelerated stability study on optimised formulation was performed and it was found to be stable. It can be concluded that Plantago ovata as Superdisintegrant showed better release than Banana and orange peel powder.