Abstract

ENHANCEMENT OF SOLUBILITY & BIOAVAILABILITY OF SELECTED DRUG USING INCLUSION COMPLEX TECHNIQUE

P. V. Rao, K. Tejaswi and Kalyana Sunitha*

ABSTRACT

The present work has been undertaken with an overall objective of studying the complexation of Fluvastatin with β-cyclodextrin to evaluate the feasibility of enhancing it solubility, dissolution rate, bioavailability and therapeutic efficacy. The feasibility of formulating the cyclodextrin complexes into tablets with enhanced dissolution rate characteristics was also investigated. From the present study, the following conclusions can be drawn. Cyclodextrins can be used to prepare inclusion complexes of Fluvastatin with improved solubility of drug. Phase solubility studies of Fluvastatin with β-cyclodextrin illustrate the solubility enhanced capacity of β-cyclodextrin, the stability constant (Kc) of the drug: β-cyclodextrin complex was found to be 164.557M-1. The FT-IR studies shown that all the materials used in the preparation of Immediate release tablets of Fluvastatin inclusion complex were compatible. The dissolution of Fluvastatin from inclusion complex FK2 prepared by Kneading method was found to be higher than the pure drug and other complexes. The inclusion complexes of Fluvastatin prepared by Kneading method FK2 and tablets formulation code F6 (containing FK2 complex and CSS 7.5%) were subjected to short-term accelerated stability studies has shown no appreciable in its physical appearance, drug content value and dissolution profiles. From the above results it can be concluded that β-cyclodextrin can be used to enhance the solubility and there-by increasing the drug release from the formulation of Fluvastatin.

Keywords: Cyclodextrins, FK2, FT-IR studies.