FORMULATION AND EVALUATION OF FAST DISSOLVING TABLET OF CYCLODEXTRIN INCLUSION COMPLXED WATER INSOLUBLE DRUG: ACECLOFENAC
A. Bhargav, F. R. Sheeba, B. V. Vinutha*, Dr. Shivanand K. Mutta and H. S. Keerthy
ABSTRACT
The enhancement of solubility of poorly water-soluble drugs is one of the challenging aspects of drug development. Therefore, formulation approaches are being explored to enhance solubility of poorly water-soluble drugs. The aim of the present study was formulation and evaluation of a fast-dissolving tablet of cyclodextrin inclusion complex with water insoluble drug aceclofenac. Complexation is an extensively used technique in the pharmaceutical field to improve solubility of several pharmaceutical ingredients and poorly water-soluble drugs. The inclusion complex of aceclofenac with β-cyclodextrin was prepared in 1:0.5, 1:1, 1:1.5 and 1:2 ratios in various methods such as physical mixture method, kneading method, and co-precipitation method. Among all the inclusion complex formulations, the aceclofenac and β-cyclodextrin 1:2 ratio in the physical mixture method showed an increase in solubility than pure drug. The best inclusion complex was prepared as a mouth dissolving tablet by using various types of super disintegrants such as sodium croscarmellose, polyvinylpyrrolidone and starch maize. The granules were evaluated for angle of repose, bulk density, tapped density and Carr’s index. Tablets are prepared by direct compression method and evaluated for weight variation, hardness, friability, wetting time, water absorption ratio, disintegration time and in-vitro drug release. The F3 formulation containing sodium croscarmellose was best among all the formulations. It disintegrates within 48sec, wetting time was 30 sec and 94% of drug release in 30 minutes.
Keywords: Aceclofenac, cyclodextrin, inclusion complexes, solubility enhancement, fast dissolving tablets.
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