Abstract

DESIGN AND DEVELOPMENT OF SUSTAINED RELEASE AMBROXOL HYDROCHLORIDE MATRIX TABLETS USING THE COMBINATION GUAR GUM AND KARAYA GUM

Sunil Kumar*, Someswara Rao B , Suresh V Kulkarni

ABSTRACT

In the present investigation, an attempt was made to design and develop of Sustained Release Ambroxol Hydrochloride Matrix Tablets using the combination Guar gum and Karaya gum, in order to improve efficacy, reduce the frequency of administration, and better patient compliance. Ambroxol hydrochloride is a potent mucolytic agent capable of inducing bronchial secretions used in the treatment of respiratory disorders. The Sustained release matrix tablets containing 75 mg Ambroxol hydrochloride were developed using different drug: polymer ratios. Sustained release matrix tablets were prepared by wet granulation method. Granules were prepared and evaluated for loose bulk density, tapped bulk density, compressibility index and angle of repose, shows satisfactory results. The prepared tablets were further evaluated for uniformity of weight, hardness, friability, thickness, content uniformity, In-vitro dissolution, drug-excipients interactions. The FT-IR studies revealed that there was no chemical interaction between drug and excipients. In-vitro release studies were carried out using USP XXII type II (paddle method) dissolution apparatus at 50 rpm by taking 900 ml of 0.1 N HCl (pH 1.2) as dissolution medium for first 2 hours and later replacing it with 900 ml pH 6.8 phosphate buffer solution for rest of the time period at 37 ± 0.50C. The release data was fitted to various mathematical models such as, Higuchi, Korsmeyer-Peppas, First-order, and Zero order to evaluate the kinetics and mechanism of the drug release. Among all the formulations, F 4 shows 98.21 % better controlled release at the end of 11 hr. The drug release of optimized formulations F-4 follows zero order kinetics. The stability studies were carried out according to ICH guideline which indicates that the selected formulations were stable.

Keywords: Ambroxol Hydrochloride, Matrix tablet, Sustained release, Karaya gum, Guar gum, Wet Granulation.