FORMULATION AND EVALUATION OF SUSTAINED RELEASE MATRIX TABLETS OF AMBROXOL HYDROCHLORIDE USING NATURAL POLYMERAbstract
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, swelling index study also carried out. 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. 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, F4 shows 99.15% better-controlled release at the end of 12 h. 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.
S. Kumar *, B. S. Rao and S. V. Kulkarni
Department of Pharmacy, Sree Siddaganga College of Pharmacy, Tumkur, Karnataka, India.
19 March 2014
19 May 2014
05 July 2014
01 October 2014