Formulation and Development of Sustained Release Matrix Tablets of Ambroxol hydrochloride by QBD Approach

Ambroxol hydrochloride is a potent mucolytic agent capable of inducing bronchial secretions used in the treatment of respiratory disorders linked to thick or viscous mucus. The Sustained release matrix tablets containing 75 mg Ambroxol hydrochloride were developed using different drug: polymer ratios. Sustained release matrix tablets were prepared by direct compression method. 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 type II (paddle method) dissolution apparatus at 50 rpm. The absorbance of these solutions was identified at 250 nm using a UV Spectrophotometer. Among all formulations, the preparation of the F4 batch showed the highest percent drug release at 98.56% after 12 hours. end of 12 h. The stability studies were carried out according to ICH guideline, which indicates that the selected formulations were stable.