FORMULATION AND IN-VITRO CHARACTERIZATION OF AMBROXOL HYDROCHLORIDE SUSTAINED-RELEASE MATRIX TABLETS

The present study involves the formulation and in-vitro characterization of sustained release matrix tablets of Ambroxol hydrochloride, a potent mucolytic agent used in the treatment of respiratory disorders. FTIR analysis confirmed the absence of drug-polymer interactions. Sustained release matrix tablets containing 75 mg were formulated employing HPMCK15 and xanthan gum as release retarding polymer and dicalcium phosphate and microcrystalline cellulose as diluents. The powder blend was evaluated for micromeritic properties. The matrix tablets were prepared by direct compression technique. The prepared tablets were evaluated for uniformity of weight, hardness, friability, and uniformity of content. All the formulations showed compliance with pharmacopoeial standards. The in-vitro drug release studies were carried out for a period of 12 h using USP type II dissolution apparatus at 50 rpm by taking 900 ml of 0.1 N HCl (pH 1.2) as dissolution medium for first 2 h and later replacing it with 900 ml pH 6.8 phosphate buffer solution for a period of 10 h at 37 ± 0.5 °C.  Among the different combinations of polymers in different ratios studied, the desired in-vitro drug release (97.65% for 12 h) was found with the combination of HPMC K15M and xanthan gum with the drug in the ratio of 1: 0.75 (F7). The drug release from the F7 formulation followed zero order kinetics and mechanism was found to be erosion.