Formulation and Evaluation of Sustained Release Tablets of Ambroxol Hydrochloride

In the present study, an attempt was made to formulate the oral sustained release matrix tablets of Ambroxol HCl in order to improve the efficacy, reduce the frequency of administration, and better patient compliance. Ambroxol Hydrochloride is a potent mucolytic agent which induces bronchial secretions used in the treatment of respiratory disorders. FTIR analysis confirmed the absence ofany drug polymer interaction. Sustained release tablets of Ambroxol Hydrochloride were formulated employing hydrophilic polymers HPMC K4M and HPMC K100M. The powder blend was evaluated for micromeritic properties. The sustained release tablets were prepared by wet granulation method. The tablets were evaluated for thickness, weight variation test, hardness, friability, and drug content. The in vitro drug release characteristics were studied in simulated gastric fluid (2 hours) and intestinal fluid for a period of 10 hours using USP type II dissolution apparatus (total 12hours). The results of dissolution studies indicated that formulation F11 is the most successful of the study with satisfactory drug release. At the end of 12 hrs, the drug release was found to be 96.1%.