DEVELOPMENT AND EVALUATION OF AMBROXOL HYDROCHLORIDE SUSTAINED RELEASE TABLETS USING HPMC AS POLYMER

Ambroxol hydrochloride tablets were prepared by wet granulation method using hydrophilic polymer HPMC K4M with different compositions of drug: polymer ratio of 1:0.33, 1:0.5, 1:0.75, and 1:1 as F-1, F-2, F-3 and F-4 formulations respectively in order to have a sustained release of the drug in a predetermined interval. The prepared matrix tablets were tested for evaluation parameters such as drug content, hardness, friability, weight variation, in vitro drug release profile and water uptake capacity. The granules which were prepared by passing through #12 were dried and passed through #16 exhibited good flowing properties; hence they were selected for the compression in order to obtain a matrix tablet. The drug content in the prepared granules was in the range of 96.1 + 0.02 to 102+ 0.05 %. The formulation F3 which consisted of the drug: polymer ratio of 1:0.75, exhibited continuous and sustained release of the drug upto 12 hours during the dissolution study. The drug release of the formulation exhibited nearly zero-order kinetics and obeyed non-fickian drug release mechanism.