Development of Nanostructured Ambroxol Hydrochloride-Loaded Matrix Tablets for Enhanced Bioavailability

Abstract

The present study focuses on the development and evaluation of nanostructured Ambroxol Hydrochloride-loaded matrix tablets for sustained drug delivery and enhanced bioavailability. Preformulation studies confirmed the purity, solubility, and compatibility of the drug with selected excipients. Nanoparticles were successfully prepared with a particle size range of 120–180 nm and satisfactory entrapment efficiency, indicating effective drug incorporation. Matrix tablets were formulated by the direct compression method using varying concentrations of Hydroxypropyl Methylcellulose (HPMC) as a release-controlling polymer. The formulations were evaluated for pre- and post-compression parameters and were found to be within acceptable pharmacopoeial limits. In vitro dissolution studies revealed that drug release depended on polymer concentration, with higher levels producing slower release rates. Among all formulations, batch F4 showed an optimal sustained release profile, achieving approximately 95% drug release over 12 hours. Drug release kinetics followed the Higuchi model, indicating diffusion-controlled release with non-Fickian behavior. Stability studies confirmed the formulation’s robustness under accelerated conditions. Overall, the findings demonstrate that nanostructured matrix tablets are a promising approach for sustained delivery of Ambroxol Hydrochloride, leading to improved therapeutic efficacy and patient compliance.

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