DEVELOPMENT AND EVALUATION OF MUCOADHESIVE TABLETS CONTAINING BROMHEXINE HYDROCHLORIDE IN β - CYCLODEXTRIN COMPLEX FOR BUCCAL DELIVERY

Athulya P. V.*, Dr. Suja C.

Bromhexine hydrochloride, a potent mucolytic for respiratory disorders, exhibits low oral bioavailability (22–27%) due to extensive hepatic first-pass metabolism. This study aimed to develop and evaluate mucoadhesive buccal tablets of bromhexine hydrochloride in beta-cyclodextrin to bypass pre-systemic clearance and optimize drug delivery through the oral mucosa. Inclusion complexes of the drug with -cyclodextrin prepared to enhance solubility of drug. Tablets containing 8 mg of the active drug were formulated using Hydroxypropyl Methylcellulose, and Carbopol as bio adhesive polymers, with microcrystalline cellulose as the filler. A 13-run Central Composite Design was applied to optimize the polymeric matrix designed with the help of Design Expert software. The formulations were evaluated for flow properties, hardness, thickness, surface pH, weight variation, drug content uniformity, swelling index, and in vitro dissolution behaviour. Among the prepared batches, the optimized formulation demonstrated superior performance. It exhibited a surface pH compatible with salivary conditions, ensuring minimal mucosal irritation. The swelling index was successfully maintained below 100%, preventing rapid matrix erosion while preserving structural integrity. In vitro dissolution studies confirmed a controlled and sustained drug release profile. FT-IR analysis verified structural compatibility between the drug and excipients. 90-day stability study showed no significant changes in quality or release behaviour. The optimized buccal tablet offers a viable approach for delivering bromhexine hydrochloride, providing a promising strategy to avoid first-pass metabolism, enhance systemic availability, and improve clinical outcomes.