Development and Evaluation of Polymer-conjugated Solid Fast Dissolving Tablets of Ambroxol Hydrochloride

Objectives: This study aimed to develop polymer-conjugated Fast Dissolving Tablets (FDTs) of ambroxol hydrochloride using direct compression with Amberlite IPR64 and Sodium Starch Glycolate (SSG) to achieve effective taste masking and enhance palatability and patient compliance. Materials and Methods: A 3² factorial design was employed to optimize formulation variables, producing nine formulation batches (F1-F9). Both Amberlite IRP64 (X1-20- 80 mg) and SSG (X2-10-30 mg) levels are independent variables. Two factors' quantities were determined by initial research and their effects on two dependent variables (disintegration time and in vitro drug release) were then investigated. Both the precompression and post compression parameters were evaluated, including disintegration time, wetting time, water absorption ratio, and in vitro drug release. Stability testing and in vivo taste masking activity were achieved using the BATA (brief-access taste aversion) model in rats. Results: The optimized formulation (F6) exhibited rapid disintegration (16.0 sec), high water absorption ratio (91.9%) and cumulative drug release 95.8% within 15 min. In vivo taste-masking analysis demonstrated that the 95% similarity to the marketed formulation (p>0.05). Stability studies conformed no significant changes under accelerated condition. Conclusion: Without compromising the drugs therapeutic efficacy, the Amberlite IRP64 polymer solid dispersion successfully covers the taste. Still, during in vivo examination, the (F6) formulation confirmed encouraging results in terms of taste masking, signifying improved patient compliance. All things measured, the Amberlite IRP64 polymer-conjugated solid dispersion used in this formulation suggestions a rich strategy for refining medicine palatability without forgoing its effectiveness.