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FORMULATION AND EVALUATION OF THE ORO- DISPERSIBLE TABLETS OF AMBROXOL HYDROCHLORIDE USING NATURAL DISINTEGRANTS BANANA POWDER

Abstract

The objective of this study was to evaluate the formulation efficiency and long-term stability of Ambroxol HCl orally dissolving tablets (ODTs). The experimental methodology involved an assay of 20 randomly selected tablets, which were crushed and processed in a phosphate buffer at a pH of 6.8. Drug concentration was quantified using UV/Visible spectrophotometry by measuring absorbance at 345 nm, utilizing 10 ppm dilutions of both the test sample and a 50 mg standard for comparative calculation. In-vitro dissolution profiles were established using a Type-2 dissolution apparatus. Among the formulations tested, batch F8 exhibited the most superior performance, achieving a cumulative drug release of 99.76% within an 18-minute interval. This accelerated release rate is attributed to the synergistic disintegrating effects of Banana Extract and Croscarmellose Sodium. Furthermore, the tablets underwent a rigorous three-month stability program under accelerated stress conditions. Throughout the evaluation period, the formulations were monitored for critical changes in physical dimensions, weight variation, hardness, friability, and disintegration time. The results indicated no significant degradation in physical characteristics or chemical potency. The stability data, combined with the efficient drug release from formulation F8, suggests that this delivery system is both robust and effective for clinical applications.

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