The Formulation Study of Ambroxol

• Main Authors: Yu-Pei Chen, 陳鈺佩
• Other Authors: Gan-lin Chen
• Format: Others
• Language: zh-TW
• Published: 2001
• Online Access: http://ndltd.ncl.edu.tw/handle/60764254877221550227

碩士 === 中國醫藥學院 === 藥物化學研究所 === 89 === Abstract Ambroxol HCl (trans-4-(2-amino-3,5-dibromobenzyl-amino) cyclohexanol), a mucolytic agent, is a metabolite of bromhexine and has similar action and use. It is a mucolubricant that promotes secretion of surfactant and airway fluid, enhances ciliary movement and normalizes airway mucosa. Conventional oral formulations of ambroxol HCl must be administered at least 3 times per day to provide 24-hour efficacy. Thus attempts have been made to develope an oral controlled-release preparation. In this study, we have focused on: 1. The physicochemical of ambroxol HCl are determined. 2. A stability indicating HPLC procedure for the determination of ambroxol HCl is described. The degraded samples were analyzed by HPLC with C-18 columns. Peak purity of ambroxol HCl in C-18 chromatograms wrer checked by Diode Array Detector (DAD). 3. Using the stability indicating assay method, the effect of pH's, buffers (citrate, phosphate, and glycine), temperatures, solvents, and the presents of hydrogen peroxide, on the stability of ambroxol HCl aqueous solution has been studied. Their degradation reactions, followed pseudo-first-order kinetic model. 4.The stability pH-log(rate) profile of ambroxol HCl was described. 5. An oral controlled-release teblet has been prepared. The formulation of this matrix type tablet contains the coprecipitates of Ambroxol HCl with Eudragit . Use HPMCP, Eudragit L-100 and dissolution profiles were similar to commercial reference. Key words: Ambroxol HCl，Stability indicating HPLC assay method， pH-log(rate) profile，Oral controlled-release teblet， Dissolution profile.