Shanghai Sine Pharmaceutical Co. Ltd.

Objective: To study the correlation between in vitro dissolution and bioequivalence of ambroxol hydrochloride capsules.Methods: The cumulative dissolution of the home-made preparation in different dissolution media was determined and the bioequivalence was studied to investigate the rationality of the prescription process and the similarity of the dissolution profile.Results: Home-made preparations prepared after the optimization of prescription and process were able to meet the requirements of the established quality standards and the fasting and postprandial bioequivalence was consistent with the reference preparationConclusion: Home-made ambroxol hydrochloride capsules showed consistency with the reference formulation in vitro and in vivo, and the new formulation process established can be adapted to industrial production

A review with 23 references on advance in studies of melt pelletization (granulation) in high shear mixer with emphasis technol. and prescription variability; influence of equipment and formation of pellets and the mechanism of its formation.