Abstract
PREPARATION AND EVALUATION OF ORAL DISPERSIBLE TABLETS OF AMIODARONE HYDROCHLORIDE

Ibrahim E. Alakraa*, Ebtessam A. Essa and Ahmed A. Donia

ABSTRACT

Amiodarone is one of the most common antiarrhythmic medicines used for the treatment of both supraventricular and ventricular arrhythmias. However, the bioavailability of Amiodarone is low due to its poor water solubility that results in poor bioavailability. This work aimed to improve amiodarone dissolution through co-processing with inert excipients with the aim of formulating fast disintegrating tablets. Mechanochemical method was adopted by dry co-grinding of amiodarone with increasing proportions of xylitol, mannitol or benzoic acid. The prepared binary mixtures were investigated using differential scanning calorimetry, Fourier Transform Infrared spectroscopy, powder X-ray diffraction and in vitro drug dissolution rate. Optimum co-processed mixtures were formulated into fast disintegrating tablets after addition of suitable additives. Dry co-grinding improved drug dissolution parameters compared to unprocessed (negative control) and processed (positive control) drug, with xylitol was superior to other excipients. Physical characterizations reflected possible salt formation between the drug and benzoic acid and suggested amorphousization of the drug in case of mannitol and xylitol. The selected co-processed mixtures were successively formulated into tablets with optimum drug release. The study introduced simple co-processing as a tool to enhance dissolution rate of amiodarone with subsequent formulation of fast disintegrating tablets.

Keywords: Amiodarone, mannitol, xylitol, benzoic acid, salt form, co-grinding.


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