Is there variability in drug release and physical characteristics of amiodarone chloride from different commercially available tablets? Possible therapeutic implications

The International Journal of Pharmacy Practice
Suong N T Ngo, Timothy Barnes

Abstract

Amiodarone is a low-solubility, high-permeability drug with a narrow therapeutic index and reported bioavailability problems associated with switching formulations. The aim of this study was to identify whether there is variability in drug release and physical characteristics of different commercially available amiodarone hydrochloride formulations in Australia. Four available formulations (innovator Cordarone (COR) and generic products G1, G2 and G3) were tested for drug dissolution, content uniformity, hardness, weight variation, friability and disintegration in accordance with the US Pharmacopeia specifications. The tested formulations exhibited variable dissolution behaviours: G1 and G3 exhibited the fastest dissolution, G2 dissolution was the slowest and Cordarone showed a medium dissolution. After 3 months' exposure to high temperature (40 +/- 2 degrees C) and relative humidity (75 +/- 5%), the products exhibited a higher degree of disparity, with drug-release profiles of the generics being markedly different from that of Cordarone. This suggests possible implications on bioequivalence for patients who live in warm/tropical regional areas. Most products met the US Pharmacopeia specifications for drug-content uniformity an...Continue Reading

References

Apr 27, 2000·The American Journal of Cardiology·J A Reiffel, P R Kowey
Sep 27, 2000·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·F M Besag
Nov 2, 2004·Progress in Cardiovascular Diseases·James A Reiffel
Mar 27, 2007·Journal of Clinical Pharmacy and Therapeutics·S N T Ngo

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Citations

Jul 13, 2011·CMAJ : Canadian Medical Association Journal = Journal De L'Association Medicale Canadienne·Meytal A TsadokLouise Pilote

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