Effect of pharmaceutical excipients on the stability of angiotensin-converting enzyme inhibitors in their solid dosage formulations

Drug Development and Industrial Pharmacy
Beata StaniszPiotr Garbacki

Abstract

The compatibility studies of moexipril hydrochloride (MOXL), imidapril hydrochloride (IMD), enalapril maleate, (ENA) and lisinopril (LIS) in solid state with magnesium stearate and glyceryl behenate were performed. The aim of this study was to detect any possible drug-excipient interactions in order to optimize technological process conditions by the selection of the most adequate lubricant. Reversed-phase high-performance liquid chromatography was employed for studying drug-excipient binary mixtures in 1:1 ratio and pure drugs under forced ageing test conditions: temperature 318K (45 °C) and relative humidity range of 50.9%-75.4%. The method had been revalidated prior to use. The degradation rate constants for the binary mixtures and pure substances were calculated. The experimental results evidenced that moexipril and enalapril degradation accorded with autocatalytic-second-order kinetics, imidapril degradation followed first-order reaction mechanism, and LIS followed reversible first-order reaction mechanism. A degradation pathway for each substance was proposed to account for the observed decomposition products. It was determined that moexipril stability decreased threefold in the presence of magnesium stearate indicating a...Continue Reading

References

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Jan 20, 2004·AAPS PharmSciTech·V Swaminathan, D O Kildsig
Aug 14, 2010·Drug Development and Industrial Pharmacy·M PerraultJ Chaouki

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Citations

Jan 15, 2014·Drug Development and Industrial Pharmacy·Gustavo H C VarcaHumberto G Ferraz
Jun 17, 2015·Drug Development and Industrial Pharmacy·Przemysław ZalewskiAnna Jelińska
Mar 19, 2014·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·Erik SjögrenPeter Langguth
Sep 10, 2016·AIDS Research and Human Retroviruses·Minlu HuLisa C Rohan
Jul 15, 2020·Molecules : a Journal of Synthetic Chemistry and Natural Product Chemistry·Małgorzata StaniszTeofil Jesionowski
Nov 3, 2020·Chemical & Pharmaceutical Bulletin·Kousuke TamuraEtsuo Yonemochi

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