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THE INFLUENCE OF COMPLEXATION WITH HYDROXYPROPYL-?-CYCLODEXTRIN AND SURFACTANTS ON THE DISSOLUTION PROFILE OF AMIODARONE HYDROCHLORIDE
Abstract
The objective of the study was to increase the solubility of amiodarone hydrochloride by complexation with hydroxypropyl-пїЅ-cyclodextrin. After complexation a cyclodextrin/amiodarone inclusion complex was formed. The use of media containing surfactants is a suitable solubilizing method and as a result, a non-ionic surfactant - Tween 80 and an anionic one - sodium lauryl sulfate have been used. The dissolution profile of amiodarone hydrochloride and that of the inclusion complex, regarding the release of the active substance, with or without surfactants was carried out in simulated physiological environment, at pH 1.2 (simulated gastric fluids) and pH 6.8 (simulated intestinal fluids). The dissolution test was carried out using two USP validated methods: paddle II apparatus dissolution test and Enhancer cell dissolution test.
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