Evaluation of Extemporaneous Oral Itraconazole Suspensions by Dissolution Profiles Mapping

Tong, Henry H Y; Chan, Hokman; Du, Zhen; Zheng, Ying

Abstract

Evaluation of Extemporaneous Oral Itraconazole Suspensions by Dissolution Profiles Mapping

Author(s): Tong Henry H Y, Chan Hokman, Du Zhen, Zheng Ying

Issue: Jul/Aug 2010 - Sterile Compounding

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Page(s): 342-345

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Abstract

The objective of this study was to evaluate by dissolution profiles mapping five extemporaneous oral itraconazole suspensions reported in literature. Dissolution profiles of the extemporaneous oral itraconazole preparations were mapped and correlated with their reported clinical data therein. Four out of five extemporaneous preparations had either too early or insufficient release of itraconazole during dissolution study, potentially limiting the in vivo oral bioavailability in patients. Dissolution profile in the remaining extemporaneous preparation was closely similar to that in commercial itraconazole capsules. Based on the reported clinical data and dissolution results in this study, the extemporaneous preparation proposed in a study by Ong and Fobes seems to be the most reasonable choice for our patients. Dissolution profile evaluation is an important quality-control parameter during the evaluation of extemporaneous preparations by pharmacists.

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