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Toward Biorelevant Dissolution: Application of a …

dissolution technologies | FEBRUARY 201225e-mail: Biorelevant dissolution : Application of a Biphasic dissolution Model as a Discriminating Tool for HPMC Matrices Containing a Model BCS Class II DrugDaniel J. Phillips1, Samuel R. Pygall2, V. Brett Cooper2, and James C. Mann2,*1 Department of Chemistry, University of Warwick, Coventry, Warwickshire, CV4 7AL, UK2 Development Laboratories, MSD Development Laboratories, Hertford Road, Hoddesdon, Herts, EN11 9BU, UKABSTRACTThe potential of a biphasic dissolution system to assist with the analysis of controlled-release (CR), Biopharmaceutics Classification System (BCS) Class II pharmaceutical products has been investigated. Use of a biphasic dissolution medium (aqueous/octanol) provided sink conditions and afforded complete dissolution of nifedipine formulated in a CR matrix tablet while maintaining the dosage form in an aqueous environment.

Dissolution Technologies | FEBRUARY 2012 25 e-mail: james_mann@merck.com Toward Biorelevant Dissolution: Application of a Biphasic Dissolution Model as a Discriminating Tool for HPMC Matrices

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