Developing a Discriminating Dissolution Procedure for a ...

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13DissolutionTechnologies| FEBRUARY 2004Developing a Discriminating DissolutionProcedure for a Dual Active PharmaceuticalProduct with Unique solubility CharacteristicsLagace, ,2,Gravelle, ,Di Maso, McClintock, : testing is a required test currently used todemonstrate the performance of all solid oral dosageforms in which absorption of the drug is necessaryfor the product to exert a therapeutic effect (1). The chal-lenge for scientists working in a research and developmentenvironment is to develop a Procedure that can not onlyguide the formulation development process but can alsobe used as a regulatory test to detect manufacturing devia-tions and to ensure product consistency at release andover the product s shelf life. The test must be rugged andreproducible and highlight only significant changes inproduct performance.

Dissolution Technologies| FEBRUARY 2004 13 Developing a Discriminating Dissolution Procedure for a Dual Active Pharmaceutical Product with Unique Solubility Characteristics Lagace, M.1,2,Gravelle,L.2,Di Maso,M. 2 and McClintock, S.2 e-mail: marylene_lagace@merck.com IntroductionD

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