The Development of a Novel in Vitro Discriminatory Dissolution Method for a Class I Drug in a Matrix Tablet Formulation
A controlled release hydrophilic matrix tablet formulation of a Class I (Amidon et al., 1995) drug containing hydroxypropylmethylcellulose (HPMC) has been developed. The level of HPMC has previously been shown to influence the in vivo release of the drug from this formulation. However, a standard dissolution test utilising USP II aqueous methodology failed to discriminate sufficiently between formulations. Therefore, work was undertaken to develop a novel discriminatory dissolution method based on retrospective in vivo data.
KeywordsDissolution Profile Dissolution Method Vitro Dissolution Elan Corporation Cooperative Working Group
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