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Development of a new controlled-release formulation of chlorpheniramine maleate using in vitro/in vivo correlations

✍ Scribed by Roger L. Williams; Robert A. Upton; Luann Ball; Richard L. Braun; Emil T. Lin; Winnie Liang-Gee; Lewis J. Leeson

Publisher: John Wiley and Sons
Year: 1991
Tongue: English
Weight: 442 KB
Volume: 80
Category: Article
ISSN: 0022-3549
DOI: 10.1002/jps.2600800106

No coin nor oath required. For personal study only.

✦ Synopsis

Development of a controlled-released formulation of chlorpheniramine maleate is described, using in vitro/in vivo correlates, according to a process that has been termed "biorelevant dissolution". The process begins with simulations using several possible input rates combined with known disposition parameters of chlorpheniramine maleate. Based on desired plasma concentrations, an input rate is selected for further development which consists of a combination of clinical bioequivalence studies and further in vitro testing and simulations. The method is designed to reduce the requirements for trial and error clinical bioequivalence testing of a new controlled-release formulation.

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