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Summary Results of these studies indicate that the USP Apparatus 3pH-gradient method is a convenient and discriminatingmethod for comparing the drug release behavior of ERdosage forms during their passage through the GI tract. Inthe present study,it could be shown that it is possible todifferentiate between individual release characteristics ofmetoprolol ER dosage forms. Specificity of drug releaseprofiles during gastrointestinal passage as well as pH-dependency of drug release could be shown.The methodused in the present study therefore represents a useful toolin estimating the interchangeability of seemingly similardosage forms when administered in the fasted state. References 1. Guidance for Industry:Waiver of in vivo bioavailabilityand bioequivalence studies for immediate-releasesolid oral dosage forms based on a biopharmaceuticsclassification system. U.S. Department of Health andHuman Services,Food and Drug Administration,Center for Drug Evaluation and Research (CDER):Rockville,MD,2000.

Comparison of Drug Release From Metoprolol Modified Release Dosage Forms in Single Buffer versus a pH-Gradient Dissolution Test