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Modeling and Comparison of Dissolution
Dissolution Technologies | MAY 2009 41
Modeling and Comparison of Dissolution
Profiles of Diltiazem Modified-Release
Formulations
D. Samaha, R. Shehayeb, and S. Kyriacos1
Department of Pharmaceutical Sciences, School of Pharmacy, Lebanese American University,
P.O. Box 36, Byblos, Lebanon
e-mail: soula.boustani@.lb
1Corresponding author.
ABSTRACT
Generic drugs offer a cost-effective alternative to brand-name products. However, the main concern with
modified-release formulations is the substitution of one product for another. Accordingly, the first objective of this study
was to assess the interchangeability of the available diltiazem extended-release (ER) products on the basis of their in vitro
dissolution characteristics using USP Apparatus 2 and 3. The second objective was to compare dissolution profiles in
simulated fasted and fed states and determine whether there is a change in the mechanism of drug release. Dissolution
profiles characterized using Apparatus 2 or 3 under fasted conditions were similar. However, Apparatus 3 testing provided
a more discriminating and comprehensive evaluation of the drug release performance of ER products. Testing using
Apparatus 3 in the fed state highlighted some difference in dissolution profiles, suggesting a food effect on drug release.
This implies that, depending on the targeted concentration, a patient should be instructed whether to take the
medication in fasted or fed state. The study therefore shows the necessity of testing the products in both fasted and fed
states to determine their similarity and therapeutic interchangeability. Apparatus 3 testing was also more accurate in
determining the release mechanism than the Apparatus 2 method. No change in the mechanism of drug release between
fasted and fed state was observed.
INTRODUCTION
Diltiazem is an orally administered, nondihydropyri-dine calcium-channel blocker that is used for the treatment of hypertension and atrial fibrillation.
According to the Bio
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