Optimization of Sustained-release Diltiazem Formulations in Man by use of an In-vitro/In-vivo Correlation

In‐vitro/in‐vivo correlations (IVIVC) are useful for predicting in‐vivo results from in‐vitro data. An IVIVC has been used to optimize a hydrocolloidal‐based matrix tablet designed to be bioequivalent to an existing once‐daily diltiazem HCl*** product (Dilacor XR 240 mg; Rhone‐Poulenc Rorer). Data f...

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Bibliographic Details
Published in:Journal of pharmacy and pharmacology 1998-08, Vol.50 (8), p.845-850
Main Authors: YU, K., GEBERT, M., ALTAF, S. A., WONG, D., FRIEND, D. R.
Format: Article
Language:English
Subjects:
Antianginal agents. Coronary vasodilator agents
Biological and medical sciences
Cardiovascular Agents - administration & dosage
Cardiovascular Agents - pharmacokinetics
Cardiovascular system
Cross-Over Studies
Delayed-Action Preparations
Diltiazem - administration & dosage
Diltiazem - pharmacokinetics
Drug Compounding
Fasting
Female
General pharmacology
Humans
Male
Medical sciences
Pharmaceutical technology. Pharmaceutical industry
Pharmacology. Drug treatments
Reference Values
Time Factors
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Summary:In‐vitro/in‐vivo correlations (IVIVC) are useful for predicting in‐vivo results from in‐vitro data. An IVIVC has been used to optimize a hydrocolloidal‐based matrix tablet designed to be bioequivalent to an existing once‐daily diltiazem HCl*** product (Dilacor XR 240 mg; Rhone‐Poulenc Rorer). Data from a preliminary formulation dosed to fasted and fed subjects were used to establish the IVIVC. The correlation was then used during reformulation of the dosage forms to predict changes in the maximum plasma concentration (Cmax) and the area under the plasma‐concentration‐time curve (AUC) for fasted and fed subjects using in‐vitro dissolution data. The IVIVC adequately predicted plasma profiles of two optimized formulations in studies with fasted and fed subjects.
ISSN:0022-3573
2042-7158
DOI:10.1111/j.2042-7158.1998.tb03998.x