In vitro-in vivo relationship of oral extended-release dosage forms

A method to establish the in vitro-in vivo relationship of oral extended-release products is proposed. The approach utilizes incremental amounts of drug released and absorbed within defined time intervals, to construct a chi2 distributed variable for testing in vitro-in vivo similarity. A case study...

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Bibliographic Details
Published in:Pharmaceutical research 1996-10, Vol.13 (10), p.1501-1506
Main Authors: LIU, F.-Y, SAMBOL, N. C, GIANNINI, R. P, CHUI YU LIU
Format: Article
Language:English
Subjects:
Absorption
Administration, Oral
Biological and medical sciences
Delayed-Action Preparations
General pharmacology
Hydrogen-Ion Concentration
In Vitro Techniques
Mathematical Computing
Medical sciences
Methods
Pharmacokinetics
Pharmacokinetics. Pharmacogenetics. Drug-receptor interactions
Pharmacology. Drug treatments
Solubility
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Summary:A method to establish the in vitro-in vivo relationship of oral extended-release products is proposed. The approach utilizes incremental amounts of drug released and absorbed within defined time intervals, to construct a chi2 distributed variable for testing in vitro-in vivo similarity. A case study is used to demonstrate that the similarities between incremental values of in vivo absorbed and in vivo dissolved fractions are distinguishable for different dissolution profiles despite naturally significant linear correlations between cumulative in vivo absorbed and in vitro dissolved fractions (with different dissolution tests) of an oral extended-release product. The method enables investigators to compare different in vitro dissolution profiles of an oral extended-release product to find an optimized dissolution profile to be the surrogate of the in vivo release process of the product.
ISSN:0724-8741
1573-904X
DOI:10.1023/A:1016023428028