Development of In Vitro-In Vivo Correlation/Relationship Modeling Approaches for Immediate Release Formulations Using Compartmental Dynamic Dissolution Data from "Golem": A Novel Apparatus.

Abstract:

:Different batches of atorvastatin, represented by two immediate release formulation designs, were studied using a novel dynamic dissolution apparatus, simulating stomach and small intestine. A universal dissolution method was employed which simulated the physiology of human gastrointestinal tract, including the precise chyme transit behavior and biorelevant conditions. The multicompartmental dissolution data allowed direct observation and qualitative discrimination of the differences resulting from highly pH dependent dissolution behavior of the tested batches. Further evaluation of results was performed using IVIVC/IVIVR development. While satisfactory correlation could not be achieved using a conventional deconvolution based-model, promising results were obtained through the use of a nonconventional approach exploiting the complex compartmental dissolution data.

journal_name

Biomed Res Int

authors

Čulen M,Tuszyński PK,Polak S,Jachowicz R,Mendyk A,Dohnal J

doi

10.1155/2015/328628

subject

Has Abstract

pub_date

2015-01-01 00:00:00

pages

328628

eissn

2314-6133

issn

2314-6141

journal_volume

2015

pub_type

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