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IN VITRO – IN VIVO CORRELATIONS FOR LIPOPHILIC, POORLY WATER – SOLUBLE DRUGS: AN OVERVIEW. Ranjith annishetty, Sachin Kumar Singh, Soorajpal Verma s

IN VITRO – IN VIVO CORRELATIONS FOR LIPOPHILIC, POORLY WATER – SOLUBLE DRUGS: AN OVERVIEW.

Ranjith annishetty, Sachin Kumar Singh, Soorajpal Verma

International Journal of Natural Product Science 2012: Spl Issue 1:92.

Abstract (RBIP-92)

In vitro–in vivo correlation (IVIVC) is a general term that refers to a relationship between a biological property produced by a dosage form and a physicochemical characteristic of the same dosage form. Establishment of an IVIVC could facilitate drug development by reducing the number of in vivo studies required for confirming either the safety or the efficacy of a drug product or the bioequivalence of products containing the same drug. The development of a meaningful dissolution procedure for drug products with limited water solubility has been a challenge to both the pharmaceutical industry and the agencies that regulate them. These challenges include developing and validating the test methods, ensuring that methods are appropriately discriminatory, and addressing the potential for an in vivo–in vitro correlation (IVIVC). This article is an overview on the approaches like simulation of the in vivo gastrointestinal physiology with in vitro dissolution testing methods. These approaches include media composition, volume and hydrodynamics of the contents in the gastrointestinal lumen. Four media have been overviewed to simulate composition of the gastric and intestinal contents before and after meal intake. These are SGF (Simulated Gastric Fluid), milk, FASSIF (Fast State Simulated Intestinal Fluids) and FeSSIF (Fed State Simulated Intestinal Fluids), which simulates fasted and fed state conditions in the stomach and small intestine respectively. Using these media, excellent correlations have been obtained with the following poorly soluble drugs.
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