The influence of dissolution conditions on the drug ADME phenomena.
Cascone, Sara; De Santis, Felice; Lamberti, Gaetano *; Titomanlio, Giuseppe
[Article]
European Journal of Pharmaceutics & Biopharmaceutics.
79(2):382-391, October 2011.
(Format: HTML, PDF)
In this work, a review of the apparatuses available to mimic what happens to a drug (or to foodstuffs) once ingested is presented. Similarly, a brief review of the models proposed to simulate the fate of a drug administered to a living body is reported. Then, the release kinetics of extended release of diclofenac from a commercial enteric-coated tablet was determined both in a conventional dissolution tester (USP Apparatus 2, Method A) as well as in an apparatus modified to reproduce a given pH evolution, closer to the real one than the one suggested by USP. The two experimental release profiles were reported and discussed; therefore, they were adopted as input functions for a previously proposed pharmacokinetic model. The obtained evolutions with time of plasma concentration were presented and used to assess the effectiveness of the commercial pharmaceutical products. The importance of a correct in vitro simulation for the design of pharmaceutical dosage systems was thus emphasized.
(C) 2011Elsevier, Inc.