Dissolution Modeling of Bead Formulations and Predictions of Bioequivalence for a Highly Soluble, Highly Permeable Drug

• Published in: Molecular pharmaceutics Vol. 7; no. 5; pp. 1450 - 1457
• Main Authors: Sperry, David C, Thomas, Steven J, Lobo, Evelyn
• Format: Journal Article
• Language: English
• Published: United States American Chemical Society 04.10.2010
• Subjects: Chemistry, Pharmaceutical - methods; Half-Life; Humans; Intestinal Absorption; Models, Biological; Permeability; Pharmacokinetics; Solubility; Surface Properties; Tablets, Enteric-Coated; Therapeutic Equivalency; particle size; diffusion; enteric coating; absorption; bead formulation; model; delayed-release surface area; Dissolution; bioequivalence

The objective of this study was to assess the impact of observed in vitro dissolution rate differences on in vivo pharmacokinetics for two enteric-coated bead formulations of a highly soluble, highly permeable drug. A new bead dissolution model was developed to quantitatively simulate the dissolutio...