Dissolution and Drug Release

Project Team: Faculty: B. Michniak-Kohn (Project Leader, Rutgers), A. Cuitino, F. Muzzio, P. Takhistov (Rutgers), R. Romanach (University of Mayaguez, Puerto Rico), R. Pinal, (Purdue University), R. Dave (NJIT)

Collaborating Faculty: B. Khusid (NJIT), S. Mitra (NJIT)
Postdoctoral Fellows: K. Pingali (Rutgers), Y. Shen (NJIT), L. Sievens- Figuerora (NJIT)
Graduate Students: D. Braido, A. Bhakay, E. Elele (NJIT), X. Meng (NJIT), M.Brown (Rutgers)
LDD Researcher: G. Keyvan (Rutgers)

Goals and Role within ERC Strategic Plan:

Biopharmaceutics considers the interrelationship of the physicochemical properties of the drug, the dosage form in which the drug is given, and the route of administration on the rate and extent of systemic drug absorption. Thus, biopharmaceutics involves factors that influence the release of the drug from the drug product/formulation, the rate of dissolution of the drug, and the eventual bioavailability of the drug. Dissolution, by definition, is the process by which a solid substance dissolves. As a fundamental phenomenon, it is controlled by the affinity between the solid and the medium. The dissolution rate is defined as the amount of drug substance that goes into solution per unit time under standardized conditions of liquid/solid interface, temperature and solvent composition. Several investigators noticed correlations between structure of actives and formulation excipients (such as lubricants in tablets) and their effects on dissolution and hence systemic absorption in patients. These effects are often complex. In addition, we have noted that many standardized dissolution tests are often not an absolute predictor of in vivo bioavailability. Currently, attempts are being made to design equipment that more correctly predicts in vitro dissolution behavior to performance of the dosage form in vivo. In this project we will aim to:

a) examine drug release profiles as well as drug distribution of tablets and edible polymer films;
b) develop mechanistic models for drug release taking into account drug distribution in the dosage form and properties of the matrix; and
c) develop novel approaches to relate dissolution and formulation properties to in vivo bioavailability.

Three examples of subprojects are illustrated below:

Physical Dissolution Assays of Polymer Film Strips of Griseofulvin

Drug Release from Printed Drug Dosage Units

TIM-1 vs. USP Apparatus II Comparison Study