Using Extrusion-Spheronization to Develop Controlled-Release Formulations of Azithromycin
February 2nd 2005Extrusion-spheronization and pellet compression are effective means of developing first-order kinetic, controlled-release drug delivery systems of azithromycin (AZI). The authors prepared, evaluated, and optimized AZI formulations and assessed the stability of the selected formulation under accelerated storage conditions.
Toward a Generic Approach for Stress Testing of Drug Substances and Drug Products
February 2nd 2005The Impurity Profiling Group reviews stress testing according to regulatory guidance documents. The authors emphasize what should be considered for late clinical phases and for registration application dossiers.