Event Date/Time: Feb 18, 2008
End Date/Time: Feb 18, 2008
Developing discriminating dissolution methods is paramount in the modern pharmaceutical laboratory. Dissolution methods that show fast dissolution profiles do not give the practitioner any tools for predicting the performance of the drug in vivo or in vitro. This course will discuss ways to develop the dissolution method so that it is accurate and meaningful. The course will begin with a history of dissolution testing along with providing the relevant international regulatory documents information available. Equipment performance and sources of error will be covered. Conventional method development will be discussed, and then methods for the more challenging dosage forms will be explored. Since poorly soluble drug absorption is limited by the dissolution rate, drug products in this class, Class 2 (low solubility/high permeability) in the Biopharmaceutics Classification System, are good candidates for an in vivo and in vitro correlation; a practical approach will be considered. The course will conclude with method validation and setting specifications and pharmacopeial harmonization.