PHAC 831 - Pharmaceutical Preformulation and Drug Product Development

Cr Hrs: 4 (64-0-0)

In this course the scientific basis for establishing quality attributes for drug products and determining them experimentally will be emphasized. Preformulation studies are scientific studies to characterize the physical and chemical characteristics of the drug substance and formulated products. Results of these studies are the basis for defining the critical quality attributes and processing variables that are necessary to manufacture quality drug products. In order to design an acceptable final drug product, a comprehensive knowledge of the underlying scientific principles is necessary. The proposed course is aimed at identifying, determining and assessing the critical scientific information to optimize the quality of new drug products that will eventually be tested in humans. Additionally, understanding of the scientific basis of the drug development process is essential to the future role of these students. This course provides the basic information for the pharmaceutical preformulation studies which include the physicochemical characterization of drug molecules (solubility, stability, salt selection, permeability, lipophilicity, pKa, prodrugs, crystalline, and amorphous states).

Grade Mode: Standard
Instructional Method: Lecture
Prerequisites: Permission of instructor
Term offered: Offered as needed

Spring - Instructor of Record: Hassan Almoazen