Dosage Form Design and Development

This course will review the scientific principles as well as practical aspects of dosage form design and development for traditional and biotech drugs. The content will include topics relevant to the discovery interface (drug candidate selection, preformulation, and route of administration considerations). In addition to addressing the various types of pharmaceutical dosage forms, there will be coverage of theories relevant to a variety of dosage forms such as solubility, surface chemistry, and reaction kinetics and mechanism. Practical aspects of development will address packaging, intellectual property, tech transfer, and regulatory and GMP considerations during the various phases of development. Prerequisite: Undergraduate level organic chemistry; biochemistry and physical chemistry preferred.