Pre-formulation

Pre-formulation

This course is part of Drug Hunting: The Science of Making New Medicines Specialization

Instructors: Erland Stevens, PhD

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Assessments

14 assignments

Taught in English

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This course is part of the Drug Hunting: The Science of Making New Medicines Specialization

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There are 3 modules in this course

In this course we will focus on how active compounds are developed into a formulation suitable for dosing in animal studies and early human clinical trials.  Factors such as the route of administration, enhancing the solubility of the drug substance, the crystalline form of the drug substance, drug substance vs. drug product, storage requirements, and how special requirements of the patient population play a role in the design of an ideal formulation will be covered.  Finally, some of the differences encountered when formulating a biologic vs. a small molecule will be discussed.

Welcome, by the end of the course students will be able to: Define the concepts of formulation, drug substance, and drug product. Describe the role of pre-formulation in drug discovery and its impact on route of administration selection. List and explain the importance of physicochemical properties in drug discovery and development. Compare and contrast the pre-formulation considerations for small molecule drugs and biologics.