Pre-formulation

Overview

Class Central Tips

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. Target audience: This course is suitable for life scientists, clinicians, and individuals from fields that support drug discovery (e.g., patents, finance, licensing, etc.) interested in learning more about the pharmaceutical/biotechnology sector. Advanced undergraduate coursework or practical familiarity/working knowledge in biological sciences and organic chemistry is recommended.

Syllabus

Pre-formulation, part 1

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.

Pre-formulation, part 2
Pre-formulation, part 3

Taught by

Erland Stevens, PhD, W. Ross Tracey, PhD, Douglas S. Auld, PhD, Alan P. Brown, PhD, DABT, Sujal Deshmukh, PhD, Stephanie Dodd, MSc., Sabine Guth, PhD, and Thomas M. Smith, PhD