Applied Drug Development Core Curriculum - Course Description

Who Should Attend

Scientists and technical managers who work in early drug development and who are responsible for preclinical and/or phase 1 clinical formulations.  Attendees should include BS, MS and PhD graduates with less than 5 years of experience in the formulation discipline.  Additional scientists and managers who would benefit from the course include those working in analytical, preformulation, various biological sciences (toxicologists, pharmacokineticists, pharmacologists), and other groups interested in gaining a better understanding of principles and practices in early formulation development.  Other individuals who would be well-suited to attend this short course are those who have previously completed the other core Applied Drug Development short courses: 1) Pre-Clinical and Drug Development Design Strategies (CMC Track) and/or 2) Strategies and Experimental Techniques in Preformulation and Candidate Selection.

Goals & Objectives

This course covers practical aspects of dosage form development for preclinical and phase 1 formulations.  The formulation approaches include solubilization and disperse phase systems (suspensions, emulsions, microemulsions, liposomes and micelles) for preclinical as well as powders for reconstitution, capsules and tablets for phase 1.

The course is a practical guide in that its focus is on major considerations in selecting and evaluating oral dosage forms for preclinical and phase 1 studies by examining the excipients used, their typical level ranges and various preparation/processing procedures on small laboratory and pilot scales. The challenges in developing oral dosage forms at this early stage will be examined in detail, including the major problems encountered and the common strategies that are used to overcome them.

In addition to its focus as a formulation guide, the course content includes key points in stability evaluation, such as excipient compatibility approaches and the ICH guidelines. The major physical tests used to assess formulations are an integral part of the course material and are covered in terms of their application to problem solving and in setting the product specification.

Upon completion of the course, the attendees should be able to describe:

• Solubilization approaches used for poorly soluble compounds
• Preclinical animal species considerations for testing formulations, including allometric scaling for estimating exposure in humans
• Strategies and major issues to consider in oral dosage form development for phase 1, including lab and pilot scale processing factors, excipient compatibility for capsules and tablets, common problems encountered and problem solving approaches
• Bioenhanced formulation strategies for phase 1 capsules and tablets, including particle size reduction techniques, solid dispersions and liquid-filled capsules
• Formal stability assessment of solid oral dosage forms for phase 1, including common problems encountered and problem solving approaches

See the full Program section for a detailed account of the course topics, problem sets and discussion sessions.