Core Courses

This course is an introduction to the making of medicines with a focus on manufacturing of drug substances or Active Pharmaceutical Ingredients, APIs (which are combined with excipients (non-actives) to make drug products). The course discusses the pharmaceutical engineering and production of APIs including chemical and biological synthesis, separation, filtration, drying and sterilization. The interplay between the FDA and pharmaceutical companies for new and generic drugs will be discussed.

The course provides an introduction to the essential operations used in the manufacture of pharmaceutical products. The course discusses the pharmaceutical product life-cycle, variability, testing, and specifications of pharmaceutical ingredients. This course focuses on the manufacturing steps used in production of the Pharmaceutical Product or Dosage Form. Unit operations including blending, granulation, fluidized bed operations, milling, capsule filling, compaction, tablet coating and other processes will be addressed. Students learn to recognize how the output of one process is the input to the next process, and how deviations can cascade along the production sequence until they cause process failures. The course emphasizes design, scale-up, trouble-shooting, and optimization.

The course provides an introduction to statistical analysis and experimental design methods and their applications to designing and optimizing pharmaceutical processes. Classic statistical concepts and methods will be discussed using pharmaceutical examples including product/process development scenarios, routine in-process and finished product testing, and failure investigations. Regulatory requirements for test of samples, sampling plans, tablet and capsule assay, content uniformity, hardness, friability, dissolution and bioavailability tests will be discussed in detail.

The course applies pharmaceutical engineering principles to examine what happens to medicines in the body and how medicines affect the body. Students learn how to model pharmaceutical processes in the patient including various routes of administration of medicines; fundamentals of delivery; and kinetics of drug absorption, distribution, metabolism and excretion. Other topics will include the role of medicines, pharmaceutical companies and the US Food and Drug Administration (FDA) in society and opportunities for improving these roles.

The course provides an introduction to pharmaceutical materials engineering as applied to designing and optimizing pharmaceutical processes and products. The course focuses on the production, characterization and usage of pharmaceutical materials. The course examines the relationship between pharmaceutical materials and pharmaceutical products.