Core Courses

The course provides an introduction to synthesis, separation, and sterile processing and their applications to designing and optimizing pharmaceutical processes. Fundamentals of drug synthesis will be discussed using industrial pharmaceutical examples including separation, distillation, crystallization, filtration, lyophilization, and drying processes. This course focuses on the manufacturing steps used in production of the Active Pharmaceutical Ingredient (API).

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 discusses the application of engineering science principles to drug product development, drug administration to patients, and drug absorption and elimination in the body. The course discusses challenges in drug product development, pharmacokinetics, pharmacodynamics, pharmacologic activity, drug-target concepts and transport processes in the body. Concepts include routes of administration; fundamentals of drug delivery; kinetics of drug absorption, distribution, metabolism and excretion; clearance concepts; and compartmental and physiological models. Students learn how to apply engineering science principles to model pharmaceutical processes and interpret pharmaceutical experiments. Fundamental issues relevant to the design of drug products having immediate release, delayed release, sustained release, and extended release profiles are reviewed. Generation and fate of metabolites is discussed.

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.