COURSES/Core Courses

These core courses are for the Master of Engineering in Pharmaceutical Engineering and Science Degree. These courses also make up the “electives” for students choosing the Pharmaceutical option in the MS or PhD in Chemical and Biochemical Engineering.

• 155:545 Pharmaceutical Process Design I (Synthesis, Separation and Sterile Processing in the Pharmaceutical Industry)
• 155:546 Pharmaceutical Process Design II (Pharmaceutical Unit Operations)
• 155:547 Statistical Analysis and Design of Pharmaceutical Operations
• 155:549 Advanced Engineering, Pharmaceutical Kinetics, Thermodynamics and Transport Processes
• 155:541 Pharmaceutical Materials Engineering

Course descriptions or Core Courses:

155:545 Pharmaceutical Process Design I (Synthesis, Separations & Sterile Processing)

• 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.

155:546 Pharmaceutical Process Design II (Pharmaceutical Unit Operations)

• 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. 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.

155:547 Statistical Analysis and Design of Pharmaceutical Operations

• 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.

155:549 Advanced Engineering, Pharmaceutical Kinetics, Thermodynamics and Transport Processes

• The course reviews concepts from transport phenomena, thermodynamics, and reaction engineering, as well as basic physiology, to provide students with an understanding of the fundamentals of drug delivery: kinetics of drug absorption, distribution, and elimination; clearance concepts; compartmental, noncompartmental, and physiological models. 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.

155:541 Pharmaceutical Materials Engineering

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