Solid dosage forms are the most common commercial drug delivery system in use today. This short course covers the “a to z” of solid dosage form design and development, from pre-clinical excipient selection to commercial manufacturing.
Concepts covered in this course include:
- Patient-centric drug product design
- Development of a target product profile (QTPP)
- Importance of physicochemical properties of drug molecules
- Basics of biopharmaceutics and gastrointestinal physiology
- Solid-state properties of salts, co-crystals, polymorphs & hydrates
- Challenges associated with low/high doses & low solubility
- Amorphous solid dispersions
- Controlled release platform technologies
- Excipient selection for immediate and controlled release dosage forms
- Common manufacturing processes (such as blending, granulation tableting, film coating, encapsulation)
- Continuous vs batch manufacturing
- Drug product manufacturing process optimization & troubleshooting
- Quality-by-Design principles
- Solid state stability testing
- Regulatory guidelines for solid dosage forms
Course participants will be provided with up-to-date research-based information taught by industry leaders with over 100-years of collective experience. They will learn this material through lectures, classroom discussions (with opportunities for information sharing), and case-studies based on real-life examples.
This course is part of the Drug Product Development Certificate. It fulfills one elective. Take the course ‘as-is’ or as part of the certificate.
Developed & Conducted by the Division of Pharmacy Professional Development, School of Pharmacy, University of Wisconsin-Madison.