Role of Pharmaceutics in Drug Development
Start with the big picture
Formulation development begins with understanding the API. Preformulation studies assess properties such as solubility, pKa, polymorphism, and stability to inform excipient selection and processing. Developers then consider the delivery route and ways to influence bioavailability, alongside the chemical, physical, and microbiological stability of the product. Quality by Design, risk management, and biopharmaceutics help guide product and process decisions. The broader development pathway also involves analytical methods, scalable manufacturing, and technology transfer from laboratory to commercial production. Patient-centred considerations, regulatory documentation, and specialized concerns for biologics and advanced delivery approaches complete the picture. Together, these functions help translate formulation rationale into a consistent, manufacturable dosage form.
What you'll learn
- Explain how pharmaceutics translates an API into a patient-acceptable dosage form.
- Identify API properties assessed during preformulation studies.
- Describe how route selection and formulation approaches can influence bioavailability.
- Recognize the roles of quality, manufacturing, and technology transfer in development.
- Summarize how patient needs and regulatory support inform formulation decisions.
Continue your study
Work through the complete notes and reinforce the topic with the study tools available in the full lesson.
