Preformulation in Drug Discovery and Development eLearning Series
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A fundamental role of formulation scientists is to convert candidate drugs into drug products. To achieve this goal, it is important to have a thorough understanding of a drug’s pharmaceutical properties. The objective of this course is to provide fundamentals of the preformulation studies and how the physicochemical, physicomechanical, and biopharmaceutical properties data generated during these studies can impact:
- Candidate selection
- Formulation design
- Choice of drug delivery technology
- Drug product manufacturing process
- Pharmacokinetic/biopharmaceutical properties of the resulting product
- Stability of the drug substance and drug product.
- Choice of the analytical techniques
- Packaging of the product
By the end of this course, participants will understand the role of preformulation in formulation development and gain familiarity with the main tasks performed in preformulation space. More specifically, (1) drug substance: selection of appropriate physical form of the drug substance and material properties and determination of physico-chemical and biopharmaceutical properties e.g. pKa, LogD, MP, Tg, solubility and dissolution in pharmaceutical and biorelevent solvents, permeability, chemical and physical stability, and mechanism of degradation and (2) drug product: excipient compatiblity studies including physicomechanical impact on stability, prototype formulations, bioperformance evaluation, bioavailability enhancement through solubilization approaches, on-site formulation development.
See a full listing of AAPS Preformulation101's lecture titles, instructors, reviewers, and CORE team members.
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