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; and
Packaging of the product.

Upon completion of this eCourse, the participant will understand the role of preformulation in formulation development and gain familiarity with the main tasks performed in preformulation space and should be able to:

Select the 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) for a given drug substance and drug product
Evaluate excipient compatibility studies including physicomechanical impact on stability, prototype formulations, bioperformance evaluation, bioavailability enhancement through solubilization approaches, on-site formulation development for a given drug product