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By Meredith Weston

Meredith WestonThese days, almost all drugs are created into tablet or capsule form (sometimes both). But before they can take on major dosage forms, it is essential that the fundamental physical and chemical properties of the lead drug candidates are analyzed. The information gathered from these studies decides many of the subsequent strategies and approaches further down the drug development road. This exploratory phase is commonly known as preformulation. The ultimate goal of preformulation is designing an optimum new chemical entity (NCE) for consumption. As you can imagine, having a good preformulation team in the lab can mean invaluable time and resources saved.

In order to address the significant gap in understanding the role of preformulation and its function in the drug development process, AAPS has launched its second ecourse in 2015 entitled Preformulation 101: Preformulation in Drug Discovery and Development. This comprehensive ecourse consists of 10 lectures, delivered by leading experts in the field, and covers the fundamentals and latest approaches and tools used in preformulation to accelerate the development of NCEs.

Upon completion 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:

    • Drug substance
      • Selection of appropriate physical form of the drug substance and material properties
      • 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
    • Drug product
      • Excipient compatibility studies including physicomechanical impact on stability, prototype formulations, bioperformance evaluation, bioavailability enhancement through solubilization approaches, and on-site formulation development

On behalf of AAPS, I would like to acknowledge the members of the CORE team for their hard work in constructing this diverse and innovative learning series: Irina Kazakevich, Balvinder Vig, Joanna Bis, Roman Shimanovich, Madhushree Gokhale, and Teresa Carvajal.

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If you have any questions about this course or any of AAPS’s elearning programs, please contact elearning@aaps.org.

Meredith Weston, M.S. is the eLearning Program Manager at AAPS.