Drug Delivery Roundtable

摘要

At what point in the drug development process should the drug delivery method be chosen? Dr. Nitin Swarnakar, Scientist III Global Technical Marketing (Pharma Solutions), BASF Corporation: The drug development process involves rigorous in vitro and in vivo studies to understand phar-macodynamic and pharmacokinetic properties of lead compounds. Overall, knowledge of biopharmaceutical properties of the compound such as potency, selectivity, Biopharmaceutical Classification System (BCS), ADME (absorption, distribution, metabolism and excretion) and physiochemical properties are required to define the drug delivery method early in development. For example, a BCS class I API with a good safety profile drug can be delivered orally by instant release mechanisms while BCS class I APIs with a low therapeutic window would require a controlled (sustained or modified) release profile. BASF has instant and modified release excipients such as binders, matrices and fillers, disintegrants, and polymers to help customers achieve their drug delivery needs. APIs that are BCS class III and IV are difficult-to-deliver because of their poor permeability and need special novel drug delivery strategies such as self-emulsifying drug delivery systems, amorphous solid dispersions, etc. BASF offers solubilization technologies to help its customers achieve therapeutic and commercial value of their finished products.