This article covers examining key strategies for solubility and dissolution assessment of new drug products, drug product intermediates and APIs.
There must be an initial stage where the API properties are well studied and the impact of these properties on solubility and dissolution are assessed. Supersaturation studies are very important in this initial stage to help establishing drug concentrations used during method development and to help selecting the best formulation during polymer screening. The next step should get to know better solubilization strategies and the effective concentration of drug substance based on the most physiologically relevant methods.
Based on the knowledge acquired during the biorelevant screening methodologies, a faster and reliable QC method suitable for daily routine and release purposes should then be developed.