Drug Characterization
Before conducting pharmaceutical drug product formulation activities, pre-formulation studies are initiated to determine the physical and chemical properties of the drug candidates. The information obtained from these studies can help the design and development of an initial dosage form, both for pre-clinical and clinical use. The drug candidates will be characterized by evaluating their solubility profiles, physical and chemical stabilities, dissociation constants (pKa), partition coefficients (Log P), BCS classification assessment, particle size, solubility studies in organic and pharmaceutical solvents (at various pH and in simulated media), excipient compatibility studies, and forced degradation studies.
