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Building Blocks

Drug Product Development

Pre-formulation

•  Physicochemical properties: solubility, pKa, logP, hygroscopicity

•  Screening: polymorph, salt, cocrystal, amorphous dispersion

•  Solid state/solution stability: heat, humidity, light, pH, oxidation


Formulation

•  Oral solid dosage form design, development

•  Drug/excipient compatibility, stability

•  Solubility, bioavailability enhancement

•  Controlled release dosage form design, patent strategy


Process Development and Scale-up

•  Pharmaceutical manufacturing process

•  Development: wet/dry granulating, tableting, coating,

•  Beads drug layering/coating, lyophilization

•  Commercial size scale-up