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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

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