PRE-FORMULATION DATA PACKAGE

Before conducting pharmaceutical drug product formulation activities, pre-formulation studies are initiated. During the pre-formulation phase, the physical and chemical properties of the active pharmaceutical ingredient (API) are determined. The knowledge gained on the API helps to select the right salt or polymorphic form, and supports the design and development of an initial dosage form, both for pre-clinical and clinical use. Ascendia’s pharmaceutical science team characterizes the drug candidate by evaluating its solubility profile, physical and chemical stability, and potential salt forms; and identifies impurities and degradation pathways. Characterization of the API during pre-formulation may include determination of: dissociation constant (pKa), partition coefficient (Log P), BCS classification assessment, particle size and morphology (laser diffraction, microscopic imaging), crystallinity (X-ray diffraction), thermal properties (melting point and glass transition), solubility studies in organic and pharmaceutical solvents (at various pH and in simulated media), excipient compatibility studies, and forced degradation studies (heat, acid, alkali, light, peroxides, metal ions).

Ascendia can generate the data needed for your CMC package in support of an IND filing, and the data guides the development of small-scale formulations for in vivo pharmacokinetic, efficacy, and toxicology studies or proof-of-concept testing.

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