BioDuro-Sundia’s pre-formulation solutions includes chemical and physical characterization coupled with biological evaluation such as Caco-2 permeability and small animal DMPK. Characterization of the API includes solubility studies in pharmaceutically acceptable solvents, aqueous solubility at various pH and in simulated media, determination of dissociation constant (pKa), partition coefficient (Log P and Log D), BCS/DCS classification assessment, particle morphology (polarized light microscopy with precise image analysis software), particle size distribution (Laser Light Diffraction) , crystallinity (X-ray diffraction), thermal properties (mDSC: melting point and glass transition), excipient compatibility studies, and forced degradation studies (heat, acid, alkali, light, peroxides, metal ions).
Polymorph and salt screening are important components in drug development. Bioduro-Sundia provides a variety of polymorph/salt/co-crystal screening techniques to produce an optimal solid form with increased solubility and bioavailability to aid in the determination of the appropriate formulation path.
Supported by integrated project management, BioDuro-Sundia’s extensive pre-formulation program elucidates candidate attributes to drive decision making in formulation development, helping predict the best formulation approach.