BioDuro’s tailored pre-formulation solutions provide critical insights for developing an optimal formulation strategy that best suits each API. We offer comprehensive chemical and physical characterization paired with biological evaluations, including Caco-2 permeability and small animal DMPK, to ensure data-rich decision-making from the start.
Our pre-formulation capabilities cover solubility studies in pharmaceutically acceptable solvents, pH-dependent aqueous solubility, BCS/DCS classification, and extensive API characterization such as particle morphology, crystallinity, and thermal profiling. With expertise in excipient compatibility and forced degradation studies, BioDuro’s pre-formulation program quickly identifies optimal conditions for enhanced solubility and bioavailability.
For poorly soluble compounds, our Solution Engine utilizes advanced ASD technologies to select the best approach for increasing bioavailability and achieving desired release profiles. With robust polymorph, salt, and co-crystal screening options, BioDuro identifies the ideal solid form to unlock each compound’s full therapeutic potential. Supported by integrated project management, we guide clients toward faster clinical progression and optimal formulation outcomes.
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