Determination Of API Crystalline State

Summary: As the drug-polymer homogeneity is known to be one of the critical parameters for the stability of the solid dispersions, X-ray and Raman spectroscopy have been used to determine the physical state of amorphous API content in the hot melt extrudates. It is the structure and stability of this API/polymer matrix that is pivotal to develop stable and efficacious products. Catalent’s OptiMelt™ hot melt extrusion platform provides an integrated formulation strategy for generating melt extruded solid dispersions of poorly water soluble API‘s in a polymer matrix.

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