Assessment of API Recrystallization
and Phase Distribution
One approach to improve the solubility and bioavailability of poorly soluble drugs is to formulate the API in an amorphous state as an amorphous solid dispersion (ASD). Manufacturing of ASD based drug products involves complex mechanical and thermal transformations necessary to render the API in a kinetically stabilized amorphous state. However, detection and monitoring crystallization, either from residual crystalline API or crystallization of amorphous API, is extremely important in assessing the effectiveness of the formulation design and process.
Based on the qualitative insight obtained from two-dimensional correlative imaging techniques, this work quantified API crystallinity using 3D X-Ray Micro-Computed Tomography (Micro-CT).
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Four images showing the original image, DigiM machine learning segmentation image result, low threshold image with noisy segmentation, and a high threshold image with failing to segment out the polymer and API.