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Amorphous solid dispersion (ASD) molecularly disperses a drug in a polymer matrix to form an amorphous solid solution or suspension, improving apparent solubility and oral bioavailability. Because the amorphous state is thermodynamically less stable and prone to recrystallization, rigorous control of crystal form is essential to prevent loss of performance. This case study outlines the strategy used to develop and control the amorphous solid dispersion of everolimus, focusing on crystalline-phase quantitation and limit-setting.
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