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| Solid pharmaceuticals are often milled, dried, compressed or otherwise manipulated during production of the final tablet or capsule format. Since any of these steps can change the solid state properties of the drug, each step must be carefully characterized and understood in order to ensure that the overall formulation process is robust and generates a reproducible and stable final product. For example, milling is often used to reduce the particle size of a drug in order to improve solubility, flow characteristics or compressibility. However, milling can also affect critical physical properties such as formation of an amorphous fraction, metastable crystalline polymorphs, or an unwanted hydrate fraction. The formation of any of these phases can impact both bioavailability and chemical stability of the drug. |
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