Applying Extrusion to Pharmaceutical Formulation Design
نویسندگان
چکیده
The drivers to produce solid solution formulations are reviewed together with specific challenges of implementing extrusion in a pharmaceutical setting. A solvent-based approach to screen formulations with less than 10 mg drug/screen is introduced and validated with experimental data. Process development challenges associated with the use of hygroscopic fine polymer powders are addressed through the adoption of a more open feed screw and barrel design. The use of transmission near infra-red (NIR) to measure residence time distributions (RTDs), measure extrudate chemical composition, and assess a predictive model to describe extrudate chemical composition is demonstrated with two additional application examples.
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