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A quality by design approach to understand formulation and process variability in pharmaceutical melt extrusion

Ketaki Patwardhan1, Firouz Asgarzadeh, Thomas Dassinger

  • 1Department of Pharmaceutics & Drug Delivery, The University of Mississippi, University, MS, USA.

The Journal of Pharmacy and Pharmacology
|January 24, 2015
PubMed
Summary

Quality by Design (QbD) principles were applied to pharmaceutical melt extrusion. Optimized ibuprofen formulations achieved ideal drug loading (40-48%) and extrusion temperatures (90-130°C).

Keywords:
experimental designhot melt extrusionquality by designrisk assessmentsolubility enhancement

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