What is it about?

The current study was intended to statistically evaluate the effect of various process and material variables on the solubility enhancement and in vitro dissolution performance of ternary inclusion complexes (TIC) produced by the HME process. Ibuprofen (IBU) was chosen as a model API because of its low solubility and high permeability,

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Why is it important?

Conventional cyclodextrin complexation enhances the solubility of poorly soluble drugs but is solvent-intensive and environmentally unfavorable. This study evaluated solvent-free hot melt extrusion (HME) for forming cyclodextrin inclusion complexes to improve the solubility and dissolution of ibuprofen (IBU).

Perspectives

The successful formation of the complex was confirmed after extrusion through HME, resulting in a significantly improved saturation solubility of IBU compared to that of the physical mixtures.

Dr Sateesh Kumar Vemula
University of Mississippi

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This page is a summary of: Continuous Manufacturing of Solvent-Free Cyclodextrin Inclusion Complexes for Enhanced Drug Solubility via Hot-Melt Extrusion: A Quality by Design Approach, Pharmaceutics, August 2023, MDPI AG,
DOI: 10.3390/pharmaceutics15092203.
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