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Amorphous solid dispersions of darunavir: Comparison between spray drying and electrospraying
Annelies Smeets1, Robin Koekoekx2, Christian Clasen2
1KU Leuven - University of Leuven, Department of Pharmaceutical and Pharmacological Sciences, Drug Delivery and Disposition, Leuven B-3000, Belgium.
Summary
Electrospraying is a viable method for creating amorphous solid dispersions, comparable to spray drying. Formulation and process parameters like feed flow rate significantly impact particle characteristics, but not overall pharmaceutical performance.
Area of Science:
- Pharmaceutical Technology
- Materials Science
Background:
- Amorphous solid dispersions (ASDs) enhance drug solubility and bioavailability.
- Electrospraying offers potential for ASD manufacturing, but parameter optimization is crucial.
Purpose of the Study:
- To compare electrospraying and spray drying for preparing darunavir ASDs.
- To investigate the influence of formulation and process parameters on electrosprayed ASDs.
Main Methods:
- Preparation of ASDs using electrospraying and spray drying with HPMC, HPMC AS, and PVP.
- Full factorial design to study electrospraying parameters (feed flow rate, tip-to-collector distance) and formulation parameters (drug loading, solids concentration).
Main Results:
- Electrospraying produced amorphous darunavir ASDs with comparable residual solvent and drug release to spray drying.
- Particle morphology and size distribution differed between methods but did not affect pharmaceutical performance.
- Feed flow rate significantly impacted particle diameter and morphology; drug loading affected homogeneity and residual solvent.
Conclusions:
- Electrospraying is a comparable and effective technique for producing amorphous solid dispersions.
- Process and formulation parameters must be optimized to control ASD properties, particularly particle morphology and homogeneity.
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