LAPSE:2018.0433
Published Article
LAPSE:2018.0433
Comparison of a Novel Miniaturized Screening Device with Büchi B290 Mini Spray-Dryer for the Development of Spray-Dried Solid Dispersions (SDSDs)
Aymeric Ousset, Joke Meeus, Florent Robin, Martin Alexander Schubert, Pascal Somville, Kalliopi Dodou
August 28, 2018
Spray-drying is an increasingly popular technology for the production of amorphous solid dispersions (ASDs) in the pharmaceutical industry that is used in the early evaluation and industrial production of formulations. Efficient screening of ASD in the earliest phase of drug development is therefore critical. A novel miniaturized atomization equipment for screening spray-dried solid dispersions (SDSDs) in early formulation and process development was developed. An in-depth comparison between the equipment/process parameters and performance of our novel screening device and a laboratory Büchi B290 mini spray-dryer was performed. Equipment qualification was conducted by comparing the particle/powder attributes, i.e., miscibility/solid state, residual solvent, and morphological properties of binary SDSDs of itraconazole prepared at both screening and laboratory scales. The operating mode of the miniaturized device was able to reproduce similar process conditions/parameters (e.g., outlet temperature (Tout)) and to provide particles with similar drug⁻polymer miscibility and morphology as laboratory-scale SDSDs. These findings confirm that the design and operation of this novel screening equipment mimic the microscale evaporation mechanism of a larger spray-dryer. The miniaturized spray-dryer was therefore able to provide a rational prediction of adequate polymer and drug loading (DL) for SDSD development while reducing active pharmaceutical ingredient (API) consumption by a factor of 120 and cycle time by a factor of 4.
Keywords
amorphous solid dispersions, downscaling, miniaturization, miscibility, Polymers, screening, spray-dryer
Suggested Citation
Ousset A, Meeus J, Robin F, Schubert MA, Somville P, Dodou K. Comparison of a Novel Miniaturized Screening Device with Büchi B290 Mini Spray-Dryer for the Development of Spray-Dried Solid Dispersions (SDSDs). (2018). LAPSE:2018.0433
Author Affiliations
Ousset A: School of Pharmacy and Pharmaceutical Sciences, Faculty of Health Sciences and Wellbeing, University of Sunderland, Sunderland SR13SD, UK [ORCID]
Meeus J: UCB Pharma S.A., Product Development, B-1420 Braine l’Alleud, Belgium
Robin F: UCB Pharma S.A., Product Development, B-1420 Braine l’Alleud, Belgium
Schubert MA: UCB Pharma S.A., Product Development, B-1420 Braine l’Alleud, Belgium
Somville P: UCB Pharma S.A., Product Development, B-1420 Braine l’Alleud, Belgium
Dodou K: School of Pharmacy and Pharmaceutical Sciences, Faculty of Health Sciences and Wellbeing, University of Sunderland, Sunderland SR13SD, UK [ORCID]
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Journal Name
Processes
Volume
6
Issue
8
Article Number
E129
Year
2018
Publication Date
2018-08-16
Published Version
ISSN
2227-9717
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Original Submission
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PII: pr6080129, Publication Type: Journal Article
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LAPSE:2018.0433
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doi:10.3390/pr6080129
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Aug 28, 2018
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