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Prediction of Phase Behavior of Spray-Dried Amorphous Solid Dispersions: Assessment of Thermodynamic Models, Standard Screening Methods and a Novel Atomization Screening Device with Regard to Prediction Accuracy

Ousset, Aymeric, Chavez, Pierre-François, Meeus, Joke, Robin, Florent, Schubert, Martin Alexander, Somville, Pascal and Dodou, Kalliopi (2018) Prediction of Phase Behavior of Spray-Dried Amorphous Solid Dispersions: Assessment of Thermodynamic Models, Standard Screening Methods and a Novel Atomization Screening Device with Regard to Prediction Accuracy. Pharmaceutics, 10 (1). pp. 29-54. ISSN 1999-4923

Item Type: Article

Abstract

The evaluation of drug–polymer miscibility in the early phase of drug development is essential to ensure successful amorphous solid dispersion (ASD) manufacturing. This work investigates the comparison of thermodynamic models, conventional experimental screening methods (solvent casting, quench cooling), and a novel atomization screening device based on their ability to predict drug–polymer miscibility, solid state properties (Tg value and width), and adequate polymer selection during the development of spray-dried amorphous solid dispersions (SDASDs). Binary ASDs of four drugs and seven polymers were produced at 20:80, 40:60, 60:40, and 80:20 (w/w). Samples were systematically analyzed using modulated differential scanning calorimetry (mDSC) and X-ray powder diffraction (XRPD). Principal component analysis (PCA) was used to qualitatively assess the predictability of screening methods with regards to SDASD development. Poor correlation was found between theoretical models and experimentally-obtained results. Additionally, the limited ability of usual screening methods to predict the miscibility of SDASDs did not guarantee the appropriate selection of lead excipient for the manufacturing of robust SDASDs. Contrary to standard approaches, our novel screening device allowed the selection of optimal polymer and drug loading and established insight into the final properties and performance of SDASDs at an early stage, therefore enabling the optimization of the scaled-up late-stage development.

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More Information

Depositing User: Kalliopi Dodou

Identifiers

Item ID: 8895
Identification Number: https://doi.org/10.3390/pharmaceutics10010029
ISSN: 1999-4923
URI: http://sure.sunderland.ac.uk/id/eprint/8895
Official URL: http://www.mdpi.com/1999-4923/10/1/29/html

Users with ORCIDS

ORCID for Kalliopi Dodou: ORCID iD orcid.org/0000-0002-2822-3543

Catalogue record

Date Deposited: 14 Mar 2018 12:23
Last Modified: 20 Aug 2020 11:16

Contributors

Author: Kalliopi Dodou ORCID iD
Author: Aymeric Ousset
Author: Pierre-François Chavez
Author: Joke Meeus
Author: Florent Robin
Author: Martin Alexander Schubert
Author: Pascal Somville

University Divisions

Faculty of Health Sciences and Wellbeing
Faculty of Health Sciences and Wellbeing > School of Pharmacy and Pharmaceutical Sciences

Subjects

Sciences > Chemistry
Sciences > Pharmacy and Pharmacology
Engineering > Thermodynamics

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