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Effects of drying methods on physical properties and morphology of trehalose/mannitol mixtures
RISE Research Institutes of Sweden, Bioeconomy and Health, Chemical Process and Pharmaceutical Development. Vinnova, Sweden.ORCID iD: 0000-0001-7419-0829
Vinnova, Sweden; Nanexa AB, Sweden.
Vinnova, Sweden; Lund University, Sweden.
RISE Research Institutes of Sweden, Bioeconomy and Health, Chemical Process and Pharmaceutical Development. Vinnova, Sweden.ORCID iD: 0000-0001-9891-8968
2023 (English)In: Drying Technology, ISSN 0737-3937, E-ISSN 1532-2300, Vol. 41, no 4, p. 503-522Article in journal (Refereed) Published
Abstract [en]

Solid-state properties of dried protein formulations are important for stability and functionality of the product. This study investigates how different drying technologies (freeze-drying with and without annealing, spray drying and spray-freeze drying) affect the structure and solid-state properties of a set of matrix formulations composed of trehalose (glass former) and mannitol (scaffolding agent) in five ratios. The dried materials were characterized using differential scanning calorimetry, thermogravimetric analysis, x-ray diffraction and scanning electron microscopy. The morphology of the dried matrix is determined by the drying technology and the composition. In all mixtures, mannitol partially dissolved in the amorphous trehalose, resulting in reduced glass transition temperature. At least 50% mannitol is required to achieve a scaffolding effect through crystallized mannitol. At 25% mannitol poor structural stability is obtained regardless of drying technology. Despite the vast differences in drying kinetics, all drying technologies resulted in similar amorphous content in the dried material. © 2022 The Author(s). 

Place, publisher, year, edition, pages
Taylor and Francis Ltd. , 2023. Vol. 41, no 4, p. 503-522
Keywords [en]
Freeze-drying, morphology, scaffolding, solid-state, spray drying, spray-freeze drying, Differential scanning calorimetry, Drug products, Glass, Glass transition, Mixtures, Polyols, Scanning electron microscopy, Stability, Thermogravimetric analysis, Drying methods, Drying technology, Freeze drying, Physical morphology, Protein formulation, Solid-state properties, Spray freeze drying, Spray-drying
National Category
Cell Biology
Identifiers
URN: urn:nbn:se:ri:diva-60065DOI: 10.1080/07373937.2022.2103564Scopus ID: 2-s2.0-85135627393OAI: oai:DiVA.org:ri-60065DiVA, id: diva2:1692912
Note

This research was funded by Swedish Governmental Agency for Innovation Systems (VINNOVA) and was carried out within the NexBioForm Competence Centre.

Available from: 2022-09-05 Created: 2022-09-05 Last updated: 2023-11-03Bibliographically approved

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Osanloo, DanielMillqvist-Fureby, Anna

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