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Formulation factors affecting foam properties during vacuum foam-drying
RISE Research Institutes of Sweden, Bioeconomy and Health, Chemical Process and Pharmaceutical Development. Lund University, Sweden.ORCID iD: 0000-0001-7419-0829
RISE Research Institutes of Sweden, Bioeconomy and Health, Chemical Process and Pharmaceutical Development.ORCID iD: 0000-0001-8028-7360
Ferring Pharmaceuticals A/S, Denmark.
Lund University, Sweden.
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2024 (English)In: International Journal of Pharmaceutics, ISSN 0378-5173, E-ISSN 1873-3476, Vol. 652, article id 123803Article in journal (Refereed) Published
Abstract [en]

This paper explores how vacuum foam-drying of a protein is influenced by formulation parameters by investigating the foam structure, physical properties of the foam, and the stability of the protein. Recombinant human bile salt-stimulated lipase was used as a model of a protein drug. The stability of the lipase was evaluated through activity measurements. Two disaccharides (sucrose and trehalose), strongly tending to an amorphous form, were used as matrix formers, and the physical properties were assessed through residual water content, glass transition temperature, and crystalline state. Moreover, some formulations included surfactants with different sizes and structures of the head group. The alkyl chain length was kept constant to only investigate the impact of the surfactant head group, in the presence of the lipase, on the foamability and surface coverage of the lipase. The study demonstrated that the lipase allowed for a dry, solid foam with a foam overrun of up to 2600 %. The wall thickness of the dry, solid foam was estimated to be 20–50 µm. Clear differences between sucrose and trehalose as matrix former were identified. The lipase showed no tendency to lose activity because of the drying and rehydration, despite a proportion of the lipase covering the surfaces of the dry material. 

Place, publisher, year, edition, pages
Elsevier B.V. , 2024. Vol. 652, article id 123803
Keywords [en]
Lipase, Matrix former, Protein formulations, Solid-state properties, Surface composition, Vacuum foam-drying
National Category
Chemical Engineering
Identifiers
URN: urn:nbn:se:ri:diva-71913DOI: 10.1016/j.ijpharm.2024.123803Scopus ID: 2-s2.0-85184501646OAI: oai:DiVA.org:ri-71913DiVA, id: diva2:1839823
Funder
Vinnova, 2018-04730
Note

'Correspondence Address: D. Tristan Osanlóo; RISE Research Institutes of Sweden, Stockholm, Box 5604, SE-114 86, Sweden; The authors would like to thank Swedish Orphan Biovitrum for providing the lipase and Croda Nordica AB for the delivery of the surfactants. Dr. Stefan Ulvenlund (ENZA Biotech AB) is gratefully acknowledged for the delivery of surfactants and valuable discussions. This research was funded by the Swedish Governmental Agency for Innovation Systems (VINNOVA) and was carried out within the competence center NextBioForm (grant number 2018-04730).

Available from: 2024-02-22 Created: 2024-02-22 Last updated: 2024-05-21Bibliographically approved

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Osanloo, DanielMahlin, DennyMillqvist-Fureby, Anna

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