Comparison of melibiose and trehalose as stabilising excipients for spray-dried beta-galactosidase formulations

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dc.contributor.author Lipiäinen, Tiina
dc.contributor.author Räikkönen, Heikki
dc.contributor.author Kolu, Anna-Maija
dc.contributor.author Peltoniemi, Marikki
dc.contributor.author Juppo, Anne
dc.date.accessioned 2019-03-18T22:55:55Z
dc.date.available 2021-12-17T22:02:35Z
dc.date.issued 2018-05-30
dc.identifier.citation Lipiäinen , T , Räikkönen , H , Kolu , A-M , Peltoniemi , M & Juppo , A 2018 , ' Comparison of melibiose and trehalose as stabilising excipients for spray-dried beta-galactosidase formulations ' , International Journal of Pharmaceutics , vol. 543 , no. 1-2 , pp. 21-28 . https://doi.org/10.1016/j.ijpharm.2018.03.035
dc.identifier.other PURE: 101444040
dc.identifier.other PURE UUID: 84fad330-1b19-4444-b6d7-d12a62af804a
dc.identifier.other RIS: urn:1CC4C949B80688A925EF5FEE15C93508
dc.identifier.other WOS: 000432755900003
dc.identifier.other Scopus: 85044469901
dc.identifier.other ORCID: /0000-0002-4460-3079/work/45626842
dc.identifier.uri http://hdl.handle.net/10138/300199
dc.description.abstract Spray-dried protein formulations commonly require stabilising excipients to prevent protein degradation during processing and storage, and trehalose has been commonly used. The purpose of this work was to evaluate melibiose in spray-dried protein formulations in comparison to trehalose. The protein-activity-preserving efficacy, process behaviour and storage stability were studied. Spray drying of beta-galactosidase was carried out using different process temperature, drying air flow and feed liquid atomisation settings. Both melibiose and trehalose reduced protein activity loss during drying. A decrease in activities was observed when the process temperature exceeded a threshold temperature. During storage (30 days at 18% RH and 20 or 40 degrees C), the formulations dried below this threshold temperature showed no further activity loss, and the stabilising efficacy of the two disaccharides was equal. With higher process temperatures, the remaining protein activities after storage trended higher with melibiose formulations. All formulations remained amorphous. The powder yields of melibiose formulations were similar to trehalose. There was a difference in residual moisture contents, with melibiose formulations giving drier products. In conclusion, protein formulations with melibiose could be spray dried into amorphous powders that were physically stable, contained lower moisture contents and protected protein activity at least as well as trehalose formulations. en
dc.format.extent 8
dc.language.iso eng
dc.relation.ispartof International Journal of Pharmaceutics
dc.rights cc_by_nc_nd
dc.rights.uri info:eu-repo/semantics/openAccess
dc.subject 317 Pharmacy
dc.subject Spray drying
dc.subject Protein stability
dc.subject Excipients
dc.subject Melibiose
dc.subject Trehalose
dc.title Comparison of melibiose and trehalose as stabilising excipients for spray-dried beta-galactosidase formulations en
dc.type Article
dc.contributor.organization Division of Pharmaceutical Chemistry and Technology
dc.contributor.organization Pharmaceutical Design and Discovery group
dc.contributor.organization Faculty of Pharmacy
dc.contributor.organization Anne Juppo / Principal Investigator
dc.contributor.organization Drug Research Program
dc.description.reviewstatus Peer reviewed
dc.relation.doi https://doi.org/10.1016/j.ijpharm.2018.03.035
dc.relation.issn 0378-5173
dc.rights.accesslevel openAccess
dc.type.version acceptedVersion

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