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

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http://hdl.handle.net/10138/300199

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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

Titel: Comparison of melibiose and trehalose as stabilising excipients for spray-dried beta-galactosidase formulations
Författare: Lipiäinen, Tiina; Räikkönen, Heikki; Kolu, Anna-Maija; Peltoniemi, Marikki; Juppo, Anne
Upphovmannens organisation: Division of Pharmaceutical Chemistry and Technology
Pharmaceutical Design and Discovery group
Faculty of Pharmacy
Anne Juppo / Principal Investigator
Drug Research Program
Datum: 2018-05-30
Språk: eng
Sidantal: 8
Tillhör serie: International Journal of Pharmaceutics
ISSN: 0378-5173
DOI: https://doi.org/10.1016/j.ijpharm.2018.03.035
Permanenta länken (URI): http://hdl.handle.net/10138/300199
Abstrakt: 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.
Subject: 317 Pharmacy
Spray drying
Protein stability
Excipients
Melibiose
Trehalose
Referentgranskad: Ja
Licens: cc_by_nc_nd
Användningsbegränsning: openAccess
Parallelpublicerad version: acceptedVersion


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