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dc.contributor.authorSchiller, Stefan
dc.contributor.authorHanefeld, Andrea
dc.contributor.authorSchneider, Marc
dc.contributor.authorLehr, Claus-Michael
dc.date.accessioned2020-11-06T12:59:15Z
dc.date.available2020-11-06T12:59:15Z
dc.date.issued2020-10-06
dc.identifier.citationAAPS PharmSciTech. 2020 Oct 6;21(7):269. doi: 10.1208/s12249-020-01814-w.en_US
dc.identifier.pmid33025335
dc.identifier.doi10.1208/s12249-020-01814-w
dc.identifier.urihttp://hdl.handle.net/10033/622560
dc.description.abstractTo develop a scalable and efficient process suitable for the continuous manufacturing of poly(lactic-co-glycolic acid) (PLGA) nanoparticles containing ovalbumin as the model protein. PLGA nanoparticles were prepared using a double emulsification spray-drying method. Emulsions were prepared using a focused ultrasound transducer equipped with a flow cell. Either poly(vinyl alcohol) (PVA) or poloxamer 407 (P-407) was used as a stabilizer. Aliquots of the emulsions were blended with different matrix excipients and spray dried, and the yield and size of the resuspended nanoparticles was determined and compared against solvent displacement. Nanoparticle sizes of spray-dried PLGA/PVA emulsions were independent of the matrix excipient and comparable with sizes from the solvent displacement method. The yield of the resuspended nanoparticles was highest for emulsions containing trehalose and leucine (79%). Spray drying of PLGA/P-407 emulsions led to agglomerated nanoparticles independent of the matrix excipient. PLGA/P-407 nanoparticles pre-formed by solvent displacement could be spray dried with limited agglomeration when PVA was added as an additional stabilizer. A comparably high and economically interesting nanoparticle yield could be achieved with a process suitable for continuous manufacturing. Further studies are needed to understand the robustness of a continuous process at commercial scale.en_US
dc.language.isoenen_US
dc.publisherSpringeren_US
dc.rightsAttribution-NonCommercial-ShareAlike 4.0 International*
dc.rights.urihttp://creativecommons.org/licenses/by-nc-sa/4.0/*
dc.subjectPLGA nanoparticlesen_US
dc.subjectcontinuous manufacturingen_US
dc.subjectfocused ultrasounden_US
dc.subjectprotein deliveryen_US
dc.subjectspray dryingen_US
dc.titleTowards a Continuous Manufacturing Process of Protein-Loaded Polymeric Nanoparticle Powders.en_US
dc.typeArticleen_US
dc.identifier.eissn1530-9932
dc.contributor.departmentHIPS, Helmholtz-Institut für Pharmazeutische Forschung Saarland, Universitätscampus E8.1 66123 Saarbrücken, Germany.en_US
dc.identifier.journalAAPS PharmSciTechen_US
dc.source.volume21
dc.source.issue7
dc.source.beginpage269
dc.source.endpage
refterms.dateFOA2020-11-06T12:59:16Z
dc.source.journaltitleAAPS PharmSciTech
dc.source.countryUnited States


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