A microstructural study of water effects in lipid-based pharmaceutical formulations for liquid filling of capsules

dc.accessRightsAnonymous
dc.audienceScience
dc.contributor.authorMachado, Alexandra H.E.
dc.contributor.authorKokubo, Tohru
dc.contributor.authorDujovny, Gabriela
dc.contributor.authorJones, Brian
dc.contributor.authorScialdone, Claudio
dc.contributor.authorBravo, Roberto
dc.contributor.authorKuentz, Martin
dc.date.accessioned2016-12-16T11:18:29Z
dc.date.available2016-12-16T11:18:29Z
dc.date.issued2016-07-30
dc.description.abstractWater is known to exhibit pronounced effects on lipid-based formulations (LBFs) and much research has focused on aqueous dispersion and dilution behavior regarding biopharmaceutical performance. From a product quality perspective, it is also critical to study a range of lower water amounts in formulations with respect to capsule filling. The present work addressed the need for a better understanding of LBF microstructure by taking percolation theory into account. The effects of increasing amounts of water on LBFs were analyzed by conductivity, water activity, time-domain nuclear magnetic resonance, and diffusing wave spectroscopy. Results were interpreted using percolation theory and preliminary mechanical tests were conducted on gelatin and hypromellose (HPMC) capsule shells. For both LBF systems, increasing water amounts led to marked changes in the microstructure of the formulations. Percolation laws could be fitted adequately to the data and thresholds were identified for the formation of continuous water channels (ϕwc~0.02-0.06). A new theoretical model was proposed for water activity. The preliminary shell material studies showed that the threshold for generating water channels in the formulation could be correlated to mechanical changes of the capsule shell that were relatively more pronounced in the case of gelatin. This mechanistic study demonstrated the importance of understanding and monitoring of microstructural changes occurring in LBFs with increasing amounts of water, which will help to design quality into the final dosage form.
dc.identifier.doihttp://dx.doi.org/10.1016/j.ejps.2016.04.035
dc.identifier.issn0928-0987
dc.identifier.issn1879-0720
dc.identifier.urihttp://hdl.handle.net/11654/23744
dc.language.isoenen_US
dc.publisherElsevieren_US
dc.relation.ispartofEuropean Journal of Pharmaceutical Sciencesen_US
dc.subjectColloids
dc.subjectContinuous water channels
dc.subjectGelatin
dc.subjectHPMC
dc.subjectHard-shell capsules
dc.subjectLipid-based formulations
dc.subjectPercolation theory
dc.titleA microstructural study of water effects in lipid-based pharmaceutical formulations for liquid filling of capsules
dc.type01A - Beitrag in wissenschaftlicher Zeitschrift
dc.volume90
dspace.entity.typePublication
fhnw.InventedHereYes
fhnw.IsStudentsWorkno
fhnw.PublishedSwitzerlandNo
fhnw.ReviewTypeAnonymous ex ante peer review of a complete publication
fhnw.affiliation.hochschuleHochschule für Life Sciencesde_CH
fhnw.affiliation.institutInstitut für Pharma Technologyde_CH
fhnw.pagination64-75
fhnw.publicationOnlineJa
fhnw.publicationStatePublished
relation.isAuthorOfPublication68819448-8611-488b-87bc-1b1cf9a6a1b4
relation.isAuthorOfPublication.latestForDiscovery68819448-8611-488b-87bc-1b1cf9a6a1b4
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