A microstructural study of water effects in lipid-based pharmaceutical formulations for liquid filling of capsules
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Autor:innen
Machado, Alexandra H.E.
Kokubo, Tohru
Dujovny, Gabriela
Jones, Brian
Scialdone, Claudio
Bravo, Roberto
Autor:in (Körperschaft)
Publikationsdatum
30.07.2016
Typ der Arbeit
Studiengang
Sammlung
Typ
01A - Beitrag in wissenschaftlicher Zeitschrift
Herausgeber:innen
Herausgeber:in (Körperschaft)
Betreuer:in
Ãœbergeordnetes Werk
European Journal of Pharmaceutical Sciences
Themenheft
Reihe / Serie
Jahrgang / Band
90
Ausgabe / Nummer
Seiten / Dauer
64-75
Patentnummer
Verlag / Herausgebende Institution
Elsevier
Verlagsort / Veranstaltungsort
Auflage
Version
Programmiersprache
Abtretungsempfänger:in
Praxispartner:in/Auftraggeber:in
Zusammenfassung
Water 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 (Ï•wc~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.
Schlagwörter
Colloids, Continuous water channels, Gelatin, HPMC, Hard-shell capsules, Lipid-based formulations, Percolation theory
Fachgebiet (DDC)
Veranstaltung
Startdatum der Ausstellung
Enddatum der Ausstellung
Startdatum der Konferenz
Enddatum der Konferenz
Datum der letzten Prüfung
ISBN
ISSN
0928-0987
1879-0720
1879-0720
Sprache
Englisch
Während FHNW Zugehörigkeit erstellt
Ja
Publikationsstatus
Veröffentlicht
Begutachtung
Peer-Review der ganzen Publikation
Open Access-Status
Lizenz
Zitation
MACHADO, Alexandra H.E., Tohru KOKUBO, Gabriela DUJOVNY, Brian JONES, Claudio SCIALDONE, Roberto BRAVO und Martin KUENTZ, 2016. A microstructural study of water effects in lipid-based pharmaceutical formulations for liquid filling of capsules. European Journal of Pharmaceutical Sciences. 30 Juli 2016. Bd. 90, S. 64–75. DOI 10.1016/j.ejps.2016.04.035. Verfügbar unter: http://hdl.handle.net/11654/23744