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

Autor/Autorin
Machado, Alexandra H.E.
Kokubo, Tohru
Dujovny, Gabriela
Jones, Brian
Scialdone, Claudio
Bravo, Roberto
Kuentz, Martin
Datum
30.07.2016
Metadata
Zur Langanzeige
Type
01 - Zeitschriftenartikel, Journalartikel oder Magazin
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 (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.
Link
http://www.sciencedirect.com/science/article/pii/S0928098716301415
URI
http://hdl.handle.net/11654/23744
DOI der Originalausgabe
https://doi.org/10.1016/j.ejps.2016.04.035
Übergeordnetes Werk
European Journal of Pharmaceutical Sciences
Jahrgang
90
Seiten
64-75
Zitation

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