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Extrinsic lactose fines improve dry powder inhaler formulation performance of a cohesive batch of budesonide via agglomerate formation and consequential co-deposition

Kinnunen, H; Hebbink, G; Peters, H; Huck, D; Makein, L; Price, R

Extrinsic lactose fines improve dry powder inhaler formulation performance of a cohesive batch of budesonide via agglomerate formation and consequential co-deposition Thumbnail


Authors

H Kinnunen

G Hebbink

H Peters

D Huck

L Makein

R Price



Contributors

H Bown (née Kinnunen) kwmd75@durham.ac.uk
Other

Abstract

The aim of the study was to investigate how the fine particle content of lactose carriers prepared with different types of lactose fines regulates dry powder inhaler (DPI) formulation performance of a cohesive batch of micronised budesonide. Budesonide formulations (0.8 wt-% ) were prepared with three different lactose carriers (Lactohale (LH) LH100, 20 wt-% LH210 in LH100 and 20 wt-% LH300 in LH100). Fine particle fraction of emitted dose (FPFED) and mean mass aerodynamic diameter (MMAD) of budesonide was assessed with a Next Generation Impactor (NGI) using a Cyclohaler at 90 l/min. Morphological and chemical characteristics of particles deposited on Stage 2 were determined using a Malvern Morphologi G3-ID. The results indicate that increasing concentration of lactose fines (<4.5 μm) not only increased the FPFED but also the MMAD of budesonide, suggesting drug deposition in agglomerates. Presence of agglomerates on Stage 2 was confirmed by morphological analysis of particles. Raman analysis of material collected on Stage 2 indicated that the more fine lactose particles were available the more agglomerates of budesonide and lactose were delivered to the Stage 2. These results suggest drug-fines agglomerate formation is an important mechanism for how lactose fines improve and regulate DPI formulation performance.

Citation

Kinnunen, H., Hebbink, G., Peters, H., Huck, D., Makein, L., & Price, R. (2015). Extrinsic lactose fines improve dry powder inhaler formulation performance of a cohesive batch of budesonide via agglomerate formation and consequential co-deposition. International Journal of Pharmaceutics, 478(1), 53-59. https://doi.org/10.1016/j.ijpharm.2014.11.019

Journal Article Type Article
Publication Date Jan 15, 2015
Deposit Date Nov 17, 2014
Publicly Available Date Mar 28, 2024
Journal International Journal of Pharmaceutics
Print ISSN 0378-5173
Publisher Elsevier
Peer Reviewed Peer Reviewed
Volume 478
Issue 1
Pages 53-59
DOI https://doi.org/10.1016/j.ijpharm.2014.11.019
Keywords Lactose, Dry powder inhaler, Raman spectroscopy.

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Copyright Statement
NOTICE: this is the author’s version of a work that was accepted for publication in International Journal of Pharmaceutics. Changes resulting from the publishing process, such as peer review, editing, corrections, structural formatting, and other quality control mechanisms may not be reflected in this document. Changes may have been made to this work since it was submitted for publication. A definitive version was subsequently published in International Journal of Pharmaceutics, 478, 1, 15 January 2015, 10.1016/j.ijpharm.2014.11.019.




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