期刊
JOURNAL OF PHARMACY AND PHARMACOLOGY
卷 64, 期 9, 页码 1275-1290出版社
OXFORD UNIV PRESS
DOI: 10.1111/j.2042-7158.2012.01488.x
关键词
inhalation; nanoporous; nanoparticulate microparticles; spray-drying; trypsin
资金
- Enterprise Ireland [CFTD/06/119]
- Science Foundation Ireland [7/SRC/B1154, 07/SRC/B1158]
- EU
Objectives The aim of this study was to determine if spray-drying could successfully produce microparticles containing the model protein trypsin in a form suitable for inhalation. Methods Trypsin was spray-dried with raffinose from a methanol : n-butyl acetate solvent system (MeOH : BA). The solvent system was then adjusted to include water, and trypsin was co-spray-dried with raffinose, trehalose or hydroxpropyl-beta-cyclodextrin. The spray-dried products were characterised by SEM, XRD, DSC, TGA and FTIR. Protein biological activity and in-vitro deposition of trypsin : excipient nanoporous/nanoparticulate microparticles (NPMPs) was also assessed. Key findings The inclusion of water in a MeOH : BA solvent system allowed for the successful production of NPMPs of trypsin : excipient by spray-drying. Trypsin formulated as trypsin : excipient NPMPs retained biological activity on processing and showed no deterioration in activity or morphological characteristics when stored with desiccant at either 4 or 25 degrees C. Hydroxpropyl-beta-cyclodextrin showed advantages over the sugars in terms of producing powders with appropriate density and with greater physical stability under high-humidity conditions. Fine particle fractions of between 41 and 45% were determined for trypsin : excipient NPMPs. Conclusions NPMPs of trypsin : excipient systems can be produced by spray-drying by adjustment of the solvent system to allow for adequate solubility of trypsin.
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