Journal
JOURNAL OF PHARMACEUTICAL SCIENCES
Volume 101, Issue 9, Pages 3434-3444Publisher
ELSEVIER SCIENCE INC
DOI: 10.1002/jps.23197
Keywords
budesonide; excipients; NanoClusters; inhalation; attrition; aerosols; nanoparticles; nanotechnology; formulation; pulmonary drug delivery
Funding
- Coulter Foundation
- Higuchi Biosciences Center
- NSF [CHE 0968972, 0966614]
- Directorate For Engineering
- Div Of Chem, Bioeng, Env, & Transp Sys [0966614] Funding Source: National Science Foundation
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Wet milling was previously demonstrated as a simple process for producing agglomerates of budesonide nanoparticles (also known as NanoClusters) for use in dry powder aerosol formulation. The resulting budesonide NanoCluster powders exhibited a large emitted fraction and a high fine particle fraction (FPF) from a Monodose (R) dry powder inhaler. In this work, excipients were added premilling or postmilling and the performance of budesonide NanoCluster dry powders was investigated. Sodium chloride, Pluronic (R), or ethanol was added prior to milling due to their ability to modify surface tension or ionic strength and thereby affect the attrition/agglomeration process. Lactose or l-leucine was added after milling because these are known to modify powder flow and dispersion. The chemical stability of budesonide was maintained in all cases, but the physical aerosol properties changed substantially with the addition of excipients. In all cases, the addition of excipients led to an increase in the size of the budesonide NanoClusters and tended to reduce the emitted fraction and FPF. Titrating excipients may provide a means to discretely modify the aerosol properties of budesonide NanoClusters but did not match the performance of excipient-free NanoCluster powder. (c) 2012 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci 101:34343444, 2012
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