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Novel pMDI Formulations for Pulmonary Delivery of Proteins

Li, H.-Y. and Seville, Peter C. ORCID: https://orcid.org/0000-0001-8546-3474 (2010) Novel pMDI Formulations for Pulmonary Delivery of Proteins. International Journal of Pharmaceutics, 385 (1-2). pp. 73-78. ISSN Online: 0378-5173

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Abstract

In this paper, we demonstrate that co-spray-drying a model protein with sodium carboxymethylcellulose (NaCMC) protects protein integrity during spray-drying, and that the resultant spray-dried powders can be successfully dispersed in hydrofluoroalkane (HFA) propellant to prepare pressurised metered dose (pMDI) formulations that exhibit high respirable fractions. The spray-dried powders were formulated as HFA-134a pMDI suspensions in the absence of any other excipients (e.g. surfactants) or co-solvents (e.g. ethanol). The in vitro aerosolisation profile of these systems was assessed using the twin stage impinger; fine particle fractions (FPF) ≥50% of the recovered dose were obtained. Following storage for five months, the aerosolisation performance was reassessed; the NaCMC-free formulation demonstrated a significant decrease in FPF, whereas the performance of the NaCMC-modified formulations was statistically equivalent to their initial performance. Thus, formulation of pMDI suspensions using NaCMC-based spray-dried powders is a promising approach for the pulmonary delivery of proteins and peptides.

Item Type: Article
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Uncontrolled Keywords: sodium carboxymethylcellulose, HFA-134a, pMDI, protein, spray-drying
Subjects: Q Science > Q Science (General)
R Medicine > RM Therapeutics. Pharmacology
Divisions: Academic Departments > Institute of Science and the Environment
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Depositing User: Peter Seville
Date Deposited: 17 Jun 2019 11:10
Last Modified: 17 Jun 2019 11:10
URI: https://eprints.worc.ac.uk/id/eprint/8183

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