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Formulation of a protein with propellant HFA 134a for aerosol delivery
Institution:1. PPME, Université de la Nouvelle-Calédonie BPR4, 98851 Nouméa Cedex, New Caledonia;2. GSMA, UMR CNRS 7331, Université de Reims Champagne Ardenne, UFR Sciences Exactes et Naturelles, Moulin de la House, BP 1039–51687 Reims Cedex 2, France;1. College of Environmental & Resource Sciences, Zhejiang University, Hangzhou 310058, China;2. Department of Land, Air, and Water Resources, University of California, Davis, CA 95616 USA;3. Zhejiang Provincial Key Laboratory of Subtropical Soil and Plant Nutrition, Zhejiang University, Hangzhou 310058, China;4. Ministry of Education Key Laboratory of Environment Remediation and Ecological Health, Zhejiang University, Hangzhou 310058, China;1. University of Alabama, Department of Biological Sciences, Tuscaloosa, AL 35487, USA;2. Dauphin Island Sea Lab, 101 Bienville Blvd, Dauphin Island, AL 36528, USA;3. Institute of Soil Sciences and Agricultural Chemistry, Center for Agricultural Research, Hungarian Academy of Sciences, Herman O. St. 15, Budapest 1022, Hungary
Abstract:The purpose of this study was to investigate the formulation and delivery of a protein in a pressurized metered-dose inhaler (pMDI) containing HFA 134a as the propellant for aerosol delivery. Ethanol and surfactants, including polyoxyethylene 10 oleyl ether (Brij 97), polyoxyethylene 20 oleyl ether (Brij 98), polyoxyethylene sorbitan monooleate (Tween 80) and Aerosol OT (AOT), were investigated as formulation adjuvants to improve the dose delivery characteristics of the model protein (bovine serum albumin) containing pMDI formulations. The aqueous solution of a surfactant and protein was lyophilized to obtain a solid carrier system of the protein. Readily dispersible suspensions were obtained by suspending this solid carrier system in HFA 134a with ethanol as a dispersing aid. The formulations containing Tween 80 resulted in the highest respirable fraction. This study suggested a potential formulation containing a lyophilized complex of surfactant and protein readily dispersible in HFA 134a for delivering a therapeutic protein to the respiratory tract by inhalation.
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