Physicochemical characterization and aerosol dispersion performance of organic solution advanced spray-dried cyclosporine A multifunctional particles for dry powder inhalation aerosol delivery

Xiao Wu,1 Weifen Zhang,1,2 Don Hayes Jr,3–5 Heidi M Mansour1,61Department of Pharmaceutical Sciences – Drug Development Division, University of Kentucky, Lexington, KY, USA; 2College of Pharmacy and Biological Science, Weifang Medical University, Weifang, People's Republi...

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Autores principales:	Wu X, Zhang W, Hayes D Jr, Mansour HM
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2013
Materias:	Medicine (General) R5-920
Acceso en línea:	https://doaj.org/article/dac4a47308ca4a22af3c7fd75e1c6a60
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spelling	oai:doaj.org-article:dac4a47308ca4a22af3c7fd75e1c6a602021-12-02T02:44:37ZPhysicochemical characterization and aerosol dispersion performance of organic solution advanced spray-dried cyclosporine A multifunctional particles for dry powder inhalation aerosol delivery1176-91141178-2013https://doaj.org/article/dac4a47308ca4a22af3c7fd75e1c6a602013-03-01T00:00:00Zhttp://www.dovepress.com/physicochemical-characterization-and-aerosol-dispersion-performance-of-a12553https://doaj.org/toc/1176-9114https://doaj.org/toc/1178-2013Xiao Wu,1 Weifen Zhang,1,2 Don Hayes Jr,3–5 Heidi M Mansour1,61Department of Pharmaceutical Sciences – Drug Development Division, University of Kentucky, Lexington, KY, USA; 2College of Pharmacy and Biological Science, Weifang Medical University, Weifang, People's Republic of China; 3Department of Pediatrics, 4Department of Internal Medicine, The Ohio State University College of Medicine, Nationwide Children's Hospital Lung and Heart-Lung Transplant Program, 5Davis Heart and Lung Research Institute, The Ohio State University, Columbus, OH, 6Center of Membrane Sciences, University of Kentucky, Lexington, KY, USAAbstract: In this systematic and comprehensive study, inhalation powders of the polypeptide immunosuppressant drug – cyclosporine A – for lung delivery as dry powder inhalers (DPIs) were successfully designed, developed, and optimized. Several spray drying pump rates were rationally chosen. Comprehensive physicochemical characterization and imaging was carried out using scanning electron microscopy, hot-stage microscopy, differential scanning calorimetry, powder X-ray diffraction, Karl Fischer titration, laser size diffraction, and gravimetric vapor sorption. Aerosol dispersion performance was conducted using a next generation impactor with a Food and Drug Administration-approved DPI device. These DPIs displayed excellent aerosol dispersion performance with high values in emitted dose, respirable fraction, and fine particle fraction. In addition, novel multifunctional inhalation aerosol powder formulations of cyclosporine A with lung surfactant-mimic phospholipids were also successfully designed and developed by advanced organic solution cospray drying in closed mode. The lung surfactant-mimic phospholipids were 1,2-dipalmitoyl-sn-glycero-3-phosphocholine and 1,2-dipalmitoyl-sn-glycero-3-(phosphor-rac-1-glycerol). These cyclosporine A lung surfactant-mimic aerosol powder formulations were comprehensively characterized. Powder X-ray diffraction and differential scanning calorimetry confirmed that the phospholipid bilayer structure in the solid state was preserved following advanced organic solution spray drying in closed mode. These novel multifunctional inhalation powders were optimized for DPI delivery with excellent aerosol dispersion performance and high aerosol performance parameters.Keywords: dry powder inhaler (DPI), polypeptide drug, lung surfactant, calcineurin inhibitor, lung immunosuppression, dipalmitoylphosphatidylcholine (DPPC), dipalmitoylphosphatidylglycerol (DPPG), targeted lung immunosuppressionWu XZhang WHayes D JrMansour HMDove Medical PressarticleMedicine (General)R5-920ENInternational Journal of Nanomedicine, Vol 2013, Iss default, Pp 1269-1283 (2013)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine (General) R5-920
spellingShingle	Medicine (General) R5-920 Wu X Zhang W Hayes D Jr Mansour HM Physicochemical characterization and aerosol dispersion performance of organic solution advanced spray-dried cyclosporine A multifunctional particles for dry powder inhalation aerosol delivery
description	Xiao Wu,1 Weifen Zhang,1,2 Don Hayes Jr,3–5 Heidi M Mansour1,61Department of Pharmaceutical Sciences – Drug Development Division, University of Kentucky, Lexington, KY, USA; 2College of Pharmacy and Biological Science, Weifang Medical University, Weifang, People's Republic of China; 3Department of Pediatrics, 4Department of Internal Medicine, The Ohio State University College of Medicine, Nationwide Children's Hospital Lung and Heart-Lung Transplant Program, 5Davis Heart and Lung Research Institute, The Ohio State University, Columbus, OH, 6Center of Membrane Sciences, University of Kentucky, Lexington, KY, USAAbstract: In this systematic and comprehensive study, inhalation powders of the polypeptide immunosuppressant drug – cyclosporine A – for lung delivery as dry powder inhalers (DPIs) were successfully designed, developed, and optimized. Several spray drying pump rates were rationally chosen. Comprehensive physicochemical characterization and imaging was carried out using scanning electron microscopy, hot-stage microscopy, differential scanning calorimetry, powder X-ray diffraction, Karl Fischer titration, laser size diffraction, and gravimetric vapor sorption. Aerosol dispersion performance was conducted using a next generation impactor with a Food and Drug Administration-approved DPI device. These DPIs displayed excellent aerosol dispersion performance with high values in emitted dose, respirable fraction, and fine particle fraction. In addition, novel multifunctional inhalation aerosol powder formulations of cyclosporine A with lung surfactant-mimic phospholipids were also successfully designed and developed by advanced organic solution cospray drying in closed mode. The lung surfactant-mimic phospholipids were 1,2-dipalmitoyl-sn-glycero-3-phosphocholine and 1,2-dipalmitoyl-sn-glycero-3-(phosphor-rac-1-glycerol). These cyclosporine A lung surfactant-mimic aerosol powder formulations were comprehensively characterized. Powder X-ray diffraction and differential scanning calorimetry confirmed that the phospholipid bilayer structure in the solid state was preserved following advanced organic solution spray drying in closed mode. These novel multifunctional inhalation powders were optimized for DPI delivery with excellent aerosol dispersion performance and high aerosol performance parameters.Keywords: dry powder inhaler (DPI), polypeptide drug, lung surfactant, calcineurin inhibitor, lung immunosuppression, dipalmitoylphosphatidylcholine (DPPC), dipalmitoylphosphatidylglycerol (DPPG), targeted lung immunosuppression
format	article
author	Wu X Zhang W Hayes D Jr Mansour HM
author_facet	Wu X Zhang W Hayes D Jr Mansour HM
author_sort	Wu X
title	Physicochemical characterization and aerosol dispersion performance of organic solution advanced spray-dried cyclosporine A multifunctional particles for dry powder inhalation aerosol delivery
title_short	Physicochemical characterization and aerosol dispersion performance of organic solution advanced spray-dried cyclosporine A multifunctional particles for dry powder inhalation aerosol delivery
title_full	Physicochemical characterization and aerosol dispersion performance of organic solution advanced spray-dried cyclosporine A multifunctional particles for dry powder inhalation aerosol delivery
title_fullStr	Physicochemical characterization and aerosol dispersion performance of organic solution advanced spray-dried cyclosporine A multifunctional particles for dry powder inhalation aerosol delivery
title_full_unstemmed	Physicochemical characterization and aerosol dispersion performance of organic solution advanced spray-dried cyclosporine A multifunctional particles for dry powder inhalation aerosol delivery
title_sort	physicochemical characterization and aerosol dispersion performance of organic solution advanced spray-dried cyclosporine a multifunctional particles for dry powder inhalation aerosol delivery
publisher	Dove Medical Press
publishDate	2013
url	https://doaj.org/article/dac4a47308ca4a22af3c7fd75e1c6a60
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Physicochemical characterization and aerosol dispersion performance of organic solution advanced spray-dried cyclosporine A multifunctional particles for dry powder inhalation aerosol delivery

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