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Physicochemical characterization and aerosol dispersion performance of organic solution advanced spray-dried microparticulate/nanoparticulate antibiotic dry powders of tobramycin and azithromycin for pulmonary inhalation aerosol delivery.
Eur J Pharm Sci. 2014 Feb 14; 52:191-205.EJ

Abstract

The purpose of this study was to systematically design pure antibiotic drug dry powder inhalers (DPIs) for targeted antibiotic pulmonary delivery in the treatment of pulmonary infections and comprehensively correlate the physicochemical properties in the solid-state and spray-drying conditions effects on aerosol dispersion performance as dry powder inhalers (DPIs). The two rationally chosen model antibiotic drugs, tobramycin (TOB) and azithromycin (AZI), represent two different antibiotic drug classes of aminoglycosides and macrolides, respectively. The particle size distributions were narrow, unimodal, and in the microparticulate/nanoparticulate size range. The SD particles possessed relatively spherical particle morphology, smooth surface morphology, low residual water content, and the absence of long-range molecular order. The emitted dose (ED%), fine particle fraction (FPF%) and respirable fraction (RF%) were all excellent. The MMAD values were in the inhalable range (<10 μm) with smaller MMAD values for SD AZI powders in contrast to SD TOB powders. Positive linear correlations were observed between the aerosol dispersion performance parameter of FPF with increasing spray-drying pump rates and also with the difference between thermal parameters expressed as Tg-To (i.e. the difference between the glass transition temperature and outlet temperature) for SD AZI powders. The aerosol dispersion performance for SD TOB appeared to be influenced by its high water vapor sorption behavior (hygroscopicity) and pump rates or To. Aerosol dispersion performance of SD powders were distinct for both antibiotic drug aerosol systems and also between different pump rates for each system.

Authors+Show Affiliations

University of Kentucky, College of Pharmacy, Department of Pharmaceutical Sciences-Drug Development Division, 789 S. Limestone St., Lexington, KY 40536-0596, USA.GlaxoSmithKline, Analytical Sciences, Product Development, King of Prussia, PA 19406, USA.The Ohio State University, College of Medicine, Departments of Pediatrics and Internal Medicine, Lung and Heart-Lung Transplant Programs, Columbus, OH 43205, USA; The Ohio State University, College of Medicine, The Davis Heart and Lung Research Institute, Columbus, OH 43205, USA.University of Arizona-Tucson, College of Pharmacy, Skaggs Pharmaceutical Sciences Center, 1703 E. Mabel St., Tucson, AZ 85721, USA. Electronic address: mansour@pharmacy.arizona.edu.

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

24215736

Citation

Li, Xiaojian, et al. "Physicochemical Characterization and Aerosol Dispersion Performance of Organic Solution Advanced Spray-dried Microparticulate/nanoparticulate Antibiotic Dry Powders of Tobramycin and Azithromycin for Pulmonary Inhalation Aerosol Delivery." European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences, vol. 52, 2014, pp. 191-205.
Li X, Vogt FG, Hayes D, et al. Physicochemical characterization and aerosol dispersion performance of organic solution advanced spray-dried microparticulate/nanoparticulate antibiotic dry powders of tobramycin and azithromycin for pulmonary inhalation aerosol delivery. Eur J Pharm Sci. 2014;52:191-205.
Li, X., Vogt, F. G., Hayes, D., & Mansour, H. M. (2014). Physicochemical characterization and aerosol dispersion performance of organic solution advanced spray-dried microparticulate/nanoparticulate antibiotic dry powders of tobramycin and azithromycin for pulmonary inhalation aerosol delivery. European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences, 52, 191-205. https://doi.org/10.1016/j.ejps.2013.10.016
Li X, et al. Physicochemical Characterization and Aerosol Dispersion Performance of Organic Solution Advanced Spray-dried Microparticulate/nanoparticulate Antibiotic Dry Powders of Tobramycin and Azithromycin for Pulmonary Inhalation Aerosol Delivery. Eur J Pharm Sci. 2014 Feb 14;52:191-205. PubMed PMID: 24215736.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Physicochemical characterization and aerosol dispersion performance of organic solution advanced spray-dried microparticulate/nanoparticulate antibiotic dry powders of tobramycin and azithromycin for pulmonary inhalation aerosol delivery. AU - Li,Xiaojian, AU - Vogt,Frederick G, AU - Hayes,Don,Jr AU - Mansour,Heidi M, Y1 - 2013/11/09/ PY - 2013/05/03/received PY - 2013/10/10/revised PY - 2013/10/29/accepted PY - 2013/11/13/entrez PY - 2013/11/13/pubmed PY - 2014/9/10/medline KW - Aerosol dispersion performance modeling KW - Cystic fibrosis KW - Dry powder inhalers (DPIs) KW - Glass transition KW - Pulmonary infections KW - Respiratory delivery SP - 191 EP - 205 JF - European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences JO - Eur J Pharm Sci VL - 52 N2 - The purpose of this study was to systematically design pure antibiotic drug dry powder inhalers (DPIs) for targeted antibiotic pulmonary delivery in the treatment of pulmonary infections and comprehensively correlate the physicochemical properties in the solid-state and spray-drying conditions effects on aerosol dispersion performance as dry powder inhalers (DPIs). The two rationally chosen model antibiotic drugs, tobramycin (TOB) and azithromycin (AZI), represent two different antibiotic drug classes of aminoglycosides and macrolides, respectively. The particle size distributions were narrow, unimodal, and in the microparticulate/nanoparticulate size range. The SD particles possessed relatively spherical particle morphology, smooth surface morphology, low residual water content, and the absence of long-range molecular order. The emitted dose (ED%), fine particle fraction (FPF%) and respirable fraction (RF%) were all excellent. The MMAD values were in the inhalable range (<10 μm) with smaller MMAD values for SD AZI powders in contrast to SD TOB powders. Positive linear correlations were observed between the aerosol dispersion performance parameter of FPF with increasing spray-drying pump rates and also with the difference between thermal parameters expressed as Tg-To (i.e. the difference between the glass transition temperature and outlet temperature) for SD AZI powders. The aerosol dispersion performance for SD TOB appeared to be influenced by its high water vapor sorption behavior (hygroscopicity) and pump rates or To. Aerosol dispersion performance of SD powders were distinct for both antibiotic drug aerosol systems and also between different pump rates for each system. SN - 1879-0720 UR - https://www.unboundmedicine.com/medline/citation/24215736/Physicochemical_characterization_and_aerosol_dispersion_performance_of_organic_solution_advanced_spray_dried_microparticulate/nanoparticulate_antibiotic_dry_powders_of_tobramycin_and_azithromycin_for_pulmonary_inhalation_aerosol_delivery_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0928-0987(13)00423-5 DB - PRIME DP - Unbound Medicine ER -