Surface Composition and Aerosolization Stability of an Inhalable Combinational Powder Formulation Spray Dried Using a Th
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RESEARCH PAPER
Surface Composition and Aerosolization Stability of an Inhalable Combinational Powder Formulation Spray Dried Using a Three-Fluid Nozzle Nivedita Shetty 1,2 & Yiwen Zhang 1 & Heejun Park 1 & Dmitry Zemlyanov 3 & Dishan Shah 1 & Athena He 1 & Patricia Ahn 1 & Tarun Tejasvi Mutukuri 1 & Hak-Kim Chan 4 & Qi (Tony) Zhou 1 Received: 10 August 2020 / Accepted: 22 September 2020 # Springer Science+Business Media, LLC, part of Springer Nature 2020
ABSTRACT Purpose This study aims to understand the impact of spray drying nozzles on particle surface composition and aerosol stability. Methods The combination formulations of colistin and azithromycin were formulated by 2-fluid nozzle (2 N) or 3-fluid (3 N) spray drying in a molar ratio of 1:1. A 3-factor, 2-level (23) factorial design was selected to investigate effects of flow rate, inlet temperature and feed concentration on yield of spray drying and the performance of the spray dried formulations for the 3 N. Results FPF values for the 2 N formulation (72.9 ± 1.9% for azithromycin & 73.4 ± 0.8% for colistin) were higher than those for the 3 N formulation (56.5 ± 3.8% for azithromycin & 55.1 ± 1.6% for colistin) when stored at 20% RH for 1 day, which could be attributed to smaller physical size for the 2 N. There was no change in FPF for both drugs in the 2 N formulation after storage at 75% RH for 90 days; however, there was a slight increase in FPF for colistin in the 3 N formulation at the same storage conditions. Surface enrichment of Nivedita Shetty and Yiwen Zhang contributed equally to this work. Electronic supplementary material The online version of this article (https://doi.org/10.1007/s11095-020-02937-2) contains supplementary material, which is available to authorized users. * Qi (Tony) Zhou [email protected] 1
Department of Industrial and Physical Pharmacy, College of Pharmacy, Purdue University, 575 Stadium Mall Drive, West Lafayette, Indiana 47907, USA
2
Department of Small Molecule Pharmaceutical Sciences, Genentech Inc., 1 DNA Way, South San Francisco, California 94080, USA
3
Birck Nanotechnology Center, Purdue University, 1205 West State Street, West Lafayette, Indiana 47907, USA
4
Sydney Pharmacy School, The University of Sydney, Camperdown, NSW 2006, Australia
hydrophobic azithromycin was measured by X-ray photoelectron spectroscopy for both 2 N and 3 N formulations and interactions were studied using FTIR. Conclusions The 3-fluid nozzle provides flexibility in choosing different solvents and has the capability to spray dry at higher feed solid concentrations. This study highlights the impact of hydrophobic azithromycin enrichment on particle surface irrespective of the nozzle type, on the prevention of moisture-induced deterioration of FPF for hygroscopic colistin.
KEY WORDS aerosol performance . dry powder inhaler . spray drying . surface composition . three-fluid nozzle
ABBREVIATIONS 2N 3N ColAz (1-1) DOE DPI DVS ED FPF FTIR GSD MMAD NGI PXRD RH SD SEM XPS
Two-fluid nozzle Three-fluid nozzle Co-spray dried colistin and azi
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