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Spray-drying of inhalable, multifunctional formulations for the treatment of biofilms formed in cystic fibrosis.

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Affiliations

  • 1. Department of Pharmacy, Biopharmaceutics and Pharmaceutical Technology, Saarland University, Campus C4 1, 66123, Saarbrücken, Germany.
      Authors
    • Lababidi N 1
    • Sigal V 1
    • Schneider M 1
    (3 authors)
  • 2. Department of Pharmacy, Faculty of Mathematics and Natural Sciences, University of Oslo, 0316, Oslo, Norway; Department of Pharmacy, Faculty of Health and Medical Science, University of Copenhagen, Universitetsparken 2, DK-2100, Copenhagen, Denmark.
      Authors
    • Ofosu Kissi E 2
    (1 author)
  • 3. Helmholtz Institute for Pharmaceutical Research Saarland (HIPS) - Helmholtz Centre for Infection Research (HZI), Department of Drug Design and Optimization, Campus E8 1, 66123, Saarbrücken, Germany.
      Authors
    • Elgaher WAM 3
    • Haupenthal J 3
    (2 authors)
  • 4. Pferdeklinik Altforweiler, Raiffeisenstraße 100, 66802, Überherrn, Germany.
      Authors
    • Schwarz BC 4
    (1 author)
  • 5. Helmholtz Institute for Pharmaceutical Research Saarland (HIPS) - Helmholtz Centre for Infection Research (HZI), Department of Drug Design and Optimization, Campus E8 1, 66123, Saarbrücken, Germany; Department of Pharmacy, Medicinal Chemistry, Saarland University, Campus E8 1, 66123, Saarbrücken, Germany.
      Authors
    • Hirsch AKH 5
    (1 author)
    • Show all (6)

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Journal of Controlled Release : Official Journal of the Controlled Release Society, 22 Oct 2019, 314:62-71
https://doi.org/10.1016/j.jconrel.2019.10.038 PMID: 31654686 

Abstract 

Cystic fibrosis (CF) is a serious lung disease, commonly susceptible to Pseudomonas aeruginosa colonization. The dense mucus together with biofilm formation limit drug permeability and prevent the drug from reaching the site of action, causing treatment failure of the bacterial infection. Besides the use of antibiotics, the mucolytic agent N-acetylcysteine (NAC) is recommended to be co-administered in the treatment of CF. Although several formulations have been developed for inhalation therapy to improve the pulmonary condition in CF patients, there is still no comprehensive study on a combined multifunctional dry powder formulation of antibiotics with NAC. In this work, we developed an innovative multifunctional dry powder inhaler (DPI) formulation based on salt formation between NAC and antibiotics and characterized their solid state properties and physical stability. NAC could be spray dried together with three different antibiotics, azithromycin (Azi), tobramycin (Tobra) and ciprofloxacin (Cipro), without the use of organic solvents to form Azi/NAC, Tobra/NAC and Cipro/NAC DPI formulations. Solid-state characterization of these DPI formulations showed that they were amorphous after spray drying. Azi/NAC and Tobra/NAC form co-amorphous salt systems that were physically stable under storage at stress conditions. For particle characterization, the obtained mass median aerodynamic diameters were in a suitable range for inhalation (< 5.0μm). The multifunctional antibiotic/NAC formulations conserved or improved the antibiotic susceptibility and showed promising results regarding the inhibition of P. aeruginosa PA14 biofilm formation.

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Read article at publisher's site: https://doi.org/10.1016/j.jconrel.2019.10.038

Read article for free, from open access legal sources, via Unpaywall: https://repository.helmholtz-hzi.de/bitstream/10033/622054/1/Lababidi%20et%20al.pdfUnpaywall

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Funding 

Funders who supported this work.

European Research Council (1)

Helmholtz Association’s Initiative and Networking Fund