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Open Access Physicochemical compatibility of nebulizable drug mixtures containing dornase alfa and ipratropium and/or albuterol

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Abstract:

Patients suffering from cystic fibrosis (CF) often need to inhale multiple doses of different nebulizable drugs per day. Patients attempt to shorten the time consuming administration procedure by mixing drug solutions/suspensions for simultaneous inhalation. The objective of this experimental study was to determine whether mixtures of Pulmozyme® inhalation solution with Atrovent® or Sultanol® are physicochemically compatible. Drug combinations were prepared in accordance with the product information and clinical practice by mixing the content of one respule Pulmozyme® with 2 mL Atrovent® LS and 0.5 mL Sultanol® Inhalationslösung (inhalation solution) or with one respule of either Atrovent® 500 μg/2 mL Fertiginhalat (unit dose formulation) or Sultanol® forte Fertiginhalat. Test solutions were stored at room temperature and exposed to light. Dornase alfa activity was determined by a kinetic colorimetric DNase activity assay. Ipratropium bromide and albuterol concentrations were investigated by a stability-indicating HPLC assay with ultraviolet detection. Physical compatibility was determined by visual inspection and measurements of pH and osmolality. Ipratropium bromide and albuterol concentrations were not affected by mixing the drug products. Dornase alfa activity is affected by benzalkonium chloride, used as excipient in Atrovent® LS and Sultanol® Inhalationslösung, and disodium edetate used as an excipient in Atrovent® LS. Patients should be advised not to mix Pulmozyme® with Atrovent® LS and/or Sultanol® Inhalationslösung, because of the incompatibility reaction. Mixtures of Pulmozyme® with Atrovent® 500 μg/2 mL Fertiginhalat or Sultanol® forte Fertiginhalat can be designated as compatible for a limited period of time.

Document Type: Research Article

DOI: http://dx.doi.org/10.1691/ph.2007.10.7027

Affiliations: 1: Department of Pharmacy, Johannes Gutenberg-Universität Mainz, Langenbeckstraße 1, Mainz, 55101, Germany, Email: Kraemer@apotheke.klinik.uni-mainz.de 2: Department of Pharmacy, Johannes Gutenberg-Universität Mainz, Mainz, Germany 3: Department of Clinical Chemistry, Medizinische Hochschule Hannover, Hannover, Germany 4: Childrens Hospital, Johannes Gutenberg-Universität Mainz, Mainz, Germany

Publication date: October 1, 2007

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  • Pharmazie is one of the world's leading pharmaceutical journals. As a peer-reviewed scientific journal, DiePharmazie is regularly indexed in Current Contents/Life Sciences, Excerpta Medica, Analytical Abstracts, International Pharmaceutical Abstracts, Beilstein Current Facts in Chemistry, Chemical Engineering and Biotechnology Abstracts (CEABA) and Science Citation Index.
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