Article history: The high hygroscopicity of gentamicin (G) as raw material hampers the production of respirable parti- Received 17 November 2011 cles during aerosol generation and prevents its direct use as powder for inhalation in patients suffering Received in revised form 12 January 2012 from cystic ﬁbrosis (CF). Therefore, this research aimed to design a new dry powder formulation of G Accepted 13 January 2012 studying dispersibility properties of an aminoacid, l-leucine (leu), and appropriate process conditions. Available online 23 January 2012 Spray-dried powders were characterized as to water uptake, particle size distribution, morphology and stability, in correlation with process parameters. Aerodynamic properties were analyzed both by Single Keywords: Stage Glass Impinger and Andersen Cascade Impactor. Moreover, the potential cytotoxicity on bronchial Cystic ﬁbrosis epithelial cells bearing a CFTR F508/F508 mutant genotype (CuFi1) were tested. Results indicated that Gentamicin sulfate leu may improve the aerosol performance of G-dried powders. The maximum ﬁne particle fraction (FPF) l-leucine of about 58.3% was obtained when water/isopropyl alcohol 7:3 system and 15–20% (w/w) of leu were Spray drying Dry powder inhaler used, compared to a FPF value of 13.4% for neat G-dried powders. The enhancement of aerosol efﬁciency CF airway epithelial cells was
International Journal of Pharmaceutics – Elsevier
Published: Apr 15, 2012
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