4.4 Article

Development of dry powder inhaler formulation loaded with alendronate solid lipid nanoparticles: solid-state characterization and aerosol dispersion performance

Journal

DRUG DEVELOPMENT AND INDUSTRIAL PHARMACY
Volume 41, Issue 9, Pages 1431-1437

Publisher

TAYLOR & FRANCIS LTD
DOI: 10.3109/03639045.2014.956111

Keywords

Alendronate; dry powder inhaler; fine particle fraction; solid lipid nanoparticle

Funding

  1. Research Center for Pharmaceutical Nanotechnology (RCM), Tabriz University of Medical Sciences [5/87/260, 90/014/104/2]

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Alendronate sodium is a bisphosphonate drug used for the treatment of osteoporosis and acts as a specific inhibitor of osteoclast-mediated bone resorption. Inhalable solid lipid nanoparticles (SLNs) of the alendronate were successfully designed and developed by spraydried and co-spray dried inhalable mannitol from aqueous solution. Emulsification technique using a simple homogenization method was used for preparation of SLNs. In vitro deposition of the aerosolized drug was studied using a Next Generation Impactor at 60 L/min following the methodology described in the European and United States Pharmacopeias. The Carr's Index, Hausner ratio and angle of repose were calculated as suitable criteria for estimation of the flow behavior of solids. Scanning electron microscopy showed spherical particle morphology of the respirable particles. The proposed spray-dried nanoparticulate-on-microparticles dry powders displayed good aerosol dispersion performance as dry powder inhalers with high values in emitted dose, fine particle fraction and mass median aerodynamic diameter. These results indicate that this novel inhalable spray-dried nanoparticulate-on-microparticles aerosol platform has great potential in systemic delivery of the drug.

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