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AssigneeNektar Therapeutics
InventorsRobert M. Platz, John S. Patton, Linda Foster, Mohammed Eljamal
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According to the subject invention, dispersible dry powder pharmaceutical-based compositions are provided, including methods for their manufacture and dry powder dispersion devices. A dispersible dry powder pharmaceutical-based composition is one having a moisture content of less than about 10% by weight (%w) water, usually below about 5%w and preferably less than about 3%w; a particle size of about 1.0-5.0 μm mass median diameter (MMD), usually 1.0-4.0 μm MMD, and preferably 1.0-3.0 μm MMD; a delivered dose of about >30%, usually >40%, preferably >50%, and most preferred >60%; and an aerosol particle size distribution of about 1.0-5.0 μm mass median aerodynamic diameter (MMAD), usually 1.5-4.5 μm MMAD, and preferably 1.5-4.0 μm MMAD. Such compositions are of pharmaceutical grade purity.
An aerosolizable, spray-dried powder formulation for pulmonary delivery comprising a growth hormone and a pharmaceutically acceptable carrier, wherein the powder comprises a plurality of particles having an average particle size of less than about 10 microns MMD and further wherein each particle is comprised of the growth hormone and the carrier.
A method for preparing a growth hormone-based dry powder composition suitable for pulmonary delivery, said method comprising spray drying an aqueous solution of growth hormone and a pharmaceutically acceptable carrier under conditions effective to provide a respirable, spray dried powder, wherein the powder comprises a plurality of particles having an average particle size of less than about 10 microns MMD and further wherein each particle is comprised of the growth hormone and the carrier.
Dependencies are inferred from the claim text.