Secretory leukocyte protease inhibitor dry powder...

A - Human Necessities – 61 – K

Patent

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Details

A61K 38/55 (2006.01) A61K 9/72 (2006.01) C07K 14/50 (2006.01) A61K 38/00 (2006.01) A61K 48/00 (2006.01)

Patent

CA 2308123

The present invention relates to the pulmonary administration of a therapeutic protein by means of powdered pharmaceutical composition suitable for inhalation therapy. In particular the invention relates to dry powder formulations of secretory leukocyte protease inhibitor (SLPI) for pulmonary delivery. Exemplary pharmaceutical compositions contain SLPI and a pharmaceutically acceptable carrier in the form of a dry powder which is typically less than about 10 % by weight water. About 50 % to 95 % by mass of the powder comprises particles or agglomerates of particles having a diameter within the range of from about 1.0 microns to about 8 microns, with a mass median diameter ranging from about 3.0 microns to about 6 microns.

Cette invention se rapporte à l'administration dans les poumons d'une protéine thérapeutique au moyen de compositions pharmaceutiques pulvérulentes se prêtant à une thérapie par inhalation. Cette invention se rapporte en particulier à des formulations en poudre sèche d'un inhibiteur des protéases leucocytaires sécrétrices (SLPI), en vue de leur administration dans les poumons. De telles compositions pharmaceutiques exemplaires contiennent l'inhibiteur SLPI et un excipient acceptable sur le plan pharmaceutique, se présentant sous la forme d'une poudre sèche qui contient généralement moins de 10 % en poids d'eau. Une proportion d'environ 50 à 95 % en masse de cette poudre contient des particules ou des agglomérats de particules ayant un diamètre compris entre 1,0 micron environ et 8 micron environ, avec un diamètre moyen de la masse compris entre 3,0 microns environ et 6 microns environ.

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