Inhalable sustained therapeutic formulations

A - Human Necessities – 61 – K

Patent

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Details

A61K 9/12 (2006.01) A61K 9/14 (2006.01) A61K 9/16 (2006.01) A61K 9/50 (2006.01) A61K 38/17 (2006.01)

Patent

CA 2478974

The present invention is based, in part, on the unexpected discovery that particles for pulmonary delivery of a therapeutic, prophylactic or diagnostic agent that comprise a phospholipid and a sufficient amount of leucine can produce sustained effect of the agent. Specifically, particles for pulmonary delivery of a therapeutic, prophylactic or diagnostic agent that contain a phospholipid or combination of phospholipids, wherein the phospholipid or combination of phospholipids is present in the particles in an amount of about 1 to 46 weight percent; and leucine, wherein leucine is present in the particles in an amount of at least 46 weight percent, can contribute to sustained effect of the agent. Particles that comprise at least 46 weight percent leucine but that do not contain phospholipids do not exhibit these same sustained effect properties.

L'invention repose, en partie, sur la découverte inattendue selon laquelle des particules destinées à l'administration pulmonaire d'un agent thérapeutique, prophylactique ou diagnostique qui contient un phospholipide et une dose suffisante de leucine, peuvent produire un effet soutenu dudit agent. En particulier, ces particules destinées à l'administration pulmonaire d'un agent thérapeutique, prophylactique ou diagnostique qui contient un phospholipide ou une combinaison de phospholipides, ledit phospholipide ou ladite combinaison de phospholipides étant présent dans les particules en quantité comprise entre 1 et 48 % en poids; et de la leucine, présente dans les particules en quantité au moins égale à 46 % en poids, peuvent contribuer à l'effet soutenu dudit agent. Lesdites particules qui comprennent au moins 46 % en poids de leucine mais qui ne contiennent pas de phospholipides ne présentent pas les mêmes propriétés d'effet soutenu.

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