Processes for making particle-based pharmaceutical...

A - Human Necessities – 61 – K

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A61K 9/00 (2006.01) A61K 9/14 (2006.01)

Patent

CA 2631493

Dry powder pharmaceutical formulations for pulmonary or nasal administration are made to provide an improved respired dose. These formulations may be blends of milled blends and may include a phospholipid, alone or Ên combination with other excipient materials. In one case, the process includes the steps of (a) providing particles which comprise a pharmaceutical agent; (b) blending the particles with particles of at least one first excipient to form a first powder blend; (c) railling the first powder blend to form a milled blend which comprises microparticies or nanoparticles of the pharmaceutical agent; and (d) blending the milled blend with particles of a second excipient to form a blended dry powder blend pharmaceutical formulation suitable for pulmonary or nasal administration.

L'invention concerne des préparations pharmaceutiques de poudre sèche pour administration pulmonaire ou nasale permettant d'améliorer la dose respirée. Ces préparations peuvent être constituées par des mélanges de mélanges broyés et inclure un phospholipide seul ou combiné à d'autres excipients. Dans un cas précis, le procédé d'élaboration englobe les opérations suivantes : (a) utilisation de particules comprenant un agent pharmaceutique; (b) mélange des particules à au moins un premier excipient dans le but de former un premier mélange en poudre; (c) broyage du premier mélange en poudre dans le but du former un mélange broyé comprenant des microparticules ou des nanoparticules de l'agent pharmaceutique ; et (d) mélange du mélange broyé aux particules d'un second excipient afin d'obtenir une préparation pharmaceutique sous forme de poudre sèche mélangée pour administration pulmonaire ou nasale.

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