Formulations comprising dehydrated particles of...

A - Human Necessities – 61 – K

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A61K 9/14 (2006.01) A61K 9/12 (2006.01) A61K 9/19 (2006.01) A61K 38/28 (2006.01) A61L 9/04 (2006.01) A61K 47/20 (2006.01) A61K 47/26 (2006.01)

Patent

CA 2375914

A formulation for non-invasive delivery of pharmaceutical agents, particularly proteins and peptides, by absorption through a membrane at a targeted site is provided, along with a process of making the formulation. The formulation comprises a suspension of solid-phase dehydrated particles in a delivery medium. The particles comprise the dehydration product of the pharmaceutical agent and at least one of a surfactant and permeation enhancer, and the delivery medium preferably comprises a propellant for pressurized aerosol delivery of the formulation. The formulation can be conveniently delivered to the patient's targeted site where the pharmaceutical agent is absorbed through the mucosa to achieve a desired bioavailability.

L'invention porte sur une formulation d'agents pharmaceutiques, notamment des protéines et des peptides, destinée à être administrée de manière non invasive, à savoir par absorption à travers une membrane au niveau d'un site cible. L'invention porte également sur un procédé de fabrication de cette formulation. La formulation comprend une suspension de particules déshydratées en phase solide dans un milieu d'administration. Ces particules comprennent le produit de déshydratation de l'agent pharmaceutique et d'au moins un renforçateur de tensioactif et de la résistance à la pénétration, le milieu de pénétration comprenant de préférence un agent propulseur permettant d'administrer la formulation par bombe aérosol. La formulation peut être administrée sans inconvénient sur le site cible du patient où l'agent pharmaceutique est absorbé par les muqueuses de façon à atteindre la biodisponibilité désirée.

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