Drug delivery system using membrane mimetics

A - Human Necessities – 61 – K

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Details

A61K 9/127 (2006.01) A61K 9/12 (2006.01) A61K 47/00 (2006.01)

Patent

CA 2383724

A mixed liposome pharmaceutical formulation with multilamellar vesicles, which formulation may be administered through the oral or nasal membranes, or by pulmonary access. The formulation includes a proteinic pharmaceutical agent, water, an alkali metal C8 to C22 alkyl sulphate in a concentration of from 1 to 10 wt./wt.%, at least one membrane-mimetic amphiphile and at least one phospholipid. The amount of each membrane mimetic amphiphile and phospholipid is present in a concentration of from 1 to 10 wt./wt.% of the total formulation, and the total concentration of membrane mimetic amphiphiles and phospholipids is less than 50 wt./wt.% of the formulation. A process for making the formulation, a container housing the formulation, and a method of administering the formulation are also disclosed. The method of administration includes mixing the formulation with a propellant and administering the mixture orally using a metered dose dispenser.

L'invention concerne une préparation pharmaceutique mixte à base de liposomes, comprenant des vésicules multilamellaires, laquelle préparation peut être administrée via les membranes buccale ou nasale, ou par voie pulmonaire. La préparation renferme un agent pharmaceutique protéinique, de l'eau, un sulfate alkyle C8-C22 de métal alcalin à une concentration, en pourcentage en poids, comprise entre 1 et 10 %, au moins un amphiphile du type mimétique membranaire et au moins un phospholipide. La proportion de chaque amphiphile du type mimétique membranaire et de chaque phospholipide présents dans la préparation varie, en pourcentage en poids, entre 1 et 10 % de la préparation totale, la concentration totale en amphiphiles du type mimétiques membranaires et en phospholipides étant inférieure à 50 % en poids de la préparation. L'invention concerne également un procédé de fabrication de la préparation, un récipient renfermant la préparation, ainsi qu'une méthode d'administration la préparation. Cette méthode d'administration consiste à mélanger la préparation avec un agent propulseur et à administrer le mélange oralement au moyen d'un distributeur-doseur.

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