Mixed micellar pharmaceutical delivery system and method of...

A - Human Necessities – 61 – K

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A61K 38/28 (2006.01) A61K 9/107 (2006.01) A61K 9/12 (2006.01) A61K 9/127 (2006.01) A61K 47/10 (2006.01) A61K 47/24 (2006.01)

Patent

CA 2382535

A mixed micellar pharmaceutical formulation and process for making the formulation. The formulation includes a micellar proteinic pharmaceutical agent, an alkali metal C8 to C22 alkyl sulphate, alkali metal salicylate, a pharmaceutically acceptable edetate and at least one absorption enhancing compound. The absorption enhancing compound is selected from the group consisting of lecithin, hyaluronic acid, pharmaceutically acceptable salts of hyaluronic acid, octylphenoxypolyethoxyethanol, glycolic acid, lactic acid, chamomile extract, cucumber extract, oleic acid, linolenic acid, borage oil, evening primrose oil, trihydroxy oxo cholanylglycine, glycerin, polyglycerin, lysine, polylysine, triolein and mixtures thereof. The amount of each absorption enhancing compound is present in a concentration of from 1 to 10 wt./wt.% of the total formulation, and the total concentration of absorption enhancing compounds are less than 50 wt./wt.% of the formulation. Preferably, the formulation is administered, in combination with a propellant, to the buccal cavity, using a metered dose dispenser, which is also described.

La présente invention concerne une formulation pharmaceutique micellaire mélangée ainsi qu'un procédé permettant de produire ladite formulation. Cette formulation contient un agent pharmaceutique protéique micellaire, un sulfate d'alkyle C8 à C22 de métal alcalin, un salicylate de métal alcalin, un édétate pharmaceutiquement acceptable et au moins un composé favorisant l'absorption, choisi dans le groupe constitué de lécithine, d'acide hyaluronique, de sels pharmaceutiquement acceptables d'acide hyaluronique, d'octylphénoxypolyéthoxyéthanol, d'acide glycolique, d'acide lactique, d'extrait de camomille, d'extrait de concombre, d'acide oléique, d'acide linoléique, d'huile de bourrache, d'huile d'onagre, de trihydroxy-oxo-cholanylglycine, de glycérine, de polyglycérine, de lysine, de polylysine, de trioléine et de mélanges de ceux-ci. La proportion de chaque composé favorisant l'absorption est de 1 à 10 % en poids du poids total de la formulation, et la concentration totale de composés favorisant l'absorption est inférieure à 50 % en poids du poids total de la formulation. Cette formulation sera, de préférence, administrée, avec un agent propulseur, dans la cavité buccale au moyen d'un distributeur doseur. La présente invention concerne également ce distributeur doseur.

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