초록 ▼

A mixed micellar pharmaceutical formulation includes a micellar proteinic pharmaceutical agent, an lkali metal C8 to C22 alkyl sulphate, alkali metal salicylate, a pharmaceutically acceptable edetate and at least one absorption enhancing compounds. The absorption enhancing compounds are selected fro

A mixed micellar pharmaceutical formulation includes a micellar proteinic pharmaceutical agent, an lkali metal C8 to C22 alkyl sulphate, alkali metal salicylate, a pharmaceutically acceptable edetate and at least one absorption enhancing compounds. The absorption enhancing compounds are 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 of 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.

대표청구항 ▼

[ What is claimed is:] [1.]1. A process for making a pharmaceutical composition suitable for delivery through mucosal membranes comprising:a) preparing a pharmaceutical agent composition in micellar form in an aqueous medium which has an alkali metal salicylate in a concentration of from 1 to 10 wt.

[ What is claimed is:] [1.]1. A process for making a pharmaceutical composition suitable for delivery through mucosal membranes comprising:a) preparing a pharmaceutical agent composition in micellar form in an aqueous medium which has an alkali metal salicylate in a concentration of from 1 to 10 wt./wt. % of the aqueous micellar pharmaceutical agent composition, an alkali metal C8 to C22 alkyl sulphate in a concentration of from 1 to 10 wt./wt. % of the aqueous micellar pharmaceutical agent composition and a pharmaceutically acceptable edetate in a concentration of from 1 to 10 wt./wt. % of the aqueous micellar pharmaceutical agent composition;b) slowly adding the micellar pharmaceutical agent composition, while mixing, to at least one absorption enhancing compound, while continuing to mix vigorously, said absorption enhancing compounds being selected from the group consisting of saturated phospholipd, unsaturated phospholipid, 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, menthol, trihydroxy oxo cholanylglycine and pharmaceutically acceptable salts of trihydroxy oxo cholanyl glycine, glycerin, polyglycerin, lysine, polylysine, polidocanol alkyl ethers and analogues of polidocanol alkyl ethers, triolein, chenodeoxycholate, deoxycholate and mixtures thereof,wherein 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 alkali metal salicylate, alkali metal C8 to C22 alkyl sulphate, edetate and absorption enhancing compounds is less than 50 wt./wt. % of the formulation.