TH23071B - Liquid formulation containing gonadotropin - Google Patents

Abstract

DC60 (30/01/41) This invention is about liquid formulations containing gonadotropin. Showing the specific characteristics that this formula contains a type of gonadotropin And polycarboxylic acids or salts of such acids and Of thiother compounds In stabilizing quantities, a specific protein (eg LH, TSH, FSH or HCG) is mixed with a specific stabilizer in Aqueous solution These preparations contain polycarboxylic acid or salts of this acid. That is, ideally, a sufficient amount of sodium sydate And thioether compounds Which is ideal methionin in sufficient quantity To stabilize proteins These preparations Ideally, there are non-reducing disaccharides such as sucrose and deionized surfactants. This invention is about liquid formulations containing gonadotropin. Showing the specific characteristics that this formula contains a type of gonadotropin And polycarboxylic acids or salts of such acids and Of thiother compounds In stabilizing quantities, a specific protein (eg LH, TSH, FSH or HCG) is mixed with a specific stabilizer in Aqueous solution These preparations contain polycarboxylic acid or salts of this acid. That is, ideally, a sufficient amount of sodium sydate And thioether compounds Which is ideal methionin in sufficient quantity To stabilize proteins These preparations Ideally, there are also non-reducing disaccharides such as sucrose and non-ionic surfactants.

Claims (5)

1. Liquid formulas containing gonadotropin show the specific characteristics that The formula contains gona Dotropin and polycarboxylic acid or salts of this acid and of thioether compounds in the resulting amount 2. The liquid formulation containing gonadotropine of Claim No. 1 shows the specific characteristics that the thioether compound is an amino methionin acid 3. Mixture The gonadotropin liquid of claim 1 or 2 shows the specific nature of whether polycarboxylic acid is cidric acid or sodium salt of this acid. The gonadotropin of claim 3 shows the specific characteristics that The concentration of sodium citrate is 25-100 mmolar and at the methionin concentration is 1-10 mmolar. 5. Liquid formulation containing gonadotropin of the claim. Any of the clauses 1 through 4 show a specific nature that The formula also contains non-reducing sugar 6. The liquid formulation with gonadotropin of claim 5 exhibits a specific characteristic that this non-reducing sugar is sucrose in a concentration of 25-300 mmo. Lar 7. The liquid formulation containing the gonadotropin of any of the Claims Claims 1 through 6 show the specific characteristics that The formulation also contains a non-ionic surfactant. 8. The liquid formulation containing gonadotropin of any of Claims 1 through 7 indicates that the The pH of the formulation is between 6.5 and 7.2 and is ideally 7 9. The liquid formulation containing gonadotropin of any of the claims of Claims 1 to 8 is characterized Specifically that Gonadotropin is selected from the lutinizing hormone (LH), human chorionic gonadotropin (hCG), follicle-stimulating hormone (FSH), or its derivatives. And mixtures of these substances 1 0. The gonadotropin-containing liquid formulation of Clause 9 indicates that gonadotropin is a recombinant FSH (recFSH). Human or recFSH-CTP 1 1. Method for preparing gonadotropin liquid formulation containing Adding the gonado call At least one type of pin in aqueous solution. With polycarboxylic acid or salts of this acid in the amount made To be stable And thioether compounds in amounts that make them stable That may allow it to dissolve A certain amount of non-reducing saccharides are included in the mixture. And may allow dissolving surfactants without vapor On in the above mixture And to adjust the pH of the solution to be between 6.5 and 7.2 1 2. Method for preparing gonadotropin liquid formulation according to claim 11, which characterizes Specifically, polycarboxylic acid is a sodium citrate at a concentration of 25-100 mmolar thioether is methionine at a concentration of 1-10 mmolar; and Non-reducing disaccharides are sucrose at a concentration of 25-300 mmolar, and where deionized surfactants may be dissolved in this mixture. 3. Cartridge containing sterile liquid formulation containing the gonadotropin of the claim Any of the claims 1 to 10 1 4. Giving device containing cartridges in accordance with claim 13 1. 5. The use of gonadotropin, formulated in accordance with one of Claim 1-10, is used as a direct injectable liquid for the treatment of sterility conditions.