Liquid gonadotropin containing formulations

A - Human Necessities – 61 – K

Patent

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Details

A61K 38/24 (2006.01) A61K 47/12 (2006.01) A61K 47/18 (2006.01) A61K 47/20 (2006.01) A61K 47/26 (2006.01)

Patent

CA 2226803

The invention concerns a liquid gonadotropin-containing formulation characterised in that the formulation comprises a gonadotropin and stabilising amounts of a polycarboxylic acid or a salt thereof and of a thioether compound. The particular proteins (e.g. LH, TSH, FSH, or HCG) are in admixture with the particular stabilizers in an aqueous solution. The preparations contain a sufficient amount of the polycarboxylic acid or a salt thereof, preferably sodium citrate, and a sufficient amount of the thioether compound, preferably methionine, to stabilize the protein. The preparations preferably also include a nonreducing disaccharide like sucrose, and a non-ionic surfactant.

L'invention porte sur une formulation liquide renfermant une gonadotrophine ainsi que des quantités stabilisatrices d'un acide polycarboxylique ou d'un sel de ce dernier, et un thioéther. Des protéines spéciales (p. ex. LH, TSH, FSH ou HCG) sont mélangées avec les stabilisateurs dans une solution aqueuse. Les préparations renferment assez d'acide polycarboxylique ou un sel de ce dernier, de préférence du citrate de sodium, et assez de thioéther, de préférence la méthionine, pour stabiliser la protéine. Il est préférable que les préparations renferment également un disaccharide non réducteur, comme le sucrose, et un surfactif non ionique.

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