Stabilised growth hormone formulation and method of...

Details Stabilised growth hormone formulation and method of... Stabilised growth hormone formulation and method of...

A - Human Necessities

61

K

A61K 38/27 (2006.01) A61K 9/08 (2006.01) A61K 47/10 (2006.01) A61K 47/24 (2006.01) A61K 47/28 (2006.01) A61K 47/32 (2006.01) A61K 47/38 (2006.01)

Patent

CA 2246501

A method for the preparation of a stable, liquid formulation of growth hormone, comprising growth hormone, a buffer and a stabilising effective amount of at least one stabilising agent selected from the group consisting of: (i) polyethylene-polypropylene glycol non-ionic surfactants, (ii) taurocholic acid or salts or derivatives thereof, and (iii) methyl cellulose derivatives, wherein the method comprises admixing the growth hormone with the buffer and the stabilising agent(s) under conditions such that the growth hormone is not exposed to concentrations of the buffer or stabilising agent(s) which are greater than 2x the final concentrations of the buffer or stabilising agent(s) in the formulation.

L'invention concerne un procédé pour préparer une formulation liquide stable d'hormone de croissance contenant l'hormone de croisance, un tampon et une quantité suffisante d'au moins un agent stabilisant, choisi dans le groupe constitué par (i) les tensioactifs du type polyéthylène-polypropylène glycol, (ii) l'acide taurocholique, les sels ou dérivés de cet acide et (iii) les dérivés méthyl-cellulosiques. Le procédé consiste à mélanger l'hormone de croissance avec le tampon et le ou les agents stabilisants dans des conditions telles que l'hormone de croissance ne soit pas exposée à des concentrations de tampon et du ou des agents stabilisants, supérieures à 2 fois la concentration finale du tampon et du ou des agents stabilisants dans la formulation.

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