A pharmaceutical formulation containing growth hormone, an...

A - Human Necessities – 61 – K

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A61K 38/27 (2006.01) A61K 9/08 (2006.01) A61K 47/10 (2006.01) A61K 47/18 (2006.01) A61K 47/22 (2006.01) A61K 47/26 (2006.01) A61K 47/34 (2006.01)

Patent

CA 2252535

The invention relates to pharmaceutical formulations comprising growth hormone, an amino acid selected from the group of Asp, Ile, Val, Leu or His, or a derivative of histidine, or a peptide comprising at least one basic amino acid and at least one acidic amino acid, and a non-ionic detergent, e.g. polysorbate or poloxamer. The formulation is stabilized against deamidation and aggregation. The formulation may be an aqueous formulation. The growth hormone may be human growth hormone.

Cette invention concerne des formulations pharmaceutiques qui contiennent une hormone de croissance. Ces formulations contiennent également un acide aminé choisi dans le groupe Asp, Ile, Val, Leu et His, ou un dérivé d'histidine ou, encore, un peptide comprenant un ou plusieurs acides aminés basiques et un ou plusieurs acides aminés acides. Ces formulations comprennent enfin un détergent non ionique comme, par exemple, un polysorbate ou un poloxamère. Ces formulations restent stables en ce qui concerne la déamidation et l'agrégation, et peuvent se présenter sous forme d'une formulation aqueuse, l'hormone de croissance pouvant quant à elle consister en une hormone de croissance humaine.

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