Stable lyophilized pharmaceutical preparation of monoclonal...

A - Human Necessities – 61 – K

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Details

A61K 39/395 (2006.01) A61K 9/19 (2006.01) A61K 47/18 (2006.01) A61K 47/26 (2006.01) C07K 16/08 (2006.01) C07K 16/28 (2006.01) A61K 38/00 (2006.01)

Patent

CA 2272245

Disclosed are lyophilized pharmaceutical substances from monoclonal or polyclonal antibodies, containing a sugar or amino sugar as well as a surfactant as a stabilizing agent. Also disclosed are the method of preparing said stable lyophilizates as well as the use of a sugar or amino sugar, an amino acid and a surfactant as stabilizers for therapeutic and diagnostic agents containing antibodies.

La présente invention concerne des préparations pharmaceutiques lyophilisées d'anticorps monoclonaux ou polyclonaux, contenant un sucre ou un sucre aminé ainsi qu'un composé tensio-actif comme agent stabilisateur. Elle concerne en outre le mode de fabrication de ces lyophilisats stables ainsi que l'utilisation d'un sucre ou sucre aminé, d'un acide aminé et d'un composé tensio-actif comme stabilisateurs d'agents thérapeutiques et diagnostiques contenant des anticorps.

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