A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
A61K 47/26 (2006.01) A61K 9/19 (2006.01) A61K 39/395 (2006.01)
Patent
CA 2610987
Disclosed is a method for stabilizing a protein comprising the step of mixing meglumine with the protein or a method for preventing the assembly of proteins. Also disclosed is an agent for stabilizing a protein or agent for preventing the assembly of proteins which comprises meglumine. Further disclosed are a pharmaceutical composition comprising an antibody molecule stabilized with meglumine, a process for producing the pharmaceutical composition and a kit comprising the pharmaceutical composition. A study was made on the antibody-stabilizing effect of meglumine which is an amino sugar. As a result, it is now found that meglumine is useful as a stabilizer for an antibody molecule and that meglumine is also useful as an excipient for a lyophilized preparation.
L'invention concerne un procédé de stabilisation d'une protéine comprenant étape consistant à mélanger de la méglumine avec la protéine ou un procédé de prévention de l'assemblage de protéines. L'invention concerne également un agent destiné à stabiliser une protéine ou un agent destiné à prévenir l'assemblage de protéines qui comprend de la méglumine. L~invention concerne, en outre, une composition pharmaceutique comprenant une molécule d'anticorps stabilisée avec de la méglumine, un procédé de production de la composition pharmaceutique et un kit comprenant la composition pharmaceutique. Une étude a été réalisée sur l'effet stabilisateur d'anticorps de la méglumine, qui est un sucre aminé. Par conséquent, on sait désormais que la méglumine est utile en tant que stabilisant pour une molécule d'anticorps et qu~elle est également utile en tant qu~excipient pour une préparation lyophilisée.
Igawa Tomoyuki
Kameoka Daisuke
Bereskin & Parr Llp/s.e.n.c.r.l.,s.r.l.
Chugai Seiyaku Kabushiki Kaisha
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