A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
A61K 39/395 (2006.01) A61K 9/08 (2006.01) A61K 9/19 (2006.01) A61K 47/00 (2006.01) A61K 47/26 (2006.01) A61K 47/34 (2006.01) C07K 16/28 (2006.01) C07K 16/36 (2006.01) C12P 21/08 (2006.01)
Patent
CA 2371427
A parenteral medicinal composition which contains a humanized monoclonal antibody fragment, a nonionic surfactant and sugars and has a weakly acidic pH value; and a method for stabilizing a humanized antibody fragment by blending therewith a nonionic surfactant and sugars and adjusting the pH value to a weakly acidic level. Thus, it is possible to provide a parenteral medicinal composition or a parenteral medicinal preparation containing a stabilized humanized monoclonal antibody fragment which is free from any restrictions in using, for example, storage in a cold place avoiding freezing, transportation/handling avoiding shaking, and filtering off particles in using.
L'invention concerne une composition médicamenteuse parentérale renfermant un fragment d'anticorps monoclonal humanisé, un tensioactif non ionique et des sucres, et ayant un pH acide faible. L'invention concerne en outre un procédé de stabilisation de ce fragment qui consiste à mélanger ledit fragment avec un tensioactif non ionique et des sucres et à ajuster le pH par rapport au faible niveau acide. Ainsi, il est possible d'établir une composition ou préparation médicamenteuse parentérale renfermant le fragment considéré stabilisé, sans restrictions d'utilisation par exemple en matière de stockage au froid ne présentant aucun risque de congélation, en matière de transport/manipulation ne présentant aucun risque de secousse, et en matière de filtrage des particules à l'emploi.
Kobayashi Mitsugu
Mori Atsuhide
Okada Akira
Astellas Pharma Inc.
Dennison Associates
Yamanouchi Pharmaceutical Co. Ltd.
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