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1. WO2009084659 - SOLUTION PREPARATION CONTAINING ANTIBODY AT HIGH CONCENTRATION

Publication Number WO/2009/084659
Publication Date 09.07.2009
International Application No. PCT/JP2008/073798
International Filing Date 26.12.2008
IPC
A61K 39/395 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
39Medicinal preparations containing antigens or antibodies
395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
A61K 9/08 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
08Solutions
A61K 47/18 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
16containing nitrogen
18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
A61P 43/00 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
43Drugs for specific purposes, not provided for in groups A61P1/-A61P41/108
CPC
A61K 2039/505
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
39Medicinal preparations containing antigens or antibodies
505comprising antibodies
A61K 39/00
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
39Medicinal preparations containing antigens or antibodies
A61K 39/395
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
39Medicinal preparations containing antigens or antibodies
395Antibodies
A61K 39/3955
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
39Medicinal preparations containing antigens or antibodies
395Antibodies
39533against materials from animals
3955against proteinaceous materials, e.g. enzymes, hormones, lymphokines
A61K 39/39591
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
39Medicinal preparations containing antigens or antibodies
395Antibodies
39591Stabilisation, fragmentation
A61K 47/183
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
16containing nitrogen, ; e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
183Amino acids, e.g. glycine, EDTA or aspartame
Applicants
  • 中外製薬株式会社 CHUGAI SEIYAKU KABUSHIKI KAISHA [JP]/[JP] (AllExceptUS)
  • エフ.ホフマン-ラ ロシュ アーゲー F. HOFFMANN-LA ROCHE AG [CH]/[CH] (AllExceptUS)
  • 森近 俊行 MORICHIKA, Toshiyuki [JP]/[JP] (UsOnly)
  • 亀岡 大介 KAMEOKA, Daisuke [JP]/[JP] (UsOnly)
  • 今枝 好美 IMAEDA, Yoshimi [JP]/[JP] (UsOnly)
  • 前田 照利 MAEDA, Terutoshi [JP]/[JP] (UsOnly)
  • シュタオヒ オリバー ボリス STAUCH, Oliver Boris [DE]/[DE] (UsOnly)
Inventors
  • 森近 俊行 MORICHIKA, Toshiyuki
  • 亀岡 大介 KAMEOKA, Daisuke
  • 今枝 好美 IMAEDA, Yoshimi
  • 前田 照利 MAEDA, Terutoshi
  • シュタオヒ オリバー ボリス STAUCH, Oliver Boris
Agents
  • 小野 新次郎 ONO, Shinjiro
Priority Data
2007-33631027.12.2007JP
Publication Language Japanese (ja)
Filing Language Japanese (JA)
Designated States
Title
(EN) SOLUTION PREPARATION CONTAINING ANTIBODY AT HIGH CONCENTRATION
(FR) PRÉPARATION DE SOLUTION CONTENANT UN ANTICORPS À HAUTE CONCENTRATION
(JA) 高濃度抗体含有溶液製剤
Abstract
(EN) A stable solution preparation containing an antibody, which is characterized by containing arginine and methionine, is provided as a stable antibody-containing preparation suitable for subcutaneous administration wherein dimer formation and deamidation are prevented during prolonged storage.
(FR) L'invention porte sur la préparation d'une solution stable contenant un anticorps, caractérisée en ce qu'elle contient de l'arginine et de la méthionine. La solution fournit un anticorps stable approprié pour une administration sous-cutanée, mais dans laquelle la formation d'un dimère et la déamidation est prévenue pendant un stockage prolongé.
(JA)  長期保存時の二量体生成や脱アミド化が抑制された、安定な、皮下投与に適した抗体含有製剤として、アルギニン及びメチオニンを含有することを特徴とする、安定な抗体含有溶液製剤を提供する。
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