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1. JP2012072170 - HIGH CONCENTRATION ANTIBODY-CONTAINING LIQUID FORMULATION

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Office
Japan
Application Number 2011257255
Application Date 25.11.2011
Publication Number 2012072170
Publication Date 12.04.2012
Grant Number 5906067
Grant Date 25.03.2016
Publication Kind B2
IPC
A61K 39/395
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
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
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
A61K 47/20
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
20containing sulfur, e.g. dimethyl sulfoxide , docusate, sodium lauryl sulfate or aminosulfonic acids
A61K 47/22
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
22Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
A61K 47/34
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
30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
34Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
CPC
A61K 9/0019
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
0012Galenical forms characterised by the site of application
0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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
A61K 47/26
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
26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
C07K 2317/76
CCHEMISTRY; METALLURGY
07ORGANIC CHEMISTRY
KPEPTIDES
2317Immunoglobulins specific features
70characterized by effect upon binding to a cell or to an antigen
76Antagonist effect on antigen, e.g. neutralization or inhibition of binding
Applicants CHUGAI PHARMACEUT CO LTD
中外製薬株式会社
F HOFFMANN LA ROCHE AG
エフ．ホフマン－ラ　ロシュ　アーゲー
Inventors MORICHIKA TOSHIYUKI
森近　俊行
KAMEOKA DAISUKE
亀岡　大介
IMAEDA YOSHIMI
今枝　好美
MAEDA TERUTOSHI
前田　照利
STAUCH OLIVER BORIS
シュタオヒ，オリバー・ボリス
Agents 小野　新次郎
小林　泰
千葉　昭男
富田　博行
中濱　明子
Priority Data 2007336310 27.12.2007 JP
Title
(EN) HIGH CONCENTRATION ANTIBODY-CONTAINING LIQUID FORMULATION
(JA) 高濃度抗体含有溶液製剤
Abstract
(EN)

PROBLEM TO BE SOLVED: To provide an antibody-containing formulation which is stable and suited for subcutaneous administration, wherein dimerization and deamidation are suppressed during long-term storage.

SOLUTION: This stable antibody-containing formulation includes an antibody, 40-1,000 mM of arginine, and 10-200 mM of methionine in buffer solution, and generation of antibody dimer by optical acceleration is suppressed.

COPYRIGHT: (C)2012,JPO&INPIT


(JA)

【課題】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を提供する。
【解決手段】抗体およびアルギニン４０〜１０００ｍＭ及びメチオニン１０〜２００ｍＭを緩衝液中に含有し、光加速による抗体二量体の生成が抑制される、安定な抗体含有溶液製剤。
【選択図】なし
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