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1. WO2022092183 - PHARMACEUTICAL COMPOSITION

Publication Number WO/2022/092183
Publication Date 05.05.2022
International Application No. PCT/JP2021/039769
International Filing Date 28.10.2021
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
A61P 1/04 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
1Drugs for disorders of the alimentary tract or the digestive system
04for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
A61P 1/16 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
1Drugs for disorders of the alimentary tract or the digestive system
16for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
A61P 19/02 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
19Drugs for skeletal disorders
02for joint disorders, e.g. arthritis, arthrosis
A61P 25/00 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
25Drugs for disorders of the nervous system
A61P 25/04 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
25Drugs for disorders of the nervous system
04Centrally acting analgesics, e.g. opioids
Applicants
  • エーザイ・アール・アンド・ディー・マネジメント株式会社 EISAI R&D MANAGEMENT CO., LTD. [JP]/[JP]
Inventors
  • 渡邉 洋介 WATANABE, Yosuke
Agents
  • 南条 雅裕 NANJO, Masahiro
  • 瀬田 あや子 SETA, Ayako
  • 伊波 興一朗 IHA, Koichiro
  • 原 秀貢人 HARA, Hokuto
Priority Data
2020-18260630.10.2020JP
Publication Language Japanese (ja)
Filing Language Japanese (JA)
Designated States
Title
(EN) PHARMACEUTICAL COMPOSITION
(FR) COMPOSITION PHARMACEUTIQUE
(JA) 医薬組成物
Abstract
(EN) [Problem] The purpose of the present disclosure is to provide a highly concentrated preparation of an anti-fractalkine (FKN) antibody, the preparation having a viscosity that facilitates handling. [Solution] Provided is a pharmaceutical composition containing anti-FKN antibody at a concentration of 200 mg/mL. This pharmaceutical composition is characterized by containing 200 mg/mL of anti-FKN antibody and 100 to 400 mM of a basic amino acid wherein the basic amino acid comprises at least one amino acid selected from arginine, histidine, lysine, and ornithine.
(FR) Le problème à résoudre par la présente invention est de fournir une préparation hautement concentrée d'un anticorps anti-fractalkine (FKN), la préparation ayant une viscosité qui facilite la manipulation. La solution selon l'invention porte sur une composition pharmaceutique contenant un anticorps anti-FKN à une concentration de 200 mg/mL. Cette composition pharmaceutique est caractérisée en ce qu'elle contient 200 mg/mL d'anticorps anti-FKN et 100 à 400 mM d'un acide aminé basique, l'acide aminé basique comprenant au moins un acide aminé choisi parmi l'arginine, l'histidine, la lysine et l'ornithine.
(JA) 【課題】 本開示の目的は、取り扱いが容易な粘度を有する、抗フラクタルカイン(FKN)抗体の高濃度製剤を提供することである。 【解決手段】 200mg/mLの濃度で抗FKN抗体を含有する医薬組成物が提供される。当該医薬組成物は、200mg/mLの抗FKN抗体、および100~400mMの塩基性アミノ酸を含み、塩基性アミノ酸は、アルギニン、ヒスチジン、リシン、およびオルニチンから選択される少なくとも1つのアミノ酸を含むことを特徴とする。
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