Processing

Please wait...

Settings

Settings

Goto Application

1. WO2018124277 - LYOPHILIZED PREPARATION

Publication Number WO/2018/124277
Publication Date 05.07.2018
International Application No. PCT/JP2017/047207
International Filing Date 28.12.2017
IPC
A61K 38/46 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
38Medicinal preparations containing peptides
16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
43Enzymes; Proenzymes; Derivatives thereof
46Hydrolases (3)
A61K 9/19 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
14Particulate form, e.g. powders
19lyophilised
A61K 39/395 2006.01
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 47/02 2006.01
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
02Inorganic compounds
A61K 47/10 2006.01
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
08containing oxygen
10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols ; Poloxamers; PEG/POE alkyl ethers
A61K 47/26 2006.01
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
CPC
A61K 38/46
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
38Medicinal preparations containing peptides
16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
43Enzymes; Proenzymes; Derivatives thereof
46Hydrolases (3)
A61K 38/465
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
38Medicinal preparations containing peptides
16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
43Enzymes; Proenzymes; Derivatives thereof
46Hydrolases (3)
465acting on ester bonds (3.1), e.g. lipases, ribonucleases
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 47/02
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
02Inorganic compounds
A61K 47/10
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
08containing oxygen, ; e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
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
Applicants
  • JCRファーマ株式会社 JCR PHARMACEUTICALS CO., LTD. [JP]/[JP]
Inventors
  • 安川 秀仁 YASUKAWA, Hidehito
  • 山口 裕加 YAMAGUCHI, Yuka
  • 岡部 真二 OKABE, Shinji
Agents
  • 山本 佳希 YAMAMOTO, Yoshiki
Priority Data
2016-25706028.12.2016JP
Publication Language Japanese (JA)
Filing Language Japanese (JA)
Designated States
Title
(EN) LYOPHILIZED PREPARATION
(FR) PRÉPARATION LYOPHILISÉE
(JA) 凍結乾燥製剤
Abstract
(EN)
[Problem] To provide a pharmaceutical composition that contains a fusion protein of an antibody and a lysosomal enzyme as an active ingredient and is stable enough to be distributed on the market. [Solution] A lyophilized preparation that contains a fusion protein of an antibody and a lysosomal enzyme as an active ingredient, and furthermore contains a neutral salt, a disaccharide, a non-ionic surfactant, and a buffer. An example of such a lyophilized preparation contains a fusion protein of an anti-transferrin receptor antibody and human iduronate-2-sulfatase as an active ingredient, and furthermore contains sodium chloride as a neutral salt, sucrose as a disaccharide, poloxamer as a non-ionic surfactant, and a phosphate buffer as a buffer.
(FR)
Le problème décrit par la présente invention est de fournir une composition pharmaceutique qui contient une protéine de fusion d'un anticorps et une enzyme lysosomale comme principe actif et qui est suffisamment stable pour être commercialisée. La solution selon l'invention porte sur une préparation lyophilisée qui contient une protéine de fusion d'un anticorps et une enzyme lysosomale comme principe actif, et qui contient en outre un sel neutre, un disaccharide, un tensioactif non ionique et un tampon. Un exemple d'une telle préparation lyophilisée contient une protéine de fusion d'un anticorps de récepteur anti-transferrine et de l'iduronate-2-sulfatase humaine comme principe actif, et contient en outre du chlorure de sodium comme sel neutre, du saccharose comme disaccharide, un poloxamère comme tensioactif non ionique, et un tampon phosphate comme tampon.
(JA)
【課題】抗体とリソソーム酵素との融合蛋白質を有効成分として含有してなる,市場に流通させることが可能な程度に安定な医薬組成物を提供すること。 【解決手段】抗体とリソソーム酵素との融合蛋白質を有効成分として含有し,更に,中性塩,ニ糖類,非イオン性界面活性剤,及び緩衝剤を含有してなる,凍結乾燥製剤。かかる凍結乾燥製剤としては,例えば,抗トランスフェリン受容体抗体とヒトイズロン酸-2-スルファターゼとの融合蛋白質を有効成分として含有し,更に,中性塩として塩化ナトリウム,ニ糖類としてスクロース,非イオン性界面活性剤としてポロキサマー,及び緩衝剤としてリン酸緩衝剤を含有してなるものが挙げられる。
Latest bibliographic data on file with the International Bureau