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1. WO2022005113 - FORMULATION FOR ANTI-FCRN ANTIBODY

Publication Number WO/2022/005113
Publication Date 06.01.2022
International Application No. PCT/KR2021/008000
International Filing Date 25.06.2021
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
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 47/26 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
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
A61K 47/22 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
22Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
A61K 47/12 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
08containing oxygen
12Carboxylic acids; Salts or anhydrides thereof
A61K 47/20 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
20containing sulfur, e.g. dimethyl sulfoxide , docusate, sodium lauryl sulfate or aminosulfonic acids
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 39/39591
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
39Medicinal preparations containing antigens or antibodies
395Antibodies
39591Stabilisation, fragmentation
A61K 47/12
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
12Carboxylic acids; Salts or anhydrides thereof
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 [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
Applicants
  • 한올바이오파마주식회사 HANALL BIOPHARMA CO., LTD. [KR]/[KR]
Inventors
  • 안혜경 AHN, Hyea Kyung
  • 김영주 KIM, Young Ju
  • 정미진 JUNG, Mi Jin
Agents
  • 류종우 RYU, Jong Woo
  • 이내영 LEE, Rae Young
  • 한윤호 HAN, Yun Ho
Priority Data
10-2020-007913529.06.2020KR
Publication Language Korean (ko)
Filing Language Korean (KO)
Designated States
Title
(EN) FORMULATION FOR ANTI-FCRN ANTIBODY
(FR) FORMULATION POUR UN ANTICORPS ANTI-FCRN
(KO) 항-FcRn 항체에 대한 제형
Abstract
(EN) One aspect of the present invention provides an aqueous pharmaceutical formulation with a pH of 4.0 to 8.0, comprising (a) an HL161 BKN antibody or a fragment thereof, (b) one or more additives selected from mannitol, sorbitol, arginine, histidine, glycine and salts thereof, (c) a buffer system selected from citrate or histidine, and (d) polysorbate. The HL161 BKN antibody present in the formulation has improved stability and is non-toxic, and thus has high industrial applicability.
(FR) Un aspect de la présente invention concerne une formulation pharmaceutique aqueuse ayant un pH compris entre 4,0 et 8,0, comprenant (a) un anticorps HL161 BKN ou un fragment de ce dernier, (b) un ou plusieurs additifs choisis parmi le mannitol, le sorbitol, l'arginine, l'histidine, la glycine et leurs sels, (c) un système tampon choisi parmi le citrate ou l'histidine, et (d) du polysorbate. L'anticorps HL161 BKN présent dans la formulation présente une stabilité améliorée et est non toxique, et présente ainsi une applicabilité industrielle élevée.
(KO) 본 발명의 일 측면은, (a) HL161 BKN 항체 또는 이의 단편, (b) 만니톨, 솔비톨, 아르기닌, 히스티딘, 글리신 및 이들의 염으로부터 선택되는 1종 이상의 첨가제, (c) 시트레이트 또는 히스티딘으로부터 선택된 완충 시스템, 및 (d) 폴리소르베이트를 포함하는 pH 4.0 내지 8.0의 수성 약제학적 제제를 제공한다. 상기 제형 내에 존재하는 HL161BKN 항체는 안정성이 향상되며, 독성이 없어 산업적으로 활용 가능성이 높다.
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