BR112012017982A2 - formulações líquidas para conjugado de eritropoietina de longa ação - Google Patents

formulações líquidas para conjugado de eritropoietina de longa ação

Info

Publication number
BR112012017982A2
BR112012017982A2 BR112012017982A BR112012017982A BR112012017982A2 BR 112012017982 A2 BR112012017982 A2 BR 112012017982A2 BR 112012017982 A BR112012017982 A BR 112012017982A BR 112012017982 A BR112012017982 A BR 112012017982A BR 112012017982 A2 BR112012017982 A2 BR 112012017982A2
Authority
BR
Brazil
Prior art keywords
liquid formulation
liquid formulations
conjugated
long acting
free
Prior art date
Application number
BR112012017982A
Other languages
English (en)
Inventor
Chang Ki Lim
Dae Seong Im
Min Young Kim
Se Chang Kwon
Sung Min Bae
Sung Youb Jung
Original Assignee
Hanmi Science Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Hanmi Science Co Ltd filed Critical Hanmi Science Co Ltd
Publication of BR112012017982A2 publication Critical patent/BR112012017982A2/pt

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A61K47/6801—Drug-antibody or immunoglobulin conjugates defined by the pharmacologically or therapeutically active agent
    • A61K47/6803—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates
    • A61K47/6811—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug being a protein or peptide, e.g. transferrin or bleomycin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A61K47/6835—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/12—Drugs for disorders of the urinary system of the kidneys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/06—Antianaemics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Biochemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Dermatology (AREA)
  • Zoology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Diabetes (AREA)
  • Urology & Nephrology (AREA)
  • Endocrinology (AREA)
  • Hematology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

Abstract

formulação líquida para ação prolongada de eritropoietina conjugada. é divulgadal uma formulação líquida que permite ação prolongada de epo conjugados, que têm melhorado a duração in vivo e a estabilidade, para ser estável quando armazenado durante um longo período de tempo. isto compreende uma composição estabilizada caracterizada por tampão e manitol. sendo livre de albumina de soro humano e de outros fatores potencialmente prejudiciais para o corpo, a formulação líquida é livre de preocupações sobre infecções virais e garante e estabilidade de armazenamento excelente para ação prolongada de epo conjugados.
BR112012017982A 2010-01-19 2011-01-18 formulações líquidas para conjugado de eritropoietina de longa ação BR112012017982A2 (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR20100004840 2010-01-19
PCT/KR2011/000370 WO2011090306A2 (en) 2010-01-19 2011-01-18 Liquid formulations for long-acting erythropoietin conjugate

Publications (1)

Publication Number Publication Date
BR112012017982A2 true BR112012017982A2 (pt) 2016-05-03

Family

ID=44307382

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112012017982A BR112012017982A2 (pt) 2010-01-19 2011-01-18 formulações líquidas para conjugado de eritropoietina de longa ação

Country Status (14)

Country Link
US (1) US8829163B2 (pt)
EP (1) EP2525779B1 (pt)
JP (1) JP5638628B2 (pt)
KR (1) KR101335765B1 (pt)
CN (1) CN102753147B (pt)
AR (1) AR079946A1 (pt)
AU (1) AU2011207916B2 (pt)
BR (1) BR112012017982A2 (pt)
CA (1) CA2787652C (pt)
ES (1) ES2700925T3 (pt)
MX (1) MX2012008453A (pt)
RU (2) RU2682720C2 (pt)
TW (1) TWI417104B (pt)
WO (1) WO2011090306A2 (pt)

Families Citing this family (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR101303388B1 (ko) * 2010-10-26 2013-09-03 한미사이언스 주식회사 지속형 인터페론 알파 결합체의 액상 제제
CA2930801C (en) * 2010-11-05 2019-05-28 Rinat Neuroscience Corporation Engineered polypeptide conjugates and methods for making thereof using transglutaminase
KR20130049671A (ko) 2011-11-04 2013-05-14 한미사이언스 주식회사 생리활성 폴리펩타이드 결합체 제조 방법
AR090281A1 (es) 2012-03-08 2014-10-29 Hanmi Science Co Ltd Proceso mejorado para la preparacion de un complejo polipeptidico fisiologicamente activo
AR091902A1 (es) * 2012-07-25 2015-03-11 Hanmi Pharm Ind Co Ltd Formulacion liquida de un conjugado de insulina de accion prolongada
AR092862A1 (es) * 2012-07-25 2015-05-06 Hanmi Pharm Ind Co Ltd Formulacion liquida de insulina de accion prolongada y un peptido insulinotropico y metodo de preparacion
US10441665B2 (en) 2012-07-25 2019-10-15 Hanmi Pharm. Co., Ltd. Liquid formulation of long acting insulinotropic peptide conjugate
AR094821A1 (es) 2012-07-25 2015-09-02 Hanmi Pharm Ind Co Ltd Formulación líquida de un conjugado de péptido insulinotrópico de acción prolongada
JP6521959B2 (ja) 2013-07-31 2019-05-29 ライナット ニューロサイエンス コーポレイション 操作されたポリペプチドコンジュゲート
AU2015242657B2 (en) * 2014-03-31 2020-05-21 Hanmi Pharm. Co., Ltd. Method for improving solubility of protein and peptide by using immunoglobulin Fc fragment linkage
BR112016024370A2 (pt) 2014-04-25 2017-10-10 Pfizer conjugados de anticorpo-fármaco com alto carregamento de fármaco
CN104984323B (zh) * 2015-06-12 2018-05-01 北京四环生物制药有限公司 注射用重组人促红素冻干粉针剂
CN105311624A (zh) * 2015-11-23 2016-02-10 哈药集团生物工程有限公司 一种含有重组人促红素的药物组合物
CN106729627B (zh) * 2016-12-14 2021-07-13 深圳未名新鹏生物医药有限公司 一种重组人促红细胞生成素制剂
WO2018142514A1 (ja) * 2017-02-01 2018-08-09 協和発酵キリン株式会社 ダルベポエチンを含む液体医薬組成物
CN116249552A (zh) * 2020-08-11 2023-06-09 隆延生物科技（上海）有限公司 一种液体制剂及其应用

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DE3729863A1 (de) 1987-09-05 1989-03-16 Boehringer Mannheim Gmbh Stabilisierte erythropoietin-lyophilisate
TW518219B (en) 1996-04-26 2003-01-21 Chugai Pharmaceutical Co Ltd Erythropoietin solution preparation
CA2362927C (en) * 1999-02-22 2011-07-12 University Of Connecticut Novel albumin-free factor viii formulations
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JP4494977B2 (ja) * 2002-12-17 2010-06-30 メルク パテント ゲゼルシャフト ミット ベシュレンクテル ハフツング Ｇｄ２に結合するマウス１４．１８抗体のヒト化抗体（ｈ１４．１８）およびそのｉｌ−２融合タンパク質
US20050176108A1 (en) * 2003-03-13 2005-08-11 Young-Min Kim Physiologically active polypeptide conjugate having prolonged in vivo half-life
RU2268067C2 (ru) 2003-06-09 2006-01-20 Государственное предприятие Государственный научный центр "Институт иммунологии Федерального медико-биологического агентства" (ГНЦ "Институт иммунологии ФМБА России") Вирусные вакцины
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KR100560697B1 (ko) 2003-08-06 2006-03-16 씨제이 주식회사 알부민을 함유하지 않는 에리스로포이에틴 제제
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US9283260B2 (en) * 2006-04-21 2016-03-15 Amgen Inc. Lyophilized therapeutic peptibody formulations

Also Published As

Publication number Publication date
KR20110085918A (ko) 2011-07-27
RU2015103071A3 (pt) 2018-09-06
JP5638628B2 (ja) 2014-12-10
KR101335765B1 (ko) 2013-12-02
EP2525779A4 (en) 2014-07-09
CA2787652C (en) 2015-06-02
US8829163B2 (en) 2014-09-09
ES2700925T3 (es) 2019-02-20
AU2011207916B2 (en) 2014-01-23
RU2012135505A (ru) 2014-02-27
CA2787652A1 (en) 2011-07-28
US20120296069A1 (en) 2012-11-22
AU2011207916A1 (en) 2012-08-23
RU2682720C2 (ru) 2019-03-21
CN102753147B (zh) 2017-10-31
CN102753147A (zh) 2012-10-24
TWI417104B (zh) 2013-12-01
EP2525779B1 (en) 2018-09-05
AR079946A1 (es) 2012-02-29
WO2011090306A2 (en) 2011-07-28
EP2525779A2 (en) 2012-11-28
MX2012008453A (es) 2012-11-21
RU2015103071A (ru) 2015-06-20
TW201141512A (en) 2011-12-01
JP2013517325A (ja) 2013-05-16
WO2011090306A3 (en) 2011-12-01

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Free format text: DE ACORDO COM O ARTIGO 229-C DA LEI NO 10196/2001, QUE MODIFICOU A LEI NO 9279/96, A CONCESSAO DA PATENTE ESTA CONDICIONADA A ANUENCIA PREVIA DA ANVISA. CONSIDERANDO A APROVACAO DOS TERMOS DO PARECER NO 337/PGF/EA/2010, BEM COMO A PORTARIA INTERMINISTERIAL NO 1065 DE 24/05/2012, ENCAMINHA-SE O PRESENTE PEDIDO PARA AS PROVIDENCIAS CABIVEIS.

B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]
B08F Application dismissed because of non-payment of annual fees [chapter 8.6 patent gazette]

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B08K Patent lapsed as no evidence of payment of the annual fee has been furnished to inpi [chapter 8.11 patent gazette]

Free format text: EM VIRTUDE DO ARQUIVAMENTO PUBLICADO NA RPI 2614 DE 09-02-2021 E CONSIDERANDO AUSENCIA DE MANIFESTACAO DENTRO DOS PRAZOS LEGAIS, INFORMO QUE CABE SER MANTIDO O ARQUIVAMENTO DO PEDIDO DE PATENTE, CONFORME O DISPOSTO NO ARTIGO 12, DA RESOLUCAO 113/2013.