BR112012012080B1 - Formulações de histidina-trealose do anticorpo t1h - Google Patents

Formulações de histidina-trealose do anticorpo t1h Download PDF

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Publication number
BR112012012080B1
BR112012012080B1 BR112012012080-8A BR112012012080A BR112012012080B1 BR 112012012080 B1 BR112012012080 B1 BR 112012012080B1 BR 112012012080 A BR112012012080 A BR 112012012080A BR 112012012080 B1 BR112012012080 B1 BR 112012012080B1
Authority
BR
Brazil
Prior art keywords
formulations
histidine
formulation
phosphate
trehalose
Prior art date
Application number
BR112012012080-8A
Other languages
English (en)
Portuguese (pt)
Other versions
BR112012012080A2 (https=
Inventor
Ramani Karthik
Jayakar Sucharitha
Original Assignee
Biocon Limited
Centro De Immunologia Molecular
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 Biocon Limited, Centro De Immunologia Molecular filed Critical Biocon Limited
Publication of BR112012012080A2 publication Critical patent/BR112012012080A2/pt
Publication of BR112012012080B1 publication Critical patent/BR112012012080B1/pt

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • 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
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • 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
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Immunology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Dermatology (AREA)
  • Organic Chemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
BR112012012080-8A 2009-11-20 2010-11-19 Formulações de histidina-trealose do anticorpo t1h BR112012012080B1 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IN2859CH2009 2009-11-20
IN2859/CHE/2009 2009-11-20
PCT/IB2010/055296 WO2011061712A1 (en) 2009-11-20 2010-11-19 Formulations of antibody

Publications (2)

Publication Number Publication Date
BR112012012080A2 BR112012012080A2 (https=) 2021-11-03
BR112012012080B1 true BR112012012080B1 (pt) 2022-11-29

Family

ID=44059267

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112012012080-8A BR112012012080B1 (pt) 2009-11-20 2010-11-19 Formulações de histidina-trealose do anticorpo t1h

Country Status (20)

Country Link
US (4) US20120231009A1 (https=)
EP (2) EP2501408B1 (https=)
JP (2) JP5896471B2 (https=)
KR (1) KR101333276B1 (https=)
CN (1) CN102770157B (https=)
AU (1) AU2010320515B2 (https=)
BR (1) BR112012012080B1 (https=)
CA (1) CA2781467C (https=)
CU (1) CU20120080A7 (https=)
DK (1) DK3721904T3 (https=)
ES (1) ES2897500T3 (https=)
IL (1) IL219884A (https=)
MX (1) MX2012005863A (https=)
MY (1) MY165614A (https=)
NZ (1) NZ600096A (https=)
PL (1) PL3721904T3 (https=)
PT (1) PT3721904T (https=)
RU (1) RU2548772C2 (https=)
WO (1) WO2011061712A1 (https=)
ZA (1) ZA201204459B (https=)

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WO2009113083A1 (en) 2008-03-14 2009-09-17 Biocon Limited A monoclonal antibody and a method thereof
JO3672B1 (ar) 2008-12-15 2020-08-27 Regeneron Pharma أجسام مضادة بشرية عالية التفاعل الكيماوي بالنسبة لإنزيم سبتيليسين كنفرتيز بروبروتين / كيكسين نوع 9 (pcsk9).
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JOP20200043A1 (ar) 2011-05-10 2017-06-16 Amgen Inc طرق معالجة أو منع الاضطرابات المختصة بالكوليسترول
AR087305A1 (es) 2011-07-28 2014-03-12 Regeneron Pharma Formulaciones estabilizadas que contienen anticuerpos anti-pcsk9, metodo de preparacion y kit
HUE069234T2 (hu) 2011-09-16 2025-02-28 Regeneron Pharma Eljárások lipoprotein(a)-szint csökkentésére proprotein-konvertáz szubtilizin/kexin 9 (PCSK9) inhibitorának beadásával
KR102063028B1 (ko) 2012-01-23 2020-01-07 리제너론 파아마슈티컬스, 인크. 항-ａｎｇ2 항체를 함유하는 안정화된 제형
EA039663B1 (ru) 2012-05-03 2022-02-24 Амген Инк. Применение антитела против pcsk9 для снижения сывороточного холестерина лпнп и лечения связанных с холестерином расстройств
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CN104780940B (zh) 2012-11-06 2017-11-07 拜耳制药股份公司 用于双特异性t细胞衔接体(bites)的制剂
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EP3024485B1 (en) 2013-07-23 2020-11-18 Biocon Limited Use of a cd6 binding partner and method based thereon
IL312865B2 (en) 2013-09-11 2025-06-01 Eagle Biologics Inc Liquid protein formulations containing viscosity-lowering agents
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WO2015181757A1 (en) * 2014-05-28 2015-12-03 Nono Inc. Lyophilized formulation of tat-nr2b9c with acetylation scavenger
KR20230074283A (ko) 2014-07-16 2023-05-26 사노피 바이오테크놀로지 이형접합성 가족성 고콜레스테롤혈증(heFH) 환자의 치료방법
AU2015325055B2 (en) 2014-10-01 2021-02-25 Eagle Biologics, Inc. Polysaccharide and nucleic acid formulations containing viscosity-lowering agents
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KR101776879B1 (ko) 2015-01-19 2017-09-08 주식회사 녹십자 항-egfr 항체를 포함하는 약학 제제
JP2018523684A (ja) 2015-08-18 2018-08-23 リジェネロン・ファーマシューティカルズ・インコーポレイテッドＲｅｇｅｎｅｒｏｎ Ｐｈａｒｍａｃｅｕｔｉｃａｌｓ， Ｉｎｃ． リポタンパク質アフェレーシスを受けている高脂血症の患者を治療するための抗ｐｃｓｋ９阻害抗体
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KR102546471B1 (ko) * 2016-09-27 2023-06-21 프레제니우스 카비 도이치란트 게엠베하 액상의 약학 조성물
ES2991182T3 (es) 2016-10-21 2024-12-02 Biocon Ltd Un anticuerpo monoclonal y un método de uso para el tratamiento del lupus
CN106800598B (zh) * 2017-02-09 2020-08-07 广州桂雨生物科技有限公司 一种抗体保存液及其制备方法
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CN111110841A (zh) * 2018-10-31 2020-05-08 上海君实生物医药科技股份有限公司 含有抗pcsk9抗体的稳定制剂
CN120241997A (zh) 2019-02-18 2025-07-04 伊莱利利公司 治疗性抗体制剂
CN113116812A (zh) * 2019-12-30 2021-07-16 百奥泰生物制药股份有限公司 含抗Trop2抗体-药物偶联物的制剂及其制备方法和应用
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Also Published As

Publication number Publication date
RU2548772C2 (ru) 2015-04-20
US20120231009A1 (en) 2012-09-13
MX2012005863A (es) 2013-01-18
CU20120080A7 (es) 2012-10-15
NZ600096A (en) 2013-08-30
ES2897500T8 (es) 2022-03-10
CN102770157B (zh) 2017-05-17
KR101333276B1 (ko) 2013-11-27
MY165614A (en) 2018-04-18
EP2501408A1 (en) 2012-09-26
RU2012125254A (ru) 2013-12-27
US20210290525A1 (en) 2021-09-23
EP2501408B1 (en) 2020-05-27
IL219884A (en) 2015-11-30
US20190321285A1 (en) 2019-10-24
CA2781467C (en) 2015-10-13
US20240058263A1 (en) 2024-02-22
AU2010320515A1 (en) 2012-06-14
EP2501408A4 (en) 2014-10-08
EP3721904A1 (en) 2020-10-14
JP2016104780A (ja) 2016-06-09
AU2010320515B2 (en) 2013-05-02
CA2781467A1 (en) 2011-05-26
PL3721904T3 (pl) 2022-01-31
EP3721904B1 (en) 2021-10-13
KR20130028894A (ko) 2013-03-20
BR112012012080A2 (https=) 2021-11-03
WO2011061712A1 (en) 2011-05-26
JP5896471B2 (ja) 2016-03-30
ZA201204459B (en) 2013-02-27
IL219884A0 (en) 2012-07-31
JP2013511510A (ja) 2013-04-04
PT3721904T (pt) 2021-11-15
DK3721904T3 (da) 2021-11-15
ES2897500T3 (es) 2022-03-01
CN102770157A (zh) 2012-11-07

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B12F Other appeals [chapter 12.6 patent gazette]
B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B06U Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]
B07A Application suspended after technical examination (opinion) [chapter 7.1 patent gazette]
B09A Decision: intention to grant [chapter 9.1 patent gazette]
B16A Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]

Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 19/11/2010, OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME ADI 5.529/DF, QUE DETERMINA A ALTERACAO DO PRAZO DE CONCESSAO.