BRPI0514408B8 - preparação liquida de peptídeo fisiologicamente ativo - Google Patents

preparação liquida de peptídeo fisiologicamente ativo

Info

Publication number
BRPI0514408B8
BRPI0514408B8 BRPI0514408A BRPI0514408A BRPI0514408B8 BR PI0514408 B8 BRPI0514408 B8 BR PI0514408B8 BR PI0514408 A BRPI0514408 A BR PI0514408A BR PI0514408 A BRPI0514408 A BR PI0514408A BR PI0514408 B8 BRPI0514408 B8 BR PI0514408B8
Authority
BR
Brazil
Prior art keywords
acid
physiologically active
liquid preparation
ghrelins
active peptide
Prior art date
Application number
BRPI0514408A
Other languages
English (en)
Inventor
Matsumoto Masako
Matsumoto Masaru
Wakabayashi Naomi
Hanada Takeshi
Original Assignee
Asubio Pharma Co Ltd
Daiichi Sankyo Co Ltd
Daiichi Asubio Pharma Co Ltd
Kenji Kangawa
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 Asubio Pharma Co Ltd, Daiichi Sankyo Co Ltd, Daiichi Asubio Pharma Co Ltd, Kenji Kangawa filed Critical Asubio Pharma Co Ltd
Publication of BRPI0514408A publication Critical patent/BRPI0514408A/pt
Publication of BRPI0514408B1 publication Critical patent/BRPI0514408B1/pt
Publication of BRPI0514408B8 publication Critical patent/BRPI0514408B8/pt

Links

Classifications

    • 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
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; 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
    • A61K38/22—Hormones
    • A61K38/25—Growth hormone-releasing factor [GH-RF], i.e. somatoliberin
    • 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
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61P13/10—Drugs for disorders of the urinary system of the bladder
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/06—Drugs for disorders of the endocrine system of the anterior pituitary hormones, e.g. TSH, ACTH, FSH, LH, PRL, GH
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/10—Drugs for disorders of the endocrine system of the posterior pituitary hormones, e.g. oxytocin, ADH
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/14—Drugs for disorders of the endocrine system of the thyroid hormones, e.g. T3, T4
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/40—Cyclodextrins; Derivatives thereof

Landscapes

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

Abstract

preparação líquida de peptídeo fisiologicamente ativo. uma preparação líquida eficaz consegue grande biodisponibilidade (ba) de peptídeos ou proteínas fisiologicamente ativos, inclusive grelinas, que são administrados como drogas. também é fornecida um método para aumentar a ba de peptídeos ou proteínas fisiologicamente ativos, inclusive grelinas, que são injetados em soluções aquosas por via subcutânea. a preparação liquida contém: um peptídeo ou proteína fisiologicamente ativo, tal coma grelinas, como ingrediente ativo; uma solução ácida incluindo um ou uma combinação de dois ou mais selecionadas do grupo que consiste em ácido acético, ácido láctico, ácido fosfórico, glicina, ácido cítrico, ácido clorídrico, ácido propiônico, ácido butírico, ácido benzóico e sais dos mesmos: um álcool; um liquido orgânico polar incluindo um ou uma combinação de dois ou mais selecionados do grupo que consiste em n-metil-2-pirrolidona, dimetilformamida, dimetil sulfóxido e metilparabeno.
BRPI0514408A 2004-08-24 2005-08-24 preparação liquida de peptídeo fisiologicamente ativo BRPI0514408B8 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
JP2004244339 2004-08-24
JP2004-244339 2004-08-24
PCT/JP2005/015362 WO2006022301A1 (ja) 2004-08-24 2005-08-24 生理活性ペプチド液状製剤

Publications (3)

Publication Number Publication Date
BRPI0514408A BRPI0514408A (pt) 2008-06-10
BRPI0514408B1 BRPI0514408B1 (pt) 2021-02-23
BRPI0514408B8 true BRPI0514408B8 (pt) 2021-05-25

Family

ID=35967510

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI0514408A BRPI0514408B8 (pt) 2004-08-24 2005-08-24 preparação liquida de peptídeo fisiologicamente ativo

Country Status (11)

Country Link
US (2) US20080193997A1 (pt)
EP (1) EP1800689B1 (pt)
JP (1) JP4951344B2 (pt)
KR (1) KR101149454B1 (pt)
CN (1) CN101022822B (pt)
AU (1) AU2005275779B2 (pt)
BR (1) BRPI0514408B8 (pt)
CA (1) CA2576473C (pt)
ES (1) ES2620326T3 (pt)
IL (1) IL181348A (pt)
WO (1) WO2006022301A1 (pt)

Families Citing this family (12)

* Cited by examiner, † Cited by third party
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CA2649538C (en) * 2006-04-21 2014-06-03 Yatin Gokarn Buffering agents for biopharmaceutical formulations
EP2054073B1 (en) * 2006-07-11 2014-11-26 Foresee Pharmaceuticals, Inc. Pharmaceutical compositions for sustained release delivery of peptides
JP5859987B2 (ja) * 2010-02-24 2016-02-16 アレコー リミテッド タンパク質製剤
WO2013027823A1 (ja) * 2011-08-25 2013-02-28 三菱化学メディエンス株式会社 グルカゴン様ペプチド－１の測定方法及びそれに使用するキット
US20150011473A1 (en) * 2012-01-20 2015-01-08 Lupin Limited Stabilized pth formulation
CN103301058A (zh) * 2013-06-17 2013-09-18 深圳翰宇药业股份有限公司 一种特立帕肽注射用组合物及其制备方法和制剂
EP2823808A1 (en) * 2013-07-09 2015-01-14 Ipsen Pharma S.A.S. Pharmaceutical composition for a sustained release of lanreotide
NL2015865B1 (en) 2015-11-27 2017-06-13 Le Vet B V Maropitant Formulation.
WO2019059303A1 (ja) 2017-09-22 2019-03-28 旭化成ファーマ株式会社 薬物動態及び／又は安全性に優れるテリパラチド含有液状医薬組成物
US20200289621A1 (en) * 2017-09-22 2020-09-17 Asahi Kasei Pharma Corporation Teriparatide-containing liquid pharmaceutical composition having excellent stability
EP4640210A1 (en) * 2022-12-23 2025-10-29 Hanmi Pharm. Co., Ltd. Formulation containing immunoactive interleukin 2 analog conjugate
CN116718762B (zh) * 2023-06-09 2025-01-24 上海品峰医疗科技有限公司 一种多肽类样本稳定剂

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JPH0651637B2 (ja) 1985-03-28 1994-07-06 エーザイ株式会社 ペプタイドの吸着防止組成物
JPH0669956B2 (ja) 1988-09-30 1994-09-07 旭化成工業株式会社 ポリペプタイド類の吸着防止剤
JPH032136A (ja) 1989-05-30 1991-01-08 Asahi Glass Co Ltd 複金属シアン化物錯体の製造方法，およびその用途
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Also Published As

Publication number Publication date
WO2006022301A1 (ja) 2006-03-02
US20110077195A1 (en) 2011-03-31
JP4951344B2 (ja) 2012-06-13
US8969298B2 (en) 2015-03-03
CA2576473C (en) 2015-06-30
KR20070057850A (ko) 2007-06-07
JPWO2006022301A1 (ja) 2008-05-08
AU2005275779A1 (en) 2006-03-02
US20080193997A1 (en) 2008-08-14
EP1800689A1 (en) 2007-06-27
BRPI0514408B1 (pt) 2021-02-23
CA2576473A1 (en) 2006-03-02
CN101022822B (zh) 2012-06-27
CN101022822A (zh) 2007-08-22
BRPI0514408A (pt) 2008-06-10
KR101149454B1 (ko) 2012-05-25
IL181348A0 (en) 2007-07-04
AU2005275779B2 (en) 2011-09-15
IL181348A (en) 2014-06-30
EP1800689A4 (en) 2009-09-23
ES2620326T3 (es) 2017-06-28
EP1800689B1 (en) 2016-12-28

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B25D Requested change of name of applicant approved

Owner name: KENJI KANGAWA (JP) , ASUBIO PHARMA CO., LTD. (JP)

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B25A Requested transfer of rights approved

Owner name: KENJI KANGAWA (JP) , DAIICHI SANKYO COMPANY LIMITE

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B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
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B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]
B06A Patent application procedure suspended [chapter 6.1 patent gazette]
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