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

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/04Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22Hormones
    • A61K38/25Growth hormone-releasing factor [GH-RF] (Somatoliberin)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • A61P13/10Drugs for disorders of the urinary system of the bladder
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/06Drugs for disorders of the endocrine system of the anterior pituitary hormones, e.g. TSH, ACTH, FSH, LH, PRL, GH
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/10Drugs for disorders of the endocrine system of the posterior pituitary hormones, e.g. oxytocin, ADH
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/14Drugs for disorders of the endocrine system of the thyroid hormones, e.g. T3, T4
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/40Cyclodextrins; Derivatives thereof

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
JP2004-244339 2004-08-24
JP2004244339 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)

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EP2021030A2 (en) * 2006-04-21 2009-02-11 Amgen, Inc. Buffering agents for biopharmaceutical formulations
KR101466933B1 (ko) * 2006-07-11 2014-12-01 큐피에스 엘엘씨 펩타이드의 지속 방출 전달을 위한 의약 조성물
WO2011104557A1 (en) * 2010-02-24 2011-09-01 Arecor Limited Protein formulations
US9103841B2 (en) * 2011-08-25 2015-08-11 Lsi Medience Corporation Method for determining glucagon-like peptide-1, and kit for use in said method
IN2014MN01470A (pt) * 2012-01-20 2015-04-17 Lupin Ltd
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.
EP3685849A4 (en) * 2017-09-22 2021-12-22 Asahi Kasei Pharma Corporation LIQUID PHARMACEUTICAL COMPOSITION CONTAINING TRIPARATIDE WITH EXCELLENT STABILITY
US20200289622A1 (en) 2017-09-22 2020-09-17 Asahi Kasei Pharma Corporation Teriparatide-containing liquid pharmaceutical composition having excellent pharmacokinetics and/or safety
CN116718762A (zh) * 2023-06-09 2023-09-08 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
JPH0397083A (ja) 1989-09-08 1991-04-23 Tokyo Electric Co Ltd ラベル発行装置
DE4126983A1 (de) 1991-08-15 1993-02-18 Boehringer Mannheim Gmbh Verfahren zur herstellung von humanprotein-enthaltenden, konservierten arzneimitteln fuer infusions- oder injektionszwecke
SE9201073D0 (sv) * 1992-04-03 1992-04-03 Kabi Pharmacia Ab Protein formulation
SE9300105D0 (sv) * 1993-01-15 1993-01-15 Kabi Pharmacia Ab Stable protein solution
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DE4340781C3 (de) * 1993-11-30 2000-01-27 Novartis Ag Cyclosporin enthaltende flüssige Zubereitungen und Verfahren zu ihrer Herstellung
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Also Published As

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

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Legal Events

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B25D Requested change of name of applicant approved

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

Free format text: ALTERADO DE: DAIICHI ASUBIO PHARMA CO., LTD.

B25A Requested transfer of rights approved

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

Free format text: TRANSFERIDO POR FUSAO DE: ASUBIO PHARMA CO., LTD.

B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]
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]
B09A Decision: intention to grant [chapter 9.1 patent gazette]
B16A Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]

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