BRPI0621841B8 - formulação líquida - Google Patents

formulação líquida

Info

Publication number
BRPI0621841B8
BRPI0621841B8 BRPI0621841A BRPI0621841A BRPI0621841B8 BR PI0621841 B8 BRPI0621841 B8 BR PI0621841B8 BR PI0621841 A BRPI0621841 A BR PI0621841A BR PI0621841 A BRPI0621841 A BR PI0621841A BR PI0621841 B8 BRPI0621841 B8 BR PI0621841B8
Authority
BR
Brazil
Prior art keywords
liquid formulation
polyethylene glycol
poly
polyoxystearate
deamidation
Prior art date
Application number
BRPI0621841A
Other languages
English (en)
Inventor
Young Chang Jae
Suk Lee Min
Kil Lee Sang
Kook Park Seung
Hee Kim Sun
Kyung Chung Yo
Original Assignee
Daewoong 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 Daewoong Co Ltd filed Critical Daewoong Co Ltd
Publication of BRPI0621841A2 publication Critical patent/BRPI0621841A2/pt
Publication of BRPI0621841B1 publication Critical patent/BRPI0621841B1/pt
Publication of BRPI0621841B8 publication Critical patent/BRPI0621841B8/pt

Links

Classifications

    • 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
    • A61K38/27—Growth hormone [GH], i.e. somatotropin
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • 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
    • A61K9/14—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
    • 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

Landscapes

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

Abstract

formulações líquidas. desamidação(25°c) é aqui revelada uma formulação líquida estável que compreende o hormônio do crescimento humano; l-lisina, l-arginina ou polieti- leno glicol 300; e copolímero de poli(oxietileno) poli(oxipropileno), polietileno glicol- 15 polioxiestearato ou polietileno glicol-35 óleo de rícino.
BRPI0621841A 2006-07-06 2006-07-06 formulação líquida BRPI0621841B8 (pt)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/KR2006/002640 WO2008004717A1 (en) 2006-07-06 2006-07-06 A stable liquid formulation of human growth hormone

Publications (3)

Publication Number Publication Date
BRPI0621841A2 BRPI0621841A2 (pt) 2011-12-20
BRPI0621841B1 BRPI0621841B1 (pt) 2020-12-29
BRPI0621841B8 true BRPI0621841B8 (pt) 2021-05-25

Family

ID=38894670

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI0621841A BRPI0621841B8 (pt) 2006-07-06 2006-07-06 formulação líquida

Country Status (11)

Country Link
US (1) US8409586B2 (pt)
EP (1) EP2049148B1 (pt)
JP (1) JP5180202B2 (pt)
CN (1) CN101505789A (pt)
BR (1) BRPI0621841B8 (pt)
ES (1) ES2605022T3 (pt)
HK (1) HK1216992A1 (pt)
HU (1) HUE031329T2 (pt)
LT (1) LT2049148T (pt)
PT (1) PT2049148T (pt)
WO (1) WO2008004717A1 (pt)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2011001273A (ja) * 2009-06-16 2011-01-06 Eci Inc ｅＭＩＰを有効成分とする水溶性製剤
EP2501367B1 (en) * 2009-11-17 2015-01-21 Ipsen Pharma S.A.S. Formulation for HGH and RHIGF-1 combination
WO2013096835A1 (en) * 2011-12-23 2013-06-27 Abbvie Inc. Stable protein formulations
AP2016009159A0 (en) * 2013-11-12 2016-04-30 Cadila Healthcare Ltd Formulation for gonadotropins
US9908976B2 (en) 2015-03-18 2018-03-06 Psmg, Llc Stable polyethylene glycol particle dispersions and methods for forming the stable dispersions
CN110151988A (zh) * 2018-02-11 2019-08-23 百奥泰生物制药股份有限公司 一种靶向治疗TNF-α相关疾病的人抗体制剂

Family Cites Families (23)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS61296598A (ja) 1985-06-21 1986-12-27 Mitsubishi Electric Corp Ｍｏｓダイナミツクｒａｍのダミ−ワ−ド線駆動回路
EP0303746B2 (en) * 1987-08-21 1998-12-02 Mallinckrodt Group Inc. Stabilization of growth promoting hormones
US5981485A (en) * 1997-07-14 1999-11-09 Genentech, Inc. Human growth hormone aqueous formulation
DK0955062T3 (da) 1992-07-31 2007-09-17 Genentech Inc Vandig formulering indeholdende humant væksthormon
ZA965368B (en) * 1995-07-14 1997-01-14 Novo Nordisk As A pharmaceutical formulation
KR970006498A (ko) 1995-07-31 1997-02-21 유충식 활성형 인성장호르몬의 정제 방법
AUPN801296A0 (en) * 1996-02-12 1996-03-07 Csl Limited Stabilised growth hormone formulation and method of preparation thereof
US20020077461A1 (en) * 1996-04-24 2002-06-20 Soren Bjorn Pharmaceutical formulation
KR100210840B1 (ko) 1996-12-24 1999-07-15 구본준 기계 화학적 연마 방법 및 그 장치
KR19990001217A (ko) 1997-06-13 1999-01-15 윤종용 스탠바이 모드에서의 시스템 구동방법 및 장치
JP3723857B2 (ja) 1998-02-04 2005-12-07 日本ケミカルリサーチ株式会社 ヒト成長ホルモン含有水性医薬組成物
KR100316347B1 (ko) 1998-09-15 2002-08-27 한미약품(주) 대장균엔테로톡신ⅱ신호펩티드의변형체와인체성장호르몬의융합단백질을발현하는재조합미생물및그를이용한인체성장호르몬의제조방법
KR100573704B1 (ko) 1998-12-02 2006-07-21 동아제약주식회사 인성장 호르몬의 안정화된 액상제제_
CZ20021186A3 (cs) * 1999-10-04 2002-11-13 Chiron Corporation Farmaceutické prostředky obsahující stabilizovaný kapalný polypeptid
DK1455839T3 (da) 1999-10-08 2013-05-06 Nektar Therapeutics Heterobifunktioneller poly(ethylenglycol)-derivater og fremgangsmåder til fremstilling heraf
AU2001271491A1 (en) 2000-06-26 2002-01-08 Monsanto Technology Llc Non-aqueous surfactant-containing formulations for extended release of somatotropin
EP1536835A1 (en) * 2002-07-09 2005-06-08 Sandoz AG Liquid formulations with high concentration of human growth hormone (hgh) comprising phenol
JP4949828B2 (ja) * 2003-03-18 2012-06-13 アレス トレーディング ソシエテ アノニム 溶液中での成長ホルモンの安定化
KR100537260B1 (ko) 2003-09-03 2005-12-19 한미약품 주식회사 인간 성장 호르몬의 안정화된 액상 제제용 조성물
EP1667724A2 (en) * 2003-09-19 2006-06-14 Novo Nordisk A/S Albumin-binding derivatives of therapeutic peptides
EP1663296A4 (en) 2003-09-25 2009-11-25 Cangene Corp LIQUID FORMULATION OF HUMAN GROWTH HORMONE CONTAINING POLYETHYLENE GLYCOL
DE10355189B4 (de) 2003-11-26 2015-04-30 Johnson & Johnson Medical Gmbh Verfahren zum Herstellen eines chirurgischen Implantats sowie chirurgisches Implantat
WO2005063298A1 (en) 2003-12-23 2005-07-14 Pharmacia Corporation Stable growth hormone liquid formulation

Also Published As

Publication number Publication date
EP2049148A1 (en) 2009-04-22
CN101505789A (zh) 2009-08-12
HK1216992A1 (zh) 2016-12-16
WO2008004717A9 (en) 2013-08-29
EP2049148A4 (en) 2013-12-11
US8409586B2 (en) 2013-04-02
JP2009542629A (ja) 2009-12-03
LT2049148T (lt) 2016-11-25
JP5180202B2 (ja) 2013-04-10
US20090298768A1 (en) 2009-12-03
ES2605022T3 (es) 2017-03-10
WO2008004717A1 (en) 2008-01-10
HUE031329T2 (hu) 2017-07-28
BRPI0621841B1 (pt) 2020-12-29
BRPI0621841A2 (pt) 2011-12-20
PT2049148T (pt) 2016-12-30
EP2049148B1 (en) 2016-09-28

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Legal Events

Date Code Title Description
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]
B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 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: 10 (DEZ) ANOS CONTADOS A PARTIR DE 29/12/2020, OBSERVADAS AS CONDICOES LEGAIS.

B16C Correction of notification of the grant [chapter 16.3 patent gazette]

Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 06/07/2006 OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME ADI 5.529/DF