[go: up one dir, main page]

AR040526A1 - Formulaciuones de hgh en alta concentracion que contienen fenol - Google Patents

Formulaciuones de hgh en alta concentracion que contienen fenol

Info

Publication number
AR040526A1
AR040526A1 AR20030102458A ARP030102458A AR040526A1 AR 040526 A1 AR040526 A1 AR 040526A1 AR 20030102458 A AR20030102458 A AR 20030102458A AR P030102458 A ARP030102458 A AR P030102458A AR 040526 A1 AR040526 A1 AR 040526A1
Authority
AR
Argentina
Prior art keywords
crystallization
growth hormone
human growth
formulations
liquid
Prior art date
Application number
AR20030102458A
Other languages
English (en)
Original Assignee
Grandis Biotech Gmbh
Sandoz Ag
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=30119134&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=AR040526(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Grandis Biotech Gmbh, Sandoz Ag filed Critical Grandis Biotech Gmbh
Publication of AR040526A1 publication Critical patent/AR040526A1/es

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
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • 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
    • A61P19/00—Drugs for skeletal disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A61P19/10—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00—Drugs for disorders of the muscular or neuromuscular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • 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
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Endocrinology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Inorganic Chemistry (AREA)
  • Rheumatology (AREA)
  • Zoology (AREA)
  • Dermatology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Cardiology (AREA)
  • Urology & Nephrology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Diabetes (AREA)
  • Neurology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

Formulaciones líquidas de hormona de crecimiento humano (hGh, somatrofina) que son estables durante el almacenamiento, presenta una cristalización reducida o ninguna cristalización durante el almacenamiento y son adecuadas para administrar a un ser humano o animal. Con mayor particularidad, se refiere a formulaciones líquidas de hormona de crecimiento humano que es estable y presenta una cristalización mínima o ninguna cristalización cuando son almacenadas al menos durante un tiempo a temperaturas superiores a las temperaturas de refrigeración. Reivindicación 1: Una formulación farmacéutica líquida multidosis que contiene esencialmente hormona de crecimiento humano en una concentración de alrededor de 5 mg/ml hasta alrededor de 100 mg/ml, fenol, un buffer acuoso, un agente tensioactivo no iónico, en donde dicha formulación farmacéutica presenta una tonicidad de alrededor de 100 mosm/kg a alrededor de 500 mosm/kg, tiene un pH de alrededor de 6,1 hasta alrededor de 6,3 y está esencialmente libre de un excipiente aminoácido.
AR20030102458A 2002-07-09 2003-07-08 Formulaciuones de hgh en alta concentracion que contienen fenol AR040526A1 (es)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US39461202P 2002-07-09 2002-07-09
US39461102P 2002-07-09 2002-07-09
US39469902P 2002-07-09 2002-07-09

Publications (1)

Publication Number Publication Date
AR040526A1 true AR040526A1 (es) 2005-04-13

Family

ID=30119134

Family Applications (3)

Application Number Title Priority Date Filing Date
AR20030102461A AR040529A1 (es) 2002-07-09 2003-07-08 Formulaciones de hgh en alta concentracion que contienen 1,2-propilenglicol
AR20030102459A AR040527A1 (es) 2002-07-09 2003-07-08 Formulaciones de hgh en alta concentracion que contienen glicina
AR20030102458A AR040526A1 (es) 2002-07-09 2003-07-08 Formulaciuones de hgh en alta concentracion que contienen fenol

Family Applications Before (2)

Application Number Title Priority Date Filing Date
AR20030102461A AR040529A1 (es) 2002-07-09 2003-07-08 Formulaciones de hgh en alta concentracion que contienen 1,2-propilenglicol
AR20030102459A AR040527A1 (es) 2002-07-09 2003-07-08 Formulaciones de hgh en alta concentracion que contienen glicina

Country Status (9)

Country Link
US (2) US20060165733A1 (es)
EP (3) EP1536835A1 (es)
JP (3) JP2005535651A (es)
CN (3) CN1665540A (es)
AR (3) AR040529A1 (es)
AU (2) AU2003250915A1 (es)
CA (3) CA2491685A1 (es)
MX (3) MXPA05000412A (es)
WO (3) WO2004004779A1 (es)

Families Citing this family (28)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
JP4991522B2 (ja) * 2004-04-07 2012-08-01 アレス トレーディング ソシエテ アノニム 成長ホルモン液剤
PT1773878E (pt) 2004-07-19 2015-06-05 Biocon Ltd Conjugados de insulina-oligómero, formulaçôes e usos dos mesmos
CN101505789A (zh) * 2006-07-06 2009-08-12 株式会社大熊 稳定的人生长激素液体制剂
NZ585135A (en) 2007-10-16 2012-08-31 Biocon Ltd An orally administerable solid pharmaceutical composition comprising in-105 and a process thereof
CA2780554C (en) * 2009-11-17 2017-08-15 Ipsen Pharma S.A.S. Formulation for hgh and rhigf-1 combination
US8859626B2 (en) * 2010-03-08 2014-10-14 Case Western Reserve University Anti-virulence compositions and methods
JP6363949B2 (ja) 2011-07-25 2018-07-25 サンド アクチェンゲゼルシャフト 少なくとも中性塩および生物薬学的タンパク質を含む、水性製剤
PE20191815A1 (es) 2012-09-07 2019-12-27 Coherus Biosciences Inc Formulaciones acuosas estables de adalimumab
UA116217C2 (uk) 2012-10-09 2018-02-26 Санофі Пептидна сполука як подвійний агоніст рецепторів glp1-1 та глюкагону
SG10201705097PA (en) 2012-12-21 2017-07-28 Sanofi Sa Functionalized exendin-4 derivatives
EP3080154B1 (en) 2013-12-13 2018-02-07 Sanofi Dual glp-1/gip receptor agonists
TW201609796A (zh) 2013-12-13 2016-03-16 賽諾菲公司 非醯化之艾塞那肽－４（ｅｘｅｎｄｉｎ－４）胜肽類似物
WO2015086728A1 (en) 2013-12-13 2015-06-18 Sanofi Exendin-4 peptide analogues as dual glp-1/gip receptor agonists
TW201609797A (zh) 2013-12-13 2016-03-16 賽諾菲公司 雙重ｇｌｐ－１／升糖素受體促效劑
TW201625669A (zh) 2014-04-07 2016-07-16 賽諾菲公司 衍生自艾塞那肽－４（Ｅｘｅｎｄｉｎ－４）之肽類雙重ＧＬＰ－１／升糖素受體促效劑
TW201625668A (zh) 2014-04-07 2016-07-16 賽諾菲公司 作為胜肽性雙重ｇｌｐ－１／昇糖素受體激動劑之艾塞那肽－４衍生物
TW201625670A (zh) 2014-04-07 2016-07-16 賽諾菲公司 衍生自ｅｘｅｎｄｉｎ－４之雙重ｇｌｐ－１／升糖素受體促效劑
US9932381B2 (en) 2014-06-18 2018-04-03 Sanofi Exendin-4 derivatives as selective glucagon receptor agonists
AR105319A1 (es) 2015-06-05 2017-09-27 Sanofi Sa Profármacos que comprenden un conjugado agonista dual de glp-1 / glucagón conector ácido hialurónico
AR105284A1 (es) 2015-07-10 2017-09-20 Sanofi Sa Derivados de exendina-4 como agonistas peptídicos duales específicos de los receptores de glp-1 / glucagón
US11229702B1 (en) 2015-10-28 2022-01-25 Coherus Biosciences, Inc. High concentration formulations of adalimumab
US11071782B2 (en) 2016-04-20 2021-07-27 Coherus Biosciences, Inc. Method of filling a container with no headspace
HRP20240485T1 (hr) 2017-08-24 2024-07-05 Novo Nordisk A/S Pripravci glp-1 i njihova upotreba
KR20210024082A (ko) * 2018-06-25 2021-03-04 제이씨알 파마 가부시키가이샤 단백질 함유 수성 액제
CN114728043B (zh) * 2019-10-30 2024-04-16 Jcr制药股份有限公司 含有血清白蛋白与生长激素的融合蛋白的水性药物组合物
MX2022009844A (es) 2020-02-18 2022-09-05 Novo Nordisk As Composiciones y usos del peptido similar al glucagon-1 (glp-1).
CN115400076B (zh) * 2022-08-17 2023-09-05 安徽安科生物工程（集团）股份有限公司 重组人生长激素-Fc融合蛋白注射液制剂配方

Family Cites Families (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4783441A (en) * 1979-04-30 1988-11-08 Hoechst Aktiengesellschaft Aqueous protein solutions stable to denaturation
DE3325223A1 (de) * 1983-07-13 1985-01-24 Hoechst Ag, 6230 Frankfurt Gegen denaturierung bestaendige, waessrige proteinloesungen, verfahren zu ihrer herstellung und ihre verwendung
US4857505A (en) * 1987-03-09 1989-08-15 American Cyanamid Company Sustained release compositions for parenteral administration and their use
US5981485A (en) * 1997-07-14 1999-11-09 Genentech, Inc. Human growth hormone aqueous formulation
US5096885A (en) * 1988-04-15 1992-03-17 Genentech, Inc. Human growth hormone formulation
US5763394A (en) * 1988-04-15 1998-06-09 Genentech, Inc. Human growth hormone aqueous formulation
US5681814A (en) * 1990-06-07 1997-10-28 Genentech, Inc. Formulated IGF-I Composition
US5374620A (en) * 1990-06-07 1994-12-20 Genentech, Inc. Growth-promoting composition and its use
SE9201073D0 (sv) * 1992-04-03 1992-04-03 Kabi Pharmacia Ab Protein formulation
IL106524A (en) * 1992-07-31 2000-08-31 Genentech Inc Human growth hormone aqueous formulation
IL114848A0 (en) * 1994-08-16 1995-12-08 Chile Lab Sa New composition and subcompositions of same process for obtaining them and their molecular identification and their anti-inflammatory analgesic antipruritic and local antipyretic therapeutic effect in human beings and animals
JP2000506119A (ja) * 1996-02-15 2000-05-23 ノボ ノルディスク アクティーゼルスカブ ポリペプチドのコンジュゲーション
CA2283466A1 (en) * 1997-03-12 1998-09-17 Novo Nordisk A/S Storage-stable liquid formulation comprising a laccase
US7534443B1 (en) * 1998-07-16 2009-05-19 Ichiro Azuma Preparations for immunotherapy for cancer having bacterial somatic constituent as the active ingredient
JP2000336041A (ja) * 1999-03-19 2000-12-05 Wakamoto Pharmaceut Co Ltd プロピレングリコールを含有することを特徴とするウリナスタチン含有水性製剤
WO2001003741A1 (en) * 1999-07-12 2001-01-18 Grandis Biotech Gmbh Growth hormone formulations
GB2371227A (en) * 2001-01-10 2002-07-24 Grandis Biotech Gmbh Crystallisation - resistant aqueous growth hormone formulations

Also Published As

Publication number Publication date
CN1665541A (zh) 2005-09-07
CN100475267C (zh) 2009-04-08
MXPA05000412A (es) 2005-07-22
EP1521597A1 (en) 2005-04-13
CN1668332A (zh) 2005-09-14
MXPA05000413A (es) 2005-07-22
AU2003249991B2 (en) 2007-01-25
AR040529A1 (es) 2005-04-13
CA2491682A1 (en) 2004-01-15
WO2004004779A1 (en) 2004-01-15
JP2005538068A (ja) 2005-12-15
CA2491685A1 (en) 2004-01-15
US20060165733A1 (en) 2006-07-27
WO2004004781A1 (en) 2004-01-15
CA2491478A1 (en) 2004-01-15
CN1665540A (zh) 2005-09-07
AU2003249991A1 (en) 2004-01-23
MXPA05000414A (es) 2005-07-22
US20070014818A1 (en) 2007-01-18
WO2004004779A8 (en) 2005-07-07
JP2005535652A (ja) 2005-11-24
EP1521596A1 (en) 2005-04-13
AU2003250915A1 (en) 2004-01-23
AU2003249992A1 (en) 2004-01-23
EP1536835A1 (en) 2005-06-08
AR040527A1 (es) 2005-04-13
WO2004004780A1 (en) 2004-01-15
JP2005535651A (ja) 2005-11-24

Similar Documents

Publication Publication Date Title
AR040526A1 (es) Formulaciuones de hgh en alta concentracion que contienen fenol
ES2569949T3 (es) Formulaciones farmacéuticas que comprenden un péptido complejado con una dicetopiperazina
TW518235B (en) A gonadotropin-containing pharmaceutical composition with improved stability on prolong storage
ES2253774T3 (es) Formulacion farmaceutica conteniendo hormona de crecimiento humana, histidina y un detergente no ionico.
AR040881A1 (es) Formulacion de anticuerpos humanos para el tratamiento de trastornos asociados con tnf-alfa
KR100221123B1 (ko) 안정화된 고나도트로핀을 함유하는 제제
ES2372470T3 (es) Formulación líquida de fsh.
RU2407514C2 (ru) Водные композиции чфсг
RU95121755A (ru) Водный раствор фактора viii со сниженной концентрацией кислорода
DK1044015T3 (da) Formuleringer med amylinagonistpeptider og insulin
ES2383691T3 (es) Formulación líquida estable de hormonas de crecimiento
HU225147B1 (en) Stabile liquide composition containing urate oxydase, and lyophilised product for its preparation
IE883295L (en) Gamma-interferon formulation
AR024728A1 (es) Formulaciones de hormona de crecimiento.
JP2003504346A5 (es)
ES2229931A1 (es) Composicion liquida bilogicamente estable de fviii, de fvw o del complejo fviii/fvw humanos.
ES2310550T3 (es) Preparacion liquida acuosa de pranoprofeno.
PE43297A1 (es) Formulaciones acuosas de risperidona
MXPA06006535A (es) Formulacion liquida estable de la hormona del crecimiento

Legal Events

Date Code Title Description
FA Abandonment or withdrawal