AR056538A1 - Formulacion acuosa hfsh - Google Patents

Formulacion acuosa hfsh

Info

Publication number
AR056538A1
AR056538A1 ARP060104208A ARP060104208A AR056538A1 AR 056538 A1 AR056538 A1 AR 056538A1 AR P060104208 A ARP060104208 A AR P060104208A AR P060104208 A ARP060104208 A AR P060104208A AR 056538 A1 AR056538 A1 AR 056538A1
Authority
AR
Argentina
Prior art keywords
hfsh
stabilized
formulation
water formulation
activity
Prior art date
Application number
ARP060104208A
Other languages
English (en)
Original Assignee
Lg Life Sciences 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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=37899985&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=AR056538(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Lg Life Sciences Ltd filed Critical Lg Life Sciences Ltd
Publication of AR056538A1 publication Critical patent/AR056538A1/es

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
    • 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
    • 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
    • A61K38/24Follicle-stimulating hormone [FSH]; Chorionic gonadotropins, e.g. HCG; Luteinising hormone [LH]; Thyroid-stimulating hormone [TSH]
    • 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
    • A61K47/02Inorganic compounds
    • 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
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • 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
    • A61K47/20Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • 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
    • A61K47/24Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
    • 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
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • A61P15/08Drugs for genital or sexual disorders; Contraceptives for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
    • 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
    • A61P5/24Drugs for disorders of the endocrine system of the sex hormones

Landscapes

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

Abstract

Formulacion acuosa de la hormona de estimulacion del folículo humano (hFSH) que se estabiliza para mantener la actividad de la hFSH durante un período de tiempo prolongado. La formulacion de la presente es una formulacion acuosa que contiene una cantidad terapéutica efectiva de hFSH estabilizado en un buffer de fosfato que contiene glicina, metionina y surfactante no-ionico, preferentemente polisorbato 20, que es capaz de mantener la actividad del hFSH durante un largo período de tiempo.
ARP060104208A 2005-09-27 2006-09-26 Formulacion acuosa hfsh AR056538A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
KR1020050089853A KR101105871B1 (ko) 2005-09-27 2005-09-27 인 난포자극호르몬의 안정한 용액 제형

Publications (1)

Publication Number Publication Date
AR056538A1 true AR056538A1 (es) 2007-10-10

Family

ID=37899985

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP060104208A AR056538A1 (es) 2005-09-27 2006-09-26 Formulacion acuosa hfsh

Country Status (18)

Country Link
US (2) US20110201554A1 (es)
EP (1) EP1928413B1 (es)
JP (1) JP5364374B2 (es)
KR (1) KR101105871B1 (es)
CN (1) CN101272764B (es)
AR (1) AR056538A1 (es)
AT (1) ATE466570T1 (es)
AU (1) AU2006295570B2 (es)
BR (1) BRPI0616300A2 (es)
DE (1) DE602006014175D1 (es)
ES (1) ES2345058T3 (es)
GT (1) GT200600431A (es)
PE (1) PE20070437A1 (es)
RU (1) RU2407514C2 (es)
SA (1) SA06270332B1 (es)
TR (1) TR200801968T2 (es)
TW (1) TW200735897A (es)
WO (1) WO2007037607A1 (es)

Families Citing this family (24)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2690773C (en) 2007-07-10 2013-09-17 Medy-Tox, Inc. Pharmaceutical liquid composition of botulinum toxin with improved stability
CA2711749A1 (en) 2008-01-09 2009-07-16 Sanofi-Aventis Deutschland Gmbh Novel insulin derivatives having an extremely delayed time-action profile
WO2009098318A1 (en) * 2008-02-08 2009-08-13 Biogenerix Ag Liquid formulation of fsh
LT2349324T (lt) 2008-10-17 2017-12-27 Sanofi-Aventis Deutschland Gmbh Insulino ir glp-1 agonisto derinys
KR101668502B1 (ko) * 2008-11-04 2016-10-21 아스카 세이야쿠 가부시키가이샤 난포자극호르몬 함유 수성 조성물
ES2534191T3 (es) 2009-11-13 2015-04-20 Sanofi-Aventis Deutschland Gmbh Composición farmacéutica que comprende un agonista de GLP-1, una insulina y metionina
PL2498801T3 (pl) 2009-11-13 2018-08-31 Sanofi Aventis Deutschland Kompozycja farmaceutyczna zawierająca desPro<sup>36</sup>eksendyno-4(1-39)-Lys6-NH2 i metioninę
CN102821782B (zh) * 2010-02-12 2015-07-15 印塔斯生物制药有限公司 促卵泡激素的液体配制品
EP2417982A1 (en) * 2010-07-30 2012-02-15 Ferring B.V. Stabilization of gonadotropins
HUE031181T2 (en) 2010-08-30 2017-06-28 Sanofi Aventis Deutschland Use of AVE0010 for the manufacture of a medicament for the treatment of type 2 diabetes
US9821032B2 (en) 2011-05-13 2017-11-21 Sanofi-Aventis Deutschland Gmbh Pharmaceutical combination for improving glycemic control as add-on therapy to basal insulin
CN108079281A (zh) 2011-08-29 2018-05-29 赛诺菲-安万特德国有限公司 用于2型糖尿病患者中的血糖控制的药物组合
AR087744A1 (es) 2011-09-01 2014-04-16 Sanofi Aventis Deutschland Composicion farmaceutica para uso en el tratamiento de una enfermedad neurodegenerativa
TWI780236B (zh) 2013-02-04 2022-10-11 法商賽諾菲公司 胰島素類似物及/或胰島素衍生物之穩定化醫藥調配物
CN105658201A (zh) 2013-11-12 2016-06-08 卡迪拉保健有限公司 促性腺激素的制剂
KR20160104724A (ko) 2014-01-09 2016-09-05 사노피 인슐린 유사체 및/또는 인슐린 유도체의 안정화된 약제학적 제형
SG11201604708VA (en) 2014-01-09 2016-07-28 Sanofi Sa Stabilized glycerol free pharmaceutical formulations of insulin analogues and/or insulin derivatives
CN114939156A (zh) 2014-01-09 2022-08-26 赛诺菲 门冬胰岛素的稳定化药物制剂
US9950039B2 (en) 2014-12-12 2018-04-24 Sanofi-Aventis Deutschland Gmbh Insulin glargine/lixisenatide fixed ratio formulation
TWI748945B (zh) 2015-03-13 2021-12-11 德商賽諾菲阿凡提斯德意志有限公司 第2型糖尿病病患治療
TW201705975A (zh) 2015-03-18 2017-02-16 賽諾菲阿凡提斯德意志有限公司 第2型糖尿病病患之治療
GB201603280D0 (en) * 2016-02-24 2016-04-13 Ferring Bv Stable liquid gonadotropin formulation
WO2020004368A1 (ja) 2018-06-25 2020-01-02 Jcrファーマ株式会社 蛋白質含有水性液剤
CN115429751B (zh) * 2022-09-21 2023-11-17 景泽生物医药(合肥)股份有限公司 一种人重组卵泡刺激素注射剂及其制备方法

Family Cites Families (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5270057A (en) * 1990-03-20 1993-12-14 Akzo N.V. Stabilized gonadotropin containing preparations
IT1250075B (it) * 1991-12-18 1995-03-30 Serono Cesare Ist Ricerca Composizioni farmaceutiche contenenti gonadotropine.
DE69524456T2 (de) * 1995-03-21 2002-08-01 Applied Research Systems Flüssige hcg-formulierungen
US6267958B1 (en) * 1995-07-27 2001-07-31 Genentech, Inc. Protein formulation
US6685940B2 (en) * 1995-07-27 2004-02-03 Genentech, Inc. Protein formulation
TW518235B (en) * 1997-01-15 2003-01-21 Akzo Nobel Nv A gonadotropin-containing pharmaceutical composition with improved stability on prolong storage
JP4719357B2 (ja) * 1998-07-23 2011-07-06 アレス トレイディング ソシエテ アノニム Fsh及びfsh変異体の製剤、製品及び方法
DK1165119T3 (da) * 1999-04-08 2003-12-15 Genentech Inc Sammensætning baseret på modsat ladede polypeptider
US7514239B2 (en) * 2000-03-28 2009-04-07 Amgen Inc. Nucleic acid molecules encoding beta-like glycoprotein hormone polypeptides and heterodimers thereof
ATE556591T1 (de) * 2001-11-08 2012-05-15 Abbott Biotherapeutics Corp Stabile pharmazeutische flüssigformulierung von igg-antikörpern
NZ535008A (en) * 2002-02-08 2005-09-30 Alkermes Inc Polymer-based compositions for sustained release
US20050232899A1 (en) * 2002-05-31 2005-10-20 Aradigm Corporation Compositions methods and systems for pulmonary delivery of recombinant human interferon alpha-2b
CN1195069C (zh) * 2002-11-28 2005-03-30 南京医科大学 人卵泡刺激素β亚基单克隆抗体的制备方法
AR043972A1 (es) * 2003-04-02 2005-08-17 Ares Trading Sa Formulaciones farmaceuticas de fsh y lh
US20060069021A1 (en) * 2004-08-13 2006-03-30 Nastech Pharmaceutical Company Inc. Compositions and methods for intranasal administration of inactive analogs of PTH or inactivated preparations of PTH or PTH analogs
MY139088A (en) * 2005-02-21 2009-08-28 Lg Life Sciences Ltd Sustained release composition of protein drug
EP1909831A4 (en) * 2005-06-14 2013-02-20 Amgen Inc PREPARATIONS OF SPONTANEOUS TAMPING PROTEINS
WO2009098318A1 (en) * 2008-02-08 2009-08-13 Biogenerix Ag Liquid formulation of fsh

Also Published As

Publication number Publication date
EP1928413A4 (en) 2008-12-03
US20160243242A1 (en) 2016-08-25
EP1928413A1 (en) 2008-06-11
KR101105871B1 (ko) 2012-01-16
JP2009509953A (ja) 2009-03-12
SA06270332B1 (ar) 2011-01-15
EP1928413B1 (en) 2010-05-05
US20110201554A1 (en) 2011-08-18
AU2006295570B2 (en) 2012-08-30
TW200735897A (en) 2007-10-01
ES2345058T3 (es) 2010-09-14
TR200801968T2 (tr) 2008-06-23
RU2407514C2 (ru) 2010-12-27
CN101272764B (zh) 2011-05-04
AU2006295570A1 (en) 2007-04-05
DE602006014175D1 (de) 2010-06-17
JP5364374B2 (ja) 2013-12-11
KR20070035232A (ko) 2007-03-30
BRPI0616300A2 (pt) 2011-06-14
RU2008111632A (ru) 2009-10-10
GT200600431A (es) 2007-08-28
PE20070437A1 (es) 2007-04-26
WO2007037607A1 (en) 2007-04-05
CN101272764A (zh) 2008-09-24
ATE466570T1 (de) 2010-05-15

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