ES2183486T3 - Formulaciones de fsh y de variantes de fsh que comprenden alcohol bencilico como agente preservativo. - Google Patents

Formulaciones de fsh y de variantes de fsh que comprenden alcohol bencilico como agente preservativo.

Info

Publication number
ES2183486T3
ES2183486T3 ES99305664T ES99305664T ES2183486T3 ES 2183486 T3 ES2183486 T3 ES 2183486T3 ES 99305664 T ES99305664 T ES 99305664T ES 99305664 T ES99305664 T ES 99305664T ES 2183486 T3 ES2183486 T3 ES 2183486T3
Authority
ES
Spain
Prior art keywords
fsh
formulations
variant
products
bencilic
Prior art date
Legal status (The legal status 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 status listed.)
Expired - Lifetime
Application number
ES99305664T
Other languages
English (en)
Inventor
James Arthur Hoffmann
Jirong Lu
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Eli Lilly and Co
Original Assignee
Eli Lilly and Co
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=27536687&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=ES2183486(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Eli Lilly and Co filed Critical Eli Lilly and Co
Application granted granted Critical
Publication of ES2183486T3 publication Critical patent/ES2183486T3/es
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • 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
    • 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
    • A61K38/24—Follicle-stimulating hormone [FSH]; Chorionic gonadotropins, e.g. HCG; Luteinising hormone [LH]; Thyroid-stimulating hormone [TSH]
    • 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
    • A61K47/186—Quaternary ammonium compounds, e.g. benzalkonium chloride or cetrimide
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/007—Pulmonary tract; Aromatherapy
    • A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/0078—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a nebulizer such as a jet nebulizer, ultrasonic nebulizer, e.g. in the form of aqueous drug solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A61P15/08—Drugs for genital or sexual disorders; Contraceptives for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/575—Hormones
    • C07K14/59—Follicle-stimulating hormone [FSH]; Chorionic gonadotropins, e.g.hCG [human chorionic gonadotropin]; Luteinising hormone [LH]; Thyroid-stimulating hormone [TSH]

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Endocrinology (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Reproductive Health (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Immunology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Otolaryngology (AREA)
  • Gynecology & Obstetrics (AREA)
  • Toxicology (AREA)
  • Dispersion Chemistry (AREA)
  • Pregnancy & Childbirth (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Pulmonology (AREA)
  • Dermatology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

La invención se refiere a FSH o a una variante de FSH que contiene una subunidad alfa y beta contenida en formaulaciones, y artículos de fabricación. La invención se refiere a nuevas proteínas ventajosas y ácidos nucleicos, soluciones farmacéuticas multiuso y formulaciones y productos de dichas proteínas y ácidos nucleicos donde ninguno de estos tenían previamente un uso comercial con tales indicaciones de usos extendidas. Estos productos son particularmente útiles en regímenes terapéuticos para aumentar los niveles de suero de FSH o de una variante de FSH durante un periodo de tratamiento. Así, entre otros, la invención cumple con la necesidad de productos convenientes de FSH o de una variante de FSH:
ES99305664T 1998-07-23 1999-07-16 Formulaciones de fsh y de variantes de fsh que comprenden alcohol bencilico como agente preservativo. Expired - Lifetime ES2183486T3 (es)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US9390698P 1998-07-23 1998-07-23
US9461198P 1998-07-30 1998-07-30
US9476798P 1998-07-31 1998-07-31
US9871198P 1998-09-01 1998-09-01
US10069698P 1998-09-17 1998-09-17

Publications (1)

Publication Number Publication Date
ES2183486T3 true ES2183486T3 (es) 2003-03-16

Family

ID=27536687

Family Applications (2)

Application Number Title Priority Date Filing Date
ES99305664T Expired - Lifetime ES2183486T3 (es) 1998-07-23 1999-07-16 Formulaciones de fsh y de variantes de fsh que comprenden alcohol bencilico como agente preservativo.
ES01130213T Expired - Lifetime ES2250290T3 (es) 1998-07-23 1999-07-16 Formulaciones estables de fsh y variantes de fsh.

Family Applications After (1)

Application Number Title Priority Date Filing Date
ES01130213T Expired - Lifetime ES2250290T3 (es) 1998-07-23 1999-07-16 Formulaciones estables de fsh y variantes de fsh.

Country Status (23)

Country Link
EP (2) EP1188444B1 (es)
JP (1) JP4719357B2 (es)
KR (1) KR20010083126A (es)
CN (1) CN1309567A (es)
AR (1) AR020618A1 (es)
AT (2) ATE308990T1 (es)
AU (1) AU776823B2 (es)
BR (1) BR9912243A (es)
CA (1) CA2335340C (es)
CO (1) CO5090905A1 (es)
DE (2) DE69904262T3 (es)
DK (1) DK0974359T4 (es)
ES (2) ES2183486T3 (es)
ID (1) ID28747A (es)
IL (1) IL140984A0 (es)
MY (1) MY135913A (es)
NO (1) NO20010326L (es)
NZ (1) NZ508874A (es)
PE (1) PE20000939A1 (es)
PL (1) PL346127A1 (es)
PT (1) PT974359E (es)
SI (1) SI0974359T1 (es)
WO (1) WO2000004913A1 (es)

Families Citing this family (28)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6414123B1 (en) 1997-10-21 2002-07-02 Vitro Diagnostics, Inc. Method for purifying FSH
US20030166525A1 (en) 1998-07-23 2003-09-04 Hoffmann James Arthur FSH Formulation
JP2002541213A (ja) 1999-04-13 2002-12-03 インヘール セラピューティック システムズ， インコーポレイテッド 不妊症の処置のための乾燥粉末処方物の肺投与
TW201002201A (en) 2001-03-01 2010-01-16 Lonza Ag Preservative blends containing quaternary ammonium compounds
DK1610822T4 (en) * 2003-04-02 2019-01-14 Ares Trading Sa Liquid pharmaceutical FSH and LH formulations together with a nonionic surfactant
ES2358330T5 (es) * 2003-04-02 2018-12-03 Ares Trading S.A. Formulaciones farmacéuticas líquidas de FSH y LH junto con un tensioactivo no iónico
EP1638595B1 (en) 2003-06-20 2013-03-20 Ares Trading S.A. Freeze-dried fsh / lh formulations
KR101105871B1 (ko) * 2005-09-27 2012-01-16 주식회사 엘지생명과학 인 난포자극호르몬의 안정한 용액 제형
CA2685437C (en) * 2007-02-08 2015-06-02 Aspenbio Pharma, Inc. Compositions and methods including expression and bioactivity of bovine follicle stimulating hormone
DK2170942T3 (da) 2007-06-28 2013-11-04 Biogenerix Ag Fsh-producerende celleklon
BRPI0818324B8 (pt) * 2007-11-01 2021-05-25 Merck Serono Sa formulação líquida contendo hormônio luteinizante (lh) ou uma variante do mesmo, seu uso, sua forma de apresentação, processo para a sua preparação e composição farmacêutica
NZ586588A (en) * 2008-02-08 2012-10-26 Biogenerix Ag Formulation of ( follice stimulating hormone) fsh and varients with benzalkonium chloride and benzyl alcohol
CN102309745B (zh) * 2008-09-17 2013-05-08 上海天伟生物制药有限公司 一种卵泡刺激素冻干针剂
EP2445552B1 (de) 2009-06-24 2015-10-14 Tecpharma Licensing AG Verabreichungsgerät mit priming funktion
EP2325194A1 (en) 2009-11-24 2011-05-25 Glycotope GmbH Process for the purification of glycoproteins
WO2011076280A1 (de) 2009-12-23 2011-06-30 Tecpharma Licensing Ag Injektionsvorrichtung mit einer nadelschutzhülse
WO2011076281A1 (de) 2009-12-23 2011-06-30 Tecpharma Licensing Ag Entfernen einer nadelschutzkappe von einer nadel
US8684744B2 (en) 2010-02-11 2014-04-01 Finox Ag Injection training dummy
RU2553375C2 (ru) * 2010-02-12 2015-06-10 Интас Биофармасьютикалс Лимитед Жидкий состав фолликулостимулирующего гормона
EP2417982A1 (en) * 2010-07-30 2012-02-15 Ferring B.V. Stabilization of gonadotropins
WO2012142961A1 (zh) * 2011-04-22 2012-10-26 上海天伟生物制药有限公司 一种低溶剂残留的糖蛋白组合物及其制备方法和用途
JP5750471B2 (ja) * 2013-05-22 2015-07-22 Ｊｃｒファーマ株式会社 組換え体ヒトｆｓｈの製造方法
CN103539860B (zh) * 2013-11-01 2014-12-03 广州优联康医药科技有限公司 一种长效重组人促卵泡激素融合蛋白
CN103539861B (zh) * 2013-11-01 2015-02-18 广州联康生物科技有限公司 长效重组人促卵泡激素融合蛋白
CN103554269B (zh) * 2013-11-01 2015-02-11 广州联康生物科技有限公司 重组猪促卵泡激素融合蛋白
AP2016009159A0 (en) * 2013-11-12 2016-04-30 Cadila Healthcare Ltd Formulation for gonadotropins
CN108348465B (zh) * 2015-09-17 2020-11-10 葛莱高托普有限公司 具有提高的稳定性的哺乳动物促卵泡激素组合物
GB201603280D0 (en) * 2016-02-24 2016-04-13 Ferring Bv Stable liquid gonadotropin formulation

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GB839300A (en) * 1957-09-05 1960-06-29 Organon Labor Ltd Adrenocorticotropic hormone preparations and process for making same
US4659696A (en) † 1982-04-30 1987-04-21 Takeda Chemical Industries, Ltd. Pharmaceutical composition and its nasal or vaginal use
US5162306A (en) * 1987-01-23 1992-11-10 Donaldson Lloyd E Composition and method for producing superovulation in mammals
IT1206302B (it) * 1987-06-26 1989-04-14 Serono Cesare Ist Ricerca Ormone follicolo-stimolante urinario
FR2623715B1 (fr) * 1987-11-26 1990-12-21 Lafon Labor Structures peptidiques, immunogenes les contenant et leurs applications au controle de la fertilite
US5733572A (en) * 1989-12-22 1998-03-31 Imarx Pharmaceutical Corp. Gas and gaseous precursor filled microspheres as topical and subcutaneous delivery vehicles
IE64738B1 (en) * 1990-03-20 1995-09-06 Akzo Nv Stabilized gonadotropin containing preparations
IT1250075B (it) * 1991-12-18 1995-03-30 Serono Cesare Ist Ricerca Composizioni farmaceutiche contenenti gonadotropine.
DK0955062T3 (da) * 1992-07-31 2007-09-17 Genentech Inc Vandig formulering indeholdende humant væksthormon
US5661125A (en) * 1992-08-06 1997-08-26 Amgen, Inc. Stable and preserved erythropoietin compositions
EP0668073B1 (en) † 1994-02-21 1999-04-14 Takeda Chemical Industries, Ltd. Polyester matrix for a pharmaceutical sustained-release preparation
JP2758154B2 (ja) † 1995-04-06 1998-05-28 エフ・ホフマン−ラ ロシユ アーゲー インターフェロンを含む液体製剤
WO1997017087A1 (en) * 1995-11-07 1997-05-15 Genentech, Inc. Stabilizing formulation for ngf
GB2317010A (en) * 1996-09-04 1998-03-11 Eev Ltd Gas sensor detecting only non-reflected light
IL122732A0 (en) * 1997-01-15 1998-08-16 Akzo Nobel Nv Liquid gonadotropin-containing formulation its preparation and a device containing same
US6287587B2 (en) † 1997-07-15 2001-09-11 Takeda Chemical Industries, Ltd. Process for producing sustained-release preparation by in-water drying
ZA9811127B (en) * 1997-12-09 2000-07-11 Lilly Co Eli Stabilized teriparatide solutions.
JP2000151148A (ja) * 1998-11-13 2000-05-30 Mitsumi Electric Co Ltd 携帯用電子機器のコード接続構造

Also Published As

Publication number Publication date
NO20010326D0 (no) 2001-01-19
CN1309567A (zh) 2001-08-22
SI0974359T1 (en) 2003-04-30
PT974359E (pt) 2003-02-28
ES2250290T3 (es) 2006-04-16
ID28747A (id) 2001-06-28
AU4998099A (en) 2000-02-14
CA2335340C (en) 2013-03-05
HK1026615A1 (en) 2000-12-22
NO20010326L (no) 2001-03-20
PL346127A1 (en) 2002-01-28
DK0974359T4 (da) 2009-06-29
EP1188444B1 (en) 2005-11-09
KR20010083126A (ko) 2001-08-31
JP2002521342A (ja) 2002-07-16
JP4719357B2 (ja) 2011-07-06
ATE308990T1 (de) 2005-11-15
DE69928296D1 (de) 2005-12-15
NZ508874A (en) 2004-03-26
WO2000004913A1 (en) 2000-02-03
DK0974359T3 (da) 2003-03-03
ATE228850T1 (de) 2002-12-15
EP1188444A1 (en) 2002-03-20
CA2335340A1 (en) 2000-02-03
EP0974359B1 (en) 2002-12-04
BR9912243A (pt) 2001-10-16
EP0974359A3 (en) 2001-02-07
AU776823B2 (en) 2004-09-23
DE69904262D1 (de) 2003-01-16
DE69904262T3 (de) 2009-08-13
IL140984A0 (en) 2002-02-10
AR020618A1 (es) 2002-05-22
DE69928296T2 (de) 2006-07-27
PE20000939A1 (es) 2000-09-20
MY135913A (en) 2008-07-31
EP0974359B2 (en) 2009-04-22
CO5090905A1 (es) 2001-10-30
DE69904262T2 (de) 2003-07-24
EP0974359A2 (en) 2000-01-26

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