PE20000939A1 - Formulaciones de fsh y variantes de fsh, productos y metodos - Google Patents

Formulaciones de fsh y variantes de fsh, productos y metodos

Info

Publication number
PE20000939A1
PE20000939A1 PE1999000738A PE00073899A PE20000939A1 PE 20000939 A1 PE20000939 A1 PE 20000939A1 PE 1999000738 A PE1999000738 A PE 1999000738A PE 00073899 A PE00073899 A PE 00073899A PE 20000939 A1 PE20000939 A1 PE 20000939A1
Authority
PE
Peru
Prior art keywords
fsh
cresol
amino acids
formulation
variant
Prior art date
Application number
PE1999000738A
Other languages
English (en)
Inventor
Jirong Lu
James Arthur Hoffmann
Original Assignee
Lilly Co Eli
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=PE20000939(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Lilly Co Eli filed Critical Lilly Co Eli
Publication of PE20000939A1 publication Critical patent/PE20000939A1/es

Links

Classifications

    • 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
    • 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
    • A61K47/06Organic 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
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/186Quaternary ammonium compounds, e.g. benzalkonium chloride or cetrimide
    • 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
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/007Pulmonary tract; Aromatherapy
    • A61K9/0073Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/0078Sprays 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • 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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/575Hormones
    • C07K14/59Follicle-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)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Immunology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Otolaryngology (AREA)
  • Genetics & Genomics (AREA)
  • Dispersion Chemistry (AREA)
  • Pregnancy & Childbirth (AREA)
  • Dermatology (AREA)
  • Gynecology & Obstetrics (AREA)
  • Toxicology (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Molecular Biology (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)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

SE REFIERE A UNA FORMULACION QUE COMPRENDE a)HORMONA FOLICULO ESTIMULANTE (FSH); QUE CONTIENE UNA SUBUNIDAD ALFA DE 92 AMINOACIDOS o 96 AMINOACIDOS Y UNA SUBUNIDAD BETA DE 111 o 109 o 110 o 108 AMINOACIDOS O UNA VARIANTE DE FSH QUE COMPRENDE POR LO MENOS 90% DE DIMEROS DE FSH, QUE SE UNEN MEDIANTE ENLACES NO COVALENTES; UTILIZANDOSE DE 1 µg/ml A 50 mg/ml; b)UN PRESERVANTE SELECCIONADO DE FENOL, m-CRESOL, p-CRESOL, o-CRESOL, CLOROCRESOL, ALCOHOL BENCILICO, ALQUILPARABENO, CLORURO DE BENZALCONIO, CLORURO DE BENCENTONIO, DEHIDROACETATO DE SODIO Y TIMEROSAL; c)UN AGENTE DE ISOTONICIDAD; d)UN AMORTIGUADOR DE FOSFATO QUE INCLUYE UNA SOLUCION SALINA. TAMBIEN SE REFIERE A UN PROCEDIMIENTO PARA LA PREPARACION DE LA FORMULACION PRESERVADA, ESTABLE O PURIFICADA DE FSH O VARIANTE DE FSH. LA FORMULACION PUEDE SER UTIL PARA INCREMENTAR LOS NIVELES DE FSH Y PARA EL TRATAMIENTO DE LA INFERTILIDAD
PE1999000738A 1998-07-23 1999-07-22 Formulaciones de fsh y variantes de fsh, productos y metodos PE20000939A1 (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
PE20000939A1 true PE20000939A1 (es) 2000-09-20

Family

ID=27536687

Family Applications (1)

Application Number Title Priority Date Filing Date
PE1999000738A PE20000939A1 (es) 1998-07-23 1999-07-22 Formulaciones de fsh y variantes de fsh, productos y metodos

Country Status (24)

Country Link
EP (2) EP0974359B2 (es)
JP (1) JP4719357B2 (es)
KR (1) KR20010083126A (es)
CN (1) CN1309567A (es)
AR (1) AR020618A1 (es)
AT (2) ATE228850T1 (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)
HK (1) HK1026615A1 (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 (27)

* 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
AU779869B2 (en) 1999-04-13 2005-02-17 Nektar Therapeutics Pulmonary administration of dry powder formulations for treating infertility
TW201002201A (en) 2001-03-01 2010-01-16 Lonza Ag Preservative blends containing quaternary ammonium compounds
AR043972A1 (es) * 2003-04-02 2005-08-17 Ares Trading Sa Formulaciones farmaceuticas de fsh y lh
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
US8518881B2 (en) 2007-02-08 2013-08-27 Aspenbio Pharma, Inc. Methods for inducing superovulation in ungulates
UA103598C2 (uk) 2007-06-28 2013-11-11 Биодженерикс Аг Клон клітин, що продукують fsh
JP5551601B2 (ja) * 2007-11-01 2014-07-16 メルク セローノ ソシエテ アノニム Lh液体調製物
WO2009098318A1 (en) * 2008-02-08 2009-08-13 Biogenerix Ag Liquid formulation of fsh
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
WO2010149214A1 (de) 2009-06-24 2010-12-29 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
EP2534650B1 (en) 2010-02-11 2016-07-13 Finox Ag Injection training dummy
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
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
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
MX2018002921A (es) * 2015-09-17 2018-12-10 Glycotope Gmbh Composicion de hormona foliculo-estimulante mamifera con estabilidad incrementada.
GB201603280D0 (en) * 2016-02-24 2016-04-13 Ferring Bv Stable liquid gonadotropin formulation

Family Cites Families (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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.
AU686567C (en) * 1992-07-31 2002-08-08 Genentech Inc. Human growth hormone aqueous formulation
US5661125A (en) * 1992-08-06 1997-08-26 Amgen, Inc. Stable and preserved erythropoietin compositions
DE69508985T2 (de) 1994-02-21 1999-08-19 Takeda Chemical Industries Ltd Polyester Matrix für eine pharmazeutische Zusammensetzung mit verzögerter Freigabe
TW426523B (en) * 1995-04-06 2001-03-21 Hoffmann La Roche Interferon solution
AU721112B2 (en) * 1995-11-07 2000-06-22 Genentech Inc. Stabilizing formulation for NGF
GB2317010A (en) * 1996-09-04 1998-03-11 Eev Ltd Gas sensor detecting only non-reflected light
TW518235B (en) * 1997-01-15 2003-01-21 Akzo Nobel Nv A gonadotropin-containing pharmaceutical composition with improved stability on prolong storage
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
ATE228850T1 (de) 2002-12-15
DE69904262T3 (de) 2009-08-13
BR9912243A (pt) 2001-10-16
HK1026615A1 (en) 2000-12-22
IL140984A0 (en) 2002-02-10
JP2002521342A (ja) 2002-07-16
CA2335340C (en) 2013-03-05
ATE308990T1 (de) 2005-11-15
ES2183486T3 (es) 2003-03-16
ES2250290T3 (es) 2006-04-16
ID28747A (id) 2001-06-28
EP0974359A2 (en) 2000-01-26
NO20010326L (no) 2001-03-20
MY135913A (en) 2008-07-31
DE69928296D1 (de) 2005-12-15
NO20010326D0 (no) 2001-01-19
CO5090905A1 (es) 2001-10-30
DE69904262D1 (de) 2003-01-16
EP1188444B1 (en) 2005-11-09
KR20010083126A (ko) 2001-08-31
CN1309567A (zh) 2001-08-22
EP0974359A3 (en) 2001-02-07
DE69928296T2 (de) 2006-07-27
WO2000004913A1 (en) 2000-02-03
CA2335340A1 (en) 2000-02-03
DK0974359T4 (da) 2009-06-29
EP0974359B1 (en) 2002-12-04
AU776823B2 (en) 2004-09-23
PL346127A1 (en) 2002-01-28
SI0974359T1 (en) 2003-04-30
DE69904262T2 (de) 2003-07-24
EP0974359B2 (en) 2009-04-22
NZ508874A (en) 2004-03-26
EP1188444A1 (en) 2002-03-20
DK0974359T3 (da) 2003-03-03
JP4719357B2 (ja) 2011-07-06
AU4998099A (en) 2000-02-14
PT974359E (pt) 2003-02-28
AR020618A1 (es) 2002-05-22

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