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PE20070437A1 - FORMULACION ACUOSA hFSH - Google Patents

FORMULACION ACUOSA hFSH

Info

Publication number
PE20070437A1
PE20070437A1 PE2006001144A PE2006001144A PE20070437A1 PE 20070437 A1 PE20070437 A1 PE 20070437A1 PE 2006001144 A PE2006001144 A PE 2006001144A PE 2006001144 A PE2006001144 A PE 2006001144A PE 20070437 A1 PE20070437 A1 PE 20070437A1
Authority
PE
Peru
Prior art keywords
formulation
hfsh
aqueous formulation
human follicle
stimulation hormone
Prior art date
Application number
PE2006001144A
Other languages
English (en)
Inventor
Suk Young Choi
Hoon Sung Jeh
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=PE20070437(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 PE20070437A1 publication Critical patent/PE20070437A1/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
    • A61K47/26Carbohydrates, 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
    • 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
    • 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)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Endocrinology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Reproductive Health (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Diabetes (AREA)
  • Molecular Biology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Zoology (AREA)
  • Immunology (AREA)
  • Dermatology (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Gynecology & Obstetrics (AREA)
  • Pregnancy & Childbirth (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

SE REFIERE A UNA FORMULACION ACUOSA QUE COMPRENDE: A) LA HORMONA DE ESTIMULACION DEL FOLICULO HUMANO (hFSH) DE ORIGEN NATURAL O RECOMBINADO; B) GLICINA QUE SE ENCUENTRA EN UNA CANTIDAD DE 0,1% HASTA 10% P/V DE LA FORMULACION; C) METIONINA QUE SE ENCUENTRA EN UNA CANTIDAD DE 0,01% HASTA 2% P/V DE LA FORMULACION; D) UN SURFACTANTE NO IONICO TAL COMO EL POLISORBATO 20 QUE SE ENCUENTRA EN UNA CANTIDAD DE 0,001% HASTA 0,02% P/V DE LA FORMULACION; E) BUFFER DE FOSFATO COMO ESTABILIZADOR QUE TIENE UN pH DE 6,5 A 7,5; F) UN CONSERVANTE TAL COMO CRESOL, ALCOHOL DE BENCIL, ENTRE OTROS; Y OPCIONALMENTE G) UN AGENTE ISOTONICO TAL COMO MANITOL, SORBITOL, GLICEROL, ENTRE OTROS. DICHA COMPOSICION PERMITE LA ESTABILIDAD DE LA HORMONA DE ESTIMULACION DEL FOLICULO HUMANO (FSH) DURANTE UN PERIODO DE TIEMPO PROLONGADO MANTENIENDO SU ACTIVIDAD TERAPEUTICA SIENDO UTIL PARA LA ASPIRACION DE OVULO EN LA INSEMINACION ARTIFICIAL Y EL TRATAMIENTO DE INFERTILIDAD
PE2006001144A 2005-09-27 2006-09-21 FORMULACION ACUOSA hFSH PE20070437A1 (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
PE20070437A1 true PE20070437A1 (es) 2007-04-26

Family

ID=37899985

Family Applications (1)

Application Number Title Priority Date Filing Date
PE2006001144A PE20070437A1 (es) 2005-09-27 2006-09-21 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)

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US8617568B2 (en) 2007-07-10 2013-12-31 Medy-Tox, Inc. Pharmaceutical liquid composition of botulinum toxin with improved stability
NZ586590A (en) 2008-01-09 2012-06-29 Sanofi Aventis Deutschland Insulin analogues or derivatives having an extremely delayed time-action profile
RS52106B (sr) 2008-02-08 2012-08-31 Biogenerix Ag Tečni preparat fsh
PL3228320T3 (pl) 2008-10-17 2020-06-01 Sanofi-Aventis Deutschland Gmbh Kombinacja insuliny i agonisty GLP-1
CN102202682B (zh) 2008-11-04 2015-08-19 Aska制药株式会社 含促卵泡激素的水性组合物
DK2498801T3 (en) 2009-11-13 2018-05-07 Sanofi Aventis Deutschland PHARMACEUTICAL COMPOSITION INCLUDING desPro36Exendin-4 (1-39) -Lys6-NH2 AND METHIONIN
SI2554183T1 (en) 2009-11-13 2018-08-31 Sanofi-Aventis Deutschland Gmbh A pharmaceutical composition comprising the GLP-1 agonist and insulin and methionine
EP2533800B1 (en) * 2010-02-12 2016-07-20 Intas Pharmaceuticals Ltd. Liquid formulation of follicle stimulating hormone
EP2417982A1 (en) * 2010-07-30 2012-02-15 Ferring B.V. Stabilization of gonadotropins
KR101823320B1 (ko) 2010-08-30 2018-01-31 사노피-아벤티스 도이칠란트 게엠베하 제2형 진성 당뇨병 치료용 약제를 제조하기 위한 ave0010의 용도
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
DK2750699T3 (en) 2011-08-29 2015-10-26 Sanofi Aventis Deutschland A pharmaceutical combination for use in glycemic control in diabetes type 2 patients
TWI559929B (en) 2011-09-01 2016-12-01 Sanofi Aventis Deutschland Pharmaceutical composition for use in the treatment of a neurodegenerative disease
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
CA2928311A1 (en) * 2013-11-12 2015-05-28 Cadila Healthcare Limited Formulation for gonadotropins
WO2015104314A1 (en) 2014-01-09 2015-07-16 Sanofi Stabilized pharmaceutical formulations of insulin analogues and/or insulin derivatives
KR20160104726A (ko) 2014-01-09 2016-09-05 사노피 인슐린 유사체 및/또는 인슐린 유도체의 안정화된 무글리세롤 약제학적 제형
CA2932873A1 (en) 2014-01-09 2015-07-16 Sanofi Stabilized pharmaceutical formulations of insulin aspart
TN2017000235A1 (en) 2014-12-12 2018-10-19 Sanofi Aventis Deutschland 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
JP2020002130A (ja) * 2018-06-25 2020-01-09 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

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Also Published As

Publication number Publication date
TR200801968T2 (tr) 2008-06-23
EP1928413A4 (en) 2008-12-03
WO2007037607A1 (en) 2007-04-05
EP1928413A1 (en) 2008-06-11
JP2009509953A (ja) 2009-03-12
GT200600431A (es) 2007-08-28
EP1928413B1 (en) 2010-05-05
ES2345058T3 (es) 2010-09-14
US20110201554A1 (en) 2011-08-18
BRPI0616300A2 (pt) 2011-06-14
CN101272764B (zh) 2011-05-04
AU2006295570B2 (en) 2012-08-30
RU2407514C2 (ru) 2010-12-27
JP5364374B2 (ja) 2013-12-11
AR056538A1 (es) 2007-10-10
SA06270332B1 (ar) 2011-01-15
RU2008111632A (ru) 2009-10-10
US20160243242A1 (en) 2016-08-25
ATE466570T1 (de) 2010-05-15
TW200735897A (en) 2007-10-01
AU2006295570A1 (en) 2007-04-05
KR20070035232A (ko) 2007-03-30
KR101105871B1 (ko) 2012-01-16
DE602006014175D1 (de) 2010-06-17
CN101272764A (zh) 2008-09-24

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