CA2805864A1 - Stabilization of fsh - Google Patents

Stabilization of fsh Download PDF

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Publication number
CA2805864A1
CA2805864A1 CA2805864A CA2805864A CA2805864A1 CA 2805864 A1 CA2805864 A1 CA 2805864A1 CA 2805864 A CA2805864 A CA 2805864A CA 2805864 A CA2805864 A CA 2805864A CA 2805864 A1 CA2805864 A1 CA 2805864A1
Authority
CA
Canada
Prior art keywords
rfsh
fsh
salts
salt
formulation
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.)
Pending
Application number
CA2805864A
Other languages
English (en)
French (fr)
Inventor
Helen Ulrika Sjoegren
Heidi Louise Bagger
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.)
Ferring BV
Original Assignee
Ferring BV
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
Application filed by Ferring BV filed Critical Ferring BV
Publication of CA2805864A1 publication Critical patent/CA2805864A1/en
Pending legal-status Critical Current

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Classifications

    • 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
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/26Carbohydrates, 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
    • 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
    • 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)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Endocrinology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Reproductive Health (AREA)
  • Organic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Immunology (AREA)
  • Inorganic Chemistry (AREA)
  • Dermatology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Toxicology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Gynecology & Obstetrics (AREA)
  • Pregnancy & Childbirth (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Peptides Or Proteins (AREA)
  • Magnetic Resonance Imaging Apparatus (AREA)
  • Fats And Perfumes (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
CA2805864A 2010-07-30 2011-07-28 Stabilization of fsh Pending CA2805864A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP10171428.5 2010-07-30
EP10171428A EP2417982A1 (en) 2010-07-30 2010-07-30 Stabilization of gonadotropins
PCT/EP2011/062986 WO2012013742A2 (en) 2010-07-30 2011-07-28 Stabilization of fsh

Publications (1)

Publication Number Publication Date
CA2805864A1 true CA2805864A1 (en) 2012-02-02

Family

ID=43216624

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2805864A Pending CA2805864A1 (en) 2010-07-30 2011-07-28 Stabilization of fsh

Country Status (27)

Country Link
US (3) US8993732B2 (https=)
EP (3) EP2417982A1 (https=)
JP (3) JP5860047B2 (https=)
KR (2) KR101991756B1 (https=)
CN (2) CN105106939A (https=)
AR (1) AR082776A1 (https=)
AU (1) AU2011284702C1 (https=)
BR (1) BR112013002312B1 (https=)
CA (1) CA2805864A1 (https=)
DK (1) DK2598160T3 (https=)
ES (1) ES2623634T3 (https=)
HR (1) HRP20170386T1 (https=)
HU (1) HUE033592T2 (https=)
IL (2) IL223821A (https=)
JO (1) JO3229B1 (https=)
LT (1) LT2598160T (https=)
MX (2) MX356951B (https=)
NZ (2) NZ606366A (https=)
PL (1) PL2598160T3 (https=)
PT (1) PT2598160T (https=)
RS (1) RS55772B1 (https=)
RU (1) RU2574012C2 (https=)
SA (1) SA114350786B1 (https=)
SI (1) SI2598160T1 (https=)
TW (1) TWI439283B (https=)
WO (1) WO2012013742A2 (https=)
ZA (1) ZA201209497B (https=)

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TWI488640B (zh) 2008-04-16 2015-06-21 菲瑞茵國際中心股份有限公司 藥學製劑
EP2417982A1 (en) * 2010-07-30 2012-02-15 Ferring B.V. Stabilization of gonadotropins
JO3092B1 (ar) 2011-08-08 2017-03-15 Ferring Bv مركب لتحفيز مسيطر عليه للمبيض
AP2016009159A0 (en) * 2013-11-12 2016-04-30 Cadila Healthcare Ltd Formulation for gonadotropins
CN105727260A (zh) * 2016-02-03 2016-07-06 华侨大学 一种卵泡刺激素的长效制剂
GB201603280D0 (en) * 2016-02-24 2016-04-13 Ferring Bv Stable liquid gonadotropin formulation
FR3083089A1 (fr) * 2018-06-29 2020-01-03 Adocia Solution injectable a ph 7 comprenant au moins une insuline basale dont le pi est compris entre 5,8 et 8,5 et un co-polyaminoacide porteur de charges carboxylates et de radicaux hydrophobes
TW201938190A (zh) 2017-12-07 2019-10-01 法商阿道洽公司 包含至少一具有pi從5.8至8.5之基礎胰島素以及一帶有羧酸鹽電荷及疏水基之共聚胺基酸的ph 7之可注射溶液
TWI813604B (zh) 2017-12-07 2023-09-01 法商阿道洽公司 包含至少一具有pi從5.8至8.5之基礎胰島素以及一帶有羧酸鹽電荷及疏水基之共聚胺基酸的可注射ph7溶液
FR3084584B1 (fr) * 2018-08-03 2020-11-06 Adocia Solution injectable a ph 7 comprenant du glucagon humain et un compose amphiphile porteur de radicaux hydrophobes
FR3084586B1 (fr) * 2018-08-03 2020-11-06 Adocia Compositions sous forme d'une solution aqueuse injectable comprenant de l'amyline, un agoniste au recepteur de l'amyline ou un analogue d'amyline et un compose amphiphile porteur de radicaux hydrophobes
JP7425459B2 (ja) * 2019-10-11 2024-01-31 株式会社シノテスト 安定化されたhmgb1含有溶液

Family Cites Families (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PT814841E (pt) 1995-03-21 2002-03-28 Applied Research Systems Formulacoes liquidas de hcg
DE69733889T3 (de) * 1996-05-29 2009-10-22 Delsitech Oy Lösliche oxide für biologische anwendungen
IL122732A0 (en) * 1997-01-15 1998-08-16 Akzo Nobel Nv Liquid gonadotropin-containing formulation its preparation and a device containing same
US20030166525A1 (en) * 1998-07-23 2003-09-04 Hoffmann James Arthur FSH Formulation
IL140984A0 (en) * 1998-07-23 2002-02-10 Lilly Co Eli Fsh and fsh variant formulations, products and methods
BRPI0508798A (pt) * 2004-04-07 2007-09-04 Ares Trading Sa formulação lìquida de hormÈnio de crescimento, composição farmacêutica, forma de apresentação da formulação lìquida de hormÈnio de crescimento e uso da formulação lìquida de hormÈnio de crescimento
KR101105871B1 (ko) * 2005-09-27 2012-01-16 주식회사 엘지생명과학 인 난포자극호르몬의 안정한 용액 제형
NZ586588A (en) * 2008-02-08 2012-10-26 Biogenerix Ag Formulation of ( follice stimulating hormone) fsh and varients with benzalkonium chloride and benzyl alcohol
TWI488640B (zh) 2008-04-16 2015-06-21 菲瑞茵國際中心股份有限公司 藥學製劑
CN101614748A (zh) * 2008-06-25 2009-12-30 上海新波生物技术有限公司 促卵泡激素时间分辨免疫荧光分析法及试剂盒
EP3366692A1 (en) * 2009-06-22 2018-08-29 Amgen, Inc Refolding proteins using a chemically controlled redox state
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

Also Published As

Publication number Publication date
US9463221B2 (en) 2016-10-11
RU2012157154A (ru) 2014-09-10
EP2598160B1 (en) 2017-02-22
US20130210727A1 (en) 2013-08-15
SA114350786B1 (ar) 2015-07-09
KR20130143692A (ko) 2013-12-31
JP2013532677A (ja) 2013-08-19
ES2623634T3 (es) 2017-07-11
NZ628962A (en) 2016-01-29
IL249920A0 (en) 2017-03-30
AU2011284702A1 (en) 2013-02-07
BR112013002312B1 (pt) 2021-09-21
KR101991756B1 (ko) 2019-06-21
EP2598160A2 (en) 2013-06-05
US20150265681A1 (en) 2015-09-24
BR112013002312A2 (pt) 2018-03-20
PT2598160T (pt) 2017-03-30
CN103052398A (zh) 2013-04-17
DK2598160T3 (en) 2017-03-27
EP2417982A1 (en) 2012-02-15
JP2016102127A (ja) 2016-06-02
WO2012013742A2 (en) 2012-02-02
WO2012013742A3 (en) 2012-04-19
HRP20170386T1 (hr) 2017-05-05
NZ606366A (en) 2014-08-29
LT2598160T (lt) 2017-04-10
SI2598160T1 (sl) 2017-07-31
AU2011284702B2 (en) 2015-05-14
EP3144010A1 (en) 2017-03-22
HUE033592T2 (hu) 2017-12-28
JO3229B1 (ar) 2018-03-08
IL223821A (en) 2017-01-31
PL2598160T3 (pl) 2017-06-30
AR082776A1 (es) 2013-01-09
AU2011284702C1 (en) 2015-09-03
US20170216405A1 (en) 2017-08-03
TWI439283B (zh) 2014-06-01
CN103052398B (zh) 2015-09-16
MX341464B (es) 2016-08-22
TW201208694A (en) 2012-03-01
MX356951B (es) 2018-06-21
ZA201209497B (en) 2013-08-28
JP2018048188A (ja) 2018-03-29
JP5860047B2 (ja) 2016-02-16
MX2013000681A (es) 2013-02-27
JP6522711B2 (ja) 2019-05-29
US8993732B2 (en) 2015-03-31
KR20180008916A (ko) 2018-01-24
RS55772B1 (sr) 2017-07-31
RU2574012C2 (ru) 2016-01-27
CN105106939A (zh) 2015-12-02
KR101820115B1 (ko) 2018-01-18

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