HRP20170386T1 - Stabilizacija fsh - Google Patents

Stabilizacija fsh Download PDF

Info

Publication number
HRP20170386T1
HRP20170386T1 HRP20170386TT HRP20170386T HRP20170386T1 HR P20170386 T1 HRP20170386 T1 HR P20170386T1 HR P20170386T T HRP20170386T T HR P20170386TT HR P20170386 T HRP20170386 T HR P20170386T HR P20170386 T1 HRP20170386 T1 HR P20170386T1
Authority
HR
Croatia
Prior art keywords
formulation
fsh
use according
salt
amount
Prior art date
Application number
HRP20170386TT
Other languages
English (en)
Croatian (hr)
Inventor
Helen Ulrika Sjögren
Heidi Louise Bagger
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 HRP20170386T1 publication Critical patent/HRP20170386T1/hr

Links

Classifications

    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • 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
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/20—Organic 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
    • 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
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K9/08—Solutions
    • 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)
  • 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)
  • Peptides Or Proteins (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Magnetic Resonance Imaging Apparatus (AREA)
  • Fats And Perfumes (AREA)
HRP20170386TT 2010-07-30 2011-07-28 Stabilizacija fsh HRP20170386T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP10171428A EP2417982A1 (en) 2010-07-30 2010-07-30 Stabilization of gonadotropins
EP11736111.3A EP2598160B1 (en) 2010-07-30 2011-07-28 Stabilization of fsh
PCT/EP2011/062986 WO2012013742A2 (en) 2010-07-30 2011-07-28 Stabilization of fsh

Publications (1)

Publication Number Publication Date
HRP20170386T1 true HRP20170386T1 (hr) 2017-05-05

Family

ID=43216624

Family Applications (1)

Application Number Title Priority Date Filing Date
HRP20170386TT HRP20170386T1 (hr) 2010-07-30 2011-07-28 Stabilizacija fsh

Country Status (27)

Country Link
US (3) US8993732B2 (enExample)
EP (3) EP2417982A1 (enExample)
JP (3) JP5860047B2 (enExample)
KR (2) KR101991756B1 (enExample)
CN (2) CN103052398B (enExample)
AR (1) AR082776A1 (enExample)
AU (1) AU2011284702C1 (enExample)
BR (1) BR112013002312B1 (enExample)
CA (1) CA2805864A1 (enExample)
DK (1) DK2598160T3 (enExample)
ES (1) ES2623634T3 (enExample)
HR (1) HRP20170386T1 (enExample)
HU (1) HUE033592T2 (enExample)
IL (2) IL223821A (enExample)
JO (1) JO3229B1 (enExample)
LT (1) LT2598160T (enExample)
MX (2) MX356951B (enExample)
NZ (2) NZ606366A (enExample)
PL (1) PL2598160T3 (enExample)
PT (1) PT2598160T (enExample)
RS (1) RS55772B1 (enExample)
RU (1) RU2574012C2 (enExample)
SA (1) SA114350786B1 (enExample)
SI (1) SI2598160T1 (enExample)
TW (1) TWI439283B (enExample)
WO (1) WO2012013742A2 (enExample)
ZA (1) ZA201209497B (enExample)

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
HK1223559A1 (zh) * 2013-11-12 2017-08-04 Cadila Healthcare Limited 用於促性腺激素的配方
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
CA3084689A1 (fr) 2017-12-07 2019-06-13 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
SG11202005322RA (en) 2017-12-07 2020-07-29 Adocia Injectable solution at ph 7 comprising at least one basal insulin having a pi of between 5.8 and 8.5 and a copolyamino acid carrying carboxylate charges and hydrophobic radicals
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
DE69524456T2 (de) 1995-03-21 2002-08-01 Applied Research Systems Flüssige hcg-formulierungen
NZ332968A (en) * 1996-05-29 2000-08-25 Bioxid Oy A controllably dissolvable silica-xerogel prepared via sol-gel
TW518235B (en) * 1997-01-15 2003-01-21 Akzo Nobel Nv A gonadotropin-containing pharmaceutical composition with improved stability on prolong storage
US20030166525A1 (en) * 1998-07-23 2003-09-04 Hoffmann James Arthur FSH Formulation
CA2335340C (en) * 1998-07-23 2013-03-05 Eli Lilly And Company Fsh and fsh variant formulations, products and methods
ES2383994T3 (es) * 2004-04-07 2012-06-28 Ares Trading S.A. Formulación líquida de hormona del crecimiento
KR101105871B1 (ko) * 2005-09-27 2012-01-16 주식회사 엘지생명과학 인 난포자극호르몬의 안정한 용액 제형
RS52106B (sr) * 2008-02-08 2012-08-31 Biogenerix Ag Tečni preparat fsh
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
SG176963A1 (en) * 2009-06-22 2012-02-28 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
EP3144010A1 (en) 2017-03-22
AU2011284702A1 (en) 2013-02-07
TW201208694A (en) 2012-03-01
MX341464B (es) 2016-08-22
JP2013532677A (ja) 2013-08-19
AU2011284702B2 (en) 2015-05-14
ZA201209497B (en) 2013-08-28
SA114350786B1 (ar) 2015-07-09
JP2016102127A (ja) 2016-06-02
LT2598160T (lt) 2017-04-10
RU2574012C2 (ru) 2016-01-27
CN103052398B (zh) 2015-09-16
NZ606366A (en) 2014-08-29
KR20130143692A (ko) 2013-12-31
RU2012157154A (ru) 2014-09-10
JP6522711B2 (ja) 2019-05-29
CN103052398A (zh) 2013-04-17
EP2598160A2 (en) 2013-06-05
WO2012013742A3 (en) 2012-04-19
JP2018048188A (ja) 2018-03-29
HUE033592T2 (hu) 2017-12-28
NZ628962A (en) 2016-01-29
AU2011284702C1 (en) 2015-09-03
MX2013000681A (es) 2013-02-27
US9463221B2 (en) 2016-10-11
PT2598160T (pt) 2017-03-30
WO2012013742A2 (en) 2012-02-02
KR101991756B1 (ko) 2019-06-21
ES2623634T3 (es) 2017-07-11
BR112013002312A2 (pt) 2018-03-20
JP5860047B2 (ja) 2016-02-16
US20170216405A1 (en) 2017-08-03
EP2598160B1 (en) 2017-02-22
KR101820115B1 (ko) 2018-01-18
RS55772B1 (sr) 2017-07-31
BR112013002312B1 (pt) 2021-09-21
JO3229B1 (ar) 2018-03-08
AR082776A1 (es) 2013-01-09
IL249920A0 (en) 2017-03-30
EP2417982A1 (en) 2012-02-15
IL223821A (en) 2017-01-31
CN105106939A (zh) 2015-12-02
PL2598160T3 (pl) 2017-06-30
US20130210727A1 (en) 2013-08-15
SI2598160T1 (sl) 2017-07-31
CA2805864A1 (en) 2012-02-02
MX356951B (es) 2018-06-21
KR20180008916A (ko) 2018-01-24
DK2598160T3 (en) 2017-03-27
US8993732B2 (en) 2015-03-31
US20150265681A1 (en) 2015-09-24
TWI439283B (zh) 2014-06-01

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