EA201891905A1 - Стабильная жидкая композиция гонадотропина - Google Patents

Стабильная жидкая композиция гонадотропина

Info

Publication number
EA201891905A1
EA201891905A1 EA201891905A EA201891905A EA201891905A1 EA 201891905 A1 EA201891905 A1 EA 201891905A1 EA 201891905 A EA201891905 A EA 201891905A EA 201891905 A EA201891905 A EA 201891905A EA 201891905 A1 EA201891905 A1 EA 201891905A1
Authority
EA
Eurasian Patent Office
Prior art keywords
gonadotropine
liquid composition
stable liquid
stabilization
composition
Prior art date
Application number
EA201891905A
Other languages
English (en)
Other versions
EA036383B1 (ru
Inventor
Хелен Ульрика Сьёгрен
Шарлотт Хёйер-Педерсен
Original Assignee
Ферринг Б.В.
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=55806922&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=EA201891905(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Ферринг Б.В. filed Critical Ферринг Б.В.
Publication of EA201891905A1 publication Critical patent/EA201891905A1/ru
Publication of EA036383B1 publication Critical patent/EA036383B1/ru

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
    • A61K47/06—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
    • A61K47/16—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
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61P15/08—Drugs for genital or sexual disorders; Contraceptives for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Reproductive Health (AREA)
  • Endocrinology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Gynecology & Obstetrics (AREA)
  • Pregnancy & Childbirth (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Immunology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Dermatology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)

Abstract

Настоящее изобретение относится в целом к области стабилизации композиций гонадотропина, в частности жидких композиций гонадотропинов. Стабилизации достигают посредством конкретной комбинации эксципиентов, предпочтительно аргинина и метионина. В предпочтительном варианте осуществления композиция не содержит буфера.
EA201891905A 2016-02-24 2017-02-24 Стабильная жидкая композиция гонадотропина EA036383B1 (ru)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GBGB1603280.7A GB201603280D0 (en) 2016-02-24 2016-02-24 Stable liquid gonadotropin formulation
PCT/EP2017/054325 WO2017144659A1 (en) 2016-02-24 2017-02-24 Stable liquid gonadotropin formulation

Publications (2)

Publication Number Publication Date
EA201891905A1 true EA201891905A1 (ru) 2019-02-28
EA036383B1 EA036383B1 (ru) 2020-11-03

Family

ID=55806922

Family Applications (1)

Application Number Title Priority Date Filing Date
EA201891905A EA036383B1 (ru) 2016-02-24 2017-02-24 Стабильная жидкая композиция гонадотропина

Country Status (36)

Country Link
US (3) US10792334B2 (ru)
EP (3) EP4257149A3 (ru)
JP (3) JP6932710B2 (ru)
KR (1) KR20180114178A (ru)
CN (2) CN113398250B (ru)
AR (1) AR107782A1 (ru)
AU (2) AU2017222292B2 (ru)
BR (1) BR112018015166A2 (ru)
CA (1) CA3012759A1 (ru)
CL (1) CL2018001984A1 (ru)
CO (1) CO2018007810A2 (ru)
DK (2) DK3419595T3 (ru)
EA (1) EA036383B1 (ru)
ES (2) ES2966262T3 (ru)
FI (1) FI3791860T3 (ru)
GB (1) GB201603280D0 (ru)
HR (2) HRP20231477T1 (ru)
HU (2) HUE064432T2 (ru)
IL (1) IL260626B2 (ru)
JO (1) JOP20170046B1 (ru)
LT (2) LT3419595T (ru)
MA (2) MA43686B1 (ru)
MD (2) MD3419595T2 (ru)
MX (1) MX2018010201A (ru)
MY (1) MY193138A (ru)
PH (1) PH12018501688A1 (ru)
PL (2) PL3419595T3 (ru)
PT (2) PT3791860T (ru)
RS (2) RS64929B1 (ru)
SG (1) SG11201806140SA (ru)
SI (2) SI3791860T1 (ru)
TN (1) TN2018000284A1 (ru)
TW (1) TWI755377B (ru)
UA (1) UA123107C2 (ru)
WO (1) WO2017144659A1 (ru)
ZA (1) ZA201804944B (ru)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB201603280D0 (en) 2016-02-24 2016-04-13 Ferring Bv Stable liquid gonadotropin formulation
WO2019164765A1 (en) * 2018-02-26 2019-08-29 Slayback Pharma Llc Ready-to-use dexmedetomidine compositions
WO2020071912A1 (en) * 2018-10-02 2020-04-09 Innocore Technologies B.V. Extended release formulations of human chorionic gonadotropin (hcg)
CN112451652A (zh) * 2020-12-07 2021-03-09 苏州智核生物医药科技有限公司 一种重组人促甲状腺素注射液
WO2022197963A1 (en) * 2021-03-19 2022-09-22 Pfizer Inc. Long-acting growth hormone compositions

Family Cites Families (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0803832A3 (en) 1996-02-28 2000-05-31 Hitachi, Ltd. Card holder-type balance display
TW518235B (en) * 1997-01-15 2003-01-21 Akzo Nobel Nv A gonadotropin-containing pharmaceutical composition with improved stability on prolong storage
WO2000004913A1 (en) * 1998-07-23 2000-02-03 Eli Lilly And Company Fsh and fsh variant formulations, products and methods
BRPI0611901A2 (pt) 2005-06-14 2012-08-28 Amgen, Inc composição, liofilizado, kit, e, processo para preparar uma composição
KR101105871B1 (ko) * 2005-09-27 2012-01-16 주식회사 엘지생명과학 인 난포자극호르몬의 안정한 용액 제형
GB0700523D0 (en) 2007-01-11 2007-02-21 Insense Ltd The Stabilisation Of Proteins
EA019432B1 (ru) * 2007-11-01 2014-03-31 Мерк Сероно С.А. Жидкие композиции lh
US8420081B2 (en) 2007-11-30 2013-04-16 Abbvie, Inc. Antibody formulations and methods of making same
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 Ferring Int Ct Sa 藥學製劑
RU2553375C2 (ru) 2010-02-12 2015-06-10 Интас Биофармасьютикалс Лимитед Жидкий состав фолликулостимулирующего гормона
WO2011108010A2 (en) 2010-03-05 2011-09-09 Intas Biopharmaceuticals Limited A thermostable liquid formulation of gonadotropins
EP2417982A1 (en) 2010-07-30 2012-02-15 Ferring B.V. Stabilization of gonadotropins
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
GB201603280D0 (en) * 2016-02-24 2016-04-13 Ferring Bv Stable liquid gonadotropin formulation

Also Published As

Publication number Publication date
CN113398250B (zh) 2024-02-23
EP3791860A1 (en) 2021-03-17
JP2023164573A (ja) 2023-11-10
PL3419595T3 (pl) 2021-06-14
RS61604B1 (sr) 2021-04-29
JP2019507153A (ja) 2019-03-14
ZA201804944B (en) 2023-02-22
US20210236600A1 (en) 2021-08-05
EP4257149A3 (en) 2023-12-20
US10792334B2 (en) 2020-10-06
PH12018501688A1 (en) 2019-05-27
MA52595A (fr) 2021-03-17
AU2017222292B2 (en) 2021-12-16
GB201603280D0 (en) 2016-04-13
EP3419595B1 (en) 2021-01-06
MA43686B1 (fr) 2021-03-31
MA52595B1 (fr) 2023-12-29
TW201733612A (zh) 2017-10-01
IL260626A (ru) 2018-09-20
LT3419595T (lt) 2021-03-10
CN113398250A (zh) 2021-09-17
US20190060409A1 (en) 2019-02-28
SI3791860T1 (sl) 2024-01-31
BR112018015166A2 (pt) 2018-12-18
CN108883061B (zh) 2021-06-08
CL2018001984A1 (es) 2018-09-14
RS64929B1 (sr) 2023-12-29
CA3012759A1 (en) 2017-08-31
FI3791860T3 (fi) 2024-01-11
TN2018000284A1 (en) 2020-01-16
TWI755377B (zh) 2022-02-21
MX2018010201A (es) 2019-06-06
IL260626B2 (en) 2023-08-01
MD3791860T2 (ro) 2024-03-31
CN108883061A (zh) 2018-11-23
ES2862193T3 (es) 2021-10-07
US11666635B2 (en) 2023-06-06
IL260626B1 (en) 2023-04-01
LT3791860T (lt) 2023-12-11
AU2022200027A1 (en) 2022-02-03
EP3791860B1 (en) 2023-10-11
SG11201806140SA (en) 2018-08-30
EP3419595A1 (en) 2019-01-02
WO2017144659A1 (en) 2017-08-31
JP2021191760A (ja) 2021-12-16
JP6932710B2 (ja) 2021-09-08
EA036383B1 (ru) 2020-11-03
MA43686A (fr) 2019-01-02
CO2018007810A2 (es) 2018-10-22
EP4257149A2 (en) 2023-10-11
DK3419595T3 (da) 2021-03-29
JOP20170046B1 (ar) 2021-08-17
MD3419595T2 (ro) 2021-06-30
HRP20210367T1 (hr) 2021-04-16
PT3419595T (pt) 2021-03-29
AU2017222292A1 (en) 2018-07-26
US20230372447A1 (en) 2023-11-23
KR20180114178A (ko) 2018-10-17
SI3419595T1 (sl) 2021-04-30
HUE053492T2 (hu) 2021-06-28
UA123107C2 (uk) 2021-02-17
HRP20231477T1 (hr) 2024-03-01
MY193138A (en) 2022-09-26
ES2966262T3 (es) 2024-04-19
AR107782A1 (es) 2018-06-06
PL3791860T3 (pl) 2024-03-18
DK3791860T3 (da) 2023-12-18
PT3791860T (pt) 2023-12-15
HUE064432T2 (hu) 2024-03-28

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Legal Events

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MM4A Lapse of a eurasian patent due to non-payment of renewal fees within the time limit in the following designated state(s)

Designated state(s): TJ TM