MD3419595T2 - Formulare de gonadotropină lichidă stabilă - Google Patents

Formulare de gonadotropină lichidă stabilă

Info

Publication number
MD3419595T2
MD3419595T2 MDE20190039T MDE20190039T MD3419595T2 MD 3419595 T2 MD3419595 T2 MD 3419595T2 MD E20190039 T MDE20190039 T MD E20190039T MD E20190039 T MDE20190039 T MD E20190039T MD 3419595 T2 MD3419595 T2 MD 3419595T2
Authority
MD
Moldova
Prior art keywords
stable liquid
formulation
liquid gonadotropin
gonadotropin formulation
stabilization
Prior art date
Application number
MDE20190039T
Other languages
English (en)
Inventor
Helen Ulrika Sjogren
Charlotte Hojer-Pedersen
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
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=MD3419595(T2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Ferring Bv filed Critical Ferring Bv
Publication of MD3419595T2 publication Critical patent/MD3419595T2/ro

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

Prezenta invenţie se referă în general la domeniul stabilizării formulărilor de gonadotropină, în special formulărilor lichide de gonadotropine. Stabilizarea se realizează printr-o combinaţie particulară de excipienţi, de preferinţă arginină şi metionină. Într-o realizare preferată, formularea nu cuprinde un tampon.
MDE20190039T 2016-02-24 2017-02-24 Formulare de gonadotropină lichidă stabilă MD3419595T2 (ro)

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 (1)

Publication Number Publication Date
MD3419595T2 true MD3419595T2 (ro) 2021-06-30

Family

ID=55806922

Family Applications (2)

Application Number Title Priority Date Filing Date
MDE20190039T MD3419595T2 (ro) 2016-02-24 2017-02-24 Formulare de gonadotropină lichidă stabilă
MDE20210250T MD3791860T2 (ro) 2016-02-24 2017-02-24 Formulare de gonadotropină lichidă stabilă

Family Applications After (1)

Application Number Title Priority Date Filing Date
MDE20210250T MD3791860T2 (ro) 2016-02-24 2017-02-24 Formulare de gonadotropină lichidă stabilă

Country Status (36)

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

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 (ro) 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
EA201891905A1 (ru) 2019-02-28
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
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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