MA52595B1 - Formulation liquide stable de gonadotrophines - Google Patents

Formulation liquide stable de gonadotrophines

Info

Publication number
MA52595B1
MA52595B1 MA52595A MA52595A MA52595B1 MA 52595 B1 MA52595 B1 MA 52595B1 MA 52595 A MA52595 A MA 52595A MA 52595 A MA52595 A MA 52595A MA 52595 B1 MA52595 B1 MA 52595B1
Authority
MA
Morocco
Prior art keywords
gonadotrophins
liquid formulation
stable liquid
stabilization
formulation
Prior art date
Application number
MA52595A
Other languages
English (en)
Other versions
MA52595A (fr
Inventor
Helen Ulrika Sjögren
Charlotte Højer-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=MA52595(B1) "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 MA52595A publication Critical patent/MA52595A/fr
Publication of MA52595B1 publication Critical patent/MA52595B1/fr

Links

Classifications

    • 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
    • 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
    • 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)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Reproductive Health (AREA)
  • Endocrinology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Zoology (AREA)
  • Pregnancy & Childbirth (AREA)
  • Gynecology & Obstetrics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Gastroenterology & Hepatology (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

La présente invention concerne de manière générale le domaine de la stabilisation de formulations de gonadotrophines, en particulier de formulations liquides de gonadotrophines. La stabilisation est obtenue grâce à une combinaison particulière d'excipients, de préférence l'arginine et la méthionine. Dans un mode de réalisation préféré, la formulation ne comprend pas de tampon.
MA52595A 2016-02-24 2017-02-24 Formulation liquide stable de gonadotrophines MA52595B1 (fr)

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 (fr) 2016-02-24 2017-02-24 Formulation liquide stable de gonadotrophines

Publications (2)

Publication Number Publication Date
MA52595A MA52595A (fr) 2021-03-17
MA52595B1 true MA52595B1 (fr) 2023-12-29

Family

ID=55806922

Family Applications (2)

Application Number Title Priority Date Filing Date
MA43686A MA43686B1 (fr) 2016-02-24 2017-02-24 Formulation liquide stable de gonadotrophines
MA52595A MA52595B1 (fr) 2016-02-24 2017-02-24 Formulation liquide stable de gonadotrophines

Family Applications Before (1)

Application Number Title Priority Date Filing Date
MA43686A MA43686B1 (fr) 2016-02-24 2017-02-24 Formulation liquide stable de gonadotrophines

Country Status (36)

Country Link
US (4) US10792334B2 (fr)
EP (3) EP3791860B1 (fr)
JP (3) JP6932710B2 (fr)
KR (1) KR102756413B1 (fr)
CN (2) CN108883061B (fr)
AR (1) AR107782A1 (fr)
AU (2) AU2017222292B2 (fr)
BR (1) BR112018015166A2 (fr)
CA (1) CA3012759A1 (fr)
CL (1) CL2018001984A1 (fr)
CO (1) CO2018007810A2 (fr)
DK (2) DK3419595T3 (fr)
EA (1) EA036383B1 (fr)
ES (2) ES2862193T3 (fr)
FI (1) FI3791860T3 (fr)
GB (1) GB201603280D0 (fr)
HR (2) HRP20210367T1 (fr)
HU (2) HUE064432T2 (fr)
IL (1) IL260626B2 (fr)
JO (1) JOP20170046B1 (fr)
LT (2) LT3791860T (fr)
MA (2) MA43686B1 (fr)
MD (2) MD3791860T2 (fr)
MX (1) MX381709B (fr)
MY (1) MY193138A (fr)
PH (1) PH12018501688B1 (fr)
PL (2) PL3791860T3 (fr)
PT (2) PT3419595T (fr)
RS (2) RS64929B1 (fr)
SG (1) SG11201806140SA (fr)
SI (2) SI3791860T1 (fr)
TN (1) TN2018000284A1 (fr)
TW (1) TWI755377B (fr)
UA (1) UA123107C2 (fr)
WO (1) WO2017144659A1 (fr)
ZA (1) ZA201804944B (fr)

Families Citing this family (7)

* 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 (fr) * 2018-02-26 2019-08-29 Slayback Pharma Llc Compositions de dexmédétomidine prêtes à l'emploi
BR112021006406A2 (pt) * 2018-10-02 2021-07-06 Innocore Tech Holding B V forma de dosagem de gonadotrofina coriônica humana (hcg) de liberação prolongada
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 (fr) * 2021-03-19 2022-09-22 Pfizer Inc. Compositions d'hormone de croissance à action prolongée
CN118209739A (zh) * 2024-03-19 2024-06-18 厦门宝太和瑞生物技术有限公司 促黄体生成素检测试剂盒
KR102821987B1 (ko) * 2024-10-24 2025-06-26 에이디텍 주식회사 베타 코어 단편 hCG를 유효성분으로 포함하는 난임 치료용 조성물

Family Cites Families (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2198299C (fr) 1996-02-28 2000-05-02 Yuhei Abe Afficheur de solde genre porte-carte
TW518235B (en) * 1997-01-15 2003-01-21 Akzo Nobel Nv A gonadotropin-containing pharmaceutical composition with improved stability on prolong storage
CA2335340C (fr) * 1998-07-23 2013-03-05 Eli Lilly And Company Formulations de fsh et de variants de fsh, produits et procedes
JP2008543839A (ja) 2005-06-14 2008-12-04 アムジェン インコーポレーテッド 自己緩衝タンパク質製剤
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
ES2393233T3 (es) * 2007-11-01 2012-12-19 Merck Serono S.A. Formulaciones de LH líquidas
US8420081B2 (en) 2007-11-30 2013-04-16 Abbvie, Inc. Antibody formulations and methods of making same
PE20091174A1 (es) 2007-12-27 2009-08-03 Chugai Pharmaceutical Co Ltd Formulacion liquida con contenido de alta concentracion de anticuerpo
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
RU2561057C2 (ru) 2008-11-04 2015-08-20 Аска Фармасьютикал Ко., Лтд. Водная композиция, содержащая фолликулостимулирующий гормон
RU2553375C2 (ru) 2010-02-12 2015-06-10 Интас Биофармасьютикалс Лимитед Жидкий состав фолликулостимулирующего гормона
WO2011108010A2 (fr) 2010-03-05 2011-09-09 Intas Biopharmaceuticals Limited Préparation liquide thermostable de gonadotropines
EP2417982A1 (fr) * 2010-07-30 2012-02-15 Ferring B.V. Stabilisation de gonadotrophines
HK1223559A1 (zh) * 2013-11-12 2017-08-04 Cadila Healthcare Limited 用於促性腺激素的配方
GB201603280D0 (en) 2016-02-24 2016-04-13 Ferring Bv Stable liquid gonadotropin formulation

Also Published As

Publication number Publication date
JP2021191760A (ja) 2021-12-16
JP6932710B2 (ja) 2021-09-08
PT3419595T (pt) 2021-03-29
PT3791860T (pt) 2023-12-15
US10792334B2 (en) 2020-10-06
EP3791860A1 (fr) 2021-03-17
CN108883061A (zh) 2018-11-23
GB201603280D0 (en) 2016-04-13
EP4257149A2 (fr) 2023-10-11
US20190060409A1 (en) 2019-02-28
SG11201806140SA (en) 2018-08-30
PH12018501688A1 (en) 2019-05-27
HUE064432T2 (hu) 2024-03-28
CA3012759A1 (fr) 2017-08-31
PL3791860T3 (pl) 2024-03-18
LT3791860T (lt) 2023-12-11
AR107782A1 (es) 2018-06-06
KR102756413B1 (ko) 2025-01-16
PL3419595T3 (pl) 2021-06-14
IL260626A (fr) 2018-09-20
FI3791860T3 (fi) 2024-01-11
MD3791860T2 (ro) 2024-03-31
JOP20170046B1 (ar) 2021-08-17
AU2017222292B2 (en) 2021-12-16
MX2018010201A (es) 2019-06-06
EP3419595B1 (fr) 2021-01-06
MA52595A (fr) 2021-03-17
MA43686B1 (fr) 2021-03-31
CN108883061B (zh) 2021-06-08
HRP20231477T1 (hr) 2024-03-01
MX381709B (es) 2025-03-13
RS64929B1 (sr) 2023-12-29
DK3419595T3 (da) 2021-03-29
DK3791860T3 (da) 2023-12-18
EA036383B1 (ru) 2020-11-03
BR112018015166A2 (en) 2018-12-18
EP4257149A3 (fr) 2023-12-20
KR20180114178A (ko) 2018-10-17
SI3419595T1 (sl) 2021-04-30
ZA201804944B (en) 2023-02-22
MY193138A (en) 2022-09-26
LT3419595T (lt) 2021-03-10
CN113398250A (zh) 2021-09-17
HRP20210367T1 (hr) 2021-04-16
AU2022200027A1 (en) 2022-02-03
EA201891905A1 (ru) 2019-02-28
MD3419595T2 (ro) 2021-06-30
TW201733612A (zh) 2017-10-01
CO2018007810A2 (es) 2018-10-22
US20250352621A1 (en) 2025-11-20
SI3791860T1 (sl) 2024-01-31
JP2019507153A (ja) 2019-03-14
IL260626B2 (en) 2023-08-01
TN2018000284A1 (en) 2020-01-16
TWI755377B (zh) 2022-02-21
EP3791860B1 (fr) 2023-10-11
WO2017144659A1 (fr) 2017-08-31
HUE053492T2 (hu) 2021-06-28
CL2018001984A1 (es) 2018-09-14
US11666635B2 (en) 2023-06-06
AU2017222292A1 (en) 2018-07-26
IL260626B1 (en) 2023-04-01
US20210236600A1 (en) 2021-08-05
US20230372447A1 (en) 2023-11-23
EP3419595A1 (fr) 2019-01-02
UA123107C2 (uk) 2021-02-17
ES2966262T3 (es) 2024-04-19
NZ744294A (en) 2024-08-30
PH12018501688B1 (en) 2023-08-02
CN113398250B (zh) 2024-02-23
DK3791860T5 (da) 2024-08-19
ES2862193T3 (es) 2021-10-07
MA43686A (fr) 2019-01-02
US12447196B2 (en) 2025-10-21
JP2023164573A (ja) 2023-11-10
RS61604B1 (sr) 2021-04-29

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