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

    • 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
    • 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
    • A61K47/06Organic 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
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Reproductive Health (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Endocrinology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Gynecology & Obstetrics (AREA)
  • Organic Chemistry (AREA)
  • Pregnancy & Childbirth (AREA)
  • Zoology (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 (3) US10792334B2 (fr)
EP (3) EP3419595B1 (fr)
JP (3) JP6932710B2 (fr)
KR (1) KR20180114178A (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) DK3791860T3 (fr)
EA (1) EA036383B1 (fr)
ES (2) ES2862193T3 (fr)
FI (1) FI3791860T3 (fr)
GB (1) GB201603280D0 (fr)
HR (2) HRP20231477T1 (fr)
HU (2) HUE053492T2 (fr)
IL (1) IL260626B2 (fr)
JO (1) JOP20170046B1 (fr)
LT (2) LT3791860T (fr)
MA (2) MA43686B1 (fr)
MD (2) MD3419595T2 (fr)
MX (1) MX2018010201A (fr)
MY (1) MY193138A (fr)
PH (1) PH12018501688A1 (fr)
PL (2) PL3791860T3 (fr)
PT (2) PT3419595T (fr)
RS (2) RS61604B1 (fr)
SG (1) SG11201806140SA (fr)
SI (2) SI3419595T1 (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 (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 (fr) * 2018-02-26 2019-08-29 Slayback Pharma Llc Compositions de dexmédétomidine prêtes à l'emploi
EP3860573A1 (fr) * 2018-10-02 2021-08-11 InnoCore Technologies Holding B.V. Formulations à libération prolongée de gonadotrophine chorionique humaine (hcg)
CN114404575A (zh) * 2020-12-07 2022-04-29 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

Family Cites Families (15)

* 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
JP4719357B2 (ja) * 1998-07-23 2011-07-06 アレス トレイディング ソシエテ アノニム Fsh及びfsh変異体の製剤、製品及び方法
EP1909831A4 (fr) * 2005-06-14 2013-02-20 Amgen Inc Préparations de protéines à tamponnage spontané
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
JP5551601B2 (ja) 2007-11-01 2014-07-16 メルク セローノ ソシエテ アノニム Lh液体調製物
SG10201604258YA (en) 2007-11-30 2016-07-28 Abbvie Biotechnology Ltd Anti-tnf antibody formulations
WO2009098318A1 (fr) 2008-02-08 2009-08-13 Biogenerix Ag Formulation liquide de fsh
TWI488640B (zh) 2008-04-16 2015-06-21 Ferring Int Ct Sa 藥學製劑
CN102821782B (zh) * 2010-02-12 2015-07-15 印塔斯生物制药有限公司 促卵泡激素的液体配制品
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
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
EP3791860A1 (fr) 2021-03-17
MY193138A (en) 2022-09-26
JP6932710B2 (ja) 2021-09-08
JOP20170046B1 (ar) 2021-08-17
CN108883061B (zh) 2021-06-08
LT3419595T (lt) 2021-03-10
AU2017222292B2 (en) 2021-12-16
EP3791860B1 (fr) 2023-10-11
CO2018007810A2 (es) 2018-10-22
US10792334B2 (en) 2020-10-06
JP2021191760A (ja) 2021-12-16
JP2023164573A (ja) 2023-11-10
ZA201804944B (en) 2023-02-22
MD3419595T2 (ro) 2021-06-30
HUE064432T2 (hu) 2024-03-28
IL260626B1 (en) 2023-04-01
IL260626A (fr) 2018-09-20
GB201603280D0 (en) 2016-04-13
EP3419595A1 (fr) 2019-01-02
SI3791860T1 (sl) 2024-01-31
EP4257149A2 (fr) 2023-10-11
MA43686A (fr) 2019-01-02
CN113398250B (zh) 2024-02-23
MX2018010201A (es) 2019-06-06
MD3791860T2 (ro) 2024-03-31
CL2018001984A1 (es) 2018-09-14
CN108883061A (zh) 2018-11-23
FI3791860T3 (fi) 2024-01-11
AR107782A1 (es) 2018-06-06
ES2966262T3 (es) 2024-04-19
PL3419595T3 (pl) 2021-06-14
RS64929B1 (sr) 2023-12-29
HUE053492T2 (hu) 2021-06-28
IL260626B2 (en) 2023-08-01
AU2017222292A1 (en) 2018-07-26
US20230372447A1 (en) 2023-11-23
EP4257149A3 (fr) 2023-12-20
SG11201806140SA (en) 2018-08-30
DK3791860T3 (da) 2023-12-18
ES2862193T3 (es) 2021-10-07
BR112018015166A2 (pt) 2018-12-18
AU2022200027A1 (en) 2022-02-03
HRP20231477T1 (hr) 2024-03-01
DK3419595T3 (da) 2021-03-29
CA3012759A1 (fr) 2017-08-31
PT3791860T (pt) 2023-12-15
CN113398250A (zh) 2021-09-17
KR20180114178A (ko) 2018-10-17
SI3419595T1 (sl) 2021-04-30
MA52595A (fr) 2021-03-17
US11666635B2 (en) 2023-06-06
WO2017144659A1 (fr) 2017-08-31
JP2019507153A (ja) 2019-03-14
PT3419595T (pt) 2021-03-29
EA201891905A1 (ru) 2019-02-28
PL3791860T3 (pl) 2024-03-18
EP3419595B1 (fr) 2021-01-06
PH12018501688A1 (en) 2019-05-27
US20210236600A1 (en) 2021-08-05
EA036383B1 (ru) 2020-11-03
TN2018000284A1 (en) 2020-01-16
TWI755377B (zh) 2022-02-21
US20190060409A1 (en) 2019-02-28
HRP20210367T1 (hr) 2021-04-16
TW201733612A (zh) 2017-10-01
MA43686B1 (fr) 2021-03-31
LT3791860T (lt) 2023-12-11
RS61604B1 (sr) 2021-04-29
UA123107C2 (uk) 2021-02-17

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