DK3791860T3 - Stabil væskeformig gonadotropinformulering - Google Patents
Stabil væskeformig gonadotropinformulering Download PDFInfo
- Publication number
- DK3791860T3 DK3791860T3 DK20202758.7T DK20202758T DK3791860T3 DK 3791860 T3 DK3791860 T3 DK 3791860T3 DK 20202758 T DK20202758 T DK 20202758T DK 3791860 T3 DK3791860 T3 DK 3791860T3
- Authority
- DK
- Denmark
- Prior art keywords
- informulation
- gonadotropine
- stable liquid
- stable
- liquid
- Prior art date
Links
- 239000007788 liquid Substances 0.000 title 1
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)
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 |
| EP17707527.2A EP3419595B1 (en) | 2016-02-24 | 2017-02-24 | Stable liquid gonadotropin formulation |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| DK3791860T3 true DK3791860T3 (da) | 2023-12-18 |
| DK3791860T5 DK3791860T5 (da) | 2024-08-19 |
Family
ID=55806922
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK20202758.7T DK3791860T5 (da) | 2016-02-24 | 2017-02-24 | Stabil væskeformig gonadotropinformulering |
| DK17707527.2T DK3419595T3 (da) | 2016-02-24 | 2017-02-24 | Stabil flydende gonadotropinformulering |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK17707527.2T DK3419595T3 (da) | 2016-02-24 | 2017-02-24 | Stabil flydende gonadotropinformulering |
Country Status (36)
| Country | Link |
|---|---|
| US (4) | US10792334B2 (da) |
| EP (3) | EP4257149A3 (da) |
| JP (3) | JP6932710B2 (da) |
| KR (1) | KR102756413B1 (da) |
| CN (2) | CN113398250B (da) |
| AR (1) | AR107782A1 (da) |
| AU (2) | AU2017222292B2 (da) |
| BR (1) | BR112018015166A2 (da) |
| CA (1) | CA3012759A1 (da) |
| CL (1) | CL2018001984A1 (da) |
| CO (1) | CO2018007810A2 (da) |
| DK (2) | DK3791860T5 (da) |
| EA (1) | EA036383B1 (da) |
| ES (2) | ES2862193T3 (da) |
| FI (1) | FI3791860T3 (da) |
| GB (1) | GB201603280D0 (da) |
| HR (2) | HRP20210367T1 (da) |
| HU (2) | HUE064432T2 (da) |
| IL (1) | IL260626B2 (da) |
| JO (1) | JOP20170046B1 (da) |
| LT (2) | LT3419595T (da) |
| MA (2) | MA43686B1 (da) |
| MD (2) | MD3419595T2 (da) |
| MX (1) | MX381709B (da) |
| MY (1) | MY193138A (da) |
| PH (1) | PH12018501688B1 (da) |
| PL (2) | PL3419595T3 (da) |
| PT (2) | PT3791860T (da) |
| RS (2) | RS61604B1 (da) |
| SG (1) | SG11201806140SA (da) |
| SI (2) | SI3791860T1 (da) |
| TN (1) | TN2018000284A1 (da) |
| TW (1) | TWI755377B (da) |
| UA (1) | UA123107C2 (da) |
| WO (1) | WO2017144659A1 (da) |
| ZA (1) | ZA201804944B (da) |
Families Citing this family (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB201603280D0 (en) | 2016-02-24 | 2016-04-13 | Ferring Bv | Stable liquid gonadotropin formulation |
| US20190262314A1 (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) |
| 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 (en) * | 2021-03-19 | 2022-09-22 | Pfizer Inc. | Long-acting growth hormone compositions |
| 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)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0803832A3 (en) | 1996-02-28 | 2000-05-31 | Hitachi, Ltd. | Card holder-type balance display |
| IL122732A0 (en) * | 1997-01-15 | 1998-08-16 | Akzo Nobel Nv | Liquid gonadotropin-containing formulation its preparation and a device containing same |
| IL140984A0 (en) * | 1998-07-23 | 2002-02-10 | Lilly Co Eli | 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 |
| BRPI0818324B8 (pt) | 2007-11-01 | 2021-05-25 | Merck Serono Sa | formulação líquida contendo hormônio luteinizante (lh) ou uma variante do mesmo, seu uso, sua forma de apresentação, processo para a sua preparação e composição farmacêutica |
| 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 |
| 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 | 菲瑞茵國際中心股份有限公司 | 藥學製劑 |
| KR101668502B1 (ko) | 2008-11-04 | 2016-10-21 | 아스카 세이야쿠 가부시키가이샤 | 난포자극호르몬 함유 수성 조성물 |
| 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 |
| AP2016009159A0 (en) * | 2013-11-12 | 2016-04-30 | Cadila Healthcare Ltd | Formulation for gonadotropins |
| GB201603280D0 (en) * | 2016-02-24 | 2016-04-13 | Ferring Bv | Stable liquid gonadotropin formulation |
-
2016
- 2016-02-24 GB GBGB1603280.7A patent/GB201603280D0/en not_active Ceased
-
2017
- 2017-02-19 JO JOP/2017/0046A patent/JOP20170046B1/ar active
- 2017-02-23 TW TW106106132A patent/TWI755377B/zh active
- 2017-02-24 SI SI201731448T patent/SI3791860T1/sl unknown
- 2017-02-24 PH PH1/2018/501688A patent/PH12018501688B1/en unknown
- 2017-02-24 CA CA3012759A patent/CA3012759A1/en active Pending
- 2017-02-24 EP EP23194814.2A patent/EP4257149A3/en not_active Withdrawn
- 2017-02-24 JP JP2018544561A patent/JP6932710B2/ja active Active
- 2017-02-24 ES ES17707527T patent/ES2862193T3/es active Active
- 2017-02-24 MA MA43686A patent/MA43686B1/fr unknown
- 2017-02-24 SG SG11201806140SA patent/SG11201806140SA/en unknown
- 2017-02-24 DK DK20202758.7T patent/DK3791860T5/da active
- 2017-02-24 EA EA201891905A patent/EA036383B1/ru not_active IP Right Cessation
- 2017-02-24 MY MYPI2018001301A patent/MY193138A/en unknown
- 2017-02-24 PT PT202027587T patent/PT3791860T/pt unknown
- 2017-02-24 PT PT177075272T patent/PT3419595T/pt unknown
- 2017-02-24 KR KR1020187027128A patent/KR102756413B1/ko active Active
- 2017-02-24 HU HUE20202758A patent/HUE064432T2/hu unknown
- 2017-02-24 HR HRP20210367TT patent/HRP20210367T1/hr unknown
- 2017-02-24 AR ARP170100475A patent/AR107782A1/es not_active Application Discontinuation
- 2017-02-24 RS RS20210361A patent/RS61604B1/sr unknown
- 2017-02-24 DK DK17707527.2T patent/DK3419595T3/da active
- 2017-02-24 WO PCT/EP2017/054325 patent/WO2017144659A1/en not_active Ceased
- 2017-02-24 BR BR112018015166A patent/BR112018015166A2/pt active Search and Examination
- 2017-02-24 MA MA52595A patent/MA52595B1/fr unknown
- 2017-02-24 SI SI201730666T patent/SI3419595T1/sl unknown
- 2017-02-24 UA UAA201809497A patent/UA123107C2/uk unknown
- 2017-02-24 ES ES20202758T patent/ES2966262T3/es active Active
- 2017-02-24 LT LTEP17707527.2T patent/LT3419595T/lt unknown
- 2017-02-24 RS RS20231172A patent/RS64929B1/sr unknown
- 2017-02-24 MD MDE20190039T patent/MD3419595T2/ro unknown
- 2017-02-24 MX MX2018010201A patent/MX381709B/es unknown
- 2017-02-24 CN CN202110585922.3A patent/CN113398250B/zh active Active
- 2017-02-24 TN TNP/2018/000284A patent/TN2018000284A1/en unknown
- 2017-02-24 AU AU2017222292A patent/AU2017222292B2/en active Active
- 2017-02-24 PL PL17707527T patent/PL3419595T3/pl unknown
- 2017-02-24 EP EP20202758.7A patent/EP3791860B1/en active Active
- 2017-02-24 PL PL20202758.7T patent/PL3791860T3/pl unknown
- 2017-02-24 US US16/079,428 patent/US10792334B2/en active Active
- 2017-02-24 EP EP17707527.2A patent/EP3419595B1/en active Active
- 2017-02-24 MD MDE20210250T patent/MD3791860T2/ro unknown
- 2017-02-24 FI FIEP20202758.7T patent/FI3791860T3/fi active
- 2017-02-24 LT LTEP20202758.7T patent/LT3791860T/lt unknown
- 2017-02-24 HU HUE17707527A patent/HUE053492T2/hu unknown
- 2017-02-24 HR HRP20231477TT patent/HRP20231477T1/hr unknown
- 2017-02-24 CN CN201780013134.9A patent/CN108883061B/zh active Active
-
2018
- 2018-07-17 IL IL260626A patent/IL260626B2/en unknown
- 2018-07-23 CL CL2018001984A patent/CL2018001984A1/es unknown
- 2018-07-23 ZA ZA2018/04944A patent/ZA201804944B/en unknown
- 2018-07-27 CO CONC2018/0007810A patent/CO2018007810A2/es unknown
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2020
- 2020-09-14 US US17/020,279 patent/US11666635B2/en active Active
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2021
- 2021-08-18 JP JP2021133422A patent/JP2021191760A/ja active Pending
-
2022
- 2022-01-05 AU AU2022200027A patent/AU2022200027A1/en not_active Abandoned
-
2023
- 2023-04-21 US US18/138,000 patent/US12447196B2/en active Active
- 2023-09-15 JP JP2023150308A patent/JP2023164573A/ja active Pending
-
2025
- 2025-04-02 US US19/098,420 patent/US20250352621A1/en active Pending
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