KR101699677B1 - 고나도트로핀을 위한 제제 - Google Patents
고나도트로핀을 위한 제제 Download PDFInfo
- Publication number
- KR101699677B1 KR101699677B1 KR1020167010341A KR20167010341A KR101699677B1 KR 101699677 B1 KR101699677 B1 KR 101699677B1 KR 1020167010341 A KR1020167010341 A KR 1020167010341A KR 20167010341 A KR20167010341 A KR 20167010341A KR 101699677 B1 KR101699677 B1 KR 101699677B1
- Authority
- KR
- South Korea
- Prior art keywords
- formulation
- delete delete
- gonadotropin
- present
- concentration
- Prior art date
- Legal status (The legal status 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 status listed.)
- Expired - Fee Related
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
- A61K47/02—Inorganic compounds
-
- 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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- 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
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/06—Drugs for disorders of the endocrine system of the anterior pituitary hormones, e.g. TSH, ACTH, FSH, LH, PRL, GH
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/24—Drugs for disorders of the endocrine system of the sex hormones
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Endocrinology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Zoology (AREA)
- Reproductive Health (AREA)
- Gastroenterology & Hepatology (AREA)
- Immunology (AREA)
- Dermatology (AREA)
- Inorganic Chemistry (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Diabetes (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IN3559/MUM/2013 | 2013-11-12 | ||
| PCT/IN2014/000691 WO2015075743A1 (en) | 2013-11-12 | 2014-10-31 | Formulation for gonadotropins |
| IN3559MU2013 IN2013MU03559A (enExample) | 2013-11-12 | 2014-10-31 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| KR20160048227A KR20160048227A (ko) | 2016-05-03 |
| KR101699677B1 true KR101699677B1 (ko) | 2017-01-24 |
Family
ID=52684607
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| KR1020167010341A Expired - Fee Related KR101699677B1 (ko) | 2013-11-12 | 2014-10-31 | 고나도트로핀을 위한 제제 |
Country Status (21)
| Country | Link |
|---|---|
| US (1) | US20160250295A1 (enExample) |
| EP (1) | EP3068374A1 (enExample) |
| JP (1) | JP6166470B2 (enExample) |
| KR (1) | KR101699677B1 (enExample) |
| CN (1) | CN105658201A (enExample) |
| AP (1) | AP2016009159A0 (enExample) |
| AR (1) | AR098386A1 (enExample) |
| AU (1) | AU2014351326B2 (enExample) |
| CA (1) | CA2928311A1 (enExample) |
| CL (1) | CL2016000944A1 (enExample) |
| EA (1) | EA201690626A1 (enExample) |
| HK (1) | HK1223559A1 (enExample) |
| IL (1) | IL244986A (enExample) |
| IN (1) | IN2013MU03559A (enExample) |
| MX (1) | MX356383B (enExample) |
| NZ (1) | NZ718960A (enExample) |
| PH (1) | PH12016500738A1 (enExample) |
| SG (1) | SG11201603142YA (enExample) |
| TW (1) | TWI579003B (enExample) |
| WO (1) | WO2015075743A1 (enExample) |
| ZA (1) | ZA201602718B (enExample) |
Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| RU2599031C1 (ru) * | 2015-08-11 | 2016-10-10 | Общество с ограниченной ответственностью "АйВиФарма" | Водная композиция рекомбинантного фолликулостимулирующего гормона человека (варианты) |
| GB201603280D0 (en) | 2016-02-24 | 2016-04-13 | Ferring Bv | Stable liquid gonadotropin formulation |
| RU2633079C2 (ru) * | 2016-06-21 | 2017-10-11 | Федеральное государственное бюджетное научное учреждение "Центр экспериментальной эмбриологии и репродуктивных биотехнологий" (ФГБНУ ЦЭЭРБ) | Фармацевтическая композиция с пролонгированным действием гонадотропинов для проведения индукции суперовуляции у самок млекопитающих |
| 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 |
| CN115634284B (zh) * | 2022-10-31 | 2025-02-11 | 景泽生物医药(合肥)股份有限公司 | 一种促性腺激素冻干制剂及其制备方法 |
Family Cites Families (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| TW518235B (en) | 1997-01-15 | 2003-01-21 | Akzo Nobel Nv | A gonadotropin-containing pharmaceutical composition with improved stability on prolong storage |
| PL346127A1 (en) * | 1998-07-23 | 2002-01-28 | Lilly Co Eli | Fsh and fsh variant formulations, products and methods |
| PT1610822E (pt) * | 2003-04-02 | 2011-01-05 | Ares Trading Sa | Formulações farmacêuticas líquidas ou liofilizadas de fsh e/ou lh em conjunto com o surfactante não iónico poloxâmero 188 e um agente bacteriostático |
| KR101105871B1 (ko) * | 2005-09-27 | 2012-01-16 | 주식회사 엘지생명과학 | 인 난포자극호르몬의 안정한 용액 제형 |
| WO2008004717A1 (en) * | 2006-07-06 | 2008-01-10 | Daewoong Co., Ltd. | A stable liquid formulation of human growth hormone |
| US8329649B2 (en) * | 2008-11-04 | 2012-12-11 | Aska Pharmaceutical Co., Ltd. | Aqueous composition containing follicle-stimulating hormone and histidine |
| IT1395957B1 (it) * | 2009-05-19 | 2012-11-02 | Pharmaguida S R L | Uso di una combinazione di d-aspartato e l-aspartato per il trattamento della infertilita' maschile. |
| EP2533800B1 (en) * | 2010-02-12 | 2016-07-20 | Intas Pharmaceuticals Ltd. | Liquid formulation of follicle stimulating hormone |
| 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 |
| US20130121961A1 (en) * | 2011-11-11 | 2013-05-16 | The Johns Hopkins University | Treatment modalities to prevent or treat loss of cardiovascular function in aging humans |
-
2014
- 2014-10-31 WO PCT/IN2014/000691 patent/WO2015075743A1/en not_active Ceased
- 2014-10-31 JP JP2016525079A patent/JP6166470B2/ja not_active Expired - Fee Related
- 2014-10-31 SG SG11201603142YA patent/SG11201603142YA/en unknown
- 2014-10-31 MX MX2016005154A patent/MX356383B/es active IP Right Grant
- 2014-10-31 IN IN3559MU2013 patent/IN2013MU03559A/en unknown
- 2014-10-31 CN CN201480057647.6A patent/CN105658201A/zh active Pending
- 2014-10-31 KR KR1020167010341A patent/KR101699677B1/ko not_active Expired - Fee Related
- 2014-10-31 AU AU2014351326A patent/AU2014351326B2/en not_active Expired - Fee Related
- 2014-10-31 EP EP14845007.5A patent/EP3068374A1/en not_active Withdrawn
- 2014-10-31 CA CA2928311A patent/CA2928311A1/en not_active Abandoned
- 2014-10-31 HK HK16111891.9A patent/HK1223559A1/zh unknown
- 2014-10-31 NZ NZ718960A patent/NZ718960A/en not_active IP Right Cessation
- 2014-10-31 AP AP2016009159A patent/AP2016009159A0/en unknown
- 2014-10-31 EA EA201690626A patent/EA201690626A1/ru unknown
- 2014-10-31 US US15/030,527 patent/US20160250295A1/en not_active Abandoned
- 2014-11-03 TW TW103138047A patent/TWI579003B/zh not_active IP Right Cessation
- 2014-11-11 AR ARP140104243A patent/AR098386A1/es unknown
-
2016
- 2016-04-07 IL IL244986A patent/IL244986A/en not_active IP Right Cessation
- 2016-04-20 CL CL2016000944A patent/CL2016000944A1/es unknown
- 2016-04-20 PH PH12016500738A patent/PH12016500738A1/en unknown
- 2016-04-20 ZA ZA2016/02718A patent/ZA201602718B/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| MX356383B (es) | 2018-05-24 |
| EP3068374A1 (en) | 2016-09-21 |
| HK1223559A1 (zh) | 2017-08-04 |
| PH12016500738A1 (en) | 2016-05-30 |
| JP2016534061A (ja) | 2016-11-04 |
| EA201690626A1 (ru) | 2016-09-30 |
| AR098386A1 (es) | 2016-05-26 |
| IN2013MU03559A (enExample) | 2015-07-24 |
| CN105658201A (zh) | 2016-06-08 |
| JP6166470B2 (ja) | 2017-07-19 |
| IL244986A0 (en) | 2016-05-31 |
| SG11201603142YA (en) | 2016-05-30 |
| NZ718960A (en) | 2017-06-30 |
| TWI579003B (zh) | 2017-04-21 |
| CA2928311A1 (en) | 2015-05-28 |
| AU2014351326B2 (en) | 2017-08-31 |
| CL2016000944A1 (es) | 2016-11-11 |
| TW201529097A (zh) | 2015-08-01 |
| ZA201602718B (en) | 2017-06-28 |
| KR20160048227A (ko) | 2016-05-03 |
| IL244986A (en) | 2016-11-30 |
| MX2016005154A (es) | 2016-08-17 |
| AU2014351326A1 (en) | 2016-05-12 |
| US20160250295A1 (en) | 2016-09-01 |
| WO2015075743A1 (en) | 2015-05-28 |
| AP2016009159A0 (en) | 2016-04-30 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| A201 | Request for examination | ||
| A302 | Request for accelerated examination | ||
| AMND | Amendment | ||
| P11-X000 | Amendment of application requested |
St.27 status event code: A-2-2-P10-P11-nap-X000 |
|
| P13-X000 | Application amended |
St.27 status event code: A-2-2-P10-P13-nap-X000 |
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| PA0105 | International application |
St.27 status event code: A-0-1-A10-A15-nap-PA0105 |
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| PA0201 | Request for examination |
St.27 status event code: A-1-2-D10-D11-exm-PA0201 |
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| PA0302 | Request for accelerated examination |
St.27 status event code: A-1-2-D10-D17-exm-PA0302 St.27 status event code: A-1-2-D10-D16-exm-PA0302 |
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| PG1501 | Laying open of application |
St.27 status event code: A-1-1-Q10-Q12-nap-PG1501 |
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| E902 | Notification of reason for refusal | ||
| PE0902 | Notice of grounds for rejection |
St.27 status event code: A-1-2-D10-D21-exm-PE0902 |
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| AMND | Amendment | ||
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| P13-X000 | Application amended |
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| E601 | Decision to refuse application | ||
| PE0601 | Decision on rejection of patent |
St.27 status event code: N-2-6-B10-B15-exm-PE0601 |
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| AMND | Amendment | ||
| E13-X000 | Pre-grant limitation requested |
St.27 status event code: A-2-3-E10-E13-lim-X000 |
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| P11-X000 | Amendment of application requested |
St.27 status event code: A-2-2-P10-P11-nap-X000 |
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| P13-X000 | Application amended |
St.27 status event code: A-2-2-P10-P13-nap-X000 |
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| PX0901 | Re-examination |
St.27 status event code: A-2-3-E10-E12-rex-PX0901 |
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| PX0701 | Decision of registration after re-examination |
St.27 status event code: A-3-4-F10-F13-rex-PX0701 |
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| X701 | Decision to grant (after re-examination) | ||
| GRNT | Written decision to grant | ||
| PR0701 | Registration of establishment |
St.27 status event code: A-2-4-F10-F11-exm-PR0701 |
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