EA201690626A1 - Новый состав гонадотропинов - Google Patents

Новый состав гонадотропинов

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Publication number
EA201690626A1
EA201690626A1 EA201690626A EA201690626A EA201690626A1 EA 201690626 A1 EA201690626 A1 EA 201690626A1 EA 201690626 A EA201690626 A EA 201690626A EA 201690626 A EA201690626 A EA 201690626A EA 201690626 A1 EA201690626 A1 EA 201690626A1
Authority
EA
Eurasian Patent Office
Prior art keywords
composition
gonadotropins
relates
fragmentation
aggregation
Prior art date
Application number
EA201690626A
Other languages
English (en)
Inventor
Чинтан Пател
Мукеш Махаджан
Санджай Бандиопадхиай
Санджив Кумар Мендиратта
Бхатт Чандреш
Original Assignee
Кадила Хелзкэр Лимитед
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=52684607&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=EA201690626(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Кадила Хелзкэр Лимитед filed Critical Кадила Хелзкэр Лимитед
Publication of EA201690626A1 publication Critical patent/EA201690626A1/ru

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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
    • A61K47/02—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
    • A61K9/14—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)
  • Immunology (AREA)
  • Reproductive Health (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Dermatology (AREA)
  • Inorganic Chemistry (AREA)
  • Diabetes (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

Настоящее изобретение относится к стабильной композиции гонадотропинов. Изобретение относится к композиции, применимой для стабилизации гонадотропинов, одновременно предотвращающей агрегацию, диссоциацию, фрагментацию и образование окисленных вариантов в растворе для инъекций. Таким образом, она предотвращает нестабильность молекул белка или полипептида, вызываемую агрегацией или фрагментацией или окислением при составлении и после него. Кроме того, изобретение относится к фармацевтической композиции гонадотропинов, которую можно терапевтически применять для лечения различных показаний в форме для однократного введения или форме для многократного введения.
EA201690626A 2013-11-12 2014-10-31 Новый состав гонадотропинов EA201690626A1 (ru)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN3559MU2013 IN2013MU03559A (ru) 2013-11-12 2014-10-31
PCT/IN2014/000691 WO2015075743A1 (en) 2013-11-12 2014-10-31 Formulation for gonadotropins

Publications (1)

Publication Number Publication Date
EA201690626A1 true EA201690626A1 (ru) 2016-09-30

Family

ID=52684607

Family Applications (1)

Application Number Title Priority Date Filing Date
EA201690626A EA201690626A1 (ru) 2013-11-12 2014-10-31 Новый состав гонадотропинов

Country Status (21)

Country Link
US (1) US20160250295A1 (ru)
EP (1) EP3068374A1 (ru)
JP (1) JP6166470B2 (ru)
KR (1) KR101699677B1 (ru)
CN (1) CN105658201A (ru)
AP (1) AP2016009159A0 (ru)
AR (1) AR098386A1 (ru)
AU (1) AU2014351326B2 (ru)
CA (1) CA2928311A1 (ru)
CL (1) CL2016000944A1 (ru)
EA (1) EA201690626A1 (ru)
HK (1) HK1223559A1 (ru)
IL (1) IL244986A (ru)
IN (1) IN2013MU03559A (ru)
MX (1) MX356383B (ru)
NZ (1) NZ718960A (ru)
PH (1) PH12016500738A1 (ru)
SG (1) SG11201603142YA (ru)
TW (1) TWI579003B (ru)
WO (1) WO2015075743A1 (ru)
ZA (1) ZA201602718B (ru)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
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
CN115634284A (zh) * 2022-10-31 2023-01-24 景泽生物医药(合肥)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)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IL122732A0 (en) 1997-01-15 1998-08-16 Akzo Nobel Nv Liquid gonadotropin-containing formulation its preparation and a device containing same
NZ508874A (en) * 1998-07-23 2004-03-26 Lilly Co Eli FSH and FSH variant formulations, products and methods of treating infertility.
KR101105486B1 (ko) * 2003-04-02 2012-01-13 아레스 트레이딩 에스.에이. Ｆｓｈ 및 ｌｈ과 비이온성 계면활성제의 액상 약제학적 제제
KR101105871B1 (ko) * 2005-09-27 2012-01-16 주식회사 엘지생명과학 인 난포자극호르몬의 안정한 용액 제형
ES2605022T3 (es) * 2006-07-06 2017-03-10 Daewoong Co., Ltd. Una formulación líquida estable de la hormona del crecimiento humana
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.
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
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

Also Published As

Publication number Publication date
KR20160048227A (ko) 2016-05-03
IN2013MU03559A (ru) 2015-07-24
TWI579003B (zh) 2017-04-21
US20160250295A1 (en) 2016-09-01
JP6166470B2 (ja) 2017-07-19
CL2016000944A1 (es) 2016-11-11
ZA201602718B (en) 2017-06-28
NZ718960A (en) 2017-06-30
HK1223559A1 (zh) 2017-08-04
IL244986A0 (en) 2016-05-31
WO2015075743A1 (en) 2015-05-28
KR101699677B1 (ko) 2017-01-24
SG11201603142YA (en) 2016-05-30
CA2928311A1 (en) 2015-05-28
CN105658201A (zh) 2016-06-08
JP2016534061A (ja) 2016-11-04
AU2014351326A1 (en) 2016-05-12
EP3068374A1 (en) 2016-09-21
AU2014351326B2 (en) 2017-08-31
MX2016005154A (es) 2016-08-17
AP2016009159A0 (en) 2016-04-30
PH12016500738A1 (en) 2016-05-30
TW201529097A (zh) 2015-08-01
AR098386A1 (es) 2016-05-26
IL244986A (en) 2016-11-30
MX356383B (es) 2018-05-24

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