AU2014351326B2 - Formulation for gonadotropins - Google Patents

Formulation for gonadotropins Download PDF

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Publication number
AU2014351326B2
AU2014351326B2 AU2014351326A AU2014351326A AU2014351326B2 AU 2014351326 B2 AU2014351326 B2 AU 2014351326B2 AU 2014351326 A AU2014351326 A AU 2014351326A AU 2014351326 A AU2014351326 A AU 2014351326A AU 2014351326 B2 AU2014351326 B2 AU 2014351326B2
Authority
AU
Australia
Prior art keywords
formulation
sodium
buffer
edta
fsh
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
Application number
AU2014351326A
Other languages
English (en)
Other versions
AU2014351326A1 (en
Inventor
Sanjay Bandyopadhyay
Bhatt CHANDRESH
Mukesh MAHAJAN
Sanjeev Kumar Mendiratta
Chintan Patel
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Zydus Lifesciences Ltd
Original Assignee
Cadila Healthcare Ltd
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=AU2014351326(B2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Cadila Healthcare Ltd filed Critical Cadila Healthcare Ltd
Publication of AU2014351326A1 publication Critical patent/AU2014351326A1/en
Application granted granted Critical
Publication of AU2014351326B2 publication Critical patent/AU2014351326B2/en
Expired - Fee Related legal-status Critical Current
Anticipated expiration legal-status Critical

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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)
AU2014351326A 2013-11-12 2014-10-31 Formulation for gonadotropins Expired - Fee Related AU2014351326B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IN3559/MUM/2013 2013-11-12
IN3559MU2013 IN2013MU03559A (OSRAM) 2013-11-12 2014-10-31
PCT/IN2014/000691 WO2015075743A1 (en) 2013-11-12 2014-10-31 Formulation for gonadotropins

Publications (2)

Publication Number Publication Date
AU2014351326A1 AU2014351326A1 (en) 2016-05-12
AU2014351326B2 true AU2014351326B2 (en) 2017-08-31

Family

ID=52684607

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2014351326A Expired - Fee Related AU2014351326B2 (en) 2013-11-12 2014-10-31 Formulation for gonadotropins

Country Status (21)

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

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
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
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)

* Cited by examiner, † Cited by third party
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
IL140984A0 (en) * 1998-07-23 2002-02-10 Lilly Co Eli Fsh and fsh variant formulations, products and methods
AU2004226666B9 (en) * 2003-04-02 2010-04-08 Ares Trading S.A. Liquid pharmaceutical formulations of FSH and LH together with a non-ionic surfactant
KR101105871B1 (ko) 2005-09-27 2012-01-16 주식회사 엘지생명과학 인 난포자극호르몬의 안정한 용액 제형
PT2049148T (pt) * 2006-07-06 2016-12-30 Daewoong Co Ltd Formulação líquida estável da hormona do crescimento 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.
WO2011099036A2 (en) * 2010-02-12 2011-08-18 Intas Biopharmaceuticals Limited 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

Also Published As

Publication number Publication date
WO2015075743A1 (en) 2015-05-28
AP2016009159A0 (en) 2016-04-30
CN105658201A (zh) 2016-06-08
KR20160048227A (ko) 2016-05-03
TW201529097A (zh) 2015-08-01
AR098386A1 (es) 2016-05-26
EP3068374A1 (en) 2016-09-21
IN2013MU03559A (OSRAM) 2015-07-24
JP2016534061A (ja) 2016-11-04
MX356383B (es) 2018-05-24
CA2928311A1 (en) 2015-05-28
CL2016000944A1 (es) 2016-11-11
TWI579003B (zh) 2017-04-21
SG11201603142YA (en) 2016-05-30
EA201690626A1 (ru) 2016-09-30
IL244986A0 (en) 2016-05-31
US20160250295A1 (en) 2016-09-01
KR101699677B1 (ko) 2017-01-24
HK1223559A1 (zh) 2017-08-04
ZA201602718B (en) 2017-06-28
JP6166470B2 (ja) 2017-07-19
PH12016500738A1 (en) 2016-05-30
IL244986A (en) 2016-11-30
NZ718960A (en) 2017-06-30
MX2016005154A (es) 2016-08-17
AU2014351326A1 (en) 2016-05-12

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Legal Events

Date Code Title Description
MK25 Application lapsed reg. 22.2i(2) - failure to pay acceptance fee