IN2013MU03559A - - Google Patents

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Publication number
IN2013MU03559A
IN2013MU03559A IN3559MU2013A IN2013MU03559A IN 2013MU03559 A IN2013MU03559 A IN 2013MU03559A IN 3559MU2013 A IN3559MU2013 A IN 3559MU2013A IN 2013MU03559 A IN2013MU03559 A IN 2013MU03559A
Authority
IN
India
Prior art keywords
gonadotropins
fragmentation
provides
dose form
aggregation
Prior art date
Application number
Inventor
Chintan Patel
Mukesh Mahajan
Sanjay Bandyopadhyay
Sanjeev Kumar Mendiratta
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=IN2013MU03559(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority to AP2016009159A priority Critical patent/AP2016009159A0/en
Priority to PCT/IN2014/000691 priority patent/WO2015075743A1/en
Priority to EP14845007.5A priority patent/EP3068374A1/en
Priority to CA2928311A priority patent/CA2928311A1/en
Priority to KR1020167010341A priority patent/KR101699677B1/en
Priority to US15/030,527 priority patent/US20160250295A1/en
Priority to NZ718960A priority patent/NZ718960A/en
Priority to MX2016005154A priority patent/MX356383B/en
Priority to AU2014351326A priority patent/AU2014351326B2/en
Priority to SG11201603142YA priority patent/SG11201603142YA/en
Priority to CN201480057647.6A priority patent/CN105658201A/en
Priority to JP2016525079A priority patent/JP6166470B2/en
Priority to IN3559MU2013 priority patent/IN2013MU03559A/en
Priority to EA201690626A priority patent/EA201690626A1/en
Application filed by Cadila Healthcare Ltd filed Critical Cadila Healthcare Ltd
Priority to TW103138047A priority patent/TWI579003B/en
Priority to ARP140104243A priority patent/AR098386A1/en
Publication of IN2013MU03559A publication Critical patent/IN2013MU03559A/en
Priority to IL244986A priority patent/IL244986A/en
Priority to PH12016500738A priority patent/PH12016500738A1/en
Priority to ZA2016/02718A priority patent/ZA201602718B/en
Priority to CL2016000944A priority patent/CL2016000944A1/en
Priority to HK16111891.9A priority patent/HK1223559A1/en

Links

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

Abstract

ABSTRACT NOVEL FORMULATION FOR GONADOTROPINS The present invention relates to a stable composition for gonadotropins. It provides a composition useful for stabilization of gonadotropins while preventing aggregation, dissociation, fragmentation and formation of oxidized species variants in solution for injection. Thus, it prevents instability of protein or polypeptide molecules caused due to aggregation or fragmentation or oxidation during or after formulation. Also, it provides a pharmaceutical composition of gonadotropins, which can be therapeutically used for the treatment of various indications either in single-dose form or in multi-dose form.
IN3559MU2013 2013-11-12 2014-10-31 IN2013MU03559A (en)

Priority Applications (21)

Application Number Priority Date Filing Date Title
PCT/IN2014/000691 WO2015075743A1 (en) 2013-11-12 2014-10-31 Formulation for gonadotropins
JP2016525079A JP6166470B2 (en) 2013-11-12 2014-10-31 New formulations for gonadotropins
CN201480057647.6A CN105658201A (en) 2013-11-12 2014-10-31 Formulation for gonadotropins
CA2928311A CA2928311A1 (en) 2013-11-12 2014-10-31 Formulation for gonadotropins
KR1020167010341A KR101699677B1 (en) 2013-11-12 2014-10-31 Formulation for gonadotropins
US15/030,527 US20160250295A1 (en) 2013-11-12 2014-10-31 Formulation for gonadotropins
NZ718960A NZ718960A (en) 2013-11-12 2014-10-31 Formulation for gonadotropins
MX2016005154A MX356383B (en) 2013-11-12 2014-10-31 Formulation for gonadotropins.
AU2014351326A AU2014351326B2 (en) 2013-11-12 2014-10-31 Formulation for gonadotropins
IN3559MU2013 IN2013MU03559A (en) 2013-11-12 2014-10-31
EP14845007.5A EP3068374A1 (en) 2013-11-12 2014-10-31 Formulation for gonadotropins
AP2016009159A AP2016009159A0 (en) 2013-11-12 2014-10-31 Formulation for gonadotropins
SG11201603142YA SG11201603142YA (en) 2013-11-12 2014-10-31 Formulation for gonadotropins
EA201690626A EA201690626A1 (en) 2013-11-12 2014-10-31 NEW COMPOSITION OF HONADOTROPINS
TW103138047A TWI579003B (en) 2013-11-12 2014-11-03 Novel formulation for gonadotropins
ARP140104243A AR098386A1 (en) 2013-11-12 2014-11-11 FORMULATION FOR GONADOTROPINS
IL244986A IL244986A (en) 2013-11-12 2016-04-07 Formulation for gonadotropins
PH12016500738A PH12016500738A1 (en) 2013-11-12 2016-04-20 Formulation for gonadotropins
ZA2016/02718A ZA201602718B (en) 2013-11-12 2016-04-20 Formulation for gonadotropins
CL2016000944A CL2016000944A1 (en) 2013-11-12 2016-04-20 New formulation of ganadotropins
HK16111891.9A HK1223559A1 (en) 2013-11-12 2016-10-14 Formulation for gonadotropins

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
IN3559MU2013 IN2013MU03559A (en) 2013-11-12 2014-10-31

Publications (1)

Publication Number Publication Date
IN2013MU03559A true IN2013MU03559A (en) 2015-07-24

Family

ID=52684607

Family Applications (1)

Application Number Title Priority Date Filing Date
IN3559MU2013 IN2013MU03559A (en) 2013-11-12 2014-10-31

Country Status (21)

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

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RU2599031C1 (en) * 2015-08-11 2016-10-10 Общество с ограниченной ответственностью "АйВиФарма" Aqueous composition of recombinant human follicle-stimulating hormone (versions)
GB201603280D0 (en) * 2016-02-24 2016-04-13 Ferring Bv Stable liquid gonadotropin formulation
RU2633079C2 (en) * 2016-06-21 2017-10-11 Федеральное государственное бюджетное научное учреждение "Центр экспериментальной эмбриологии и репродуктивных биотехнологий" (ФГБНУ ЦЭЭРБ) Pharmaceutical composition with prolonged action of gonadotropins for induction of superovulation in female mammals
CN112451652A (en) * 2020-12-07 2021-03-09 苏州智核生物医药科技有限公司 Recombinant human thyrotropin injection

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
NZ508874A (en) * 1998-07-23 2004-03-26 Lilly Co Eli FSH and FSH variant formulations, products and methods of treating infertility.
KR101105486B1 (en) * 2003-04-02 2012-01-13 아레스 트레이딩 에스.에이. Liquid pharmaceutical formulations of FSH and LH together with a non-ionic surfactant
KR101105871B1 (en) * 2005-09-27 2012-01-16 주식회사 엘지생명과학 hFSF Aqueous Formulation
JP5180202B2 (en) * 2006-07-06 2013-04-10 デウン カンパニー，リミテッド Stable liquid formulation containing human growth hormone
CN102202682B (en) * 2008-11-04 2015-08-19 Aska制药株式会社 Containing the waterborne compositions of follicle stimulating hormone
IT1395957B1 (en) * 2009-05-19 2012-11-02 Pharmaguida S R L USE OF A COMBINATION OF D-ASPARTATE AND L-ASPARTATE FOR THE TREATMENT OF MALE INFERTILITY.
RU2553375C2 (en) * 2010-02-12 2015-06-10 Интас Биофармасьютикалс Лимитед Fluid 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
EP3068374A1 (en) 2016-09-21
JP6166470B2 (en) 2017-07-19
HK1223559A1 (en) 2017-08-04
IL244986A0 (en) 2016-05-31
PH12016500738A1 (en) 2016-05-30
JP2016534061A (en) 2016-11-04
WO2015075743A1 (en) 2015-05-28
MX356383B (en) 2018-05-24
EA201690626A1 (en) 2016-09-30
TW201529097A (en) 2015-08-01
NZ718960A (en) 2017-06-30
AU2014351326A1 (en) 2016-05-12
CN105658201A (en) 2016-06-08
CA2928311A1 (en) 2015-05-28
MX2016005154A (en) 2016-08-17
AR098386A1 (en) 2016-05-26
ZA201602718B (en) 2017-06-28
AU2014351326B2 (en) 2017-08-31
SG11201603142YA (en) 2016-05-30
AP2016009159A0 (en) 2016-04-30
IL244986A (en) 2016-11-30
US20160250295A1 (en) 2016-09-01
CL2016000944A1 (en) 2016-11-11
KR20160048227A (en) 2016-05-03
KR101699677B1 (en) 2017-01-24
TWI579003B (en) 2017-04-21

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