AR092840A1 - Elaboracion de degarelix - Google Patents

Elaboracion de degarelix

Info

Publication number
AR092840A1
AR092840A1 ARP130101926A ARP130101926A AR092840A1 AR 092840 A1 AR092840 A1 AR 092840A1 AR P130101926 A ARP130101926 A AR P130101926A AR P130101926 A ARP130101926 A AR P130101926A AR 092840 A1 AR092840 A1 AR 092840A1
Authority
AR
Argentina
Prior art keywords
degarelix
elaboration
water
amount
mpas
Prior art date
Application number
ARP130101926A
Other languages
English (en)
Inventor
Schwach Gregoire
Nilsson Anders
Elisabeth Gottschalk Bving Tine
Holbech Rasmussen Jon
Mmstam Birgitta
Tsirk Anders
Annby Ulf
Fomsgaard Jens
Original Assignee
Ferring Bv
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
Application filed by Ferring Bv filed Critical Ferring Bv
Publication of AR092840A1 publication Critical patent/AR092840A1/es

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
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/08—Peptides having 5 to 11 amino acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/08—Peptides having 5 to 11 amino acids
    • A61K38/09—Luteinising hormone-releasing hormone [LHRH], i.e. Gonadotropin-releasing hormone [GnRH]; Related peptides
    • 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
    • A61K38/25—Growth hormone-releasing factor [GH-RF], i.e. somatoliberin
    • 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
    • A61K47/26—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
    • A61K9/0012—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
    • A61K9/0024—Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • 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
    • A61P35/00—Antineoplastic agents
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K7/00—Peptides having 5 to 20 amino acids in a fully defined sequence; Derivatives thereof
    • C07K7/04—Linear peptides containing only normal peptide links
    • C07K7/06—Linear peptides containing only normal peptide links having 5 to 11 amino acids
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K7/00—Peptides having 5 to 20 amino acids in a fully defined sequence; Derivatives thereof
    • C07K7/04—Linear peptides containing only normal peptide links
    • C07K7/23—Luteinising hormone-releasing hormone [LHRH]; Related peptides

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Molecular Biology (AREA)
  • Endocrinology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Organic Chemistry (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Dermatology (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Reproductive Health (AREA)
  • Zoology (AREA)
  • Genetics & Genomics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)

Abstract

Reivindicación 1: Una sustancia de droga degarelix liofilizada que consiste esencialmente en degarelix, ácido acético, y una cantidad residual de agua que muestra, ante la disolución en agua en una cantidad de 20 mg de base libre de degarelix / ml de agua conteniendo 2.5 pt.% de manitol, una viscosidad de hasta 3.2 mPas.
ARP130101926A 2012-06-01 2013-05-31 Elaboracion de degarelix AR092840A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP12170454 2012-06-01

Publications (1)

Publication Number Publication Date
AR092840A1 true AR092840A1 (es) 2015-05-06

Family

ID=48539181

Family Applications (2)

Application Number Title Priority Date Filing Date
ARP130101926A AR092840A1 (es) 2012-06-01 2013-05-31 Elaboracion de degarelix
ARP210102681A AR123619A2 (es) 2012-06-01 2021-09-27 Método para producir y para controlar la viscosidad de una composición farmacéutica liofilizada de degarelix

Family Applications After (1)

Application Number Title Priority Date Filing Date
ARP210102681A AR123619A2 (es) 2012-06-01 2021-09-27 Método para producir y para controlar la viscosidad de una composición farmacéutica liofilizada de degarelix

Country Status (19)

Country Link
US (5) US9592266B2 (es)
EP (2) EP4385517A2 (es)
JP (1) JP6226966B2 (es)
KR (1) KR102140982B1 (es)
CN (2) CN107569456A (es)
AR (2) AR092840A1 (es)
AU (1) AU2013269523B2 (es)
CA (2) CA2874927A1 (es)
HK (1) HK1209046A1 (es)
IL (1) IL235856B (es)
JO (1) JO3586B1 (es)
MX (1) MX364010B (es)
MY (1) MY182320A (es)
NZ (2) NZ701978A (es)
PH (1) PH12014502682B1 (es)
RU (1) RU2657444C2 (es)
SG (1) SG11201407679PA (es)
TW (1) TWI580443B (es)
WO (1) WO2013178788A2 (es)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JOP20090061B1 (ar) 2008-02-11 2021-08-17 Ferring Int Center Sa طريقة معالجة سرطان البروستاتا بمضادات الهرمونات التناسلية GnRH
CN107569456A (zh) 2012-06-01 2018-01-12 辉凌公司 制造地加瑞克
CN107693496A (zh) * 2017-10-23 2018-02-16 天津双硕医药科技有限公司 一种注射用地加瑞克冻干粉针及制备工艺
EP3590526A1 (en) * 2018-07-05 2020-01-08 Antev Limited A lyophilization process and a teverelix-tfa lyophilizate obtained thereby
CN111036078B (zh) * 2018-10-14 2022-04-26 深圳市健元医药科技有限公司 一种GnRH拮抗剂的后处理方法
CN112125956A (zh) * 2019-06-25 2020-12-25 深圳市健元医药科技有限公司 一种地加瑞克的制备方法
WO2021113514A1 (en) * 2019-12-05 2021-06-10 Fresenius Kabi Usa, Llc Method for analyzing degarelix and associated products
CN114460179A (zh) * 2020-11-09 2022-05-10 深圳市健翔生物制药有限公司 一种注射用醋酸地加瑞克体外释放度的测定方法

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CN107569456A (zh) * 2012-06-01 2018-01-12 辉凌公司 制造地加瑞克

Also Published As

Publication number Publication date
WO2013178788A3 (en) 2014-02-27
PH12014502682A1 (en) 2015-01-26
MX364010B (es) 2019-04-11
AU2013269523A1 (en) 2015-01-15
KR20150022854A (ko) 2015-03-04
MX2014014662A (es) 2015-02-24
IL235856B (en) 2018-12-31
NZ701978A (en) 2016-12-23
NZ727679A (en) 2018-05-25
TW201400143A (zh) 2014-01-01
CN104334182A (zh) 2015-02-04
US20210077564A1 (en) 2021-03-18
US11510962B2 (en) 2022-11-29
CN104334182B (zh) 2017-09-08
EP2854831A2 (en) 2015-04-08
MY182320A (en) 2021-01-19
CA2874927A1 (en) 2013-12-05
JO3586B1 (ar) 2020-07-05
EP2854831B1 (en) 2024-07-10
HK1209046A1 (en) 2016-03-24
CN107569456A (zh) 2018-01-12
US20190224271A1 (en) 2019-07-25
CA3228586A1 (en) 2013-12-05
IL235856A0 (en) 2015-01-29
WO2013178788A2 (en) 2013-12-05
TWI580443B (zh) 2017-05-01
KR102140982B1 (ko) 2020-08-05
AU2013269523B2 (en) 2017-09-28
JP2015518866A (ja) 2015-07-06
AR123619A2 (es) 2022-12-21
PH12014502682B1 (en) 2015-01-26
BR112014029495A2 (pt) 2017-06-27
RU2014146272A (ru) 2016-07-27
US20210138024A1 (en) 2021-05-13
US20150141337A1 (en) 2015-05-21
EP4385517A2 (en) 2024-06-19
JP6226966B2 (ja) 2017-11-08
US9592266B2 (en) 2017-03-14
RU2657444C2 (ru) 2018-06-13
SG11201407679PA (en) 2014-12-30
US10765721B2 (en) 2020-09-08
US11260102B2 (en) 2022-03-01
US10172906B2 (en) 2019-01-08
US20170319644A1 (en) 2017-11-09

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