MX2014014662A - Manufactura de degarelix. - Google Patents

Manufactura de degarelix.

Info

Publication number
MX2014014662A
MX2014014662A MX2014014662A MX2014014662A MX2014014662A MX 2014014662 A MX2014014662 A MX 2014014662A MX 2014014662 A MX2014014662 A MX 2014014662A MX 2014014662 A MX2014014662 A MX 2014014662A MX 2014014662 A MX2014014662 A MX 2014014662A
Authority
MX
Mexico
Prior art keywords
degarelix
manufacture
mpas
viscosity
shows
Prior art date
Application number
MX2014014662A
Other languages
English (en)
Other versions
MX364010B (es
Inventor
Anders Nilsson
Grégoire Schwach
Boeving Tine Elisabeth Gottschalk
Jon Holbech Rasmussen
Birgitta Mörnstam
Tsirk Anders
Ulf Annby
Jens Fomsgaard
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 MX2014014662A publication Critical patent/MX2014014662A/es
Publication of MX364010B publication Critical patent/MX364010B/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)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Molecular Biology (AREA)
  • Endocrinology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Organic Chemistry (AREA)
  • Biophysics (AREA)
  • Biochemistry (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

La presente invención proporciona métodos para generar un producto liofilizado de degarelix el cual, con la reconstitución con agua para inyección en una cantidad de 20 mg/ml, muestra una viscosidad de hasta 15 mPas. La presente invención también proporciona un principio activo liofilizado de degarelix el cual muestra, con la disolución en agua en una cantidad de 20 mg/ml, una viscosidad de hasta 3.2 mPas y procesos para proporcionar este principio activo liofilizado de degarelix.
MX2014014662A 2012-06-01 2013-05-31 Manufactura de degarelix. MX364010B (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP12170454 2012-06-01
PCT/EP2013/061264 WO2013178788A2 (en) 2012-06-01 2013-05-31 Manufacture of degarelix

Publications (2)

Publication Number Publication Date
MX2014014662A true MX2014014662A (es) 2015-02-24
MX364010B MX364010B (es) 2019-04-11

Family

ID=48539181

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2014014662A MX364010B (es) 2012-06-01 2013-05-31 Manufactura de degarelix.

Country Status (19)

Country Link
US (5) US9592266B2 (es)
EP (1) EP4385517A2 (es)
JP (1) JP6226966B2 (es)
KR (1) KR102140982B1 (es)
CN (2) CN107569456A (es)
AR (2) AR092840A1 (es)
AU (1) AU2013269523B2 (es)
CA (2) CA3228586A1 (es)
HK (1) HK1209046A1 (es)
IL (1) IL235856B (es)
JO (1) JO3586B1 (es)
MX (1) MX364010B (es)
MY (1) MY182320A (es)
NZ (2) NZ727679A (es)
PH (1) PH12014502682A1 (es)
RU (1) RU2657444C2 (es)
SG (1) SG11201407679PA (es)
TW (1) TWI580443B (es)
WO (1) WO2013178788A2 (es)

Families Citing this family (8)

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TWI539959B (zh) 2008-02-11 2016-07-01 菲瑞茵國際中心股份有限公司 治療轉移階段攝護腺癌的方法
SG11201407679PA (en) 2012-06-01 2014-12-30 Ferring Bv Manufacture of degarelix
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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Also Published As

Publication number Publication date
RU2014146272A (ru) 2016-07-27
CA2874927A1 (en) 2013-12-05
US11510962B2 (en) 2022-11-29
CN104334182A (zh) 2015-02-04
US20150141337A1 (en) 2015-05-21
MX364010B (es) 2019-04-11
JP6226966B2 (ja) 2017-11-08
SG11201407679PA (en) 2014-12-30
US20170319644A1 (en) 2017-11-09
AR092840A1 (es) 2015-05-06
KR20150022854A (ko) 2015-03-04
CN107569456A (zh) 2018-01-12
US20190224271A1 (en) 2019-07-25
US10765721B2 (en) 2020-09-08
CN104334182B (zh) 2017-09-08
US20210138024A1 (en) 2021-05-13
NZ727679A (en) 2018-05-25
AU2013269523B2 (en) 2017-09-28
HK1209046A1 (en) 2016-03-24
US11260102B2 (en) 2022-03-01
TWI580443B (zh) 2017-05-01
US9592266B2 (en) 2017-03-14
TW201400143A (zh) 2014-01-01
WO2013178788A3 (en) 2014-02-27
EP4385517A2 (en) 2024-06-19
JO3586B1 (ar) 2020-07-05
AR123619A2 (es) 2022-12-21
KR102140982B1 (ko) 2020-08-05
WO2013178788A2 (en) 2013-12-05
AU2013269523A1 (en) 2015-01-15
EP2854831A2 (en) 2015-04-08
US20210077564A1 (en) 2021-03-18
CA3228586A1 (en) 2013-12-05
PH12014502682B1 (en) 2015-01-26
NZ701978A (en) 2016-12-23
RU2657444C2 (ru) 2018-06-13
IL235856B (en) 2018-12-31
IL235856A0 (en) 2015-01-29
JP2015518866A (ja) 2015-07-06
US10172906B2 (en) 2019-01-08
PH12014502682A1 (en) 2015-01-26
BR112014029495A2 (pt) 2017-06-27
MY182320A (en) 2021-01-19

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