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SI9400087B - Novel process for the preparation of cetrorelix lyophilisate - Google Patents

Novel process for the preparation of cetrorelix lyophilisate Download PDF

Info

Publication number
SI9400087B
SI9400087B SI9400087A SI9400087A SI9400087B SI 9400087 B SI9400087 B SI 9400087B SI 9400087 A SI9400087 A SI 9400087A SI 9400087 A SI9400087 A SI 9400087A SI 9400087 B SI9400087 B SI 9400087B
Authority
SI
Slovenia
Prior art keywords
dried
cetrorelix
preparation
sterile freeze
cetrorelix acetate
Prior art date
Application number
SI9400087A
Other languages
Slovenian (sl)
Other versions
SI9400087A (en
Inventor
Engel Jurgen
Burkhard Wichert
Dieter Sauerbier
Thomas Reissmann
Original Assignee
Zentaris Ag
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=6480924&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=SI9400087(B) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Zentaris Ag filed Critical Zentaris Ag
Publication of SI9400087A publication Critical patent/SI9400087A/en
Publication of SI9400087B publication Critical patent/SI9400087B/en

Links

Classifications

    • 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
    • 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
    • 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
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/02—Drugs for disorders of the urinary system of urine or of the urinary tract, e.g. urine acidifiers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A61P15/08—Drugs for genital or sexual disorders; Contraceptives for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Reproductive Health (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Endocrinology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Dermatology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Urology & Nephrology (AREA)
  • Pregnancy & Childbirth (AREA)
  • Gynecology & Obstetrics (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Peptides Or Proteins (AREA)
  • Polysaccharides And Polysaccharide Derivatives (AREA)
  • Steroid Compounds (AREA)
  • Manufacture Of Tobacco Products (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

Sterile freeze-dried cetrorelix acetate (a peptide described in EP299402) is used in the treatment of female infertility. Independent claims are also included for the following: (1) use of sterile freeze-dried cetrorelix acetate for protecting gonads against noxious agents that damage germ cells, e.g. radiation treatment and chemotherapy; (2) a composition comprising sterile freeze-dried cetrorelix acetate and optionally excipients for use in the treatment of female infertility; (3) a composition comprising sterile freeze-dried cetrorelix acetate and optionally excipients for protecting gonads against noxious agents that damage germ cells, e.g. radiation treatment and chemotherapy with cytostatic agents.

Claims (1)

Patentni zahtevek Postopek za pripravo sterilnega lizofilizata cetrorelixacetata, v katerem cetrorelix stoji za (Ac-D-Nal(2)’, D-phe(4Cl)2, D-PaL(3)3, D-Cit6, D-Ala10)-LHRH, označen s tem, da cetrorelixacetat raztopimo v vodni ocetni kislini v razmerju 1:100 -10000 m/m, raztopino razredčimo z vodo za injiciranje, po izbiri dodamo ogrodno snov, sterilno filtriramo, napolnimo v injekcijske viale in liofiliziramo.A method for the preparation of a sterile lysophilizate of cetrorelixacetate in which cetrorelix stands for (Ac-D-Nal (2) ', D-phe (4Cl) 2, D-PaL (3) 3, D-Cit6, D-Ala10) LHRH, characterized in that the cetrorelixacetate is dissolved in aqueous acetic acid in a ratio of 1: 100-10000 m / m, diluted with water for injection, an aromatic substance is added, sterile filtered, filled into a vial and lyophilized.
SI9400087A 1993-02-19 1994-02-18 Novel process for the preparation of cetrorelix lyophilisate SI9400087B (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
DE4305225A DE4305225A1 (en) 1993-02-19 1993-02-19 New manufacturing process for Cetrorelix lyophilisate

Publications (2)

Publication Number Publication Date
SI9400087A SI9400087A (en) 1994-12-31
SI9400087B true SI9400087B (en) 2002-02-28

Family

ID=6480924

Family Applications (1)

Application Number Title Priority Date Filing Date
SI9400087A SI9400087B (en) 1993-02-19 1994-02-18 Novel process for the preparation of cetrorelix lyophilisate

Country Status (29)

Country Link
EP (2) EP0611572B1 (en)
JP (1) JP4033919B2 (en)
KR (2) KR100355686B1 (en)
CN (1) CN1109557C (en)
AT (1) ATE193653T1 (en)
AU (1) AU671881C (en)
BR (1) BR9400617A (en)
CA (1) CA2115943C (en)
CZ (2) CZ285768B6 (en)
DE (2) DE4305225A1 (en)
DK (1) DK0611572T3 (en)
ES (1) ES2148247T3 (en)
FI (1) FI110059B (en)
GR (1) GR3034237T3 (en)
HR (1) HRP940117B1 (en)
HU (1) HU218281B (en)
IL (1) IL108704A (en)
MX (1) MX9401312A (en)
NO (1) NO316601B1 (en)
NZ (2) NZ250906A (en)
PL (1) PL177177B1 (en)
PT (1) PT611572E (en)
RU (1) RU2145234C1 (en)
SG (1) SG46632A1 (en)
SI (1) SI9400087B (en)
SK (2) SK283022B6 (en)
TW (1) TW387812B (en)
UA (1) UA43829C2 (en)
ZA (1) ZA941136B (en)

Families Citing this family (22)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6828415B2 (en) * 1993-02-19 2004-12-07 Zentaris Gmbh Oligopeptide lyophilisate, their preparation and use
PE63998A1 (en) * 1996-04-19 1998-10-30 Merck & Co Inc ANTI-FUNGOUS COMPOSITIONS
DE19712718C2 (en) * 1997-03-26 1999-09-23 Asta Medica Ag Immobilized and activity-stabilized complexes of LHRH antagonists and process for their preparation
DE69912422T2 (en) * 1998-04-23 2004-08-19 Zentaris Gmbh METHOD FOR TREATING FERTILITY DISORDERS
DE10024451A1 (en) * 2000-05-18 2001-11-29 Asta Medica Ag Pharmaceutical dosage form for peptides, process for their preparation and use
DE10040700A1 (en) * 2000-08-17 2002-02-28 Asta Medica Ag Salts of biologically active peptides, their production and use
US20030186892A1 (en) * 2002-03-28 2003-10-02 Rajneesh Taneja Enhancement of endogenous gonadotropin production
CN100509053C (en) 2002-09-27 2009-07-08 赞塔里斯有限公司 Administration form for pharmaceutically active peptides with sustained release and method for the production thereof
DE602005004014T2 (en) 2004-03-12 2008-12-11 Intercell Ag PROCESS FOR SOLUBILIZING PEPTIDE MIXTURES
EP1674082A1 (en) 2004-12-22 2006-06-28 Zentaris GmbH Process for the manufacture of sterile suspensions or lyophilisates of low-soluble basic peptide complexes, pharmaceutical formulations comprising these complexes and their use as medicament
CN101629758B (en) * 2008-07-19 2012-09-26 浙江家泰电器制造有限公司 Liquid heating ware overheating protection controller assembly
CN101630607B (en) * 2008-07-19 2012-04-25 浙江家泰电器制造有限公司 Liquid heating ware overheating protection controller assembly
RU2454221C2 (en) * 2010-07-06 2012-06-27 Общество с ограниченной ответственностью "Завод Медсинтез" Method for preparing lyophilised antiviral agent
US20130303464A1 (en) 2010-12-06 2013-11-14 Astron Research Limited Stable ready-to-use cetrorelix injection
GB201022147D0 (en) * 2010-12-31 2011-02-16 Immune Targeting Systems Its Ltd Formulation
CN102423484B (en) * 2011-11-23 2014-01-15 深圳翰宇药业股份有限公司 Stable cetrorelix medicinal composition and preparation method thereof
EP3015553A1 (en) 2014-10-30 2016-05-04 Biotecon Diagnostics GmbH Stabilised reaction mixture
RU2667128C2 (en) 2016-12-29 2018-09-14 Герман Петрович Беккер Composition for preparation of anti-tumor medication and method for preparation of anti-tumor medication based on it
CA3143663A1 (en) 2019-06-17 2020-12-24 Intas Pharmaceuticals Ltd. A stable formulation of cetrorelix
CN112717119B (en) * 2021-01-27 2024-04-30 南京羚诺生物医药技术研究院有限公司 Cetrorelix pharmaceutical composition and preparation method thereof
JP2024522892A (en) 2021-06-25 2024-06-21 エクストロヴィス・アーゲー Pharmaceutical Compositions
CN114159544A (en) * 2022-01-24 2022-03-11 福州华为医药技术开发有限公司 Cetrorelix acetate for injection and preparation method thereof

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3816386A (en) * 1972-06-20 1974-06-11 Abbott Lab Purification process for gn-rh
DD141996A1 (en) * 1979-02-21 1980-06-04 Ingrid Wolf METHOD FOR PRODUCING LYOPHILIZED LHRH PRAEPARATIONS
CS230614B1 (en) * 1982-08-06 1984-08-13 Martin Cs Flegel Analogues of realising factor for luteining and folliculstimulated hormon
US4565804A (en) * 1984-09-07 1986-01-21 The Salk Institute For Biological Studies GnRH Antagonists VI
EP0268066A3 (en) * 1986-10-17 1990-07-11 Syntex (U.S.A.) Inc. Fertility control and uterine therapy in dogs with luteinizing hormone releasing hormone antagonists
DE3735614A1 (en) * 1986-10-31 1988-07-28 Asta Pharma Ag Ifosfamide lyophilisate and process for its preparation
US4801577A (en) * 1987-02-05 1989-01-31 Syntex (U.S.A.) Inc. Nonapeptide and decapeptide analogs of LHRH useful as LHRH antagonists
US4800191A (en) * 1987-07-17 1989-01-24 Schally Andrew Victor LHRH antagonists
NZ226170A (en) * 1987-09-18 1990-07-26 Ethicon Inc Stable freeze-dried pharmaceutical composition containing epidermal growth factor
US5180711A (en) * 1990-06-14 1993-01-19 Applied Research Systems Ars Holding N.V. Combined treatment with gnrh antagonist and gnrh to control gonadotropin levels in mammals
CN1036343C (en) * 1990-11-10 1997-11-05 天津市计划生育研究所 Synthesis, products and its application for luleinizing hormone releasing hormone and antagonistic znalogue

Also Published As

Publication number Publication date
IL108704A0 (en) 1994-05-30
NO940564L (en) 1994-08-22
KR100355686B1 (en) 2002-12-11
SK283022B6 (en) 2003-02-04
CN1112019A (en) 1995-11-22
HU9400481D0 (en) 1994-12-28
HRP940117A2 (en) 1996-08-31
NZ314707A (en) 1999-02-25
CA2115943A1 (en) 1994-08-20
ZA941136B (en) 1994-08-29
DK0611572T3 (en) 2000-09-25
BR9400617A (en) 1994-09-27
UA43829C2 (en) 2002-01-15
SK19594A3 (en) 1994-09-07
DE4305225A1 (en) 1994-08-25
KR100372187B1 (en) 2003-02-14
EP0947200A2 (en) 1999-10-06
SG46632A1 (en) 1998-02-20
EP0611572B1 (en) 2000-06-07
PT611572E (en) 2000-11-30
NO316601B1 (en) 2004-03-08
JPH06271476A (en) 1994-09-27
HRP940117B1 (en) 2001-02-28
RU2145234C1 (en) 2000-02-10
CZ285768B6 (en) 1999-11-17
CA2115943C (en) 2003-08-05
EP0947200B1 (en) 2015-03-11
HU218281B (en) 2000-07-28
SI9400087A (en) 1994-12-31
FI110059B (en) 2002-11-29
MX9401312A (en) 1994-08-31
ES2148247T3 (en) 2000-10-16
NO940564D0 (en) 1994-02-18
EP0611572A2 (en) 1994-08-24
SK283021B6 (en) 2003-02-04
AU671881B2 (en) 1996-09-12
TW387812B (en) 2000-04-21
CN1109557C (en) 2003-05-28
NZ250906A (en) 1997-07-27
CZ284314B6 (en) 1998-10-14
EP0947200A3 (en) 2004-03-24
AU671881C (en) 2004-01-15
HUT67117A (en) 1995-02-28
ATE193653T1 (en) 2000-06-15
PL177177B1 (en) 1999-10-29
EP0611572A3 (en) 1995-01-11
AU5523594A (en) 1994-08-25
FI940779A (en) 1994-08-20
CZ31294A3 (en) 1994-09-14
IL108704A (en) 2005-05-17
DE59409389D1 (en) 2000-07-13
FI940779A0 (en) 1994-02-18
JP4033919B2 (en) 2008-01-16
GR3034237T3 (en) 2000-12-29

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Legal Events

Date Code Title Description
IF Valid on the event date
SP73 Change of data on owner

Owner name: ZENTARIS GMBH; DE

Effective date: 20060526

SP73 Change of data on owner

Owner name: ZENTARIS IVF GMBH; DE

Effective date: 20090424