DK0611572T3 - Process for preparing a freeze-dried cetrorelix preparation - Google Patents

Process for preparing a freeze-dried cetrorelix preparation

Info

Publication number
DK0611572T3
DK0611572T3 DK94101672T DK94101672T DK0611572T3 DK 0611572 T3 DK0611572 T3 DK 0611572T3 DK 94101672 T DK94101672 T DK 94101672T DK 94101672 T DK94101672 T DK 94101672T DK 0611572 T3 DK0611572 T3 DK 0611572T3
Authority
DK
Denmark
Prior art keywords
dried
cetrorelix
freeze
preparing
preparation
Prior art date
Application number
DK94101672T
Other languages
Danish (da)
Inventor
Juergen Prof Engel
Burkhard Dr Wichert
Thomas Dr Reissmann
Dieter Sauerbier
Original Assignee
Asta Medica 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=DK0611572(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Asta Medica Ag filed Critical Asta Medica Ag
Application granted granted Critical
Publication of DK0611572T3 publication Critical patent/DK0611572T3/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)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Reproductive Health (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Endocrinology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Dermatology (AREA)
  • Gynecology & Obstetrics (AREA)
  • Urology & Nephrology (AREA)
  • Pregnancy & Childbirth (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
  • Polysaccharides And Polysaccharide Derivatives (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Peptides Or Proteins (AREA)
  • Steroid Compounds (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Manufacture Of Tobacco Products (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (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.
DK94101672T 1993-02-19 1994-02-04 Process for preparing a freeze-dried cetrorelix preparation DK0611572T3 (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 (1)

Publication Number Publication Date
DK0611572T3 true DK0611572T3 (en) 2000-09-25

Family

ID=6480924

Family Applications (1)

Application Number Title Priority Date Filing Date
DK94101672T DK0611572T3 (en) 1993-02-19 1994-02-04 Process for preparing a freeze-dried cetrorelix preparation

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
CZ301912B6 (en) 1998-04-23 2010-07-28 Zentaris Ivf Gmbh Medicament for treating infertility by intrauterine insemination
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
US7884071B2 (en) 2002-09-27 2011-02-08 Zentaris Gmbh Administration form for pharmaceutically active peptides with sustained release and method for the production thereof
EP1987843A3 (en) 2004-03-12 2011-10-26 Intercell AG Method for solubilising 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
JP2014502282A (en) 2010-12-06 2014-01-30 アストロン リサーチ リミテッド Stable ready-to-use cetrorelix injection solution
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
US20220233631A1 (en) 2019-06-17 2022-07-28 Intas Pharmaceuticals Ltd. 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
US20240123021A1 (en) 2021-06-25 2024-04-18 Extrovis Ag 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
HU9400481D0 (en) 1994-12-28
EP0947200A2 (en) 1999-10-06
CA2115943C (en) 2003-08-05
CA2115943A1 (en) 1994-08-20
CN1112019A (en) 1995-11-22
NZ250906A (en) 1997-07-27
NO316601B1 (en) 2004-03-08
SI9400087B (en) 2002-02-28
ATE193653T1 (en) 2000-06-15
DE59409389D1 (en) 2000-07-13
EP0611572A3 (en) 1995-01-11
CN1109557C (en) 2003-05-28
IL108704A0 (en) 1994-05-30
HU218281B (en) 2000-07-28
PT611572E (en) 2000-11-30
MX9401312A (en) 1994-08-31
EP0611572A2 (en) 1994-08-24
BR9400617A (en) 1994-09-27
JPH06271476A (en) 1994-09-27
GR3034237T3 (en) 2000-12-29
SG46632A1 (en) 1998-02-20
EP0947200B1 (en) 2015-03-11
FI110059B (en) 2002-11-29
SI9400087A (en) 1994-12-31
NO940564L (en) 1994-08-22
JP4033919B2 (en) 2008-01-16
SK283021B6 (en) 2003-02-04
CZ284314B6 (en) 1998-10-14
HUT67117A (en) 1995-02-28
RU2145234C1 (en) 2000-02-10
FI940779A (en) 1994-08-20
AU671881B2 (en) 1996-09-12
KR100355686B1 (en) 2002-12-11
PL177177B1 (en) 1999-10-29
KR100372187B1 (en) 2003-02-14
EP0947200A3 (en) 2004-03-24
NO940564D0 (en) 1994-02-18
NZ314707A (en) 1999-02-25
HRP940117A2 (en) 1996-08-31
ES2148247T3 (en) 2000-10-16
ZA941136B (en) 1994-08-29
AU671881C (en) 2004-01-15
IL108704A (en) 2005-05-17
AU5523594A (en) 1994-08-25
SK19594A3 (en) 1994-09-07
CZ31294A3 (en) 1994-09-14
FI940779A0 (en) 1994-02-18
EP0611572B1 (en) 2000-06-07
HRP940117B1 (en) 2001-02-28
TW387812B (en) 2000-04-21
SK283022B6 (en) 2003-02-04
UA43829C2 (en) 2002-01-15
DE4305225A1 (en) 1994-08-25
CZ285768B6 (en) 1999-11-17

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