CA2115943A1 - Novel process for the preparation of cetrorelix lyophilisate - Google Patents
Novel process for the preparation of cetrorelix lyophilisateInfo
- Publication number
- CA2115943A1 CA2115943A1 CA002115943A CA2115943A CA2115943A1 CA 2115943 A1 CA2115943 A1 CA 2115943A1 CA 002115943 A CA002115943 A CA 002115943A CA 2115943 A CA2115943 A CA 2115943A CA 2115943 A1 CA2115943 A1 CA 2115943A1
- Authority
- CA
- Canada
- Prior art keywords
- lyophilisate
- preparation
- peptide
- novel process
- cetrorelix
- Prior art date
- Legal status (The legal status 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 status listed.)
- Granted
Links
- SBNPWPIBESPSIF-MHWMIDJBSA-N cetrorelix Chemical compound C([C@@H](C(=O)N[C@H](CCCNC(N)=O)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N1[C@@H](CCC1)C(=O)N[C@H](C)C(N)=O)NC(=O)[C@H](CO)NC(=O)[C@@H](CC=1C=NC=CC=1)NC(=O)[C@@H](CC=1C=CC(Cl)=CC=1)NC(=O)[C@@H](CC=1C=C2C=CC=CC2=CC=1)NC(C)=O)C1=CC=C(O)C=C1 SBNPWPIBESPSIF-MHWMIDJBSA-N 0.000 title abstract 2
- 229960003230 cetrorelix Drugs 0.000 title abstract 2
- 108700008462 cetrorelix Proteins 0.000 title abstract 2
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 abstract 3
- 108090000765 processed proteins & peptides Proteins 0.000 abstract 3
- 208000007984 Female Infertility Diseases 0.000 abstract 1
- 206010021928 Infertility female Diseases 0.000 abstract 1
- 150000001413 amino acids Chemical class 0.000 abstract 1
- 239000004067 bulking agent Substances 0.000 abstract 1
- 210000002149 gonad Anatomy 0.000 abstract 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 abstract 1
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)
- Pharmacology & Pharmacy (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Reproductive Health (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)
- Pregnancy & Childbirth (AREA)
- Gynecology & Obstetrics (AREA)
- Urology & Nephrology (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
- Peptides Or Proteins (AREA)
- Polysaccharides And Polysaccharide Derivatives (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Steroid Compounds (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Manufacture Of Tobacco Products (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
- Compounds Of Unknown Constitution (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
A novel lyophilisate and method of preparation as well as the use of the lyophilisate to treat female infertility and for gonad protection. A lyophilisate of a peptide with 3 - 15 amino acids and optionally one or several bulking agents is prepared by dissolving 1 part by weight of peptide in 100 - 10,000 parts by weight of acetic acid and then transferring to water, the solution so obtained being lyophilized. Cetrorelix is preferred as the peptide.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DEP4305225.8 | 1993-02-19 | ||
| DE4305225A DE4305225A1 (en) | 1993-02-19 | 1993-02-19 | New manufacturing process for Cetrorelix lyophilisate |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2115943A1 true CA2115943A1 (en) | 1994-08-20 |
| CA2115943C CA2115943C (en) | 2003-08-05 |
Family
ID=6480924
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002115943A Expired - Lifetime CA2115943C (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) | NZ314707A (en) |
| PL (1) | PL177177B1 (en) |
| PT (1) | PT611572E (en) |
| RU (1) | RU2145234C1 (en) |
| SG (1) | SG46632A1 (en) |
| SI (1) | SI9400087B (en) |
| SK (2) | SK283021B6 (en) |
| TW (1) | TW387812B (en) |
| UA (1) | UA43829C2 (en) |
| ZA (1) | ZA941136B (en) |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6319192B1 (en) | 1998-04-23 | 2001-11-20 | Zentaris Ag | Method for the treatment of fertility disorders |
| US7696149B2 (en) | 2000-05-18 | 2010-04-13 | Aeterna Zentaris Gmbh | Pharmaceutical administration form for peptides, process for its preparation, and use |
| WO2012077131A1 (en) | 2010-12-06 | 2012-06-14 | Astron Research Limited | A stable ready-to-use cetrorelix injection |
| WO2020254952A1 (en) | 2019-06-17 | 2020-12-24 | Intas Pharmaceuticals Ltd. | A stable formulation of cetrorelix |
Families Citing this family (21)
| 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 |
| DE10040700A1 (en) * | 2000-08-17 | 2002-02-28 | Asta Medica Ag | Salts of biologically active peptides, their production and use |
| DE10157628A1 (en) * | 2001-11-26 | 2003-06-12 | Zentaris Ag | Solution for injection of an LHRH antagonist |
| US20030186892A1 (en) * | 2002-03-28 | 2003-10-02 | Rajneesh Taneja | Enhancement of endogenous gonadotropin production |
| RS52966B (en) | 2002-09-27 | 2014-02-28 | Zentaris Gmbh | FORM OF THE THERAPEUTIC APPLICATION OF ACTIVE PEPTIDES WITH THE LONG TERM RELEASE OF THE ACTIVE INGREDIENT |
| 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 |
| TWI442932B (en) * | 2008-02-11 | 2014-07-01 | Ferring Int Ct Sa | Method for treating prostate cancer with GnRH antagonist |
| 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 |
| 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 |
| 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 |
| CN115969954A (en) * | 2023-01-09 | 2023-04-18 | 开封明仁药业有限公司 | A kind of cetrorelix freeze-dried pharmaceutical composition for injection and preparation method thereof |
Family Cites Families (13)
| 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 |
| DK49987A (en) * | 1987-01-30 | 1988-07-31 | Nordisk Gentofte | PROCEDURE FOR TREATING INFERTILITY AND METHOD FOR USING THE PROCEDURE |
| 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 |
| FR2635006B1 (en) * | 1988-08-02 | 1990-10-19 | Letourneur Bernard | MEDICINE FOR REGULATING HORMONAL SECRETIONS AND TREATING STERILITY |
| 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 | Preparation method of novel luteinizing hormone-releasing hormone antagonistic analog |
-
1993
- 1993-02-19 DE DE4305225A patent/DE4305225A1/en not_active Ceased
-
1994
- 1994-01-31 TW TW083100769A patent/TW387812B/en not_active IP Right Cessation
- 1994-02-04 PT PT94101672T patent/PT611572E/en unknown
- 1994-02-04 AT AT94101672T patent/ATE193653T1/en active
- 1994-02-04 EP EP94101672A patent/EP0611572B1/en not_active Expired - Lifetime
- 1994-02-04 DE DE59409389T patent/DE59409389D1/en not_active Expired - Lifetime
- 1994-02-04 ES ES94101672T patent/ES2148247T3/en not_active Expired - Lifetime
- 1994-02-04 EP EP99102340.9A patent/EP0947200B1/en not_active Expired - Lifetime
- 1994-02-04 DK DK94101672T patent/DK0611572T3/en active
- 1994-02-04 SG SG1996006874A patent/SG46632A1/en unknown
- 1994-02-14 CZ CZ98974A patent/CZ285768B6/en not_active IP Right Cessation
- 1994-02-14 CZ CZ94312A patent/CZ284314B6/en not_active IP Right Cessation
- 1994-02-17 KR KR1019940002771A patent/KR100355686B1/en not_active Expired - Lifetime
- 1994-02-17 AU AU55235/94A patent/AU671881C/en not_active Expired
- 1994-02-17 PL PL94302266A patent/PL177177B1/en unknown
- 1994-02-17 NZ NZ314707A patent/NZ314707A/en not_active IP Right Cessation
- 1994-02-17 JP JP02053294A patent/JP4033919B2/en not_active Expired - Lifetime
- 1994-02-17 NZ NZ250906A patent/NZ250906A/en not_active IP Right Cessation
- 1994-02-18 BR BR9400617A patent/BR9400617A/en not_active Application Discontinuation
- 1994-02-18 IL IL10870494A patent/IL108704A/en not_active IP Right Cessation
- 1994-02-18 RU RU94005001A patent/RU2145234C1/en active
- 1994-02-18 CN CN94101378A patent/CN1109557C/en not_active Expired - Lifetime
- 1994-02-18 FI FI940779A patent/FI110059B/en not_active IP Right Cessation
- 1994-02-18 UA UA94005526A patent/UA43829C2/en unknown
- 1994-02-18 NO NO940564A patent/NO316601B1/en not_active IP Right Cessation
- 1994-02-18 SK SK195-94A patent/SK283021B6/en not_active IP Right Cessation
- 1994-02-18 ZA ZA941136A patent/ZA941136B/en unknown
- 1994-02-18 HU HU9400481A patent/HU218281B/en unknown
- 1994-02-18 SK SK810-2001A patent/SK283022B6/en not_active IP Right Cessation
- 1994-02-18 HR HRP4305225.8 patent/HRP940117B1/en not_active IP Right Cessation
- 1994-02-18 SI SI9400087A patent/SI9400087B/en unknown
- 1994-02-18 CA CA002115943A patent/CA2115943C/en not_active Expired - Lifetime
- 1994-02-21 MX MX9401312A patent/MX9401312A/en unknown
-
2000
- 2000-08-23 GR GR20000401924T patent/GR3034237T3/en unknown
-
2001
- 2001-02-27 KR KR1020010009932A patent/KR100372187B1/en not_active Expired - Lifetime
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6319192B1 (en) | 1998-04-23 | 2001-11-20 | Zentaris Ag | Method for the treatment of fertility disorders |
| US7696149B2 (en) | 2000-05-18 | 2010-04-13 | Aeterna Zentaris Gmbh | Pharmaceutical administration form for peptides, process for its preparation, and use |
| US7718599B2 (en) * | 2000-05-18 | 2010-05-18 | Aeterna Zentaris Gmbh | Pharmaceutical administration form for peptides, process for its preparation, and use |
| WO2012077131A1 (en) | 2010-12-06 | 2012-06-14 | Astron Research Limited | A stable ready-to-use cetrorelix injection |
| WO2020254952A1 (en) | 2019-06-17 | 2020-12-24 | Intas Pharmaceuticals Ltd. | A stable formulation of cetrorelix |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request | ||
| MKEX | Expiry |
Effective date: 20140218 |