AR123619A2 - Método para producir y para controlar la viscosidad de una composición farmacéutica liofilizada de degarelix - Google Patents
Método para producir y para controlar la viscosidad de una composición farmacéutica liofilizada de degarelixInfo
- Publication number
- AR123619A2 AR123619A2 ARP210102681A ARP210102681A AR123619A2 AR 123619 A2 AR123619 A2 AR 123619A2 AR P210102681 A ARP210102681 A AR P210102681A AR P210102681 A ARP210102681 A AR P210102681A AR 123619 A2 AR123619 A2 AR 123619A2
- Authority
- AR
- Argentina
- Prior art keywords
- degarelix
- lyophilized
- pharmaceutical composition
- water
- viscosity
- Prior art date
Links
- 108010052004 acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide Proteins 0.000 title abstract 25
- MEUCPCLKGZSHTA-XYAYPHGZSA-N degarelix Chemical group C([C@H](C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCNC(C)C)C(=O)N1[C@@H](CCC1)C(=O)N[C@H](C)C(N)=O)NC(=O)[C@H](CC=1C=CC(NC(=O)[C@H]2NC(=O)NC(=O)C2)=CC=1)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(NC(N)=O)C=C1 MEUCPCLKGZSHTA-XYAYPHGZSA-N 0.000 title abstract 25
- 229960002272 degarelix Drugs 0.000 title abstract 25
- 239000008194 pharmaceutical composition Substances 0.000 title abstract 9
- 238000004519 manufacturing process Methods 0.000 title abstract 4
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 abstract 12
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 abstract 10
- 239000000594 mannitol Substances 0.000 abstract 5
- 239000012458 free base Substances 0.000 abstract 4
- 238000000034 method Methods 0.000 abstract 4
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 abstract 3
- 229930195725 Mannitol Natural products 0.000 abstract 3
- 238000004090 dissolution Methods 0.000 abstract 3
- 235000010355 mannitol Nutrition 0.000 abstract 3
- 239000008186 active pharmaceutical agent Substances 0.000 abstract 2
- 229940126534 drug product Drugs 0.000 abstract 2
- 229940088679 drug related substance Drugs 0.000 abstract 2
- 239000012535 impurity Substances 0.000 abstract 2
- 239000000203 mixture Substances 0.000 abstract 2
- 239000000825 pharmaceutical preparation Substances 0.000 abstract 2
- 239000000243 solution Substances 0.000 abstract 2
- 239000008215 water for injection Substances 0.000 abstract 2
- 239000012141 concentrate Substances 0.000 abstract 1
- 239000007791 liquid phase Substances 0.000 abstract 1
- 238000010647 peptide synthesis reaction Methods 0.000 abstract 1
- 239000007790 solid phase Substances 0.000 abstract 1
- 239000002904 solvent Substances 0.000 abstract 1
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)
- Biophysics (AREA)
- Biochemistry (AREA)
- Organic Chemistry (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
Un método para producir una composición farmacéutica liofilizada de degarelix y método para controlar su viscosidad y producto de degarelix, en donde el producto de degarelix liofilizado, al estar reconstituido con agua para inyección en una cantidad de 20 mg/ml, presenta una viscosidad de hasta 15 mPas, y también proporciona una sustancia de droga degarelix liofilizada que muestra, ante la disolución en agua en una cantidad de 20 mg/ml, una viscosidad de hasta 3.2 mPas, y procesos para proveer esta sustancia de droga degarelix liofilizado. Reivindicación 1: Un método para producir una composición farmacéutica liofilizada de degarelix, caracterizado porque comprende las etapas de: a. Purificar el degarelix en la forma obtenida mediante síntesis péptida de fase líquida o sólida para obtener una solución de degarelix con una pureza de por lo menos 95%; b. Evaporar el solvente a una temperatura máxima de 40ºC para concentrar la solución de degarelix para obtener degarelix aglomerado, en donde la concentración de degarelix (base libre) está en el rango de 10 a 35 g/l; c. Desaglomerar el degarelix aglomerado con ácido acético, en donde la concentración final del ácido acético está en el rango de 15% a 35% v/v; y d. Liofilizar el degarelix desaglomerado de manera de proveer la composición farmacéutica liofilizada de degarelix, en donde la composición farmacéutica liofilizada de degarelix consiste de degarelix, 4.5 a 10.0% (p/p) de ácido acético, una cantidad residual de agua, e impurezas, si las hay, resultantes del proceso de producción, y que muestra, ante la disolución en agua en una cantidad de 20 mg de degarelix base libre/ml de agua conteniendo 2.5% en peso de manitol, una viscosidad de hasta 3.2 mPas. Reivindicación 11: Un método para controlar la viscosidad de un producto de droga liofilizado que comprende una composición farmacéutica liofilizada de degarelix, para obtener un valor no mayor de 15 mPas, preferentemente dentro de una escala de 2 a 12 mPas, determinado ante la reconstitución con agua para inyección en una cantidad de 20 mg de base libre de degarelix/ml, caracterizado porque comprende las etapas de: a. Proveer la composición farmacéutica liofilizada de degarelix; b. Disolver la composición farmacéutica liofilizada de degarelix en agua conteniendo manitol para proveer una mezcla de degarelix-manitol acuosa; y c. Liofilizar la mezcla de degarelix-manitol acuosa para proveer el producto de droga, en donde la composición farmacéutica liofilizada de degarelix consiste de degarelix, 4.5 a 10.0% (p/p) de ácido acético, una cantidad residual de agua, e impurezas, si las hay, resultantes del proceso de producción, y que muestra, ante la disolución en agua en una cantidad de 20 mg de degarelix base libre/ml de agua conteniendo 2.5% en peso de manitol, una viscosidad de hasta 3.2 mPas.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP12170454 | 2012-06-01 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| AR123619A2 true AR123619A2 (es) | 2022-12-21 |
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 Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ARP130101926A AR092840A1 (es) | 2012-06-01 | 2013-05-31 | Elaboracion de degarelix |
Country Status (19)
| Country | Link |
|---|---|
| US (5) | US9592266B2 (es) |
| EP (1) | EP2854831A2 (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) | 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 (7)
| 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 |
| AR092840A1 (es) | 2012-06-01 | 2015-05-06 | Ferring Bv | Elaboracion de 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 |
| 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 |
| CN114938646A (zh) * | 2019-12-05 | 2022-08-23 | 费森尤斯卡比有限责任公司 | 分析地加瑞克及其相关产物的方法 |
| 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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| US3773919A (en) | 1969-10-23 | 1973-11-20 | Du Pont | Polylactide-drug mixtures |
| DE2862341D1 (en) | 1977-12-26 | 1983-11-24 | Ihara Chemical Ind Co | Process for producing aromatic monocarboxylic acid |
| DE593491T1 (de) | 1991-04-25 | 1994-11-17 | Romano Deghenghi | LHRH-Antagonisten. |
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| SI9300468A (en) | 1992-10-14 | 1994-06-30 | Hoffmann La Roche | Injectable composition for the sustained release of biologically active compounds |
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| US20020103131A1 (en) | 2001-01-26 | 2002-08-01 | Jacobson Jill D. | Prevention of diabetes by administration of GnRH antagonists |
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| CN1411803A (zh) | 2002-08-29 | 2003-04-23 | 四川大学 | 制备前体脂质体的方法及其装置 |
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| DE602005008247D1 (de) * | 2004-06-04 | 2008-08-28 | Camurus Ab | Flüssige depotformulierungen |
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| WO2006069779A1 (en) | 2004-12-30 | 2006-07-06 | F. Hoffmann-La Roche Ag | Preparing of peptides with excellent solubility |
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| JOP20090061B1 (ar) | 2008-02-11 | 2021-08-17 | Ferring Int Center Sa | طريقة معالجة سرطان البروستاتا بمضادات الهرمونات التناسلية GnRH |
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| IT1390924B1 (it) | 2008-07-31 | 2011-10-19 | Peruffo | Metodo di frenatura di attrezzi sportivi, dispositivo di frenatura ed attrezzo sportivo comprendente tale dispositivo di frenatura |
| RU2515555C2 (ru) * | 2009-04-24 | 2014-05-10 | Полипептид Лэборэторис А/С | Способ получения дегареликса |
| BRPI1010874A8 (pt) * | 2009-05-01 | 2018-01-02 | Ferring Bv | composição para o tratamento de câncer de próstata |
| TW201043221A (en) | 2009-05-06 | 2010-12-16 | Ferring Int Ct Sa | Kit and method for preparation of a Degarelix solution |
| US20110039787A1 (en) * | 2009-07-06 | 2011-02-17 | Ferring International Center S.A. | Compositions, kits and methods for treating benign prostate hyperplasia |
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| WO2011066386A1 (en) | 2009-11-25 | 2011-06-03 | Novetide, Ltd. | Process for production of degarelix |
| ES2385240B1 (es) * | 2010-07-26 | 2013-09-23 | Gp-Pharm, S.A. | Cápsulas de principios activos farmacéuticos y ácidos grasos poliinsaturados para el tratamiento de enfermedades de la próstata. |
| HUE031113T2 (en) | 2010-10-27 | 2017-06-28 | Ferring Bv | Procedure for the preparation of Degarelix and its intermediates |
| EP2447276A1 (en) | 2010-10-27 | 2012-05-02 | Ferring B.V. | Process for the manufacture of Degarelix and its intermediates |
| JO3755B1 (ar) | 2011-01-26 | 2021-01-31 | Ferring Bv | تركيبات تستوستيرون |
| CN102204889B (zh) * | 2011-05-23 | 2013-09-18 | 蚌埠丰原涂山制药有限公司 | 一种醋酸地加瑞克冻干粉针剂及其制备方法 |
| NO2731607T3 (es) | 2011-07-15 | 2018-03-10 | ||
| AR092840A1 (es) | 2012-06-01 | 2015-05-06 | Ferring Bv | Elaboracion de degarelix |
-
2013
- 2013-05-31 AR ARP130101926A patent/AR092840A1/es not_active Application Discontinuation
- 2013-05-31 CA CA3228586A patent/CA3228586A1/en active Pending
- 2013-05-31 CN CN201710709810.8A patent/CN107569456A/zh active Pending
- 2013-05-31 EP EP13726219.2A patent/EP2854831A2/en active Pending
- 2013-05-31 CN CN201380028448.8A patent/CN104334182B/zh active Active
- 2013-05-31 RU RU2014146272A patent/RU2657444C2/ru active
- 2013-05-31 KR KR1020147035636A patent/KR102140982B1/ko active IP Right Grant
- 2013-05-31 CA CA2874927A patent/CA2874927A1/en active Pending
- 2013-05-31 MY MYPI2014703537A patent/MY182320A/en unknown
- 2013-05-31 AU AU2013269523A patent/AU2013269523B2/en active Active
- 2013-05-31 NZ NZ701978A patent/NZ701978A/en unknown
- 2013-05-31 WO PCT/EP2013/061264 patent/WO2013178788A2/en active Application Filing
- 2013-05-31 NZ NZ727679A patent/NZ727679A/en unknown
- 2013-05-31 TW TW102119333A patent/TWI580443B/zh active
- 2013-05-31 US US14/403,775 patent/US9592266B2/en active Active
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