DK2198888T3 - Langvarig frigørelse af mikrokrystallinske peptidsuspensioner - Google Patents
Langvarig frigørelse af mikrokrystallinske peptidsuspensioner Download PDFInfo
- Publication number
- DK2198888T3 DK2198888T3 DK10003046.9T DK10003046T DK2198888T3 DK 2198888 T3 DK2198888 T3 DK 2198888T3 DK 10003046 T DK10003046 T DK 10003046T DK 2198888 T3 DK2198888 T3 DK 2198888T3
- Authority
- DK
- Denmark
- Prior art keywords
- suspension
- gnrh antagonist
- gel
- aqueous suspension
- counterion
- Prior art date
Links
Classifications
-
- 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
- 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
- A61K38/31—Somatostatins
-
- 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
- A61K47/02—Inorganic compounds
-
- 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
- A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
-
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/02—Drugs for disorders of the endocrine system of the hypothalamic hormones, e.g. TRH, GnRH, CRH, GRH, somatostatin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/02—Drugs for disorders of the endocrine system of the hypothalamic hormones, e.g. TRH, GnRH, CRH, GRH, somatostatin
- A61P5/04—Drugs for disorders of the endocrine system of the hypothalamic hormones, e.g. TRH, GnRH, CRH, GRH, somatostatin for decreasing, blocking or antagonising the activity of the hypothalamic hormones
-
- 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
- A61K9/10—Dispersions; Emulsions
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Endocrinology (AREA)
- Gastroenterology & Hepatology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Immunology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Dermatology (AREA)
- Organic Chemistry (AREA)
- Zoology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Reproductive Health (AREA)
- Diabetes (AREA)
- Inorganic Chemistry (AREA)
- Biomedical Technology (AREA)
- Neurosurgery (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Dispersion Chemistry (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Peptides Or Proteins (AREA)
Claims (13)
1. Fremgangsmåde til at forhindre geldannelse af en GnRH- antagonist, hvilken fremgangsmåde omfatter at bringe GnRH-antagonisten i kontakt med en modion afledt af trifluoreddikesyre eller svovlsyre i en mængde og i et molforhold tilstrækkeligt til at tilvejebringe en flydende, mælkeagtig mikrokrystallinsk vandig suspension af GnRH-antagonisten uden dannelse af en gel.
2. Flydende, mælkeagtig mikrokrystallinsk vandig suspension af en GnRH-antagonist og en modion afledt af trifluoreddikesyre eller svovlsyre i vand, hvori GnRH-antagonisten og modionen er til stede i mængder og i et molforhold tilstrækkelig til at danne, efter blanding, suspensionen uden dannelse af en gel.
3. Fremgangsmåde til fremstilling af en depotformulering af en GnRH-antagonist hvilken fremgangsmåde omfatter at bringe GnRH-antagonisten i kontakt med en modion afledt af trifluoreddikesyre eller svovlsyre, hvori GnRH- antagonisten og modionen er til stede i mængder og i et molforhold tilstrækkelig til at danne, efter blanding, suspensionen uden dannelse af en gel.
4. Fremgangsmåde ifølge krav 1 eller 3 eller suspension ifølge krav 2, hvori GnRH-antagonisten er valgt fra gruppen bestående af Azaline B, Abarelix, Antide, Ganirelix, Cetroelix, Teverelix eller FE200486.
5. Fremgangsmåde ifølge krav 1 eller 3 eller suspension ifølge krav 2, hvori GnRH-antagonistsaltet suspenderes i det vandige medium i en koncentration lig med eller højere end 25 mg/ml.
6. Fremgangsmåde ifølge krav 1 eller 3 eller suspension ifølge krav 2, hvori den vandige suspension indeholder et isotonisk middel.
7. Fremgangsmåde eller suspension ifølge krav 6, hvori det isotoniske middel er mannitol.
8. Fremgangsmåde ifølge krav 1 eller 3 eller suspension ifølge krav 2, hvori den vandige suspension indeholder et farmaceutisk acceptabelt excipiens.
9. Fremgangsmåde ifølge krav 1 eller krav 3, hvori den vandige suspension er fremstillet magistrelt fra et lyofiliseret peptidsalt.
10. Suspension ifølge krav 2, hvori mikrokrystallerne er i form af nåle med en partikelstørrelse på mellem 5 og 150 μιη.
11. Lyophiliseret sammensætning omfattende den tørrede suspension af krav 2.
12. Fremgangsmåde til fremstilling af en tørret sammensætning ifølge krav 11, som omfatter en fremgangsmåde ifølge krav 1 efterfulgt af frysetørring eller spraytørring til opnåelse af sammensætningen.
13. Fremgangsmåde til fremstilling af en injicerbar flydende, mælkeagtig, mikrokrystallinsk vandig suspension af et hydrofobt peptid, som omfatter at den frysetørrede sammensætning ifølge krav 11 rekonstitueres med vand eller en bufferløsning.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US31761601P | 2001-09-06 | 2001-09-06 | |
| EP02772214A EP1423150B1 (en) | 2001-09-06 | 2002-08-27 | Sustained release of microcrystalline peptide suspensions |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK2198888T3 true DK2198888T3 (da) | 2017-02-13 |
Family
ID=23234486
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK10003046.9T DK2198888T3 (da) | 2001-09-06 | 2002-08-27 | Langvarig frigørelse af mikrokrystallinske peptidsuspensioner |
Country Status (27)
| Country | Link |
|---|---|
| US (5) | US7098305B2 (da) |
| EP (2) | EP2198888B1 (da) |
| JP (3) | JP2005504787A (da) |
| KR (2) | KR20070107161A (da) |
| CN (1) | CN100386116C (da) |
| AR (1) | AR042592A1 (da) |
| AT (1) | ATE463258T1 (da) |
| AU (1) | AU2002337025B2 (da) |
| BR (1) | BR0212333A (da) |
| CA (1) | CA2459309C (da) |
| CY (1) | CY1118642T1 (da) |
| DE (1) | DE60235896D1 (da) |
| DK (1) | DK2198888T3 (da) |
| ES (2) | ES2618777T3 (da) |
| HK (1) | HK1062148A1 (da) |
| HU (1) | HUP0402099A2 (da) |
| IL (1) | IL160443A0 (da) |
| MX (1) | MXPA04002185A (da) |
| NO (1) | NO20040938L (da) |
| NZ (1) | NZ531734A (da) |
| PL (1) | PL368056A1 (da) |
| PT (1) | PT2198888T (da) |
| RU (1) | RU2311195C2 (da) |
| TW (1) | TWI249409B (da) |
| UA (1) | UA79435C2 (da) |
| WO (1) | WO2003022243A2 (da) |
| ZA (1) | ZA200401390B (da) |
Families Citing this family (44)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6828415B2 (en) * | 1993-02-19 | 2004-12-07 | Zentaris Gmbh | Oligopeptide lyophilisate, their preparation and use |
| US20070148228A1 (en) * | 1999-02-22 | 2007-06-28 | Merrion Research I Limited | Solid oral dosage form containing an enhancer |
| US7658938B2 (en) | 1999-02-22 | 2010-02-09 | Merrion Reasearch III Limited | Solid oral dosage form containing an enhancer |
| US8119159B2 (en) * | 1999-02-22 | 2012-02-21 | Merrion Research Iii Limited | Solid oral dosage form containing an enhancer |
| US7358330B2 (en) * | 2001-03-29 | 2008-04-15 | Biotempt B.V. | Immunoregulatory compositions |
| US7098305B2 (en) * | 2001-09-06 | 2006-08-29 | Ardana Bioscience Limited | Sustained release of microcrystalline peptide suspensions |
| US7659241B2 (en) | 2002-07-31 | 2010-02-09 | Seattle Genetics, Inc. | Drug conjugates and their use for treating cancer, an autoimmune disease or an infectious disease |
| PE20050285A1 (es) * | 2003-06-24 | 2005-06-09 | Novartis Ag | Composicion farmaceutica que comprende analogos ciclicos de somatostatina |
| GB0320806D0 (en) | 2003-09-05 | 2003-10-08 | Astrazeneca Ab | Therapeutic treatment |
| BR122018071808B8 (pt) | 2003-11-06 | 2020-06-30 | Seattle Genetics Inc | conjugado |
| GB0428151D0 (en) * | 2004-12-22 | 2005-01-26 | Novartis Ag | Organic compounds |
| EP1674082A1 (de) * | 2004-12-22 | 2006-06-28 | Zentaris GmbH | Verfahren zur Herstellung von sterilen Suspensionen oder Lyophilisaten schwerlöslicher basischer Peptidkomplexe, diese enthaltende pharmazeutische Formulierungen sowie ihre Verwendung als Arzneimittel |
| GB0511269D0 (en) * | 2005-06-02 | 2005-07-13 | Creative Peptides Sweden Ab | Sustained release preparation of pro-insulin C-peptide |
| EP1984009B1 (en) * | 2006-01-18 | 2012-10-24 | Qps, Llc | Pharmaceutical compositions with enhanced stability |
| EP2526950A1 (en) * | 2006-04-07 | 2012-11-28 | Merrion Research III Limited | Solid oral dosage form containing an enhancer |
| WO2008071984A1 (en) * | 2006-12-13 | 2008-06-19 | Ardana Bioscience Limited | Administration of the gonadotropin-releasing hormone antagonist teverelix |
| PE20090481A1 (es) | 2007-07-16 | 2009-05-18 | Genentech Inc | Anticuerpos anti-cd79b e inmunoconjugados humanizados y metodos de uso |
| CR20190516A (es) | 2007-07-16 | 2020-02-18 | Genentech Inc | ANTICUERPOS ANTI-CD79B E INMUNOCONJUGADOS (Divisional 2015-0040) |
| CN101981055B (zh) | 2008-01-31 | 2016-03-09 | 健泰科生物技术公司 | 抗cd79b抗体和免疫偶联物及使用方法 |
| KR20110007614A (ko) * | 2008-05-07 | 2011-01-24 | 메리온 리서치 Ⅲ 리미티드 | ＧｎＲＨ 관련 화합물의 조성물 및 제조 방법 |
| TWI480286B (zh) * | 2009-02-25 | 2015-04-11 | Merrion Res Iii Ltd | 雙膦酸鹽類組合物及藥物遞送 |
| CN102421414A (zh) * | 2009-05-01 | 2012-04-18 | 辉凌公司 | 用于治疗前列腺癌的组合物 |
| PT2523653T (pt) | 2010-01-13 | 2018-06-28 | Ipsen Pharma Sas | Processo para a preparação de composições farmacêuticas para a libertação prolongada de análogos de somatostatina |
| US20110182985A1 (en) * | 2010-01-28 | 2011-07-28 | Coughlan David C | Solid Pharmaceutical Composition with Enhancers and Methods of Preparing thereof |
| WO2011120033A1 (en) * | 2010-03-26 | 2011-09-29 | Merrion Research Iii Limited | Pharmaceutical compositions of selective factor xa inhibitors for oral administration |
| WO2012006566A2 (en) | 2010-07-09 | 2012-01-12 | Amylin Pharmaceuticals, Inc. | Microcrystalline y receptor agonists |
| CN103476419A (zh) | 2011-01-07 | 2013-12-25 | 梅里翁第三研究有限公司 | 口服投药的含铁药物组合物 |
| WO2014080251A1 (en) | 2012-11-24 | 2014-05-30 | Hangzhou Dac Biotech Co., Ltd. | Hydrophilic linkers and their uses for conjugation of drugs to cell binding molecules |
| EP2823808A1 (en) | 2013-07-09 | 2015-01-14 | Ipsen Pharma S.A.S. | Pharmaceutical composition for a sustained release of lanreotide |
| EP2832361A1 (en) * | 2013-07-29 | 2015-02-04 | Ipsen Pharma S.A.S. | Aqueous sustained release compositions of LHRH analogs |
| CN104844694A (zh) * | 2014-02-17 | 2015-08-19 | 深圳翰宇药业股份有限公司 | 一种醋酸加尼瑞克的制备方法 |
| DK3122757T3 (da) | 2014-02-28 | 2023-10-09 | Hangzhou Dac Biotech Co Ltd | Ladede linkere og anvendelse deraf til konjugering |
| PT3262071T (pt) | 2014-09-23 | 2020-06-16 | H Hoffnabb La Roche Ag | Métodos de utilização de imunoconjugados anti-cd79b |
| EP3250191B1 (en) | 2015-01-29 | 2024-01-17 | Novo Nordisk A/S | Tablets comprising glp-1 agonist and enteric coating |
| JP6759326B2 (ja) | 2015-07-12 | 2020-09-23 | ハンジョウ ディーエーシー バイオテック シーオー．，エルティディ．Ｈａｎｇｚｈｏｕ Ｄａｃ Ｂｉｏｔｅｃｈ Ｃｏ．，Ｌｔｄ． | 細胞結合分子の共役のための架橋連結体 |
| US9839687B2 (en) | 2015-07-15 | 2017-12-12 | Suzhou M-Conj Biotech Co., Ltd. | Acetylenedicarboxyl linkers and their uses in specific conjugation of a cell-binding molecule |
| AU2016429272A1 (en) | 2016-11-14 | 2019-05-02 | Hangzhou Dac Biotech Co., Ltd. | Conjugation linkers, cell binding molecule-drug conjugates containing the likers, methods of making and uses such conjugates with the linkers |
| RU2019127027A (ru) | 2017-01-30 | 2021-03-01 | Энтив Лимитед | КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ ПО МЕНЬШЕЙ МЕРЕ ОДИН АНТАГОНИСТ GnRH |
| RU2019144532A (ru) | 2017-06-30 | 2021-07-30 | Антев Лимитед | Композиция для лечения острой задержки мочи |
| EP3560555A1 (en) * | 2018-04-26 | 2019-10-30 | LifeArc | A composition for treating one or more estrogen related diseases |
| JP2021525242A (ja) * | 2018-05-28 | 2021-09-24 | ジャンイン ユスン ファーマシューティカル カンパニー，リミテッド | 新たな医薬品使用 |
| EP3590524B1 (en) * | 2018-07-05 | 2020-11-04 | Antev Limited | A method of reconstituting a teverelix-tfa composition |
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| EP3590526A1 (en) | 2018-07-05 | 2020-01-08 | Antev Limited | A lyophilization process and a teverelix-tfa lyophilizate obtained thereby |
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| US7098305B2 (en) * | 2001-09-06 | 2006-08-29 | Ardana Bioscience Limited | Sustained release of microcrystalline peptide suspensions |
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-
2002
- 2002-02-19 US US10/080,130 patent/US7098305B2/en not_active Expired - Lifetime
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2004
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2006
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2010
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2011
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2013
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2017
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