DK1993557T3 - Hidtil ukendt epoprostenol-formulering og fremgangsmåde til fremstilling deraf - Google Patents
Hidtil ukendt epoprostenol-formulering og fremgangsmåde til fremstilling deraf Download PDFInfo
- Publication number
- DK1993557T3 DK1993557T3 DK07763188.5T DK07763188T DK1993557T3 DK 1993557 T3 DK1993557 T3 DK 1993557T3 DK 07763188 T DK07763188 T DK 07763188T DK 1993557 T3 DK1993557 T3 DK 1993557T3
- Authority
- DK
- Denmark
- Prior art keywords
- solution
- epoprostenol
- bulk solution
- sodium
- reconstituted
- Prior art date
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- KDYFGRWQOYBRFD-UHFFFAOYSA-L succinate(2-) Chemical compound [O-]C(=O)CCC([O-])=O KDYFGRWQOYBRFD-UHFFFAOYSA-L 0.000 description 1
- 235000000346 sugar Nutrition 0.000 description 1
- 150000008163 sugars Chemical class 0.000 description 1
- 239000000725 suspension Substances 0.000 description 1
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- 229940095064 tartrate Drugs 0.000 description 1
- UEUXEKPTXMALOB-UHFFFAOYSA-J tetrasodium;2-[2-[bis(carboxylatomethyl)amino]ethyl-(carboxylatomethyl)amino]acetate Chemical compound [Na+].[Na+].[Na+].[Na+].[O-]C(=O)CN(CC([O-])=O)CCN(CC([O-])=O)CC([O-])=O UEUXEKPTXMALOB-UHFFFAOYSA-J 0.000 description 1
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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
- A61K9/14—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
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/557—Eicosanoids, e.g. leukotrienes or prostaglandins
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/557—Eicosanoids, e.g. leukotrienes or prostaglandins
- A61K31/558—Eicosanoids, e.g. leukotrienes or prostaglandins having heterocyclic rings containing oxygen as the only ring hetero atom, e.g. thromboxanes
- A61K31/5585—Eicosanoids, e.g. leukotrienes or prostaglandins having heterocyclic rings containing oxygen as the only ring hetero atom, e.g. thromboxanes having five-membered rings containing oxygen as the only ring hetero atom, e.g. prostacyclin
-
- 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
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
-
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/04—Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/12—Antihypertensives
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
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- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
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- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Cardiology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Heart & Thoracic Surgery (AREA)
- Organic Chemistry (AREA)
- Dermatology (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Vascular Medicine (AREA)
- Urology & Nephrology (AREA)
- Hospice & Palliative Care (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Claims (17)
1
1. Bulkopløsning indeholdende (a) epoprostenol eller et salt deraf, (b) arginin, og (c) natriumhydroxid, hvor bulkopløsningen har en pH på 13 eller derover.
2. Bulkopløsningen ifølge krav 1, hvor opløsningen har en pH på mere end 13.
3. Bulkopløsningen ifølge krav 1 eller 2, hvor forholdet af epoprostenolnatrium til alkaliniseringsmidlet erca. 1:25 til ca. 1:200.
4. Bulkopløsningen ifølge kravene 1 til 3, yderligere omfattende et fyldemiddel.
5. Bulkopløsningen ifølge krav 4, hvor fyldemidlet er valgt fra gruppen bestående af hydroxyethylstivelse (HES), sorbitol, lactose, dextran, maltose, mannose, ribose, saccharose, mannitol, trehalose, cyclodextrin, glycin, og polyvinylpyrrolidin (PVP).
6. Bulkopløsningen ifølge kravene 4 eller 5, hvor fyldemidlet er til stede ved ca. 1-10%.
7. Bulkopløsningen ifølge kravene 1 til 6, hvor saltet er epoprostenolnatrium.
8. Bulkopløsningen ifølge kravene 1 til 7, hvor bulkopløsningen er lyofiliseret.
9. Bulkopløsningen ifølge krav 8, indeholdt i et forseglet sterilt hætteglas.
10. Fremgangsmåde til fremstilling afen epoprostenolbulkopløsning ifølge krav 8, hvor lyofiliseringsfremgangsmåden omfatter en frysecyklus efterfulgt at en primær tørringscyklus og en sekundær tørringscyklus.
11. Fremgangsmåden ifølge krav 10, hvor frysecyklussen omfatter: (i) anbringe bulkopløsningen på en hylde i et lyofiliseringskammer; (ii) afkøle hylden til -30°C eller derunder ved hastigheden på 0,5 til 0,7°C /min.; 2 (iii) holde ved -30°C eller derunder i 30 min eller indtil den justerede bulkopløsningstemperatur når -25°C eller derunder; (iv) sænke hyldetemperaturen til -45±2°C indtil den justerede bulkopløsningstemperatur når -38±2°C; (v) holde den justerede bulkopløsning ved -38±2°C i mindst seks timer; (vi) påføre vakuum indtil lyofiliseringskammertrykket når 50 milliTorr eller derunder; og (vii) opretholde hyldetemperaturen ved -45±2°C i mindst 45 minutter efter vakuum påføring.
12. Fremgangsmåden ifølge krav 10, hvor den primære tørringscyklus omfatter trinnene: (i) hæve hyldetemperaturen til ca. 0±2°C ved opvarmningshastigheden på 20±2°C pr. time og fortsætte tørring under vakuum indtil produkttemperaturen når-3±2°C eller derover; og (ii) hæve hyldetemperaturen to 25±2°C og fortsætte tørring indtil produkttemperaturen når 20°C eller derover.
13. Fremgangsmåden ifølge krav 10, hvor den sekundære tørringscyklus omfatter trinnene: (i) hæve hyldetemperaturen til 45±2°C ved en hastighed på 3±2°C/time fortsætte tørring indtil produkttemperaturen når 38±2°C eller derover; (ii) afbryde vakuum mens kammertrykket forøges med nitrogen; og (iii) når kammertrykket når atmosfærisk tryk, afbryde nitrogen og indeslutte sammensætningen under nitrogenatmosfære. 3
14. Lyofiliseret sammensætning ifølge krav 8, hvor den lyofiliserede sammensætning rekonstitueres med et første fortyndingsmiddel valgt fra vand til injektion, 0,9% natriumchloridopløsning, lacteret Ringer's opløsning, Ringer's opløsning, natriumcarbonatopløsning, eller bicarbonatopløsning.
15. Rekonstitueret opløsning ifølge krav 14, hvor den rekonstituerede opløsning fortyndes med et andet fortyndingsmiddel.
16. Sammensætning ifølge kravene 8, 9, 14 eller 15 til anvendelse som medikament.
17. Anvendelse af en sammensætning ifølge kravene 8, 9, 14 eller 15 til fremstillingen af et medikament til behandlingen af en sygdom valgt fra gruppen bestående af atherosclerose, arteriosclerose, kongestiv hjertefejl, angina pectoris, og hypertension.
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US76476906P | 2006-02-03 | 2006-02-03 | |
| US77256306P | 2006-02-13 | 2006-02-13 | |
| US78342906P | 2006-03-20 | 2006-03-20 | |
| PCT/US2007/002948 WO2007092343A2 (en) | 2006-02-03 | 2007-02-02 | Novel epoprostenol formulation and method of making thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK1993557T3 true DK1993557T3 (da) | 2015-12-07 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
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| DK07763188.5T DK1993557T3 (da) | 2006-02-03 | 2007-02-02 | Hidtil ukendt epoprostenol-formulering og fremgangsmåde til fremstilling deraf |
Country Status (14)
| Country | Link |
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| US (2) | US8318802B2 (da) |
| EP (1) | EP1993557B1 (da) |
| JP (1) | JP5415771B2 (da) |
| KR (1) | KR101351668B1 (da) |
| CN (1) | CN101410119B (da) |
| BR (1) | BRPI0707488B8 (da) |
| CA (2) | CA2641393C (da) |
| DK (1) | DK1993557T3 (da) |
| ES (1) | ES2558705T3 (da) |
| HU (1) | HUE026166T2 (da) |
| PL (1) | PL1993557T3 (da) |
| PT (1) | PT1993557E (da) |
| SI (1) | SI1993557T1 (da) |
| WO (1) | WO2007092343A2 (da) |
Families Citing this family (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101410119B (zh) | 2006-02-03 | 2012-03-07 | 埃科特莱茵单一股份公司 | 依前列醇制剂及其制备方法 |
| CN103181893A (zh) * | 2007-09-07 | 2013-07-03 | 联合治疗公司 | 针对革兰氏阴性细菌具有选择性杀菌活性的缓冲液及其使用方法 |
| RS53234B (sr) * | 2009-08-07 | 2014-08-29 | Scipharm Sàrl | Kompozicija za lečenje cistične fibroze |
| CN101669904B (zh) * | 2009-09-29 | 2011-06-22 | 北京中海康医药科技发展有限公司 | 一种依前列醇脂质纳米粒及制备方法 |
| US20120321728A1 (en) * | 2011-06-15 | 2012-12-20 | Ven Subbiah | Nutritional formula for managing angina pectoris |
| JP5917034B2 (ja) * | 2011-07-15 | 2016-05-11 | ニプロ株式会社 | カルシウムブロッカーを含有する固形医薬組成物 |
| CN103585119A (zh) * | 2013-11-13 | 2014-02-19 | 北京泰德制药股份有限公司 | 一种包含依前列醇及其药用盐的稳定化制剂及其制备方法 |
| ITMI20142149A1 (it) * | 2014-12-16 | 2016-06-16 | L I A Di Giuseppe Capasso | Apparato di diagnosi differenziale in medicina adattato per determinare la sequenza di test ottimale atta ad identificare una patologia secondo criteri di appropriatezza diagnostica |
| HU231031B1 (hu) * | 2016-03-23 | 2019-12-30 | CHINOIN Gyógyszer és Vegyészeti Termékek Gyára Zrt. | Megnövelt stabilitású epoprostenol nátrium és eljárás előállítására |
| MX2019006938A (es) | 2016-12-14 | 2019-09-06 | Respira Therapeutics Inc | Metodos y composiciones para trataminto de hipertension pulmonar y otros trastornos del pulmon. |
| CN109330982A (zh) * | 2018-09-13 | 2019-02-15 | 常州市第四制药厂有限公司 | 依前列醇冻干粉及其制备方法 |
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| ZA787353B (en) | 1978-05-17 | 1980-08-27 | Wellcome Found | Pharmaceutical formulations |
| GB2021581B (en) | 1978-05-17 | 1982-10-20 | Wellcome Found | Stabilisation of pgl derivatives |
| US7230014B1 (en) | 1997-10-14 | 2007-06-12 | Eisai Co., Ltd. | Pharmaceutical formulation comprising glycine as a stabilizer |
| US6803386B2 (en) * | 2002-01-16 | 2004-10-12 | United Therapeutics Corporation | Prostacyclin derivative containing compositions and methods of using the same for the treatment of cancer |
| DE10225551A1 (de) * | 2002-06-06 | 2003-12-24 | Schering Ag | Verwendung von oral verfügbaren Prostacyclinderivaten für die Herstellung eines Arzneimittels zur Behandlung von Krankheiten, die mit Knochenmarködemen assoziiert sind |
| BRPI0509117A (pt) | 2004-03-04 | 2007-08-28 | Wyeth Corp | método de liofilização para melhorar a cristalização de excipientes |
| CN101410119B (zh) | 2006-02-03 | 2012-03-07 | 埃科特莱茵单一股份公司 | 依前列醇制剂及其制备方法 |
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2007
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- 2007-02-02 KR KR1020087021569A patent/KR101351668B1/ko active Active
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- 2007-02-02 SI SI200731721T patent/SI1993557T1/sl unknown
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- 2007-02-02 JP JP2008553381A patent/JP5415771B2/ja active Active
- 2007-02-02 CA CA2868998A patent/CA2868998A1/en not_active Abandoned
- 2007-02-02 PT PT77631885T patent/PT1993557E/pt unknown
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Also Published As
| Publication number | Publication date |
|---|---|
| KR101351668B1 (ko) | 2014-01-14 |
| EP1993557A2 (en) | 2008-11-26 |
| JP5415771B2 (ja) | 2014-02-12 |
| US8318802B2 (en) | 2012-11-27 |
| US20090088468A1 (en) | 2009-04-02 |
| BRPI0707488B1 (pt) | 2020-05-26 |
| PT1993557E (pt) | 2016-02-10 |
| ES2558705T3 (es) | 2016-02-08 |
| US8598227B2 (en) | 2013-12-03 |
| JP2009525344A (ja) | 2009-07-09 |
| CA2868998A1 (en) | 2007-08-16 |
| CN101410119B (zh) | 2012-03-07 |
| CN101410119A (zh) | 2009-04-15 |
| KR20090004867A (ko) | 2009-01-12 |
| WO2007092343A2 (en) | 2007-08-16 |
| US20130018093A1 (en) | 2013-01-17 |
| BRPI0707488B8 (pt) | 2021-05-25 |
| BRPI0707488A2 (pt) | 2011-05-03 |
| CA2641393C (en) | 2014-12-16 |
| HUE026166T2 (en) | 2016-05-30 |
| CA2641393A1 (en) | 2007-08-16 |
| WO2007092343A3 (en) | 2008-01-17 |
| EP1993557A4 (en) | 2012-07-25 |
| EP1993557B1 (en) | 2015-11-11 |
| PL1993557T3 (pl) | 2016-05-31 |
| SI1993557T1 (sl) | 2016-01-29 |
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