DK2424356T3 - Stabil farmaceutisk sammensætning og fremgangsmåder til brug af samme - Google Patents
Stabil farmaceutisk sammensætning og fremgangsmåder til brug af samme Download PDFInfo
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- DK2424356T3 DK2424356T3 DK10770322.5T DK10770322T DK2424356T3 DK 2424356 T3 DK2424356 T3 DK 2424356T3 DK 10770322 T DK10770322 T DK 10770322T DK 2424356 T3 DK2424356 T3 DK 2424356T3
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- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Claims (4)
1. Farmaceutisk sammensætning, der omfatter mindst 95 % ethyl-eicosa-penta-ensyre (ethyl-EPA), som er indesluttet i en kapselskal, hvilken sammensætning har (a) en baseline-peroxidværdi, der ikke er større end 5 Meq/kg, og ved opbevaring af sammensætningen ved 25 °C og 60 % RH i en periode på 6 måneder har sammensætningen en anden peroxidværdi, der ikke er større end 8 Meq/kg, og (b) hvilken kapselskal omfatter (i) gelatine i en mængde på 50 til 70 vægt-% af de ikke-vandige komponenter, men i det væsentlige ingen kemisk modificeret gelatine, såsom succineret gelatine, (ii) glycerin i en mængde på 5 % til 15 vægt-% af de ikke-vandige komponenter og sorbitol i en mængde på 15 % til 25 vægt-% af de ikke-vandige komponenter og (iii) maltitol i en mængde på 3 til 10 vægt-% af de ikke-vandige komponenter.
2. Farmaceutisk sammensætning ifølge krav 1, hvor sammensætningen ikke indeholder nogen DHA eller ethyl-DHA.
3. Farmaceutisk sammensætning ifølge krav 1, hvilken EPA ved lagring af sammensætningen ved 25 °C og 60 % RH i en periode på 6 måneder har en anden peroxidværdi, der ikke er større end 7 Meq/kg eller ikke større end 6 Meq/kg.
4. Farmaceutisk sammensætning ifølge krav 1, hvilken EPA ved lagring af sammensætningen ved 30 °C og 65 % RH i en periode på 6 måneder har en anden peroxidværdi, der ikke er større end 12 Meq/kg eller ikke større end 10 Meq/kg, eller ikke større end 6 Meq/kg.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
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| US17376309P | 2009-04-29 | 2009-04-29 | |
| PCT/US2010/032952 WO2010127103A1 (en) | 2009-04-29 | 2010-04-29 | Stable pharmaceutical composition and methods of using same |
Publications (1)
| Publication Number | Publication Date |
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| DK2424356T3 true DK2424356T3 (da) | 2017-12-04 |
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| DK10770322.5T DK2424356T3 (da) | 2009-04-29 | 2010-04-29 | Stabil farmaceutisk sammensætning og fremgangsmåder til brug af samme |
| DK17168056.4T DK3278665T3 (da) | 2009-04-29 | 2010-04-29 | Stabil farmaceutisk sammensætning og fremgangsmåder til anvendelse deraf |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
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| DK17168056.4T DK3278665T3 (da) | 2009-04-29 | 2010-04-29 | Stabil farmaceutisk sammensætning og fremgangsmåder til anvendelse deraf |
Country Status (27)
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| EP (3) | EP2424356B1 (da) |
| KR (1) | KR101343249B1 (da) |
| CN (2) | CN104856985B (da) |
| AU (1) | AU2010241571B2 (da) |
| BR (1) | BRPI1011876B1 (da) |
| CA (1) | CA2759284C (da) |
| CO (1) | CO6470838A2 (da) |
| CY (2) | CY1119596T1 (da) |
| DK (2) | DK2424356T3 (da) |
| ES (2) | ES2827204T3 (da) |
| HR (2) | HRP20171766T1 (da) |
| HU (2) | HUE034941T2 (da) |
| LT (2) | LT3278665T (da) |
| MX (3) | MX2011011538A (da) |
| MY (1) | MY157120A (da) |
| NO (1) | NO2424356T3 (da) |
| NZ (2) | NZ627238A (da) |
| PH (1) | PH12016500216B1 (da) |
| PL (2) | PL2424356T3 (da) |
| PT (2) | PT2424356T (da) |
| RU (2) | RU2538691C2 (da) |
| SG (3) | SG10201605794PA (da) |
| SI (2) | SI2424356T1 (da) |
| SM (2) | SMT202000647T1 (da) |
| WO (1) | WO2010127103A1 (da) |
| ZA (1) | ZA201107699B (da) |
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| WO2020065402A1 (en) | 2018-09-26 | 2020-04-02 | Amarin Pharmaceuticals Ireland Limited | Compositions and methods for treating or preventing diseases and/or disorders caused by exposure to air pollution |
| US20200261391A1 (en) | 2019-02-15 | 2020-08-20 | Amarin Pharmaceuticals Ireland Limited | Methods of reducing the risk of a cardiovascular event in a statin-treated subject by increasing serum and plasma epa and dpa levels |
| EP4468884A4 (en) * | 2022-01-26 | 2025-12-10 | Amarin Pharmaceuticals Ie Ltd | Lymph-releasing fatty acid compositions and their uses for lymphatic absorption and the treatment of systemic diseases |
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