DK1909736T3 - Oxygenindikator til anvendelse i lægemiddelprodukter og pakke indeholdende oxygenindikator - Google Patents
Oxygenindikator til anvendelse i lægemiddelprodukter og pakke indeholdende oxygenindikator Download PDFInfo
- Publication number
- DK1909736T3 DK1909736T3 DK06789170.5T DK06789170T DK1909736T3 DK 1909736 T3 DK1909736 T3 DK 1909736T3 DK 06789170 T DK06789170 T DK 06789170T DK 1909736 T3 DK1909736 T3 DK 1909736T3
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- DK
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- Prior art keywords
- chamber
- container
- oxygen
- formulation
- indicator
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Classifications
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- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2093—Containers having several compartments for products to be mixed
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- 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
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
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Claims (10)
1. Oxygenindikator til at detektere tilstedeværelsen af oxygen i en lægemiddelbeholder, hvilken oxygenindikator omfatter: a) større end 6 og mindre end 60 g/L indigocarmin; b) en buffer til at justere pH'en til et område på 9,0 til 9,75; c) fra 150 g/L til 210 g/L mikrokrystallinsk cellulose; d) et reduktionsmiddel; og e) vand, hvor farven af den oxiderede form af oxygenindikatoren er forskellig fra farven af den reducerede form af oxygenindikatoren og hvor, efterfølgende sterilisering ved autoklavering forbliver farven af den reducerede form forskellig fra farven af den oxiderede form og farven af den oxiderede form forbliver forskellig fra farven af den reducerede form i mindst seks måneder ved 40°C.
2. Oxygenindikator ifølge krav 1, hvor indigocarmin er til stede ved fra 10 til ca. 40 g/L, bufferen er en phosphatbuffer, og reduktionsmidlet er en reducerende sukker.
3. Oxygenindikator ifølge krav 2, hvor indigocarminen er til stede ved fra 14 til 20 g/L, bufferen er tetranatriumpyrophosphat, og reduktionsmidlet er dextrose.
4. Oxygenindikator ifølge krav 3, hvor tetranatriumpyrophosphatet er til stede ved fra 50 til 80 g/L og dextrose er til stede ved fra 1 to 5 g/L.
5. Oxygenindikator ifølge krav 4, hvor tetranatriumpyrophosphatet er til stede ved fra 60 til 75 g/L, dextrosen er til stede ved fra 2,5 til 4 g/L og den mikrokrystallinske cellulose er en vanduopløselig cellulose til stede ved 180 g/L.
6. Oxygenindikator ifølge krav 5 yderligere omfattende en oxygenpermeabel pakke der indeholder en mængde af oxygenindikatoren, oxygenindikatoren omfatter ca. 14 g/L indigocarmin, ca. 60 g/L of tetranatriumpyrophosphat, ca. 2,5 g/L dextrose, ca. 180 g/L vanduopløseligt, mikrokrystallinsk cellulose og vand.
7. Oxygenindikator ifølge krav 5 yderligere omfattende en oxygenpermeabel pakke der indeholder en mængde af oxygenindikatoren, oxygenindikatoren omfatter ca. 20 g/L indigocarmin, ca. 75 g/L tetranatriumpyrophosphat, ca. 4 g/L dextrose, ca. 180 g/L vanduopløseligt, mikrokrystallinsk cellulose og vand.
8. Oxygenindikator ifølge krav 7, hvor den oxygenpermeable pakke er fastgjort til et beholder med flere kamre med skrøbelige barrierer der adskiller de flere kamre, hver kammer indeholder en komponent afen ernæringsmæssig formulering til fluidt begrænsede patienter, en af komponenterne omfatter cystein.
9. Oxygenindikator ifølge krav 1, hvor indigocarminen er til stede ved fra 9 til 30 g/L, bufferen er en phosphatbuffer, og reduktionsmidlet er en reducerende sukker.
10. Pakke indeholdende oxygenindikatoren ifølge et hvilket som helst af kravene 1 til 9.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US70455505P | 2005-08-02 | 2005-08-02 | |
| PCT/US2006/030051 WO2007016611A2 (en) | 2005-08-02 | 2006-08-02 | Oxygen indicator for use in medical products |
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| DK1909736T3 true DK1909736T3 (da) | 2014-12-01 |
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| DK06789170.5T DK1909736T3 (da) | 2005-08-02 | 2006-08-02 | Oxygenindikator til anvendelse i lægemiddelprodukter og pakke indeholdende oxygenindikator |
| DK06836097.3T DK1909739T3 (da) | 2005-08-02 | 2006-08-02 | Flerkammerbeholder |
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| DK06836097.3T DK1909739T3 (da) | 2005-08-02 | 2006-08-02 | Flerkammerbeholder |
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2006
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