HUE035519T2 - Nátriumtioszulfát-tartalmú gyógyászati készítmény - Google Patents

Nátriumtioszulfát-tartalmú gyógyászati készítmény Download PDF

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HUE035519T2
HUE035519T2 HUE10797770A HUE10797770A HUE035519T2 HU E035519 T2 HUE035519 T2 HU E035519T2 HU E10797770 A HUE10797770 A HU E10797770A HU E10797770 A HUE10797770 A HU E10797770A HU E035519 T2 HUE035519 T2 HU E035519T2
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sodium thiosulfate
sodium
weight
solution
ppm
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HUE10797770A
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Craig Sherman
Catherine Marie Smith
Kevin Robert Wirtz
Erich Schulze
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Hope Medical Entpr Inc D B A Hope Pharmaceuticals
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Claims (14)

Nálrtunnioszullát-tartalmú gyógyászati készítmény Szabadalmi igénypontok
1. Nátriumtioszulfát pentahídrát, mely nem több, mint 10 ppm nem-illó szenes szenei tartalmaz, nem több, mint 0.01 tömcg% karbonátot tartalmaz, nem több, mint 0.05 ppm higanyt tartalmaz, nem több, mira 2 ppm alumíniumot tartalmaz; nem több, mim 0.003 tömeg% szelént tartalmaz, nem kevesebb, mint 99 tömeg% és nem több, mint 100.5 tömeg% nátriam-tíoszulfátot tartalmaz vízmentes bázisra számítva, kolorimetriás mérés alapján vagy nem kevesebb. mint 98 tömeg’% és nem több, mint 102 iömeg% nátrium-tioszul latot tartalmaz vízmentes bázisra számítva ionkromatográfiás mérés alapján, víztartalma 32% és 37 tömeg% közötti, nehéztemtartalma nem több. mint 10 ppm, nem több, mint 200 ppm klóridét tartalmaz, nem több, mint 0.001 tömeg% szulüdot tartalmaz, nem több, mint 0,002 tőmeg% vasat tartalmaz, nem több, mint 0,01 tömeg% kalciumot tartalmaz, nem több, mint 0,005 iömeg% káliumot tartalmaz, nem több, mint 0.1% szül Htot tartalmaz, nem több, mint 0.5% szulfátot tartalmaz, nem több. mint 3 ppm arzént tartalmaz, nem több, mint 0.001 tömeg% ólmot tartalmaz, teljes aerob mikrobiális terhelése nem több, mint 100 CFU/g. összes élesztő és pe-nész.tartalma nem több, mim 20 CFU/g. nem több. mint 0,02 EU/mg baktérium endotoxint tartalmaz, nem több, mint 0,002 tömegé-« nitrogénvegyületet tartalmaz, nem több, mint 0,005 tomeg% oldhatatlan anyagot tartalmaz, nátriumra pozitív azonosítási tesztet mutat, tioszullat-ra pozitív azonosítási tesztet mutat, ammonium oxaiát hatására nem okoz zavarosodást, nem több, mim 0.01 tömeg% maradék összesülést gátló szert tartalmaz, és nem több, mint ICH Q3C határérték szerves illékony szennyezést tartalmaz, ahol a nátriumtioszulfát pentahídrát egy 10%-os oldata 25 °C hőmérsékleten színtelen és pll-értéke 0.0 és 8.0 közötti, és ahol a nátriumtioszulfát pentahídrát szagtalan kristályos anyag vagy színtelen kristályos megjelenésű,
2. Gyógyászati készítmény, mely az 1. igénypont szerinti nátriumtioszulfát pentahidrátot és egy vagy több gyógyászati lag elfogadható hordozót vagy kötőanyagot tartalmaz.
3. A 2, igénypont szerinti gyógyászán készítmény, ahol a készítmény orális, parenteráiis, 111-halációs, nazális, intravesícális, vaginális, rektális, szuhlinguális, szembe történő, vagy topiká-lis adagolásra kialakított; vagy ahol a készítmény egyszeri dózisformává forrnáll,
4. A 2. igénypont szerinti gyógyászati készítmény, ahol a gyógyászatiig elfogadható kötőanyag víz,
5. A 2, igénypont szerinti gyógyászati készítmény, mely továbbá egy izotóniás szert és egy vagy több pl 1-t beállító szert tartalmaz,
6. Az 5. igénypont szerinti gyógyászati készítmény, ahol az izotóniás szer káliumklorid és a p.ll-d beállító szer bórsav és nátriumhidroxid.
7. Az 1. igénypont szerinti nátriumtioszuliát pentahidrát platina által indukált ototoxieitás, platina által indukált nephrotoxicitás, danid-mérgezés, a bőr, körömágy és/vagy körmök gombás bőríeriözései, ealciphyiaxis. vagy atherosclerosissal összefüggő érelmeszesedés kezelésére szolgáló módszerben történő alkalmazásra.
8. Eljárás az I, igénypont szerinti nátriumtioszuliát pentahidrát előállítására, melynek során: a) nátriumszulfitoí vízben kénnel érintkeztélünk egy reakcióelegy létrehozására; b) a reakcióelegyet szikjük egy oldat előállítására; ej .az. oldatot bekoneentráljuk; d) az oldatot aktivált szén hatásának tesszük ki; e) az oldatot aktív szénnel szűrjük: f) a nátriumtíoszulfátot kíkristályositi uk az oldatból: g) a Irikristályosított nátriumtíoszulfátot szárítjuk.
9. A Ü, igénypont szerinti eljárás, ahol az érintkeztelési lépést egy inert atmoszférában végezzük,
10. A 8. igénypont szerinti eljárás, ahol a reakcióelegy pH-értéke nem kevesebb, mint 7.
11. A 8. igénypont szerinti eljárás, ahol az oldatot a kristályosítási lépés előtt 1.40 és 1.50 fajlagos tömegűre koncentráljak be.
12. A 8. igénypont szerinti eljárás, ahol egy nátriumtioszuílát pentabidrát ohókristályt adunk az. oldathoz a kristályosítási lépésben.
13. Eljárás a teljes nem-illő szerves sz.éntartaíom meghatározására nátriumtioszul fát pentahid-rát-tartalmu mintában, melynek során: a) a mintát egy előre meghatározott mennyiségű, szervetlen savat tartalmazó vizes oldattal h oz zuk ér i n t kezesbe ; b) a vizes minta-oldatból eltávolítjuk a csapadékot; e) a minta-oldatot egy meghatározott mennyiségű oxídálószerrel hozzuk érintkezésbe; és d> a minta-oldatban jelenlévő szerves szenet széndioxiddá alakítjuk, szuperkritikus vizes oxidációs körülmények között.
14. A 13. igénypont szerinti eljárás, ahol a szerveden sav fosztorsav, előnyösen 6 N foszfor-sav; vagy ahol a minta-oldatban a szervetlen sav végtérfogata 6%; vagy ahol az oxidáiószcr nátrmmperszuliát, előnyösen 30%-os nátrlumpersz.ulfát oldat; vagy ahol az oxidálószer végső mennyisége a minta-oldat végtéríogatának 45%-a,
HUE10797770A 2009-07-08 2010-07-07 Nátriumtioszulfát-tartalmú gyógyászati készítmény HUE035519T2 (hu)

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US8568793B2 (en) 2009-02-11 2013-10-29 Hope Medical Enterprises, Inc. Sodium nitrite-containing pharmaceutical compositions
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