DK2988824T3 - Enterisk belagt multipartikelsammensætning med proteinholdig underbelægning - Google Patents

Enterisk belagt multipartikelsammensætning med proteinholdig underbelægning Download PDF

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DK2988824T3
DK2988824T3 DK13882940.3T DK13882940T DK2988824T3 DK 2988824 T3 DK2988824 T3 DK 2988824T3 DK 13882940 T DK13882940 T DK 13882940T DK 2988824 T3 DK2988824 T3 DK 2988824T3
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menthol
core
terpene
active ingredients
composition
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DK13882940.3T
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Fred Hassan
Syed Shah
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Zx Pharma Llc
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Claims (14)

1. Multipartikelsammensætning, der omfatter en flerhed af individuelle enteriske belagte kerner, der indeholder én eller flere terpen-baserede aktive bestanddele og har et kontinuerligt proteinholdigt underbelægningslag, der dækker de individuelle kerner og adskiller de individuelle kerner fra deres respektive enteriske belægninger.
2. Multipartikelsammensætning ifølge krav 1, hvor de enteriske belagte kerner endvidere omfatter: (a) en protonpumpehæmmer; (b) et antiinflammatorisk middel eller (c) en immunsuppressor.
3. Multipartikelsammensætning ifølge krav 1, hvor den ene eller flere terpen-baserede aktive bestanddele indbefatter: (a) terpen-holdige essentielle olier og/eller L-menthol; (b) pebermynteolie og/eller L-menthol; (c) L-menthol og kommenolie; (d) L-menthol og pebermynteolie; (e) pebermynteolie og kommenolie; (f) L-menthol og grøn the-ekstrakt, der indeholder epigallocatechingallat; eller (g) L-menthol fra en mindst 80 % ren L-mentholkilde opløst i en essentiel olie.
4. Multipartikelsammensætning ifølge krav 1, hvor den enteriske belagte kerne er sfærisk og ikke større end 3 mm i diameter.
5. Multipartikelsammensætning ifølge krav 1, hvor kernerne omfatter 10 % vægt/vægt til 35 % vægt/vægt af den ene eller flere terpen-baserede aktive bestanddele, 40 % vægt/vægt til 75 % vægt/vægt mikrokrystallinsk cellulose; underbelægningen omfatter 3,5 % vægt/vægt til 25 % vægt/vægt af de enteriske belagte kerner; og den enteriske belægning omfatter 2 % til 35 % vægt/vægt af de enteriske belagte kerner.
6. Multipartikelsammensætning ifølge krav 5, hvor: (a) den proteinholdige underbelægning omfatter en kontinuerlig gelatinefilm klæbet til kernen; (b) den proteinholdige underbelægning er en tørret proteinholdig gel; eller (c) den kontinuerlig proteinholdige underbelægningslag, der dækker kernen, er tilpasset til at forhindre den ene eller flere terpen-baserede aktive bestanddele i at blive blandet med den enteriske belægning.
7. Multipartikelsammensætning ifølge krav 5, hvor den enteriske belægning har en glasovergangstemperatur, der er højere end et standardkogepunkt eller sublimationspunkt for den ene eller flere terpen-baserede aktive bestanddele.
8. Fremgangsmåde til fremstilling af en enterisk belagt multipartikelsammensætning, hvilken fremgangsmåde omfatter: belægning af en kerne, der indeholder én eller flere farmaceutisk aktive terpen-baserede aktive bestanddele, med et flydende proteinholdigt materiale; tørring af det flydende proteinholdige materiale på kernen for at danne en kerne med underbelægning; og påføring af en enterisk belægning over kernen med underbelægning.
9. Fremgangsmåde ifølge krav 8, hvor: (a) det proteinholdige materiale omfatter gelatine; (b) det flydende proteinholdige materiale er en opløsning, der mindst indeholder ca. 35 % gelatine; (c) kernen er belagt ved sprøjtning af det flydende proteinholdige materiale på kernen; (d) kernen er fremstillet ved blanding af det ene eller flere farmaceutisk aktive terpen-holdige stoffer med vand og farmaceutisk acceptable excipienser for at danne en våd masse, ekstrudering af den våde masse, sfæronisering af den ekstruderede våde masse og tørring de resulterende sfæroniserede dele; (e) det ene eller flere farmaceutisk aktive terpen-holdige stoffer er valgt fra pebermynteolie, kommenolie, L-menthol, eller en kombination deraf; eller (f) påføring af den enteriske belægning over kernen med underbelægning indbefatter opvarmning af den enteriske belagte kerne til mindst en glasovergangstemperatur for den enteriske belægning uden frigørelse af den ene eller flere terpen-baserede aktive bestanddele fra kernen.
10. Fremgangsmåde ifølge krav 8, hvor terpen-baserede aktive bestanddele indbefatter: (a) terpen-holdige essentielle olier og/eller L-menthol; (b) pebermynteolie og/eller L-menthol; (c) en blanding af L-menthol og kommenolie; eller (d) L-menthol og kommenolie, hvor L-menthol er fra en mindst 80 % ren L-mentholkilde.
11. Fremgangsmåde ifølge krav 8, hvor den enteriske belagte kerne er sfærisk og ikke mere end 3 mm i diameter.
12. Multipartikelsammensætning ifølge et hvilket som helst af kravene 1 til 7 til anvendelse i en fremgangsmåde til behandling af en gastrointestinal forstyrrelse hos et individ.
13. Multipartikelsammensætning til anvendelse ifølge krav 12, hvor (a) sammensætningen administreres enteralt; eller (b) multipartikelsammensætningen blandes med et surt vehikel før administration.
14. Multipartikelsammensætning ifølge krav 1, hvor (a) den ene eller flere terpen-baserede aktive bestanddele indbefatter L-menthol; (b) det proteinholdige underbelægningslag er en kontinuerlig gelatinefilm; (c) de individuelle enteriske belagte kerner er sfæriske og ikke større end 3 mm i diameter; hvor underbelægningen er effektiv til i alt væsentligt at forhindre L-menthol i at trænge ind i underbelægningen og komme i kontakt med den enteriske belægning ved opbevaring ved en temperatur på 40 °C og 75 % relativ fugtighed fra mellem 1 dag og 30 dage.
DK13882940.3T 2013-04-23 2013-09-23 Enterisk belagt multipartikelsammensætning med proteinholdig underbelægning DK2988824T3 (da)

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PCT/US2013/061141 WO2014175916A1 (en) 2013-04-23 2013-09-23 Enteric coated multiparticulate composition with proteinaceous subcoat

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