DK1959994T3 - Botulinumnanoemulsioner - Google Patents
Botulinumnanoemulsioner Download PDFInfo
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- DK1959994T3 DK1959994T3 DK06851782.0T DK06851782T DK1959994T3 DK 1959994 T3 DK1959994 T3 DK 1959994T3 DK 06851782 T DK06851782 T DK 06851782T DK 1959994 T3 DK1959994 T3 DK 1959994T3
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Claims (42)
1. En botulinumnanoemulsionssammensætning omfattende: en population af nanopartikler, hvor mere end 50% af partikler har diametre mellem 10 og 300 nanometer eller hvor mere end 50% af partikler har et diameterinterval mellem 10 og 250 nanometer eller hvor mere end 50% af partikler har et diameterinterval mellem 10 og 200 nanometer, eller hvor mere end 50% partikler har et diameterinterval mellem 10 og 150 nanometer eller hvor mere end 50% af partikler har et diameterinterval mellem 10 og 120 nanometer eller hvor mere end 50% af partikler har et diameterinterval mellem 10 og 100 nanometer eller hvor mere end 50% af partikler har et diameterinterval mellem 10 og 50 nanometer, hvor partikler i nanoemulsionen omfatter botulinumtoksin; en olie; og et overfladeaktivt middel.
2. Nanoemulsion ifølge krav 1, hvor mere end 70% af partikler har en gennemsnitlig partikelstørrelse indenfor intervallet 70 og 130 nanometer eller inden for intervallet 80 og 110 nanometer.
3. Nanoemulsion ifølge krav 1, hvor populationen af partikler er uden partikler havende en diameter på over 300 nm eller hvor færre end 50% af partiklerne har en diameter på over 300 nm eller hvor færre end 25% af partiklerne har en diameter på over 300 nm eller hvor færre end 10% af partiklerne har en diameter på over 300 nm eller hvor færre end 5% af partiklerne har en diameter på over 300 nm eller hvor færre end 1% af partiklerne har en diameter på over 300 nm.
4. Nanoemulsion ifølge krav 1, hvor populationen af partikler er uden partiklerhavende en diameter på over 200 nm eller hvor færre end 50% af partiklerne har en diameter på over 200 nm eller hvor færre end 25% af partiklerne har en diameter på over 200 nm eller hvor færre end 10% af partiklerne har en diameter på over 200 nm eller hvor færre end 5% af partiklerne har en diameter på over 200 nm eller hvor færre end 1 % af partiklerne har en diameter på over 200 nm.
5. Nanoemulsionen ifølge krav 1, hvor populationen af partikler er uden partikler havende en diameter på over 120 nm eller hvor færre end 50% af partiklerne har en diameter på over 120 nm eller hvor færre end 25% af partiklerne har en diameter på over 120 nm eller hvor færre end 10% af partiklerne har en diameter på over 120 nm eller hvor færre end 5% af partiklerne har en diameter på over 120 nm eller hvor færre end 1% af partiklerne har en diameter på over 120 nm.
6. Nanoemulsion ifølge krav 1, hvor forskellen mellem minimumpartikeldiameteren og maksimumpartikeldiameteren ikke overstiger 600 nm eller hvor forskellen mellem minimumpartikeldiameteren og maksimumpartikeldiameteren ikke overstiger 500 nm eller hvor forskellen mellem minimumpartikeldiameteren og maksimumpartikeldiameteren ikke overstiger 400 nm eller hvor forskellen mellem minimumpartikeldiame-ter og maksimumpartikeldiameteren ikke overstiger 300 nm eller hvor forskellen mellem minimumpartikeldiameteren og maksimumpartikeldiameteren ikke overstiger 200 nm eller hvor forskellen mellem minimumpartikeldiameteren og maksimumpartikeldiameteren ikke overstiger 100 nm eller hvor forskellen mellem minimumpartikeldiameteren og maksimumpartikeldiameteren ikke overstiger 50 nm.
7. Nanoemulsion ifølge krav 1, hvor partiklerne har en gennemsnitlig diameter på 300 nm eller 200 nm eller 150 nm eller 100 nm eller 75 nm eller 50 nm.
8. Nanoemulsion ifølge krav 1, hvor partiklerne har en gennemsnitlig diameter mellem 10-300 nm eller hvor partiklerne har en gennemsnitlig diameter mellem 50-250 nm eller hvor partiklerne har en gennemsnitlig diameter mellem 60-200 nm eller hvor partiklerne har en gennemsnitlig diameter mellem 65-150 nm eller hvor partiklerne har en gennemsnitlig diameter mellem 70-130 nm eller hvor partiklerne har en gennemsnitlig diameter mellem 80-110 nm eller hvor partiklerne har en gennemsnitlig diameter mellem 90-100 nm.
9. Nanoemulsion ifølge krav 1, hvor nanoemulsionen er uden toksiske opløsningsmidler eller hvor nanoemulsionen omfatter mindre end 50% toksiske opløsningsmidler eller hvor nanoemulsionen omfatter mindre end 25% toksiske opløsningsmidler eller hvor nanoemulsionen omfatter mindre end 10% toksiske opløsningsmidler eller hvor nanoemulsionen omfatter mindre end 5% toksiske opløsningsmidler eller hvor nanoemulsionen omfatter mindre end 1% toksiske opløsningsmidler.
10. Nanoemulsionen ifølge krav 1, hvor nanoemulsionen blev dannet ved eksponering for høj forskydningskraft eller hvor nanoemulsionen blev dannet ved eksponering for høj forskydningskraft i mindre end 10 minutter, 2 minutter, 1 minut eller 30 sekunder.
11. Nanoemulsion ifølge krav 1, hvor nanoemulsionen blev dannet ved eksponering for tryk større end 3000 psi, 10.000 psi, 18.000 psi eller 24.000 psi.
12. Nanoemulsionen ifølge krav 1, hvor nanoemulsionen blev dannet ved mikrofluidi-sering eller hvor nanoemulsionen blev dannet ved mikrofluidisering ved et tryk på mere end 3.000 psi, 10.000 psi, 18.000 psi eller 24.000 psi, foretrukket hvor mikroflu-idiseringen er enkelt-pas mikrofluidisering.
13. Nanoemulsion ifølge krav 1, hvor nanoemulsionen blev dannet ved kavitation eller højtrykshomogenisering.
14. Nanoemulsion ifølge krav 1, hvor botulinumtoksinet er indkapslet i partiklerne eller hvor botulinumtoksinet er adsorberet på overfladen af partiklerne eller hvor botu-linumtoxinet er forbundet med partikelgrænsefladen.
15. Nanoemulsion ifølge krav 1, hvor botulinumtoksinet er udvalgt blandt gruppen omfattende type A, type B, type Ci, type C2, type D, type F og type G.
16. Nanoemulsion ifølge krav 1, hvor botulinumtoksinet er et botulinumtoksinkom-pleks, foretrukket hvor botulinumtoksinkompleks omfatter et ikke-toksin-hæmagglutininprotein og et ikke-toksin-ikke-hæmagglutininprotein.
17. Nanoemulsion ifølge krav 1, hvor botulinumtoksinet er inkorporeret i en albu-minmatrix, foretrukket hvor albuminet er humant albumin.
18. Nanoemulsion ifølge krav 1, hvor botulinumtoxinet er et oprenset botulinumtoxin- protein eller fragment deraf eller hvor botulinumtoxinet er isoleret, eller i det væsentlige isoleret, fra andre proteiner eller hvor botulinumtoksinet er isoleret, eller i det væsentlige isoleret, fra ikke-toxinproteiner eller hvor botulinumtoksinet er isoleret fra Clostridium botulinum.
19. Nanoemulsion ifølge krav 1, hvor botulinumtoxinet er kemisk syntetiseret eller hvor botulinumtoksinet er produceret rekombinant.
20. Nanoemulsion ifølge krav 1, hvor nanoemulsionen eller partiklerne eller botulinumtoksinet kan penetrere huden uden ændring eller forandring af huden eller hvor nanoemulsionen eller partiklerne eller botulinumtoksinet kan penetrere huden uden brug af hudpermeationsforstærkere eller slibemidler.
21. Nanoemulsion ifølge krav 1, hvor nanoemulsionen kan penetrere det øverste lag af huden uden anvendelse af hudpermeationsforstærkere eller slibemidler, foretrukket hvor det øverste lag af huden er overfladen af stratum corneum eller hvor det øverste lag af hud indbefatter hudporer eller hvor det øverste lag af huden indbefatter hudkirtler.
22. Nanoemulsion ifølge krav 1, hvor nanoemulsionen kan pentrere huden uden brug af kemiske permeationsforstærkere eller slibemidler eller uden brug af mekaniske permeationsforstærkere eller slibemidler.
23. Nanoemulsion ifølge krav 1, hvor nanoemulsionen ikke har mere end en olie.
24. Nanoemulsionen ifølge krav 1, hvor nanoemulsionen ikke har mere end et overfladeaktivt middel.
25. Nanoemulsion ifølge krav 1, hvor olien og det overfladeaktive middel er til stede i et forhold mellem 0,5-2,0 eller i et forhold mellem 0,5-1,5 eller i et forhold mellem 0,5-1,0 eller i et forhold mellem 1,0-2,0 eller i et forhold mellem 1,5-2,0.
26. Nanoemulsion ifølge krav 1, hvor procenten af olie i nanoemulsionen er fra 1%-30%, fra 1% -20% eller fra 1% -10%, eller hvor procenten af olie i nanoemulsionen er 8% eller 5%.
27. Nanoemulsion ifølge krav 1, hvor procenten af overfladeaktivt middel i nanoemul-sionen er fra l%-30%, fra l%-20%, fra 1%-10% eller hvor procenten af overfladeaktivt middel i nanoemulsionen er 8% eller 5%.
28. Nanoemulsion ifølge krav 1, hvor det overfladeaktive middel er et nonionisk detergent.
29. Nanoemulsion ifølge krav 1, hvor det overfladeaktive middel er udvalgt blandt gruppen bestående af phosphoglycerider; fosfatidylcholiner; dipalmitoylfosfatidylcho-lin (DPPC); dioleylfosfatidylethanolamin (DOPE); dioleyloxypropyltriethylammoni-um (DOTMA); dioleoylfosfatidylcholin; cholesterol; cholesterolester; diacylglycerol; diacylglycerolsuccinat; difosfatidylglycerol (DPPG); hexanedecanol; fede alkoholer såsom polyethylenglycol (PEG); polyoxyethylen-9-laurylether; en overfladeaktiv fedtsyre, såsom palmitinsyre eller oliesyre; fedtsyrer; fedtsyremonoglycerider; fedtsyre-diglycerider; fedtsyreamider; sorbitantrioleat (Span 85) glycocholat; sorbitan mono-laurat (Span 20); polysorbat 20 (Tween-20); polysorbat 60 (Tween-60); polysorbat 65 (Tween-65); polysorbat 80 (Tween-80); polysorbat 85 (Tween-85); polyoxyethylen monostearat; surfactin; en poloxomer; en sorbitanfedtsyreester, såsom sorbitantrioleat; lecithin; lysolecithin; fosfatidylserin; fosfatidylinositol; sphingomyelin; fosfa-tidylethanolamin (cephalin); cardiolipin; fosfatidsyre; cerebrosider; dicetylfosfat; dipalmitoylfosfatidylglycerol; stearylamin; dodecylamin; hexadecyl-amin; acetylpalmitat; glycerol-ricinoleat; hexadecyl-sterat; isopropylmy-ristat; tyloxapol; poly(ethylenglycol)5000-fosfatidylethanolamin; po-ly(ethylenglycol)400-monostearat; fosfolipider; syntetiske og/eller naturlige detergenter havende stærke overfladeaktive egenskaber; deoxycholates; cyclodextriner; cha-otropiske salte; ionparringsmidler; og kombinationer deraf.
30. Nanoemulsion omfattende en population af partikler havende diametre mellem 10 og 300 nanometer, hvor nævnte nanoemulsion omfatter mindst et botulinumtoxin, en olie og et overfladeaktivt middel og hvor botulinumtoxinet er en del af et kompleks omfattende et botulinumtoksin forbundet med ikke-toksinproteiner.
31. Nanoemulsion omfattende en population af partikler havende diametre mellem 10 og 300 nanometer, hvor nævnte nanoemulsion blev dannet ved eksponering for høj forskydningskraft; hvor nanoemulsionen omfatter mindst et botulinumtoxin, mindst en olie og mindst et nonionisk detergent; og hvor botulinumtoksinet er inkorporeret i en human albuminmatrix.
32. Nanoemulsion omfattende: en population af partikler havende diametre mellem 10 og 300 nanometer; mindst et botulinumtoksin; mindst en olie; og ikke mere end et overfladeaktivt middel; hvor nanoemulsionen blev dannet ved eksponering for høj forskydningskraft.
33. Farmaceutisk sammensætning omfattende en hvilken som helst af (i) nanoemulsionen ifølge krav 1; eller (ii) nanoemulsionen ifølge krav 1, hvor færre end 50% af partiklerne har en diameter på over 120 nm; eller (iii) nanoemulsionen ifølge krav 1, hvor forskellen mellem minimumparti-keldiameteren og maksimumpartikeldiameteren ikke overstiger 100 nm; eller (iv) nanoemulsionen ifølge krav 1, hvor partiklerne har en gennemsnitlig diameter mellem 60-200 nm, foretrukket hvor sammensætningen er udvalgt blandt gruppen bestående af en creme, en lotion, en gel, en salve, en spray, et pulver, et blødgørende middel og kombinationer deraf.
34. Sammensætning omfattende en hvilken som helst af (i) nanoemulsionen ifølge krav 1; eller (ii) nanoemulsionen ifølge krav 1, hvor færre end 50% af partiklerne har en diameter på over 120 nm; eller (iii) nanoemulsionen ifølge krav 1, hvor forskellen mellem minimumparti-keldiameteren og maksimumpartikeldiameteren ikke overstiger 100 nm; eller (iv) nanoemulsionen ifølge krav 1, hvor partiklerne har en gennemsnitlig diameter mellem 60-200 nm til transdermal administration af botulinumtoksin til et individ.
35. Kosmetisk fremgangsmåde til behandling af rynker, ansigtslinjer og/eller halslinjer, omfattende trinnene: (a) tilvejebringelse af: (i) et individ der udviser symptomer på rynker, ansigtslinjer og/eller halslinjer; (ii) en sammensætning omfattende en hvilken som helst af (I) nanoemulsionen ifølge krav 1; eller (II) nanoemulsionen ifølge krav 1, hvor færre end 50% af partiklerne har en diameter på over 120 nm; eller (III) nanoemulsionen ifølge krav 1, hvor forskellen mellem minimumpartikeldiameteren og maksimumpartikeldiameteren ikke overstiger 100 nm; eller (IV) nanoemulsionen ifølge krav 1, hvor partiklerne har en gennemsnitlig diameter mellem 60-200 nm; og (b) administration af sammensætningen til individets hud, således at symptomer reduceres.
36. Kosmetisk fremgangsmåde til forsinkelse af begyndelsen af rynker, ansigtslinjer og/eller halslinjer, omfattende trinnene: (a) tilvejebringelse af: (i) et individ der ikke udviser symptomer på rynker, ansigtslinjer og/eller halslinjer; (ii) en sammensætning omfattende en hvilken som helst af (I) nanoemulsionen ifølge krav 1, eller (II) nanoemulsionen ifølge krav 1, hvor færre end 50% af partiklerne har en diameter på over 120 nm; eller (III) nanoemulsionen ifølge krav 1, hvor forskellen mellem minimumpartikeldiameteren og maksimumpartikeldiamete-ren ikke overstiger 100 nm; eller (IV) nanoemulsionen ifølge krav 1, hvor partiklerne har en gennemsnitlig diameter mellem 60-200 nm; og (b) administration af sammensætningen til individet hud, således at symptomernes begyndelse forsinkes.
37. Fremgangsmåde til fremstilling af en nanoemulsion omfattende trinnene: (a) tilvejebringelse af en forblanding omfattende: (i) en olie; (ii) et overfladeaktivt middel; og (iii) en vandig fase; og (b) udsættelse af forblandingen for høj forskydningskraft eller højtrykshomogenisering i en tidsperiode og under betingelser der opnår en hvilken som helst af (I) en nanopartikelsammensætning ifølge krav 1, eller (II) nanoemulsionen ifølge krav 1, hvor færre end 50% af partiklerne har en diameter på over 120 nm; eller (III) nanoemulsionen ifølge krav 1, hvor forskellen mellem minimumpartikeldiameteren og maksimumpartikeldiameteren ikke overstiger 100 nm; eller (IV) nanoemulsionen ifølge krav 1, hvor partiklerne har en gennemsnitlig diameter mellem 60-200 nm, foretrukket hvor forblandingen omfatter et botulinumtoksin.
38. Fremgangsmåde til fremstilling af en nanoemulsion omfattende trinnene: (a) tilvejebringelse af en forblanding omfattende: (i) en olie; (ii) et overfladeaktivt middel; (iii) en vandig fase; og (iv) et botulinumtoksin; (b) dannelse af en opløsning omfattende forblandingen; og (c) udsættelse af opløsningen for høj forskydningskraft eller højtrykshomogenisering i en tidsperiode og under betingelser der opnår en hvilken som helst af (I) en nanopartikelsammensætning ifølge krav 1, eller (II) nanoemulsionen ifølge krav 1, hvor færre end 50% af partiklerne har en diameter på over 120 nm; eller (III) nanoemulsionen ifølge krav 1, hvor forskellen mellem mini-mumpartikeldiameteren og maksimumpartikeldiameteren ikke overstiger 100 nm; eller (IV) nanoemulsionen ifølge krav 1, hvor partiklerne har en gennemsnitlig diameter mellem 60-200 nm; hvor olien og det overfladeaktive middel eventuelt er til stede i et forhold mellem 0,5- 2,0 (efter vægt); og hvor den høje forskydningskraft eventuelt er dannet ved mikroflu-idisering.
39. Sammensætning ifølge krav 1, hvor sammensætningen er administreret transder-malt under anvendelse af et klæbende plaster eller hvor sammensætningen er administreret transdermalt under anvendelse af en spatel eller hvor sammensætning er administreret transdermalt under anvendelse af en vatpind eller hvor sammensætningen er administreret transdermalt under anvendelse af en sprøjte uden en nål eller hvor sam mensætningen er administreret transdermalt under anvendelse af en anordning som tillader påføring af sammensætningen på et målsted på huden uden at påføre sammensætningen på ikke-målsteder af huden.
40. Sammensætning ifølge krav 1 til behandling af rynker og/eller halslinjer, foretrukket hvor rynkerne og/eller halslinjeme er udvalgt blandt gruppen bestående af hyper-kinetiske ansigtslinjer, ansigtsrynker, platysmabånd og kombinationer deraf, mere foretrukket hvor ansigtsrynker involverer en eller flere af panderegionen, glabellarre-gionen, rhytidsregionen eller periorbitalregionen.
41. Sammensætning ifølge krav 1, hvor sammensætningen er administreret for at behandle hyperhidrose.
42. Sammensætning ifølge krav 1, til anvendelse ved transdermal administration af botulinum til et individ.
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| DK17183832.9T DK3295955T3 (da) | 2005-12-01 | 2006-12-01 | Botulinum nanoemulsioner |
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