DK1732512T3 - Inhalérbar formulering indeholdende sulfoalkylethercyclodextrin og kortikosteroid - Google Patents
Inhalérbar formulering indeholdende sulfoalkylethercyclodextrin og kortikosteroid Download PDFInfo
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- DK1732512T3 DK1732512T3 DK05704917.3T DK05704917T DK1732512T3 DK 1732512 T3 DK1732512 T3 DK 1732512T3 DK 05704917 T DK05704917 T DK 05704917T DK 1732512 T3 DK1732512 T3 DK 1732512T3
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Claims (25)
1. Inhalérbar væskeformulering omfattende en kortikosteroid, en sulfoalkylæter-cyclodextrin (SAE-CD) og et vandholdigt væskemedium, hvor kortikosteroiden er udvalgt blandt gruppen omfattende aldosteron, beclometha-son, betamethason, budesonid, ciclesonid, cloprednol, cortison, cortivazol, deoxycor-ton, desonid, desoximetason, dexamethason, difluorcortolon, fluclorolon, flumetha-son, flunisolid, fluocinolon, fluocinonid, fluocortinbutyl, fluorcortison, fluorcortolon, fluormetholon, flurandrenolon, fluticason, halcinonid, hydrocortison, icomethason, meprednison, methylprednisolon, mometason, paramethason, prednisolon, prednison, rofleponid, tixocortol, triamcinolon, beclomethasondipropionat, beclomethasonmono-propionat, dexamethason-21-isonicotinat, fluticasonpropionat, icomethasonenbutat, tixocortol-21-pivalat, tiiamcinolonacetonid og mometasonfuroat, og hvor molforholdet mellem kortikosteroid og SAE-CD foreligger i området fra 0,072:1 til 0,0001:1.
2. Formulering ifølge krav 1, hvor SAE-CD i formuleringen er tilstede i en koncentration, der andrager fra 10 mg til 500 mg pr. ml.
3. Formulering ifølge krav 1 eller 2, hvor kortikosteroid er udvalgt blandt gruppen omfattende beclomethason-dipropionat, budesonid, flunisolid, fluticason-propionat, mometason-furoat og triamcinolon-acetonid.
4. Formulering ifølge et hvilket som helst af kravene 1 til 3 endvidere omfattende et eller flere terapeutiske midler, som er uafhængigt udvalgt ved enhver forekomst blandt gruppen omfattende en p2-adrenoreceptor-agonist, en dopamin-(D2)-receptor-agonist, et anticholinergt middel, miMnon-(l,6-dihydro-2-methyl-6-oxo-[3,4’-bipyridin]-5-carbonitril); milrinon-laclal; og anti-lgE-antistof.
5. Formulering ifølge et hvilket som helst af kravene 13 endvidere omfattende et aktuelt (engelsk: topical) anæstetikum.
6. Formulering ifølge krav 4, hvor p2-adrenoreceptor-agonisten er udvalgt blandt gruppen omfattende albuterol-(alpha1-(((l,l-dimethylethyl)amino)methyl)-4-hydroxy-1,3-benzoldimethanol); bambuterol-(dimethylcarbaminsyre-5-(2-(( 1,1 -dimethylethyl) amino)-1 -hydroxyethyl)-1,3-phenylenester); bitolterol-(4-methylbenzoesyre-4-(2-(( 1,1- dimethylethyl)amino)-l-hydroxyethyl)-l,2-phenylenester); broxaterol (3-bromalpha-(((1,1 -dimethylethyl)amino)methyl)-5-isoxazolemethanol); isoproterenol-(4-( 1-hydroxy-2-((1-methylethyl)amino)ethyl)-l,2-benzenediol); trimetoqinol-(l,2,3,4-tetrahydro-l((3,4,5-trimethoxyphenyl)-methyl)-6,7-isochinolindiol); clenbuterol-(4-amino-3,5-dichlor-alpha-(((1,1 -dimethylethyl)amino)methyl)benzolmethanol); fenoterol-(5-( 1 -hydroxy-2-((2-(4-hydroxyphenyl)- l-methylethyl)amino)ethyl)-1,3-benzoldiol); formoterol-(2-hydroxy-5-(( 1 RS)-1 -hydroxy-2-(((lRS)-2-(p-methoxyphenyl)-1 -methylethyl)amino)ethyl)fonnamlid); (R,R)-formoterol; desformoterol-((R,R)-eller (S,S)-3-amino-4-hydroxy-alpha-(((2-(4-methoxyphenyl)-l-methylethyl)amino)methyl)benzolmethanol); hexoprenalin-(4,4’-(l,6-hexandiyl)-bis(imino(l-hydroxy-2,l-elhandiyl)))bis-l,2-benzoldiol); isoetharin-(4-(l-hydroxy-2-((l-methylethyl)amino)butyl)-l,2-benzoldiol); isoprenalin-(4-(l-hydroxy-2-((l-methyl ethyl)amino)ethyl)-l,2-benzoldiol); metaproterenol-(5-(l-hydroxy-2-((l-methylethyl) amino)ethyl)-l,3-benzoldiol); picumeterol (4-amino-3,5-dichlor-alpha(((6-(2-(2-pyridinyl) ethoxy)hexyl)amino)methyl)benzolmethanol); pirbuterol (alpha6-((( 1,1 -dimethylethyl) amino)methyl)-3-hydroxy-2,6-pyridinmethanol); procaterol (((R*,S*)-(+/-)-8-hydroxy-5-(l-hydroxy-2-((l-methylethyl)amino)butyl)-2(lH)-chinolinon); reproterol-((7-(3-((2-(3,5-dihydroxyphenyl)-2-hydroxyethyl)amino)propyl-3,7-dihydro-l,3-dimethyl-lH-purin-2,6-dion); rimiterol- (4-(hydroxy-2-piperidinylmethyl)-1,2-benzoldiol); salbutamol-((+/-)-alpha1-(((l ,1 -dimethylethyl)amino)methyl)-4-hydroxy-l ,3-benzoldimethanol); (R)-salbutamol; salmeterol-((+/-)-4-hydroxy-alpha1-(((6-(4-phenylbutoxy)hexyl)amino)methyl)-1,3-benzoldimethanol); (R)-salmeterol; terbutalin-(5-(2-(( 1 ,l-dimethylethyl)amino)-l-hydroxyethyl)-l,3-benzoldiol); tulobuterol-(2-chlor-alpha-(((l,l-dimethylethyl)amino) methyl)benzolmethanol); og TA-2005-(8-hydroxy-5-((lR)-l-hydroxy-2-(N-((lR)-2-(4-methoxyphenyl)-l-methylethyl)amino)ethyl)-carbostyrilhydrochlorid).
7. Formulering ifølge krav 4, hvor dopamin-(D2)-receptor-agonist er udvalgt blandt gruppen omfattende apomorphin-((r)-5,6,6a,7-tetrahydro-6-methyl-4H-dibenzo[de,g]-chinolin-10,ll-diol); bromcriptin-((5’-alpha)-2-brom-12’-hydroxy-2’-(l-methylethyl)-5’-(2-methylpropyl)ergotaman-3’,6’,18-ton); cabergolin-((8-beta)-N-(3-(dimethylamino) propyl)-N-((ethylamino)carbonyl)-6-(2-propenyl)ergolin-8-carboxamid); lisurid-(N’-((8-alpha)-9,10-didehydro-6-methylergolin-8-yl)-N,N-diethylurinstof); pergolid-((8-beta)-8-((methylthio)methyl)-6-propylergolin); levodopa-(3-hydroxy-L-tyrosin); pra mipexol-((s)-4,5,6,7-tetrahydro-N6-propyl-2,6-benzothiazoldiamin); chinpirolhydrochlorid-(trans-(-)-4aR-4,4a,5,6,7,8,8a,9-octahydro-5-propyl-lH-pyrazol[3,4]-chinolinhydrochlorid); ropinirol-(4-(2-(dipropylamino)ethyl)-l,3-dihdro-2H-indol-2-on); og talipexol-(5,6,7,8-tetrahydro-6-(2-propenyl)-4H-thiazol-[4,5-d]azepin-2-amin).
8. Formulering ifølge krav 4, hvor det anticholinerge middel er udvalgt blandt gruppen omfattende ipratropiumbromid, oxitropiumbromid, atropinmethylnitrat, atropin-sulfat, ipratropium, belladonna-extrakt, scopolamin, scopolaminmethobromid, ho-matropinmethobromid, hyoscyamin, isopriopramid, orphenadrin, benzalkoniumchlo-rid, tiotropiumbromid og glycopyrroniumbromid.
9. Formulering ifølge krav 5, hvor det topiske anæstetikum er udvalgt blandt gruppen omfattende lidocain, en N-arylamid, en aminoalkylbenzoat, prilocain og etidocain.
10. Formulering ifølge et hvilket som helst af kravene 1-9, hvor molforholdet mellem kortikosteroid til SAE-CD ligger i området fra 0,063:1 til 0,003:1.
11. Formulering ifølge ethvert af kravene 1-11, hvor formuleringen yderligere omfatter et sædvanligt konserveringsmiddel, en antioxidant, et buffermiddel, et syringsmiddel, et opløsningsmiddel, et farvestof, et kompleksering fremmende middel, saltopløsning, en elektrolyt, et andet terapeutisk middel, et alkaliseringsmiddel, en forbindelse, der kan anvendes til indstilling af formuleringens tonicitet, en overfladespændings-modifikator, viskositets-modifikator, densitets-modifikator, flygtigheds-modifikator, antiskumnings-middel. aromastof, sødestof, hydrofil polymer eller en kombination deraf.
12. Formulering ifølge et hvilket som helst af kravene 1-11 endvidere omfattende en anden væskebærer end vand.
13. Formulering ifølge krav 1, hvor formuleringen omfatter mindre end eller omkring 21,5% ± 5% vægt-til-vægt-forhold af en SAE-CD.
14. Formulering ifølge hvert af kravene 1-13 umfassend 1 pg/ml til 10 mg/ml, 50 pg/ml til 10 mg/ml, 100 pg/ml til 2 mg/ml, 300 pg/ml til 1 mg/ml, 10 Lig/ml til 1 mg/ml eller 20 ug/inl til 500 Lig/ml kortikosteroid.
15. Formulering ifølge et af kravene 1 til 14, hvor cyclodextrin er en sammensætning ifølge formel 1:
Formel 1 i hvilken: n er 4, 5 eller 6; Ri, R2, R3, R4, R5, Re, R7, Rs og R9 respektivt uafhængigt er -O- eller en -0-(C2-C6-alkylen)-SC>3-gruppe, hvori mindst en af R1-R9 uafhængigt er en -O- (C2-C6-alkylen)-S03-gruppe, en -0-(CH2)m-S03-gruppe, hvori m andrager 2 til 6, -0CH2CH2CH2S03- eller -0CH2CH2CH2CH2S03 ); og Si, S2, S3, S4, S5, S6, S7, S g og S9 hver uafhængigt er en pharmaceutisk accepterbar kation.
16. Formulering ifølge et hvilket som helst af kravene kravene 1 til 15, hvor cyclodextrin er en sammensætning ifølge formel Π, hvilken er SAEx-a-CD, hvori "x" strækker sig fra 1 til 18; og ifølge formel ΠΙ, hvilken er SAEy-p-CD, hvori "y" strækker sig fra 1 til 21; eller ifølge formel IV, hvilken er SAEz-y-CD ist, hvori "z" omfatter fra 1 til 24, og hvori "SAE" angiver en sulfoalkylether-substituent, og vædierne "x", "y" °8 "z" angiver middelsubstitutionsgraden i henseende til antal af sulfoalkylether-grupper per CD-molekyle.
17. Formulering ifølge Anspruch 15, hvor cyclodextrin er udvalgt blandt gruppen:
18. Forstøvningsdråber omfattende formuleringen ifølge et hvilket som helst af kravene 1 - 17, hvor forstøvningsdråberne udviser en partikelstørrelse andragende fra 0,5 pm til 5 μιη, 2,5 μιη til 5 μιη eller 0,5 um til 2,5 um.
19. Enkeltdosis (”Unit-Dose” = individuel patientdosis) omfattende formuleringen ifølge et hvilket som helst af kravene 1 - 17, hvor Unit-Dose er en enkeltdosis til en-kell-gangs-brug, indeholdende 0,125 mg til 2 mg, 0,125 mg, 0,25 mg, 0,5 mg, 1 mg eller 2 mg kortikosteroids, suspenderet i 50 μΐ til 10 ml af et flydende bæremiddel; eller en enkeltdosis til flergangsbrug indeholdende 0,125 - 2 mg kortikosteroid suspenderet i 1 til 100 ml af et flydende bæremiddel.
20. Formulering ifølge et hvilket som helst af kravene 1-17 eller unit-dose ifølge krav 19 til anvendelse ved behandlingen af en bronchoconstrictiv lidelse.
21. Formulering ifølge krav 20, hvor den bronchoconstrictive lidelse er asthma.
22. Et samlesæt til tilberedelse af formuleringen ifølge et hvilket som helst af kravene 1-17 eller af unit-dose ifølge krav 19 omfattende en kortikosteroid, SAE-CD og et vandholdigt bæremiddel, hvor kortikosteroid er udvalgt blandt gruppen omfattende aldosteron, beclomethason, betamethason, budesonid, ciclesonid, cloprednol, cortison, cortivazol, deoxycorton, desonid, desoximetason, dexamethason, difluorcortolon, fluclorolon, flumethason, flunisolid, fluocinolone, fluocinonide, fluocortinbutyl, fluorcortison, fluorcortolon, fluormetholon, flurandrenolon, fluticason, halcinonid, hydrocortison, icomethason, meprednison, methylprednisolon, mometason, paramethason, prednisolon, prednison, rofleponid, tixocortol, triamcinolon, beclomethason, dipropionat, beclomethasonmo-nopropionat, dexamethason-21-isonicotinat, fluticasonpropionat, icomethasonenbutat, tixocortol-21-pivalat, triamcinolonacetonid og mometasonfuroat, og hvor kortikosteroiden og SAE-CD tilrådighedstilles sammen eller særskilt i fast, suspenderet eller opløst form.
23. Samlesæt ifølge krav 22 omfattende en iblanding af fast kortikosteroid og fast SAE-CD.
24. Samlesæt ifølge krav 22, hvor kortikosteroiden er budesonid, og hvor SAE-CD tilrådighedstilles i en vandig opløsning, medens budesonid tilrådighedstilles i tør, fast form eller i våd suspensionderet form, eller hvor SAE-CD tilrådighedstilles i tør form, og budesonid tilrådighedstilles i en vandig suspension.
25. Formulering ifølge et hvilket som helst af kravene 1-21, hvor kortiko steroid er budesonid, og SAE-CD er suI l'obutylether-β-cycIodcxtrin med en gennemsnitlig substitutionsgrad på 6,0 til 7,1.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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US53362803P | 2003-12-31 | 2003-12-31 | |
PCT/US2005/000082 WO2005065435A2 (en) | 2003-12-31 | 2004-12-31 | Inhalant formulation containing sulfoalkyl ether cyclodextrin and corticosteroid |
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DK1732512T3 true DK1732512T3 (da) | 2017-07-10 |
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DK05704917.3T DK1732512T3 (da) | 2003-12-31 | 2004-12-31 | Inhalérbar formulering indeholdende sulfoalkylethercyclodextrin og kortikosteroid |
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EP (4) | EP3238708A1 (da) |
JP (6) | JP2007517067A (da) |
KR (3) | KR20070007075A (da) |
CN (3) | CN1921830A (da) |
AU (3) | AU2004312095A1 (da) |
BR (3) | BRPI0418386A (da) |
CA (3) | CA2552641A1 (da) |
DK (1) | DK1732512T3 (da) |
HU (1) | HUE032527T2 (da) |
IL (6) | IL176575A0 (da) |
MX (2) | MXPA06007581A (da) |
NZ (1) | NZ548225A (da) |
PT (1) | PT1732512T (da) |
RU (3) | RU2390330C2 (da) |
WO (3) | WO2005065435A2 (da) |
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