DK2473475T3 - Anvendelse af cannabidiolprodrugs i topisk og transdermal administration med mikronåle - Google Patents

Anvendelse af cannabidiolprodrugs i topisk og transdermal administration med mikronåle Download PDF

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DK2473475T3
DK2473475T3 DK10755265.5T DK10755265T DK2473475T3 DK 2473475 T3 DK2473475 T3 DK 2473475T3 DK 10755265 T DK10755265 T DK 10755265T DK 2473475 T3 DK2473475 T3 DK 2473475T3
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pharmaceutical composition
cannabidiol
drug delivery
microneedle
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DK10755265.5T
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Stan Lee Banks
Miroslaw Jerzy Golinski
Jeffrey Lynn Howard
Dana Carmel Hammell
Audra Lynn Stinchcomb
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Zynerba Pharmaceuticals Inc
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Claims (14)

1. Mikronål-lægemiddelindgivelsessystem til transdermal eller topisk administration af et cannabidiol-prodrug til et pattedyr, hvilket system omfatter: a) en farmaceutisk sammensætning, der omfatter et cannabidiolprodmg med formlen:
hvor X" er en modion afledt af farmaceutisk acceptable syrer, og b) en mikronåleenhed, hvor den farmaceutiske sammensætning er beregnet til administration til huden på pattedyret i forbindelse med mikronåleenheden, enten før administrationen af mikronåleenheden, efter administrationen af mikronåleenheden eller samtidig med administrationen af mikronåleenheden.
2. Lægemiddelindgivelsessystem ifølge krav 1, hvor cannabidiolprodrugget er til stede i en mængde på ca. 0,1 % til ca. 50 % (vægt/vægt), ca. 0,1 % til ca. 40 % (vægt/vægt), ca. 5 % til ca. 30 % (vægt/vægt) eller ca. 10 % til ca. 20 % (vægt/vægt) af den farmaceutiske sammensætning.
3. Lægemiddelindgivelsessystem ifølge krav 1, hvor den farmaceutiske sammensætning er i form af en hydrogel, fortrinsvis, hvor hydrogelen er inkorporeret i et patch af matrix-eller beholdertypen.
4. Lægemiddelindgivelsessystem ifølge krav 1, hvor den farmaceutiske sammensætning endvidere omfatter en COX-hæmmer udvalgt ffa gmppen bestående af: aspirin, diclofenac, diflunisal, fenoprofen, flurbiprofen, ibuprofen, indomethacin, ketoprofen, ketorolac, mefenaminsyre, meloxicam, nabumeton, naproxen, olsalzin, oxaprozin, piroxicam, salsalat, sulfasalazin, sulindac, tolmetin, mofezolac, SC-560, FR 122047, etodolac, celecoxib, rofecoxib, valdecoxib, parecoxib, lumiracoxib og etoricoxib.
5. Lægemiddelindgivelsessystem ifølge krav 1, hvor den farmaceutiske sammensætning endvidere omfatter en penetrationforstærker udvalgt fra gmppen bestående af: isostearinsyre, octansyre, oliesyre, oleylalkohol, laurylalkohol, ethyloleat, isopropylmyristat, buttylstearat, methyllaurat, diisopropyladipat, glycerylmonolaurat, tctrahydrofurfurylalkohol-polycthylcnglycolcthcr, polycthylcnglycol, propylcnglycol, 2-(2-ethoxyethoxy)ethanol, di-ethylenglycolmonomethyl ether, alkylarylethere af polyethylenoxid, polyethylenoxidmonomethylethere, polyethylenoxiddimethylether, dimethylsulfoxid, glycerol, aceteddikeester, N-alkylpyrrolidon, terpener, n-octanol, natriumoleat, D-limonen, monoolein, cineol, oleyloleat, efhanol, propanol, butanol, 2-butanol, pentanol, 2-pentanol, hexanol, octanol, nonanol, decanol, benzylalkohol, Polyxamer 231, Polyxamer 182, Polyxamer 184, Polysorbat 20, Polysorbat 60, Brij 30, Brij 93, Brij 96, Brij 99, Span 20, Span 40, Span 60, Span 80, Span 85, Tween 20, Tween 40, Tween 60, Tween 80, Myrj 45, Myrj 51, Myrj 52 og Miglyol 840, fortrinsvis hvor penetrationsforstærkeren er til stede i en mængde of ca. 0,1 % til ca. 40 % (vægt/vægt), ca. 0,1 % til ca. 30 % (vægt/vægt), ca. 1 % til ca. 20 % (vægt/vægt) eller 1 % til ca. 10 % (vægt/vægt) af den farmaceutiske sammensætning.
6. Lægemiddelindgivelsessystem ifølge krav 1, hvor den farmaceutiske sammensætning endvidere omfatter en lavere alkohol udvalgt fra gruppen bestående af: ethanol og isopropanol.
7. Lægemiddelindgivelsessystem ifølge krav 1, hvor den farmaceutiske sammensætning indgiver en terapeutisk effektiv mængde af cannabidiolprodrugget over et tidsrum time udvalgt fra gruppen bestående af: ca. 1 time, ca. 2 timer, ca. 3 timer, ca. 4 timer, ca. 6 timer, ca. 12 timer, ca. 24 timer, ca. 48 timer, ca. 72 timer, ca. 96 timer, ca. 5 dage, ca. 6 dage eller ca. 7 dage.
8. Mikronål-lægemiddelindgivelsessystem ifølge et hvilket som helst af kravene 1 til 7 til behandling af en sygdomstilstand, hvor sygdomstilstanden er udvalgt fra gruppen bestående af: akut pancreatitis, kronisk pancreatitis, pankreascancer, kvalme, opkastning, smerte, kakeksisyndrom, kakeksi forbundet med hiv, kemoterapiinduceret kvalme og opkastning, alkoholmisbrugsforstyrrelser, dystoni, multipel sklerose, inflammatoriske tarmforstyrrelser, artritis, dermatitis, rheumatoid artritis, systemisk lupus erythematosus, melanom, perifer neuropatisk smerte, neuropatisk smerte forbundet med post-herpetisk neuralgi, diabetisk neuropati, helvedesild, forbrændinger, aktinisk keratose, mundhulesår og ulcus, post-episiotomismerte, psoriasis, pruritis, kontaktdermatitis, eksem, bulløs dermatitis herpetiformis, exfoliativ dermatitis, mycosis fungoides, pemphigus, svær erythema multiforme (f.eks. Stevens-Johnsons syndrom), seboroisk dermatitis, ankyloscrcndc spondylitis, psoriatisk artritis, Reiters syndrom, gigt, chondrocalcinosc, ledsmerte sekundær til dysmenoré, fibromyalgi, muskel- og knoglesmerte, neuropatiske-postoperative komplikationer, polymyositis, akut non-specifik tenosynovitis, bursitis, epicondylitis, post-sekundær til osteoartritis, osteoartritis, rheumatoid artritis, synovitis, j uvenil rheumatoid artritis og hæmning af hårvækst.
9. Lægemiddelindgivelsessystem ifølge krav 1, hvor den farmaceutiske sammensætning omfatter (i) ca. 0,1 % til ca. 40 % af cannabidiolprodrugget; (ii) ca. 0,1 % til ca. 20 % af ét eller mere co-solvents; (iii) ca. 15 % til ca. 95 % en lavere alkohol; og (iv) vand i en mængde, der er tilstrækkelig til, at sammensætningen når op på i alt 100 % (vægt/vægt).
10. Lægemiddelindgivelsessystem ifølge krav 9, hvor cannabidiolprodrugget er til stede i en mængde på ca. 5 % til ca. 30 % (vægt/vægt) eller ca. 10 % til ca. 20 % (vægt/vægt) af den farmaceutiske sammensætning.
11. Lægemiddelindgivelsessystem ifølge krav 9, hvor hver af co-solventeme er udvalgt fra gruppen bestående af: ethanol, benzylalkohol og blandinger af det foregående.
12. Lægemiddelindgivelsessystem ifølge krav 9, hvor den farmaceutiske sammensætning er i form af en hydrogel, fortrinsvis hvor hydrogelen er inkorporeret i et patch af matrix-eller beholdertypen.
13. Lægemiddelindgivelsessystem ifølge krav 9, hvor den farmaceutiske sammensætning endvidere omfatter en COX-hæmmer udvalgt fra gruppen bestående af: en ikke-specifik COX-hæmmer, en COX-1-hæmmer og en COX-2-hæmmer.
14. Forbindelse udvalgt fra gruppen bestående af:
Og hvor X" er en modion afledt af farmaceutisk acceptable syrer.
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US20110052694A1 (en) 2011-03-03
PL2473475T3 (pl) 2018-02-28
JP2013503206A (ja) 2013-01-31
PT2473475T (pt) 2017-08-02
SI2473475T1 (sl) 2017-10-30
HRP20171236T1 (hr) 2017-10-20
EP2473475B1 (en) 2017-05-31
CA2772634C (en) 2017-11-21
EP2473475A1 (en) 2012-07-11
CA2772634A1 (en) 2011-03-03
ES2635084T3 (es) 2017-10-02
US9533942B2 (en) 2017-01-03
US20150197484A1 (en) 2015-07-16
SMT201700391T1 (it) 2017-09-07
HUE034235T2 (en) 2018-02-28
LT2473475T (lt) 2017-08-10
CY1119059T1 (el) 2018-01-10
WO2011026144A1 (en) 2011-03-03

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