DK2299953T3 - Bærestofsammensætning til lægemidler med vedvarende udløsning - Google Patents

Bærestofsammensætning til lægemidler med vedvarende udløsning Download PDF

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DK2299953T3
DK2299953T3 DK09797631.0T DK09797631T DK2299953T3 DK 2299953 T3 DK2299953 T3 DK 2299953T3 DK 09797631 T DK09797631 T DK 09797631T DK 2299953 T3 DK2299953 T3 DK 2299953T3
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another embodiment
bone
lipid
fatty acid
present
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DK09797631.0T
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Noam Emanuel
Moshe Neuman
Shlomo Barak
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Polypid Ltd
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Claims (14)

  1. BÆRESTOFSAMMENSÆTNING TIL LÆGEMIDLER MED VEDVARENDE UDLØSNING Patentkrav (reproklart materiale)
    1. Substrat, hvis overflade er helt eller delvis coatet med en biokompatibel matrixsammensætning, hvilken matrixsammensætning omfatter: a) en biologisk nedbrydelig polyester, der er ikke-kovalentknyttet til en første lipid, som omfatter en sterol; b) en anden lipid omfattende mindst én phosphatidylcholin med fédtsyredele på mindst 14 carbonatomer; c) et farmaceutisk aktivt middel; hvori matrixsammensætningen er lipidmættet, vægtforholdet mellem lipider i alt og den biologisk nedbrydelige polyester er mellem fra og med 1,5:1 og til og med 9:1, sterolen udgør op til 40 molprocent af matrixens samlede lipidindhold og, når den holdes i et vandigt miljø, tilvejebringer vedvarende udløsning af det farmaceutisk aktive middel.
  2. 2. Coatet substrat ifølge krav 1, hvori mindst ét af følgende er sandt: (a) substratet omfatter mindst ét materiale udvalgt fra gruppen bestående af hydroxyapatit, rustfrit stål, cobalt-chrom, titaniumlegering, tantalum, keramik og gelatine; (b) substratet er udvalgt fra ortopædiske søm, ortopædiske skruer, ortopædiske stapler, ortopædiske tråde, ortopædiske stifter, metal- eller polymerimplantater, knoglefyldningspartikler, kollagen- og ikke-kollagenmembraner, suturmaterialer, ortopædiske cementer og svampe, fortrinsvis hvori knoglefyldningspartiklerne er udvalgt fra allogene, xenogene og kunstige knoglepartikler.
  3. 3. Coatet substrat ifølge et hvilket som helst af kravene 1 eller 2, hvori mindst ét af følgende er sandt: (a) den biologisk nedbrydelige polyester er udvalgt fra gruppen bestående af PLA (polymælkesyre), PGA (polyglycolsyre) og PLGA (poly-(mælke-co-glycolsyre); (b) sterolen er en kolesterol; (c) matrixsammensætningen omfatter en flerhed af farmaceutisk aktive midler udvalgt fra et antibiotikum, et antimykotikum, et non-steroidt antiinflammatorisk lægemiddel (NSAID), et steroid, et anticancermiddel, en osteogen faktor og en knogleresorptionshæmmer; (d) matrixsammensætningen er homogen; (e) matrixsammensætningen omfatter en sphingolipid; (f) matrixsammensætningen omfatter en tocopherol; (g) matrixsammensætningen omfatter endvidere en yderligere phospholipid udvalgt Ira gruppen bestående af phosphatidylserin, en phosphatidylglycerol og en pho sphatidylino sitol; (h) matrixsammensætningen omfatter endvidere en fri fedtsyre på 14 eller flere carbonatomer; (i) matrixsammensætningen omfatter endvidere en målretningsdel, der er i stand til at interagere med et målmolekyle udvalgt fra gruppen bestående af et kollagenmolekyle, et fibrinmolekyle og en heparin, fortrinsvis hvori målretningsdelen er et fibronectinpeptid; (j) matrixsammensætningen omfatter endvidere en PEGyleret lipid.
  4. 4. Coatet substrat ifølge et hvilket som helst af kravene 1 til 3, hvori det farmaceutisk aktive middel er udvalgt fra et antibiotikum, et antimykotikum, et non-steroidt antiinflammatorisk lægemiddel, et steroid, et anticancermiddel, en osteogen faktor og en knogleresorptionshæmmer.
  5. 5. Coatet substrat ifølge krav 4, hvori det farmaceutisk aktive middel er udvalgt fra et antibiotikum eller et antimykotikum; eller hvori det farmaceutisk aktive middel er et non-steroidt antiinflammatorisk lægemiddel (NSAID).
  6. 6. Coatet substrat ifølge krav 5, hvori det farmaceutisk aktive middel er et antibiotikum udvalgt fra doxycyclin og doxycyclinhyclat.
  7. 7. Coatet substrat ifølge krav 4, hvori det farmaceutisk aktive middel er et anticancermiddel; eller hvori det farmaceutisk aktive middel er et steroid.
  8. 8. Coatet substrat ifølge krav 5, hvori det farmaceutisk aktive middel er udvalgt fra en osteogen faktor eller en knogleresorptionshæmmer.
  9. 9. Coatet substrat ifølge et hvilket som helst af kravene 1 til 8 til vedvarende udløsning af det farmaceutisk aktive middel, hvori udløsningstiden for 90 % af det farmaceutisk aktive middel in vivo er mellem 1 uge og 6 måneder.
  10. 10. Coatet substrat ifølge et hvilket som helst af kravene 1 til 9, hvori substratet er en del af et implantat.
  11. 11. Coatet substrat ifølge krav 5 til behandling af periodontitis hos et subjekt eller ifølge krav 8 til stimulering af knogleforstærkning hos et subjekt.
  12. 12. Medicinsk anordning omfattende det coatede substrat ifølge et hvilket som helst af kravene 1 til 9.
  13. 13. Fremgangsmåde til fremstilling af et substrat coatet med en matrixsammensætning ifølge krav 1, hvilken fremgangsmåde omfatter trinnene med: a) at blande i et første flygtigt organisk opløsningsmiddel: (i) en biologisk nedbrydelig polyester og (ii) en første lipid omfattende en sterol; b) at blande i et andet flygtigt organisk opløsningsmiddel: (i) mindst ét farmaceutisk aktivt middel, (ii) en anden lipid omfattende mindst én phosphatidylcholin med fedtsyredele på mindst 14 carbonatomer; c) at blande produkterne, der er resultat af trin (a) og (b), så der dannes en homogen blanding: d) at bringe blandingen, der er resultat af trin c), i kontakt med et substrat og e) mens den er i kontakt med substratet at fordampe de flygtige organiske opløsningsmidler; hvori hvert trin i fremgangsmåden i det væsentlige er fri for en vandig opløsning, hvorved der dannes en homogen matrixsammensætning.
  14. 14. Fremgangsmåde ifølge krav 13, hvori fordampningen udføres ved en temperatur i området rumtemperatur til 60 grader Celsius.
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