HRP20120613T1 - Oralni farmaceutski oblici doziranja otporni na neovlašteno korištenje koji sadrže opioidni analgetik - Google Patents
Oralni farmaceutski oblici doziranja otporni na neovlašteno korištenje koji sadrže opioidni analgetik Download PDFInfo
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- HRP20120613T1 HRP20120613T1 HRP20120613TT HRP20120613T HRP20120613T1 HR P20120613 T1 HRP20120613 T1 HR P20120613T1 HR P20120613T T HRP20120613T T HR P20120613TT HR P20120613 T HRP20120613 T HR P20120613T HR P20120613 T1 HRP20120613 T1 HR P20120613T1
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- Prior art keywords
- dosage form
- release
- weight
- formulation
- oral pharmaceutical
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- 239000002552 dosage form Substances 0.000 title claims abstract 24
- 239000000014 opioid analgesic Substances 0.000 title claims abstract 6
- 239000000203 mixture Substances 0.000 claims abstract 21
- 238000009472 formulation Methods 0.000 claims abstract 18
- 238000013268 sustained release Methods 0.000 claims abstract 13
- 239000012730 sustained-release form Substances 0.000 claims abstract 13
- 239000013543 active substance Substances 0.000 claims abstract 11
- 239000011159 matrix material Substances 0.000 claims abstract 11
- DYUTXEVRMPFGTH-UHFFFAOYSA-N 4-(2,5-dimethylphenyl)-5-methyl-1,3-thiazol-2-amine Chemical compound S1C(N)=NC(C=2C(=CC=C(C)C=2)C)=C1C DYUTXEVRMPFGTH-UHFFFAOYSA-N 0.000 claims abstract 10
- 229960002738 hydromorphone hydrochloride Drugs 0.000 claims abstract 10
- 229920003171 Poly (ethylene oxide) Polymers 0.000 claims abstract 9
- 238000000518 rheometry Methods 0.000 claims abstract 4
- 229940005483 opioid analgesics Drugs 0.000 claims abstract 2
- 238000013265 extended release Methods 0.000 claims 11
- 239000007787 solid Substances 0.000 claims 11
- 239000003826 tablet Substances 0.000 claims 11
- 238000002360 preparation method Methods 0.000 claims 9
- 230000002035 prolonged effect Effects 0.000 claims 8
- 238000004090 dissolution Methods 0.000 claims 4
- 238000007373 indentation Methods 0.000 claims 4
- 239000012729 immediate-release (IR) formulation Substances 0.000 claims 3
- 238000003860 storage Methods 0.000 claims 3
- 102000004190 Enzymes Human genes 0.000 claims 2
- 108090000790 Enzymes Proteins 0.000 claims 2
- 239000012530 fluid Substances 0.000 claims 2
- 230000002496 gastric effect Effects 0.000 claims 2
- 230000035515 penetration Effects 0.000 claims 2
- 239000003795 chemical substances by application Substances 0.000 claims 1
- 229940079593 drug Drugs 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 238000000338 in vitro Methods 0.000 claims 1
- 239000007942 layered tablet Substances 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 238000005259 measurement Methods 0.000 claims 1
- 229940121367 non-opioid analgesics Drugs 0.000 claims 1
- 239000000843 powder Substances 0.000 claims 1
- 238000003825 pressing Methods 0.000 claims 1
- 239000008184 oral solid dosage form Substances 0.000 abstract 1
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Abstract
Oralni farmaceutski oblik doziranja u krutom stanju sa produljenim otpuštanjem koji sadrži formulaciju matrice s produljenim otpuštanjem, te formulacija matrice s produljenim otpuštanjem sadrži pripravak koji sadrži barem: (1) najmanje jedan polietilen oksid koji ima, prema reološkim mjerenjima, približnu molekularnu težinu od najmanje 1,000,000; te (2) najmanje jedno aktivno sredstvo odabrano od opioidnih analgetika pri čemu je opioidni analgetik hidromorfon hidroklorid i oblik doziranja sadrži od 1 mg do oko 100 mg hidromorfon hidroklorida; tenaznačen time da pripravak sadrži najmanje oko 80 % (težinski) polietilen oksida koji ima, na osnovu reoloških mjerenja, prosječnu molekularnu težinu od najmanje 1,000,000. Patent sadrži još 22 patentna zahtjeva.
Claims (23)
1. Oralni farmaceutski oblik doziranja u krutom stanju sa produljenim otpuštanjem koji sadrži formulaciju matrice s produljenim otpuštanjem, te formulacija matrice s produljenim otpuštanjem sadrži pripravak koji sadrži barem:
(1) najmanje jedan polietilen oksid koji ima, prema reološkim mjerenjima, približnu molekularnu težinu od najmanje 1,000,000; te
(2) najmanje jedno aktivno sredstvo odabrano od opioidnih analgetika pri čemu je opioidni analgetik hidromorfon hidroklorid i oblik doziranja sadrži od 1 mg do oko 100 mg hidromorfon hidroklorida; te
naznačen time da pripravak sadrži najmanje oko 80 % (težinski) polietilen oksida koji ima, na osnovu reoloških mjerenja, prosječnu molekularnu težinu od najmanje 1,000,000.
2. Oralni farmaceutski oblik doziranja u krutom stanju sa produljenim otpuštanjem prema zahtjevu 1, naznačen time da pripravak sadrži više od 5% (težinski) hidromorfon hidroklorida.
3. Oralni farmaceutski oblik doziranja u krutom stanju sa produljenim otpuštanjem prema zahtjevu 1, naznačen time da pripravak sadrži 8 mg hidromorfon hidroklorida, te time da pripravak sadrži najmanje oko 94 % (težinski) polietilen oksida.
4. Oralni farmaceutski oblik doziranja u krutom stanju sa produljenim otpuštanjem prema zahtjevu 1, naznačen time da pripravak sadrži 12 mg hidromorfon hidroklorida, te time da pripravak sadrži najmanje oko 92 % (težinski) polietilen oksida.
5. Oralni farmaceutski oblik doziranja u krutom stanju sa produljenim otpuštanjem prema zahtjevu 1, naznačen time da pripravak sadrži 32 mg hidromorfon hidroklorida, te time da pripravak sadrži najmanje oko 90 % (težinski) polietilen oksida.
6. Oralni farmaceutski oblik doziranja u krutom stanju sa produljenim otpuštanjem prema bilo kojem od zahtjeva 1 do 5, naznačen time da je gustoća formulacije matrice s produljenim otpuštanjem jednaka ili manja od oko 1.20 g/cm3, poželjno jednaka ili manja od oko 1.19 g/cm3.
7. Oralni farmaceutski oblik doziranja u krutom stanju sa produljenim otpuštanjem prema bilo kojem od zahtjeva 1 do 6, gdje formulacija matrice s produljenim otpuštanjem nakon skladištenja na 25°C i 60 % relativne vlažnosti (RH) tijekom najmanje 1 mjeseca daje brzinu otapanja, kada je mjerenje provedeno u USP aparatu 1 (košara) pri 100 okr/min u 900 ml simulirane želučane tekućine bez enzima (SGF) pri 37°C, naznačen time da postotak količine oslobođenog aktivnog sredstva kod 1,4 i 12 sati otapanja nema odstupanje veće od oko 15 % točaka u odnosu na odgovarajuću in-vitro brzinu otapanja referentne formulacije prije skladištenja.
8. Oralni farmaceutski oblik doziranja u krutom stanju sa produljenim otpuštanjem prema zahtjevu 7, naznačen time da je formulacija matrice s produljenim otpuštanjem pohranjena na 40°C i 75 % relativne vlažnosti (RH).
9. Oralni farmaceutski oblik doziranja u krutom stanju sa produljenim otpuštanjem prema bilo kojem od zahtjeva 1 do 8, naznačen time da formulacija matrice s produljenim otpuštanjem nakon što je pohranjena na 25°C i 60 % relativne vlažnosti (RH) tijekom najmanje 1 mjeseca sadrži količinu od najmanje jednog aktivnog sredstva u % (težinski) vezano uz deklaracijski zahtjev aktivnog sredstva za formulaciju matrice s produljenim otpuštanjem tako da odstupanje nije veće od oko 10% točaka u odnosu na odgovarajuću količinu aktivnog sredstva u % (težinski) relativno prema deklaracijskom zahtjevu aktivnog sredstva za formulaciju matrice s produljenim otpuštanjem referentne formulacije prije pohranjivanja.
10. Oralni farmaceutski oblik doziranja u krutom stanju sa produljenim otpuštanjem prema zahtjevu 9, naznačen time da je formulacija matrice s produljenim otpuštanjem pohranjena na 40 °C i 75 % relativne vlažnosti (RH).
11. Oralni farmaceutski oblik doziranja u krutom stanju sa produljenim otpuštanjem prema bilo kojem od zahtjeva 1 do 10, naznačen time da oblik doziranja daje brzinu otapanja, koja kada je mjerena na USP aparatu 1 (košara) kod 100 okr/min. u 900 ml simulirane želučane tekućine bez enzima (SGF) na 37° C, je između 12.5 i 55% (težinski) otpuštene aktivne supstance nakon 1 sata, između 25 i 65% (težinski) otpuštene aktivne supstance nakon 2 sata, između 45 i 85% (težinski) otpuštene aktivne supstance nakon 4 sata i između 55 i 95% (težinski) otpuštene aktivne supstance nakon 6 sati.
12. Oblik doziranja sa produljenim otpuštanjem prema bilo kojem od zahtjeva 1 do 11, naznačen time da oblik doziranja sadrži 2 mg, 4 mg, 8 mg, 12 mg, 16 mg, 24 mg, 32 mg, 48 mg ili 64 mg hidromorfon hidroklorida.
13. Oblik doziranja sa produljenim otpuštanjem prema bilo kojem od zahtjeva 1 do 12, naznačen time da je u obliku tablete oblikovane pomoću direktnog prešanja pripravka, te koja je stvrdnuta barem podvrgavanjem navedene tablete temperaturi od najmanje oko 60°C ili najmanje oko 62°C u vremenskom periodu od najmanje oko 1 minute, poželjno najmanje oko 5 minuta ili najmanje oko 15 minuta.
14. Oblik doziranja sa produljenim otpuštanjem prema bilo kojem od zahtjeva 1 do 13, naznačen time da je u obliku tablete, te da je obložen slojem polietilen oksida u prahu tako da tvori tabletu koja ima jezgru tablete i sloj polietilen oksida koji obavija jezgru tablete.
15. Oblik doziranja sa produljenim otpuštanjem prema bilo kojem od zahtjeva 1 do 14, da je u obliku zbijene dvo ili višeslojne tablete, naznačen time da jedan od slojeva sadrži formulaciju s produljenim otpuštanjem i jedan od ostalih slojeva sadrži formulaciju s trenutnim otpuštanjem.
16. Oblik doziranja sa produljenim otpuštanjem prema zahtjevu 15, naznačen time da formulacija s produljenim otpuštanjem i formulacija s trenutnim otpuštanjem sadrže ista ili različita aktivna sredstva.
17. Oblik doziranja sa produljenim otpuštanjem prema zahtjevu 15, naznačen time da formulacija s produljenim otpuštanjem sadrži opioidni analgetik i formulacija s trenutnim otpuštanjem sadrži neopioidni analgetik.
18. Uporaba oblika doziranja prema bilo kojem od zahtjeva 1 do 17 za proizvodnju lijeka za liječenje boli, naznačena time da oblik doziranja sadrži hidromorfon hidroklorid.
19. Farmaceutska tableta prema bilo kojem od prethodnih zahtjeva naznačena time da ima silu loma od najmanje 110 N, poželjno 120 N, poželjnije 130 N, te još poželjnije 140 N, kada je podvrgnuta indentacijskom testu.
20. Farmaceutska tableta prema bilo kojem od prethodnih zahtjeva naznačena time da ima dubinu prodiranja s razmakom pukotine od najmanje 1.0 mm, poželjno 1.2 mm, poželjnije 1.4 mm, te još poželjnije 1.6 mm, kada je podvrgnuta indentacijskom testu.
21. Farmaceutska tableta prema bilo kojem od prethodnih zahtjeva naznačena time da se može oduprijeti radu od najmanje 0.06 J bez loma.
22. Farmaceutska tableta prema bilo kojem od prethodnih zahtjeva naznačena time da ima: (a) silu loma od najmanje 110 N, poželjno 120 N, poželjnije 130 N, te još poželjnije 140 N, kada je podvrgnuta indentacijskom testu; (b) dubinu prodiranja s razmakom pukotine od najmanje 1.0 mm, poželjno 1.2 mm, poželjnije 1.4 mm, te još poželjnije 1.6 mm, kada je podvrgnuta indentacijskom testu; te (c) da se može oduprijeti radu od najmanje 0.06 J bez loma
23. Farmaceutska tableta prema bilo kojem od zahtjeva 19 do 22 naznačena time da ima gustoću od manje od 1.20 g/cm3, poželjno manje od 1.19 g/cm3.
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- 2012-08-22 CY CY20121100749T patent/CY1113220T1/el unknown
- 2012-09-25 CY CY20121100874T patent/CY1113141T1/el unknown
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2013
- 2013-03-14 US US13/803,132 patent/US20140030327A1/en not_active Abandoned
- 2013-05-17 HR HRP20130434TT patent/HRP20130434T1/hr unknown
- 2013-05-17 HR HRP20130433TT patent/HRP20130433T1/hr unknown
- 2013-05-22 HR HRP20130444TT patent/HRP20130444T1/hr unknown
- 2013-05-23 US US13/901,027 patent/US20130251796A1/en not_active Abandoned
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2014
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2015
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- 2017-07-24 US US15/657,818 patent/US20170319495A1/en not_active Abandoned
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- 2017-07-24 US US15/657,895 patent/US20170319497A1/en not_active Abandoned
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- 2017-07-24 US US15/657,643 patent/US20170319491A1/en not_active Abandoned
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- 2017-07-24 US US15/657,717 patent/US20170319492A1/en not_active Abandoned
- 2017-08-22 US US15/683,472 patent/US20170348241A1/en not_active Abandoned
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2018
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