ME01580B - Farmaceutski dozni oblici - Google Patents

Farmaceutski dozni oblici

Info

Publication number
ME01580B
ME01580B MEP-2013-67A MEP6713A ME01580B ME 01580 B ME01580 B ME 01580B ME P6713 A MEP6713 A ME P6713A ME 01580 B ME01580 B ME 01580B
Authority
ME
Montenegro
Prior art keywords
tablet
dosage form
sustained
release
active agent
Prior art date
Application number
MEP-2013-67A
Other languages
English (en)
Inventor
Richard Owen Mannion
Haiyong Hugh Huang
William Henry Mckenna
Edward P O'donnell
Original Assignee
Purdue Pharma Lp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=38754532&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=ME01580(B) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Purdue Pharma Lp filed Critical Purdue Pharma Lp
Publication of ME01580B publication Critical patent/ME01580B/me

Links

Classifications

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    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
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Claims (26)

1. Čvrst oralni farmaceutski dozni oblik sa produženim oslobađanjem, koji sadrži formulaciju matrice sa produženim oslobađanjem, a formulacija matrice sa produženim oslobađanjem sadrži kompoziciju koja sadrži bar jedan aktivni agens i najmanje jedan polietilen oksid koji na osnovu reoloških merenja ima približnu molekulsku težinu od najmanje 1,000,000; i gde kompozicija sadrži bar oko 80 mas.% polietilen oksida koji na osnovu reoloških merenja ima približnu molekulsku težinu bar 1,000,000; u obliku tablete ili zrnaca, pri čemu ova tableta ili pojedinačno znce može da se zgnječi bez kidanja, naznačen time, što debljina tablete ili pojedinačnog zrnca posle ovog gnječenja, nije veća od oko 60% debljine te tablete ili pojedinačnog zrnca pre nego što su zgnječeni, pri čemu pomenuta zgnječena ili nezgnječena tableta ili zgnječena ili nezgnječena zrnca imaju brzinu rastvaranja in vitro, merenu u aparatu USP Apparatus 1 (sa korpom), pri 100 o/min, u 900 mL simuliranog želudačnog fluida bez enzima (SŽF), koji sadrži 40% ili 0% etanola na 37° C, koja je između 5 i 40 mas.% oslobođenog aktivnog agensa posle 0.5 sati.
2. Čvrsti oralni farmaceutski dozni oblik sa produženim oslobađanjem prema zahtevu 1, pri čemu ova tableta ili pojedinačno znce može da se zgnječi bez kidanja, naznačen time, što debljina tablete ili pojedinačnog zrnca posle ovog gnječenja, nije veća od oko 50%, ili nije veća od oko 40%, ili nije veća od oko 30%, ili nije veća od oko 20%, ili nije veća od oko 16% debljine te tablete ili pojedinačnog zrnca pre nego što su zgnječeni, pri čemu pomenuta zgnječena ili nezgnječena tableta ili zgnječena ili nezgnječena zrnca imaju brzinu rastvaranja in vitro, merenu u aparatu USP Apparatus 1 (sa korpom), pri 100 o/min, u 900 mL simuliranog želudačnog fluida bez enzima (SŽF), koji sadrži 40% ili 0% etanola na 37° C, koja je između 5 i 40 mas.% oslobođenog aktivnog agensa posle 0.5 sati ili između 5 i 30 mas.% aktivnog agensa oslobođenog posle 0.5 sati ili je između 5 i 20 mas.% oslobođenog posle 0.5 sati ili je između 10 i 18 mas. % aktivnog sredstva oslobođenog posle 0.5 sati.
3. Čvrsti oralni farmaceutski dozni oblik sa produženim oslobađanjem prema zahtevu 1 ili 2, gde je gustina formulacije matrice sa produženim oslobađanjem jednaka ili manja od oko 1.20 g/cm3, poželjno jednaka ili manja od oko 1.19 g/cm3.
4. Čvrsti oralni farmaceutski dozni oblik sa produženim oslobađanjem prema zahtevu 1, gde formulacija matrice sa produženim oslobađanjem posle skladištenja na 25°C i 60% relativne vlažnosti (RH), poželjno na 40°C i 75% relativne vlažnosti (RH) u toku bar 1 meseca ima brzinu rastvaranja merenu u aparatu USP Apparatus 1 (sa korpom), pri 100 o/min, u 900 mL simuliranog želudačnog fluida bez enzima (SŽF) na 37°C, naznačen time, što procentna količina bar jednog aktivnog agensa oslobođena posle 1, 4 i 12 sati rastvaranja ne odstupa više od oko 15% od odgovarajuće in-vitro brzine rastvaranja referentne formulacije pre skladištenja.
5. Čvrsti oralni farmaceutski dozni oblik sa produženim oslobađanjem prema zahtevu 1, gde formulacija matrice sa produženim oslobađanjem posle skladištenja na 25°C i 60% relativne vlažnosti (RH), poželjno na 40°C i 75% relativne vlažnosti (RH) u toku bar 1 meseca ima količinu bar jednog aktivnog agensa u mas. % u odnosu na obeleženu količinu aktivnog agensa za formulaciju matrice sa produženim oslobađanjem koja odstupa ne više od oko 10% od odgovarajuće količine aktivnog agensa u mas.% u odnosu na obeleženu količinu aktivnog agensa za formulaciju matrice sa produženim oslobađanjem referentne formulacije pre skladištenja.
6. Čvrsti oralni farmaceutski dozni oblik sa produženim oslobađanjem prema zahtevu 1, gde dozni oblik obezbeđuje brzinu rastvaranja, koja merena u aparatu USP Apparatus 1 (sa korpom), pri 100 o/min, u 900 mL simuliranog želudačnog fluida bez enzima (SŽF) na 37°C je između 12.5 i 55 mas.% aktivne supstance oslobođene posle 1 sata, između 25 i 65 mas.% aktivne supstance oslobođene posle 2 sata, između 45 i 85 mas. % aktivne supstance posle 4 sata i između 55 i 95 mas. % aktivne supstance oslobođene posle 6 sati.
7. Čvrsti oralni dozni oblik sa produženim oslobađanjem prema zahtevu 1, gde je aktivni agens oksikodon hidrohlorid i gde je dozni oblik kada se testira u komparativnoj kliničkoj studiji bioekvivalentan komercijalnom proizvodu OxyContin™.
8. Čvrsti oralni dozni oblik sa produžen oslobađanjem prema zahtevu 1, gde je aktivni agens oksidkodon hidrohlorid i gde dozni oblik koji sadrži 10 mg oksikodon hlorida kada je testiran u komparativnoj kliničkoj studiji bioekvivalentan je sa referentnom tabletom koja sadrži 10 mg oksikodon hidrohlorida u formulaciji matrice, koju čini: a) Oksikodon hidrohlorid: 10.0 mg/tableta b) Laktoza (sušena raspršivanjem): 69.25 mg/tableta c) Povidone: 5.0 mg/tableta d) Eudragit® RS 30D (čvrst): 10.0 mg/tableta e) Triacetin®: 2.0 mg/tableta f) Stearil alkohol: 25.0 mg/tableta g) Talk: 2.5 mg/tableta h) Magnezijum-stearat: 1.25 mg/tableta; a pri tome je ova referentna tableta dobijena u sledećim koracima: 1, Eudragit® RS 30D i Triacetin® se kombinuju prilikom propuštanja kroz sito od 60 meša, pa 5 min mešaju uz nisko smicanje, ili dok se ne dobije uniformna disperzija. 2, Oksikodon HCI, laktoza i povidon se stave u fluidizacionu kolonu koja je granulator/sušnica (FBD), pa se ova suspenzija rasprši u prah u fluidizacionoj koloni. 3, Posle raspršivanja, granulat se propušta kroz sito #12, ukoliko je potrebno da se smanje grudvice. 4, Ovaj suvi granulat se prebaci u mikser. 5, U međuvremenu, otopi se potrebna količina stearil alkohola, na temperaturi od približno 70°C. 6, Istopljeni stearil alkohol se uz mešanje doda u granulat. 7, Ovako ovošteni granulat se prebaci u fluidizacionu kolonu, koja je istovremeno granulator/sušnica, ili na tacne, pa se ostavi da se ohladi na sobnu ili nižu temperaturu. 8, Ovako ohlađeni granulat se propusti kroz sito #12. 9, Ovaj ovošteni granulat se prebaci u mikser/blender, i približno 3 min podmazuje sa potrebnom količinom talka i magnezijum-stearata. 10, Ovaj granulat se komprimuje u tablete od 125 mg, u pogodnoj mašini za tabletiranje.
9.    Dozni oblik sa produženim oslobađanjem prema bilo kom od zahteva 1 do 8, gde je aktivni agens opioidni analgetik.
10.    Dozni oblik sa produženim oslobađanjem prema zahtevu 9, gde je opioidni analgetik izabran iz grupe koju čine alfentanil, alilprodin, alfaprodin, anileridin, benzilmorfin, bezitramid, buprenorfin, butorfanol, klonitazen, kodein, dezomorfin, dekstromoramid, dezocin, diampromid, diamorfon, dihidrokodein, dihidromorfin, dimenoksadol, dimefeptanol, dimetiltiambuten, dioksafetil butirat, dipipanon, eptazocin, etoheptazin, etilmetiltiambuten, etilmorfin, etonitazen, etorfin, dihidroetorfin, fentanil i derivati, hidrokodon, hidromorfon, hidroksipetidin, izometadon, ketobemidon, levorfanol, levofenancilmorfan, lofentanil, meperidin, meptazinol, metazocin, metadon, metopon, morfin, mirofin, narcein, nikomorfin, norlevorfanol, normetadon, nalorfin, nalbufen, normorfin, norpipanon, opium, oksikodon, oksimorfon, papaveretum, pentazocin, fenadokson, fenomorfan, fenezocin, fenoperidin, piminodin, piritramid, profeptazin, promedol, properidin, propoksifen, sufentanil, tilidin, tramadol, njihove farmaceutski prihvatljive soli, hidrati i solvati, smeše navedenih.
11. Dozni oblik sa produženim osobađanjem prema zahtevu 9, gde je opioidni analgetik izabran iz grupe kodein, morfin, oksikodon, hidrokodon, hidromorfon ili oksimorfon ili njihove farmaceutski prihvatljive soli, hidrati i solvati, smeše navedenih.
12. Dozni oblik sa produženim oslobađanjem prema zahtevu 10, gde je opioidni analgetik oksikodon hidrohlorid i dozni oblik sadrži od oko 5 mg do oko 500 mg oksikodon hidrohlorida, poželjno 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 45 mg, 60 mg, ili 80 mg, 90 mg, 120 mg ili 160 mg oksikodon hidrohlorida.
13.    Dozni oblik sa produženim oslobađanjem prema zahtevu 9, gde je opioidni analgetik oksikodon hidrohlorid koji ima nivo 14-hidroksikodeinona niži od oko 25 ppm, poželjno niži od oko 15 ppm, niži od oko 10 ppm, ili niži od oko 5 ppm.
14.    Dozni oblik sa produženim oslobađanjem prema zahtevu 9, gde je opioidni analgetik oksimorfon hidrohlorid i dozni oblik sadrži od oko 1 mg do oko 500 mg oksimorfon hidrohlorida, poželjno 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 45 mg, 60 mg ili 80 mg, 90 mg, 120 mg ili 160 mg oksimorfon hidrohlorida.
15.    Dozni oblik sa produženim oslobađanjem prema zahtevu 9, gde je opioidni analgetik hidromorfon hidrohlorid i dozni oblik sadrži od oko 1 mg do oko 100 mg hidromorfon hidrohlorida, poželjno 2 mg, 4 mg, 8 mg, 12 mg, 16 mg, 24 mg, 32 mg, 48 mg ili 64 mg hidromorfon hidrohlorida.
16. Dozni oblik sa produženim oslobađanjem prema bilo kom od zahteva 1 do 15, koji je u obliku tablete oblikovane direktnom kompresijom kompozicije i očvršćavanjem bar izlaganjem pomenute tablete temperaturi od bar oko 60°C ili bar oko 62°C u vremenskom periodu od bar oko 1 minuta, poželjno bar oko 5 minuta ili bar oko 15 minuta.
17. Dozni oblik sa produženim oslobađanjem prema bilo kom od zahteva 1 do 16, koji je u obliku tablete i koji je obložen sa slojem praha polietilen oksida da bi se obrazovala tableta koja ima jezgro tablete i sloj polietilen oksida koji okružuje jezgro tablete.
18. Dozni oblik sa produženim oslobađanjem prema bilo kom od zahteva 1 do 16, koji je u obliku slagane dvoslojne ili višeslojne tablete, gde jedan od slojeva sadrži formulaciju sa produženim oslobađanjem a jedan ili više drugih slojeva koji sadrže formulaciju sa trenutnim oslobađanjem.
19. Dozni oblik sa produženim oslobađanjem prema zahtevu 18, gde formulacija sa produženim oslobađanjem i formulacija sa trenutnim oslobađanjem sadrže isti ili različiti aktivni agens.
20. Dozni oblik sa produženim oslobađanjem prema zahtevu 18, gde formulacija sa produženim oslobađanjem sadrži opioidni analgetik, a formulacija sa trenutnim oslobađanjem sadrži neopioidni analgetik.
21.    Upotreba doznog oblika prema bilo kom od prethodnih zahteva 1 do 20 u proizvodnji leka za lečenje bola, gde dozni oblik sadrži opioidni analgetik.
22.    Farmaceutska tableta prema prethodnim zahtevima koja ima silu stvaranja naprsline od bar 11 ON, poželjno 120N, poželjnije 130N i čak još poželjnije 140N kada je podvrgnuta testu utiskivanja.
23.    Farmaceutska tableta prema prethodnim zahtevima koja ima rastojanje duž dubine prodiranja naprsline od bar 1.0 mm, poželjno 1.2 mm, poželjnije 1.4 mm i čak poželjnije 1.6 mm kada je podvrgnuta testu utiskivanja.
24.    Farmaceutska tableta prema prethodnim zahtevima koja je otporna pri radu na bar 0.06 J bez pucanja.
25. Farmaceutka tableta prema bilo kom od prethodnih zahteva koja ima (a) silu stvaranja naprsline od bar 11 ON, poželjno 120N, poželjnije 130N i čak još poželjnije 140N, kada je podvrgnuta testu utiskivanja; (b) rastojanje duž dubine prodiranja naprsline od bar 1.0 mm, poželjno 1.2 mm, poželjnije 1.4 mm i čak poželjnije 1.6 mm kada je podvrgnuta testu utiskivanja; i (c) koja je otporna pri radu na bar 0.06 J bez pucanja.
26. Farmaceutska tableta prema prethodnim zahtevima 22 do 25 koja ima gustinu manju od 1,20 g/cm3, poželjno manju od 1,19 g/cm3
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