ME01255B - Farmaceutski dozni oblici rezistentni na zloupotrebu koji sadrže opioidni analgetik - Google Patents

Farmaceutski dozni oblici rezistentni na zloupotrebu koji sadrže opioidni analgetik

Info

Publication number
ME01255B
ME01255B MEP-2011-26A MEP2611A ME01255B ME 01255 B ME01255 B ME 01255B ME P2611 A MEP2611 A ME P2611A ME 01255 B ME01255 B ME 01255B
Authority
ME
Montenegro
Prior art keywords
dosage form
sustained
tablet
release
formulation
Prior art date
Application number
MEP-2011-26A
Other languages
German (de)
English (en)
French (fr)
Inventor
Richard Owen Mannion
William Henry Mckenna
Edward Patrick O'donnell
Haiyong Hugh Huang
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=ME01255(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 ME01255B publication Critical patent/ME01255B/me

Links

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Claims (32)

1. Čvrst oralni farmaceutski dozni oblik sa produženim oslobađanjem, koji sadrži formulaciju matrice sa produženim oslobađanjem, a formulcija matrice sa produženim oslobađanjem sadrži kompoziciju koja sadrži bar jedan aktivan agens i bar jedan polietilen oksid koji na osnovu reoloških merenja ima približnu molekulsku težinu od najmanje 1,000,000; gde je formulacija matrice sa produženim oslobađanjem očvršćavana na oko 60°C u toku vremenskog perioda od oko 1 minut 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 ova 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% etanola, na 37° C, naznačen time, što procenat oslobođene aktivne supstance tokom 0,5 sati rastvaranja, ne odstupa više od oko 20% od odgovarajuće brzine oslobađanja in vitro, merene u aparatu USP Apparatus 1 (sa korpom), pri 100, o/min, u 900 mL simuliranog želudačnog fluida bez enzima (SŽF), na 37° C, bez etanola, ako se koriste zgnječena ili nezgnječena referentna tableta ili zgnječna ili nezgnječena referentna zrnca, respektivno.
2.    Čvrsti oralni faramceutski dozni oblik sa produženim oslobađanjem prema zahtevu 1, gde tableta ili zrnca mogu biti bar zgnječeni bez kidanja, naznačen time, što debiljna tablete ili pojedinačnog zrnca posle gnječenja nije veća od oko 60%, ili nije veća od oko 50%. ili nije veća od oko 40%, ili nije veće 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 i gde zgnječena i nezgnječena tableta ili pojedinačno zrno 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% etanola, na 37° C, naznačen time, što procenat oslobođene aktivne supstance tokom 0,5 sati rastvaranja, ne odstupa više od oko 20% ili ne više od oko 15% od odgovarajuće brzine oslobađanja in vitro, merene u aparatu USP Apparatus 1 (sa korpom), pri 100 o/min, u 900 mL simuliranog želudačnog fluida bez enzima (SŽF), na 37° C, bez etanola, ako se koriste zgnječena ili nezgnječena referentna tableta ili zrnca, respektivno.
3.    Čvrsti oralni faramceutski 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 faramceutski dozni oblik sa produženim oslobađanjem prema zahtevu 1, gde formulacija matrice sa produženim oslobađanjem posle skladištenja na 25°C i 60% 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 procenat oslobođene aktivne supstance tokom 1, 4 i 12 sati rastvaranja, ne odstupa više od oko 15% od odgovarajuće brzine oslobađanja in vitro, referentne formulacije pre skladištenja.
5.    Čvrsti oralni faramceutski dozni oblik sa produženim oslobađanjem prema zahtevu 4, gde je formulacija matrice sa produženim oslobađanjem čuvana na 40°C i 75% relativne vlažnosti (RH).
6.    Čvrsti oralni faramceutski dozni oblik sa produženim oslobađanjem prema zahtevu 1, gde formulacija matrice sa produženim oslobađanjem posle skladištenja na 25°C i 60% relativne vlažnosti (RH) u toku bar 1 meseca ima količinu bar jednog aktivnog agensa u % (tež.) 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 % (tež.) u odnosu na obeleženu količinu aktivnog agensa za formulaciju matrice sa produženim oslobađanjem referentne formulacije pre skladištenja.
7.    Čvrsti oralni faramceutski dozni oblik sa produženim oslobađanjem prema zahtevu 6, gde je formualcija sa produženim oslobađanjem bila skladištena na 40°C i 75% relativne vlažnosti (RH).
8.    Čvrsti oralni faramceutski dozni oblik sa produženim oslobađanjem prema zahtevu 1, gde dozni oblik 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, koja je između 12.5% i 55% (tež.) oslobođenog aktivnog agensa posle 1 sata, između 25 i 65% (tež.) oslobođenog aktivnog agensa posle 2 sata, između 45 i 85% (tež.) oslobađenog aktivnog agensa posle 4 sata i između 55 i 95% (tež.) oslobađenog aktivnog agensa posle 6 sati.
9.    Čvrsti oralni faramceutski dozni oblik sa produženim oslobađanjem prema zahtevu 1, gde je aktivni agens oksikodon hidrohlorid i gde je dozni oblik kada se testira u komparativnom kliničkom ispitivanju bioekvivalentan komercijalnom proizvodu OxyCotin™
10.    Čvrsti oralni faramceutski dozni oblik sa produženim oslobađanjem prema zahtevu 1, gde je aktivni agens oksikodon hidrohlorid i gde dozni oblik koji sadrži 10 mg oksikodon hidrohlorida kada je testiran u komparativnom kliničkom ispitivanju je bioekvilaentan sa referentnom tabletom koja sadrži 10 mg oksikodon hidrohlorida u formulaciji matrice koja sadrži: a)    oksikodon hidrohlorid : 10.0 mg/tableti b)    Laktozu (sušenu raspršivanjem): 69.25 mg/ml c)    Povidon: 5.0 mg/tableti d)    Eudragit® RS 30 D (čvrst): 10.0 mg/tableti e)    Triacetin®: 2.0 mg/tableti f)    stearil alkohol: 25.0 mg/tableti g)    talk: 2.5 mg/tableti h)    magnezijum stearat: 1.25 mg/tableti; i gde je referentna tableta pripremljena sledećim stupnjevima: 1.    . Eudragit® RS 30D i Triacetin® se kombinuju prilikom propuštanja kroz sito od 60 mesa, 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 voskiran 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 voskirani 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.
11. Dozni oblik sa produženim oslobađanjem prema bilo kom zahtevu 1 do 10, gde kompozicija sadrži bar oko 80% (tež.) polietilen oksida.
12.    Dozni oblik sa produženim oslobađanjem prema zahtevu 11, gde kompozicija sadrži bar oko 80% (tež.) polietilen oksida, koji na osnovu reoloških merenja ima približnu molekulsku težinu od najmanje 1,000,000.
13.    Faramceutski dozni oblik sa produženim oslobađanjem prema bilo kom od zahteva 1 do 8, gde je aktivni agens opioidini analgetik.
14.    Faramceutski dozni oblik sa produženim oslobađanjem prema zahtevu 13, što se opijatni analgetik bira iz grupe koju čine alfentanil, alilprodin, alfaorodin, 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, hidrmorfon, hidroksipethidine, 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, phenadoksone, fenomorfan, fenezocin, fenoperidin, piminodin, piritramid, propheptazin, promedol, properidin, propoksifen, sufentanil, tilidin, tramadol, njihove farmaceutski prihvatljive soli, hidrati i solvati, smeše navedenih.
15.    Dozni oblik sa produženim oslobađanjem prema zahtevu 13, gde je opioidni analgetik izabran iz grupe koju čine kodein, morfin, oksikodon, hidrokodon, hidromoron ili oksimorfon ili njihove faramaceutski prihvatljive soli, hidrati i solvati, smeše bilo koga od pomenutih.
16.    Dozni oblik sa produženim oslobađanjem prema zahtevu 9 ili 14, gde je opioidni analgetik oksikodon hidrohlorid i dozni oblik sadrži od oko 5 mg do oko 500 mg oksikodon hidrohlorida.
17.    Dozni oblik sa produženim oslobađanjem prema zahtevu 16, gde dozni oblik obuhvata 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.
18.    Dozni oblik sa produženim oslobađanjem prema bilo kom od zahteva 9, 10 i 13, gde je opioidni analgetik oksikodon hidrohlorid koji ima nivo 14-hidroksikodeinona manji od oko 25 ppm, poželjno manji od oko 15 ppm, manji od oko 10 ppm ili manji od oko 5 ppm.
19.    Dozni oblik sa produženim oslobađanjem prema zahtevu 13, gde je opioidini analgetik oksimorfon hidrohlorid i dozni oblik sadrži od oko 1 mg do oko 500 mg oksimorfon hidrohlorida.
20.    Dozni oblik sa produženim oslobađanjem prema zahtevu 19, gde dozni oblik sadrži 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 illi 160 mg oksimorfon hidrohlorida.
21.    Dozni oblik sa produženim oslobađanjem prema zahtevu 13, gde je opioidni analgetik hidromorfon hidrohlorid i dozni oblik sadrži od oko 1 mg do oko 100 mg hidromorfon hidrohlorida.
22.    Dozni oblik sa produženim oslobađanjem prema zahtevu 21, gde dozni oblik sadrži 2 mg, 4 mg, 8 mg, 12 mg, 16 mg, 24 mg, 32 mg, 48 mg ili 64 mg hidromorfon hidrohlorida.
23.    Dozni oblik sa produženim oslobađanjem prema bilo kom od zahteva 1 do 22, koji je u obliku tablete obrazovane direktnim komprimovanjem i očvršćavanjem bar podvrgavanjem pomenute tablete na temperaturu od oko 60°C ili na bar oko 62°C u toku vremenskog perioda od oko 1 minut, poželjno od oko 5 minuta ili bar oko 15 minuta.
24.    Dozni oblik sa produženim oslobađanjem prema bilo kom od zahteva 1 do 23, koji je u obliku tablete i koji je prevučen sa slojem polietilen oksida u prahu da bi se obrazovala tableta koja ima jezgro i sloj polietilen oksida koji okružuje jezgro tablete.
25.    Dozni oblik sa produženim oslobađanjem prema bilo kom od zahteva 1 do 23, koji je u obliku složene dvoslojne ili višeslojene tablete, gde jedan od slojeva sadrži formulaciju sa produženim oslobađanjem, a jedan od ostalih slojeva sadrži formulaciju za trenutno oslobađanje.
26.    Dozni oblik sa produženim oslobađanjem prema zahtevu 25, gde formulacija sa produženim oslobađanjem i formulacija za trenutno oslobađanje sadrže iste ili razičite aktivne agense.
27.    Dozni oblik sa produženim oslobađanjem prema zahtevu 25, gde formulacija za produženo oslobađanje sadrži opioidni analgetik i formulaciju za trenutno oslobađanje koja sadrži neopioidni analgetik.
28.    Upotreba doze prema bilo kom od zahteva 1 do 27 u proizvodnji leka za lečenje bola, gde dozni oblik sadrži opioidni analgetik.
29.    Upotreba polietilen oksida visoke molekulske težine koja zasnovano na osnovu reoloških merenja ima molekulsku težinu bar 1,000,000, kao materijala za obrazovanje matrice u proizvodnji čvrstog oralnog doznog oblika sa produženim oslobađanjem koji sadrži aktivni agens izabran od opioida koji čine čvrsti oralni dozni oblik sa produženim oslobađanjem otpornim na ekstrakciju alkoholom.
30.    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 .
31.    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.
32.    Farmaceutska tableta prema prethodnim zahtevima, što je otporna pri radu na bar 0.06 J bez pucanja.
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