ME01339B - 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
ME01339B
ME01339B MEP-2011-27A MEP2711A ME01339B ME 01339 B ME01339 B ME 01339B ME P2711 A MEP2711 A ME P2711A ME 01339 B ME01339 B ME 01339B
Authority
ME
Montenegro
Prior art keywords
dosage form
sustained
release
sustained release
tablet
Prior art date
Application number
MEP-2011-27A
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=ME01339(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 ME01339B publication Critical patent/ME01339B/me

Links

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Claims (30)

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 (1)    bar jedan polietilen oksid koji na osnovu reoloških merenja ima približnu molekulsku težinu od najmanje 1,000,000; i (2)    bar jedan aktivan agens; i gde je formulacija matrice sa produženim oslobađanjem očvršćavana na temperaturi od oko 60°C u toku vremenskog perioda od oko 1 minut i ima silu stvaranja naprsline od bar 110N kada se podvrgne testu utiskivanja.
2.    Čvrsti oralni faramceutski dozni oblik sa produženim oslobađanjem prema zahtevu 1, gde formulacija matrice sa produženim oslobađanjem kad se podvrgne testu utiskivanja ima ‘rastojanje duž dubine prodiranja naprsline’ od bar 1.0 mm.
3.    Čvrsti oralni farmaceutski dozni oblik prema zahtevu 1 ili 2, gde formulacija matrice sa produženim oslobađanjem ima silu stvaranja naprsline od bar 120N, bar oko 130 N ili bar oko 140N i/ili ‘rastojanje duž dubine prodiranja naprsline’ od bar oko 1.2 mm, poželjno bar oko 1.4 mm, bar oko 1.5 mm ili bar oko 1.6 mm.
4.    Čvrsti oralni farmaceutski oblik sa produženim oslobađanjem prema zahtevima 1, 2 iii 3, gde je formulacija matrice sa produženim oslobađanjem otporna pri radu na bar 0.06 J bez pucanja.
5.    Čvrsti oralni faramceutski dozni oblik sa produženim oslobađanjem prema zahtevu 1 ili 2, 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.
6.    Čvrsti oralni faramceutski dozni oblik sa produženim oslobađanjem prema zahtevu 5, gde je formulacija matrice sa produženim oslobađanjem čuvana na 40°C i 75% relativne vlažnosti (RH).
7.    Čvrsti oralni faramceutski dozni oblik sa produženim oslobađanjem prema zahtevu 1 ili 2, 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.
8.    Čvrsti oralni faramceutski dozni oblik sa produženim oslobađanjem prema zahtevu 7, gde je formualcija sa produženim oslobađanjem bila skladištena na 40°C i 75% relativne vlažnosti (RH).
9. Čvrsti oralni faramceutski dozni oblik sa produženim oslobađanjem prema zahtevu 1 ili 2, 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.
10.    Čvrsti oralni faramceutski dozni oblik sa produženim oslobađanjem prema zahtevu 1 ili 2, gde je aktivni agens oksikodon hidrohlorid i gde je dozni oblik kada se testira u komparativnom kliničkom ispitivanju bioekvivalentan komercijalnom proizvodu OxyCotin™.
11.    Čvrsti oralni faramceutski dozni oblik sa produženim oslobađanjem prema zahtevu 1 ili 2, 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 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 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.
12.    Dozni oblik sa produženim oslobađanjem prema bilo kom zahtevu 1 do 11, gde kompozicija sadrži bar oko 80% (tež.) polietilen oksida.
13.    Dozni oblik sa produženim oslobađanjem prema zahtevu 12, gde kompozicija sadrži bar oko 80% (tež.) polietilen oksida, koji na osnovu reoloških merenja ima približnu molekulsku težinu od najmanje 1,000,000.
14.    Dozni oblik sa produženim oslobađanjem prema bilo kom od zahteva 1 do 13, gde je aktivni agens opioidini analgetik.
15.    Dozni oblik sa produženim oslobađanjem prema zahtevu 14, što se opijatni analgetik bira iz grupe koju čine aifentanil, 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, 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, phenadokson, fenomorfan, fenezocin, fenoperidin, piminodin, piritramid, propheptazin, promedol, properidin, propoksifen, sufentanil, tilidin, tramadol, njihove farmaceutski prihvatljive soli, hidrati i solvati, smeše navedenih.
16.    Dozni oblik sa produženim oslobađanjem prema zahtevu 14, 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 navedenih.
17.    Dozni oblik sa produženim oslobađanjem prema zahtevu 15, gde je opioidni analgetik oksikodon hidrohlorid i dozni oblik sadrži od oko 5 mg do oko 500 mg oksikodon hidrohlorida.
18.    Dozni oblik sa produženim oslobađanjem prema zahtevu 17, 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 ili 160 mg oksikodon hidrohlorida.
19.    Dozni oblik sa produženim oslobađanjem prema zahtevu 14, 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.
20.    Dozni oblik sa produženim oslobađanjem prema zahtevu 14, gde je opioidini analgetik oksimorfon hidrohlorid i dozni oblik sadrži od oko 1 mg do oko 500 mg oksimorfon hidrohlorida.
21.    Dozni oblik sa produženim oslobađanjem prema zahtevu 20, 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 ili 160 mg oksimorfon hidrohlorida.
22.    Dozni oblik sa produženim oslobađanjem prema zahtevu 14, gde je opioidni analgetik hidromorfon hidrohlorid i dozni oblik sadrži od oko 1 mg do oko 100 mg hidromorfon hidrohlorida.
23.    Dozni oblik sa produženim oslobađanjem prema zahtevu 22, 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.
24.    Dozni oblik sa produženim oslobađanjem prema bilo kom od zahteva 1 do 23, 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.
25.    Dozni oblik sa produženim oslobađanjem prema bilo kom od zahteva 1 do 24, 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.
26.    Dozni oblik sa produženim oslobađanjem prema bilo kom od zahteva 1 do 24, 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.
27.    Dozni oblik sa produženim oslobađanjem prema zahtevu 26, gde formulacija sa produženim oslobađanjem i formulacija za trenutno oslobađanje sadrže iste ili razičite aktivne agense.
28.    Dozni oblik sa produženim oslobađanjem prema zahtevu 26, gde formulacija za produženo oslobađanje sadrži opioidni analgetik i formulaciju za trenutno oslobađanje koja sadrži neopioidni analgetik.
29.    Upotreba doze prema bilo kom od zahteva 1 do 28 u proizvodnji leka za lečenje bola, gde dozni oblik sadrži opioidni analgetik.
30.    Dozni oblik sa produženim oslobađanjem prema bilo kom od zahteva 1 do 28, gde je gustina formulacije matrice sa produženim oslobađanjem jednaka ili manja od 1.20 g/cm3, poželjno jednaka ili manja od 1.19 g/cm3.
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