SI2542227T1 - Takojšnje zadržano razdeljevanje zdravila - Google Patents

Takojšnje zadržano razdeljevanje zdravila Download PDF

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SI2542227T1
SI2542227T1 SI201131396T SI201131396T SI2542227T1 SI 2542227 T1 SI2542227 T1 SI 2542227T1 SI 201131396 T SI201131396 T SI 201131396T SI 201131396 T SI201131396 T SI 201131396T SI 2542227 T1 SI2542227 T1 SI 2542227T1
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disease
active agent
disorders
acid
syndrome
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Alexander Mullen
Howard Stevens
Sarah Eccleston
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University Of Strathclyde
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Claims (10)

  1. TAKOJŠNJE/ZADRŽANO RAZDELJEVANJE ZDRAVILA EP 2 542 227 B1 PATENTNI ZAHTEVKI
    1. Formulacija pod pritiskom prevlečene tablete, za takojšnjo, čemur sledi zadržano sproščanje aktivnega sredstva, tableta obsega (a) jedro, ki vsebuje aktivno sredstvo skupaj s pomožno snovjo(mi); in (b) plast s zadržanim sproščanjem, ki obdaja jedro, in vsebuje vosek in mikronizirano nizko substituirano hidroksiipropil celulozo (L-HPC) s povprečnim premerom 20 pm, ki je netopna v vodi in vsebuje glukozni skelet, substituirano s hidroksiipropilnimi skupinami, in ima molekulsko maso okoli 115,000 in hidroksiipropil celulozno vsebnost okoli 8% v razmerju 40 : 60 do 60 : 40 m/m; kjer sloj z zadržanim sproščanjem v bistvu zakasni sproščanje aktivnega sredstva v jedru za od 3 do 8 ur po dajanju tablete osebku nakar pride do impulznega sproščanja aktivnega sredstva iz jedra, tako da se vsaj 70% aktivnega sredstva v jedru sprosti v 5 - 45 min; in (c) plast zgornje prevleke, ki vsebuje del aktivnega sredstva skupaj s sladkorjem in L-HPC, pri čemer se vsaj 70-90% aktivnega sredstva sprosti v roku 5 - 45 min po dajanju tablete osebku.
  2. 2. Pod pritiskom prevlečena tableta po zahtevku 1, ki nadalje obsega količino aktivnega sredstva v plasti z zadržanim sproščanjem, ki je enaka ali različna od aktivnega sredstva v plasti, ki obdaja jedro in/ali plasti zgornje prevleke, v plasti z zadržanim sproščanjem.
  3. 3. Pod pritiskom prevlečena tableta po kateremkoli predhodnem zahtevku, ki obsega eno ali več naslednjih aktivnih sredstev: Gastro zdravila Antacidi - aluminijev hidroksid, magnezijev karbonat, magnezijev trisilikat, hidrotalcit, simetikon alginati, Antispazmodika - atropinijev sulfat, dicikloverin hidroklorid, hioscin butilbromin, propanthelin bromid, alverin citrat, mebeverinijev klorid, Motilitetni stimulansi - metoklorpramid, domperidon H2 - antagonisti receptorjev - cimetidin, famotidinizatidin, ranitidin antimuskarinika - pirenzepin kelati - trikotijev dicitratibizmutat, sukralfat, Prostaglandinski analogi - misoprostol Aminosalicilati - balsazid natrij, mesalazin, olsalazin, sulfasalazin Kortikosteroidi - beklometazon dipropionat, budenozid, hidrokortizon, pednizolon, Vpliv na imunski odziv - ciklosporin, merkaptopurin, metotreksat, adalimumab, infliksimab Stimulantni odvajalci - bisacodil, dantron, dokusat, natrijev pikosulfat, Zdravila, ki vplivajo na biološko sestavo in pretok - ursodeoksiholna kislina Sekceptorji žolčnih kislin - kolestiramin, oksifentenciklin, kamilofin, mebeverin, trimebutin, rociverin, dicicloverin, diheksiverin, difemerin, piperidolat benzilon, mepenzolat, pipenzolat, glikopironij, oksifenonij, pentienat, metantelin, propantelin, otilonijev bromid, tridiheksetil, izopropamid, heksociklij, poldin, bevonij, difemanil, tiemonijev jodid, prifinium bromid, timepidijev bromid, fenpiverinium papaverin, drotaverin, antagonisti moksaverin 5-HT3 (kot so Alosetron, Cilansetron), agonisti 5-HT4 (kot so Mosaprid, Prucaloprid, Tegaserod) fenpiprane, diizopromin, klorbenzoksamin, pinaverij, fenoverin, idanpramin, proksazol, alverin, trepibuton, izomethepten, karoverin, floroglucinol, silikoni, trimetildifenilpropilamin atropin, hiosciaminamin skopolamin (kot so butilscopolamin, metilscopolamin), metilatropin, fentonij, cimetropijev bromid predvsem antagonisti dopamina (kot so metoklopramid/bromoprid, klebobrid, domperidon, alizaprid), agonsit 5-HT4 (kot sta cinitaprid, cisaprid), Zaviralci protonske črpalke omeprazol, iansoprazol, pantoprazol, esomeprazol, natrijev rabeprazol, opioidi in antagonisti receptorjev opioidov-npr. kodein, morfin, loperamid, difenoksilat, metilnaltrekson bromid Analgetik acetaminofen diklofenak diflunisal etodolak fenoprofen flurbiprofen ibuprofen indometacin ketoprofen ketorolac meklofenamat mefenaminska kislina meloksikam nabumeton naproksen oksaprozin fenilbutazon piroksikam sulindak tolmetin celekoksib buprenorfin butorfanol kodein hidrokodon hidromorfon levorfanol meperidin metadon morfin nalbufin oksikodon oksimorfon pentazocin, propoksifen tramadol kodein Zdravila za spanie Hipnotiki - nitrazepam, flurazepam, loprazolam, lormetazepam, temazepam, zaleplon, zolpidem, zopiklon, kloral hidrat, triklofos, klometiazol, kvazepam, triazolam estazolam klonazepam, alprazolam, eszopiklon, rozerem, trazodon, amitriptilin doksepin, benzodiazepinska zdravila, melatonin, difenhidramin in zeliščna zdravila, kot je valerian. Kardiovaskularna zdravila Srčni glikozidi - digoksin, digitoksin, Inhibitorji fosfodiesteraze - enoksimon, milrinon Tiazidi in sorodni diuretiki - bendroflumetiazid, klortalidon, ciklopentiazid, inapamid, metolazon, ksipamid Diuretiki - furosemid, bumetanid, torasemid, Diuretiki, ki varčujejo s kalijem in antagonisti aldosterona - amilorid hidroklorid, triamteren, eplerenon, spironolakton, Osmotski diuretiki - manitol Zdravila za aritmije - adenozin, amiodaron hidroklorid, disopiramid, flekainid acetat, propafenon hidroklorid, lidokain hidroklorid, Beta adrenoreceptorski blokatorji - propanalol, atenolol, acebutolol, bisoprolol fumarat, karvedilol, celiprolol, esmolol, lebatolol, metoprolol tartrat, nadolol, nebivolol, oksprenolol, pindolol, solatol, timolol, Hipertenzija - ambrisentan, bosentan, diazoksid, hidralazin, iloprost, minoksidil, sildenafil, sitaksentan, natrijev nitroprusid, klonidin, metildopa, moksonidin, gvanetidin monosulfat, doksazosin, indoramin, prazosin, terazosin, fenoksibenzamin, fentolamin mesilat, Zdravila, ki vplivajo na renin-angiotenzin sistem - captropril, cilazapril, enalapril maleat, fosinopril, imidapril, lisinopril, moeksipril, perindopril erbumin, kuinapril, ramipril, trandolapril, candesartan cileksetil, eprosartan, irbesartan, losartan, olmesartan medoksomil, telmisartan, valsartan, aliskiren. Nitrati, blokatorji kalcijevih kanalov in antianginalna zdravila - gliceril trinitrat, izosorbidni dinitrat, izosorbid mononitrat, amlodipin, diltiazem, felodipin, izradipin, lacidipin, lercanidipin, nikardipin, nifedipin, nimodipin, verapamil, ivabradin, nikorandil, ranolazine, Periferni vazodilatatorji in sorodna zdravila - cilostazol, inositol nikotinat, moksizilat, naftidrofuril oksalat, pentoksifilin, Simpatomimetiki - dopamin, dopeksamin, efedrin, metaraminol, noradrenalinski kislinski tartrat, norefidrin bitartrat, fenilefidrin, Antikoagulanti in protamin - heparin, bemiparin, dalteparin, enokaparin, tinzaparin, danaparoid, bivalirudin, lepirudin, epoprostenol, fondaprinuks, varfarin, acenokumarol, fenindion, dabigatran eteksilat, rivaroksaban, protamin sulfat, Antiplatelet zdravila - abciksimab, asiprin, klopidogrel, dipiridamol, eptifibatid, prasugrel, tirofiban, Fibrinolitična in antifibrinolitična zdravila - alteplaza, reteplaza, streptokinaza, tenekteplaza, urokinaza, etamsilat, traneksamična kislina, Zdravila za uravnavanje lipidov - atorvastatin, fluvastatin, pravastatin, rosuvastatin, simvastatin, kolesevam, colestiramin, kolestipol, ezetimib, bezafibrat, ciprofibrat, fenofibrat, gemfibrozil, acipmoks, nikotinska kilsina, omega tri spojine maščobnih kislin, etanolamin oleat, natrijev tetradecil supat. Zdravila CNS - benperidol, klorpromazin, flupentiksol, haloperidol, levomepromazin, periciazin, perfenazin, pimozid, prokloroperazin, promazin, sulpirid, trifluoperazin, zuklopentiksol, amisulprid, aripiprazol, klozapin, olanzapin, paliperidon, kvetiapin, riperidon, sertindol, zotepin, flupentiksol, fluphenazin, olanzapin-embonat, palmitat pipotiazin, risperidon, zuklopentiksol-dekanoat, karbamazepin, valproat, valprojska kislina, litijev karbonat, litijev citrat, amitriptilin, klomipramin, dosulepin, imipramin, lofepramin, nortriptilin, trimipramin, mianserin, trazodon, fenelzin, izokarboksazid, tranilcipromin, moklobemid, citalopram, escitalopram, fluoksetin, fluvoksamin, paroksetin, sertralin, agomelatin, duloksetin, flupentiksol, mirtazapin, reboksetin, tritofan, venflaksin, atomoksetin, deksametamin, metilfenidat, modafinil, eslikarbazepin, okarbazepen, etosuksimid, gabapentin, pregabalin, lakozamid, lamotrigin, levetiracetam, fenobarbital, primidon, fenitoin, rufinamid, tiagabin, topiramat, vigabatrin, zonisamid, ropinirol, rotigotin, beneldopa, levodopa, co-kareldopa, rasagilin, selegilin, entakapon, tolkapon, amantidin, orfenadrin, prociklidin, triheksifenidil, haloperidol, piracetam, riluzol, tetrabenazin, acamprozat, disulfiram, bupropion, varenicilin, buprenorfin, lofeksidin, donepezil, galantamin, memantin, rivastigimin. Anti-infektivi - benzilpenicilin, fenoksimetilpenicilin, flukloksacilin, temocilin, amoksicilin, ampicilin, co-amoksiklav, co-fluampicil, piperacilin, tikarcilin, pivmecilinam, cefalosporini, cefaklor, cefadroksil, cefaleksin, cefiksem, cefotaksim, cefradin, ceftazidim, cefuroksim, ertapenem, imipenem, meropenem, aztreonam, tetraciklin, demeklociklin, doksociklin, limeciklin, minociklin, okstetraciklin, tigeciklin, gentamicin, amikacin, neomicin, tramramicin, eritromicin, azitromicin, klaritromicin, telitromicin, klindamicin, kloramfenikol, fuzidična kislina, vankomicin, teikoplanin, daptomicin, linezolid, kuinupristin, kolistin, ko-trimoksazol, sulpadiazin, trimetoprim kapreomicin, cikloverin, etambutol, izoniazid, pirazinamid, rifabutin, rifampicin, streptomicin, dapson, klofazimin, metronidazol, tinidazol, ciproflaksacin, levoflaksacin, moksifloksacin, nalidiksova kislina, norflakin, orflaksacin, nitrofurantoin, metenaminijev hipurat, amfotericin, anidulafungin, kaspofungin, flukonazol, flucitozin, griseofluvin, itraconzol, ketokonazol, mikafungin, nistatin, posakonazol, terbinafin, vorikonazol, abacavir, didanozin, emtricitabin, lamivudin, stavudin, tenofovir disoproksil, zidovudin, atazanavir, darunavir, fosamprenavir, indinavir, lopinair, nelfinavir, ritonavir, sakvinavir, tipranavir, efavirenz, etravirin, nevarapin, enfuvirtid, maraviroc, raltegravir, aciklovir, famciklovir, inosin pranobeks, valaciklovir, cidofovir, gangciklovir, foskarnet, valgangciklovir, adefovir dipivoksil, entekavir, telbivudin, amantadin, oseltamivir, zanamivir, palivizumab, ribavirin, artemeter, klorokuin, meflokuin primaquin, proguanil, pirimetamin, kinin, doksiciklin, diloksanid furoat, metronidazol, tinidazol, natrijev mepakrin stiboglukonat, atovakuon, pentamidin izetionat, mebendazol, piperazin, Drugo: benztropiprociklidin biperiden, amantadin bromokriptin pergolid entakapon tolkapon selegelin pramipeksol, budesonid, formoterol, kvetiapin fumarat, olanzapin, pioglitazon, montelukast, zoledromska kislina, valsartan, latanoprost, irbesartan, klopidogrel, atomoksetin, deksamfetamin, metilfenidat, modafinil, bleomicin, daktinomicin, daunorubicin, idarubicin, mitomicin, mitoksantron, azacitidin, kapecitabin, kladribin, klofarabin, citarabin, fludarabin, fluorouracil, gemcitabin, merkaptopurin, metotreksat, nelarabin, pemetreksed, raltitreksed, tioguanin, apomorfin, betametazon, kortizon, deflazakort, deksametazon, hidrokortizon, metilprednizolon, prednizolon, triamcinolon, ciklosporin, sirolimus, takrolimus, interferon alfa, interferon beta.
  4. 4. Pod pritiskom prevlečena tableta po zahtevku 3 za uporabo pri postopku zdravljenja ene ali več naslednjih bolezni ali stanj: Bolezni centralnega živčnega sistema, npr. nevrogena bolečina, možganska kap, demenca, Alzheimerjeva bolezen, Parkinsonova bolezen, bolezni nevronske degeneracije, meningitisa, poškodbe hrbtenjače, cerebralnega vazospazma, amiotrofične lateralne skleroze. Kardiovaskularne bolezni, hipertenzija, ateroskleroza, angina, arterijska obstrukcija, periferna arterijska bolezen, miokardna patologija, aritmija, akutni miokardni infarkt, angina, kardiomiopatija, kongestivna srčna okvara, bolezni koronarne arterije, bolezni karotidne arterije, endokarditis, hiperholesterolemij, hiperlipidemija, periferna arterijska bolezen Genitourinarne motnje; erektilna disfunkcija, bolezen sečil, benigna hipertrofija prostate, ledvična cevasta acidoza, diabetična nefropatija, glomerulonefritis, glomeruloskleroza, okužba sečil, fekalna inkontinenca Očesne bolezni glavkom, blefartitis, očesna hipertenzija, retinopatija, konjunktivitis, skleritis, retinitis, keratitis, razjeda roženice, iritisa, korioretinalno vnetje, makularni edem, kseroftalmija Pljučne bolezni, astma, pljučna hipertenzija, akutni respiratorni distresni sindrom, KOPB, emfizem, pljučnica, tuberkuloza, bronhitis, akutni bronhitis, bronhiektazija, bronhiolitis, bronhopulmonalna displazija, bisinoza, kokcidioidomikoza, cistična fibroza, gripa, rak pljuč, mezoteliom Bolezni presnove; hiperkalciurija, hiperglikemija, hipersinemična hipoglikemija, hiperinsulinizem, hiperlizinurija, hipoglikemija Eksokrina in Endokrina; Addisonova bolezen, hipoaldosteronizem Cushingov sindrom, diabetes, golša, hipertiroidizem, hipotiroidizem, tiroiditis, pankreatitis Bolezni jeter, hepatitis, brezalkoholna bolezen maščobnih jeter, ciroza, jetrni rak, primarni sklerozni holangitis, primarna žolčna ciroza, Budd-Chiarijev sindrom, Avtoimunske in vnetne bolezni, revmatoidni artritis multiple skleroze, psoriaza, diabetes, sarkoidoza, Addisonova bolezen, alopecija areata, amiotrofična lateralna skleroza, ankilozirajoči spondilitis, poliartikularni artritis, atopična alergija, tematski dermatitis, avtoimunski hepatitis, celiakija, bolezen šag, bolezen celije, koganski sindrom, Crohnova bolezen, Cushingov sindrom, diabetes mellitus tip 1, endometrioza, eozinofilni fascilitis, fibromialgija/fibromiozitis, gastritis, glomerulonefritis, Gravesova bolezen, Guillain-Barrejev sindrom, Hashimoto-ov encefalitis, Hashimoto-ov tiroiditis, hemolitična anemija, idiopatsko vnetno demielizirajoča bolezen, idiopatska pljučna fibroza, intersticijski cistitis, juvenilni idiopatski artritis, juvenilni revmatoidni artritis, Kavvasaki bolezen, Lichen sclerosus, eritematozni lupus, Menierejeva bolezen, Myasthenia gravis, miozitis, narcolepsija, anemija pervozgodovine, periferni encefalomielitis, polimialgia revmatica, primarna žolčna ciroza, psoriatični artritis, Reiterjev sindrom, revmatoidna vročina, sarkoidoza, šizofrenija, Sjogrenov sindrom, spondiloartropatija, ulcerozni kolitis Mišično-skeletne motnje: osteoartritis, osteoporoza, osteonekroza, artritis, Pagetova bolezen bursitis, costohondritis,tendonitis Kožne nepravilnosti; akne, alopecija, kandidiaza, celuliltis, dermatitis, ekcem, bulosa epidermoliza, eritrasma, herpes, erizipel, folikulitis, impetigo, lišaji, garje, nazofaringitis, trihomikoza ENT motnje; otitis, sinusitis, faringitis, menerejeva bolezen, labirintitis, Drugo: akutna in kronična bolečina, virusna okužba, rak, mastoiditis, maringitis, meditja otitis, rinitis, sinuzitis, sialadenitis, retrofaringealni absces, tonsilofaringitis, Bolezni prebavil; sindrom razdražljivega črevesja, nekrotizirajoči enterolititis, dispepsija brez ulkusov, kronična črevesna pseudo-obstrukcija, funkcionalna dispepsija, pseudo-obstrukturiduodenogastrični refluks kolonije, gastroezofagealna refluksna bolezen, ileus vnetje, gastropareza, zgaga, zaprtje - (npr. zaprtje, povezano z uporabo zdravil kot so opioidi), kolorektalni rak, kolonijevi polipi, divertikulitis, kolorektalni rak, »barrett« požiralnik, krvavitev v prebavnem traktu, celiakija, polipi debelega črevesa, zaprtje, Crohnova bolezen, sindrom cikličnega bruhanja, odloženo gastrično praznjenje (gastropareza), diareja, divertikuloza, razjeda dvanajstnika, inkontinenca, žolčni kamni, plini v prebavnem traktu, gastritis, gastroezofagealna refluksna bolezen, zgaga, Hiatalna kila, hemohromatoza, hemoroidi, Hiatalna kila, Hirschsprungova bolezen, prebavne motnje, ingvinalna kila, laktoza nestrpnost, peptični ulkusi, polipi, porfirija, primarna biljarska ciroza, primarni sklerozni holangitis, proktitis, hitro praznjenje želodca, sindrom kratkega črevesa, razjede na želodcu, ulcerozni kolitis, razjede, VVhipplova bolezen.
  5. 5. Pod pritiskom prevlečena tableta po zahtevkih 1 ali 2, ki obsega aktivno sredstvo, ki je zasnovano za zdravljenje artritisa in/ali akutne bolečine, kjer je aktivno sredstvo po izbiri NSAID, kot je diklofenak.
  6. 6. Pod pritiskom prevlečena tableta po katerem koli od predhodnih zahtevkov, pri čemer je vosek čebelji vosek, karnuba vosek, mikrokristaliničen vosek, hidrogenirano ricinusovo olje ali ester gliceril.
  7. 7. Pod pritiskom prevlečena tableta po zahtevku 6, kjer je gliceril ester glicerol behenat.
  8. 8. Pod pritiskom prevlečena tableta po katerem koli od predhodnih zahtevkov, kjer sta vosek in L-HPC prisotna v razmerju 40 : 60 do 60 : 40 m/m.
  9. 9. Pod pritiskom prevlečena tableta po zahtevku 7, ki vsebuje 50 : 50 m/m razmerja glicerol behenata, pri čemer je uporabljeni LHPC plast z zadržanim sproščanjem.
  10. 10. Pod pritiskom prevlečena tableta po katerem koli od predhodnih zahtevkov za uporabo pri postopku zdravljenja ali profilakse.
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