TR2021021540A2 - A combination comprising ibuprofen and at least one atypical antipsychotic agent - Google Patents
A combination comprising ibuprofen and at least one atypical antipsychotic agentInfo
- Publication number
- TR2021021540A2 TR2021021540A2 TR2021/021540 TR2021021540A2 TR 2021021540 A2 TR2021021540 A2 TR 2021021540A2 TR 2021/021540 TR2021/021540 TR 2021/021540 TR 2021021540 A2 TR2021021540 A2 TR 2021021540A2
- Authority
- TR
- Turkey
- Prior art keywords
- tablets
- pharmaceutical combination
- combination according
- ibuprofen
- lurasidone
- Prior art date
Links
- HEFNNWSXXWATRW-UHFFFAOYSA-N Ibuprofen Chemical compound CC(C)CC1=CC=C(C(C)C(O)=O)C=C1 HEFNNWSXXWATRW-UHFFFAOYSA-N 0.000 title claims abstract description 23
- 229960001680 ibuprofen Drugs 0.000 title claims abstract description 22
- 239000003693 atypical antipsychotic agent Substances 0.000 title claims abstract description 17
- 208000024891 symptom Diseases 0.000 claims description 37
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- PQXKDMSYBGKCJA-CVTJIBDQSA-N lurasidone Chemical compound C1=CC=C2C(N3CCN(CC3)C[C@@H]3CCCC[C@H]3CN3C(=O)[C@@H]4[C@H]5CC[C@H](C5)[C@@H]4C3=O)=NSC2=C1 PQXKDMSYBGKCJA-CVTJIBDQSA-N 0.000 claims description 19
- 229960001432 lurasidone Drugs 0.000 claims description 17
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- QZUDBNBUXVUHMW-UHFFFAOYSA-N clozapine Chemical compound C1CN(C)CCN1C1=NC2=CC(Cl)=CC=C2NC2=CC=CC=C12 QZUDBNBUXVUHMW-UHFFFAOYSA-N 0.000 claims description 8
- ZKIAIYBUSXZPLP-UHFFFAOYSA-N brexpiprazole Chemical compound C1=C2NC(=O)C=CC2=CC=C1OCCCCN(CC1)CCN1C1=CC=CC2=C1C=CS2 ZKIAIYBUSXZPLP-UHFFFAOYSA-N 0.000 claims description 6
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- CEUORZQYGODEFX-UHFFFAOYSA-N Aripirazole Chemical compound ClC1=CC=CC(N2CCN(CCCCOC=3C=C4NC(=O)CCC4=CC=3)CC2)=C1Cl CEUORZQYGODEFX-UHFFFAOYSA-N 0.000 claims description 4
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- XMXHEBAFVSFQEX-UHFFFAOYSA-N iloperidone Chemical compound COC1=CC(C(C)=O)=CC=C1OCCCN1CCC(C=2C3=CC=C(F)C=C3ON=2)CC1 XMXHEBAFVSFQEX-UHFFFAOYSA-N 0.000 claims description 3
- KVWDHTXUZHCGIO-UHFFFAOYSA-N olanzapine Chemical compound C1CN(C)CCN1C1=NC2=CC=CC=C2NC2=C1C=C(C)S2 KVWDHTXUZHCGIO-UHFFFAOYSA-N 0.000 claims description 3
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Abstract
Mevcut buluş, ibuprofen ve en az bir atipik antipsikotik ajan içeren bir farmasötik kombinasyon ile ilgilidir.
Description
TARIFNAME IBUPROFEN VE EN AZ BIR ATIPIK ANTIPSIKOTIK AJAN IÇEREN BIR KOMBINASYON Bulusun Alani Mevcut bulus, ibuprofen ve en az bir atipik antipsikotik ajan içeren bir farmasötik kombinasyon ile ilgilidir. Bulusun Geçmisi Sizofreni, insanlarin gerçegi anormal sekilde yorumladigi ciddi bir zihinsel bozukluktur. Sizofreni, halüsinasyonlar, sanrilar ve asiri derecede düzensiz düsünce ve davranislarin, günlük isleyisi bozan ve sakatlayici olabilen bazi kombinasyonlariyla sonuçlanabilir. Sizofreni hastalari ömür boyu tedaviye ihtiyaç duyarlar. Erken tedavi, ciddi komplikasyonlar gelismeden önce semptomlarin kontrol altina alinmasina yardimci olabilir ve uzun vadeli görünümü iyilestirmeye yardimci olabilir. Sizofreni, düsünme (bilis), davranis ve duygularla ilgili bir dizi sorunu kapsar. Belirti ve semptomlar degisebilir, ancak genellikle sanrilar, halüsinasyonlar veya düzensiz konusmayi kapsar ve bir islevsel bozukluk yansitir. Ilaçlar sizofreni tedavisinin temel tasidir ve antipsikotik ilaçlar en sik reçete edilen ilaçlardir. Beyin nörotransmitter dopaminini etkileyerek semptomlari kontrol ettikleri düsünülmektedir. Antipsikotik ilaçlarla tedavinin amaci, belirti ve semptomlari mümkün olan en düsük dozda etkin bir sekilde yönetmektir. Psikiyatrist, istenen sonuca ulasmak için zamanla farkli ilaçlar, farkli dozlar veya kombinasyonlar deneyebilir. Antidepresanlar veya anti-anksiyete ilaçlari gibi diger ilaçlar da yardimci olabilir. Semptomlarda bir iyilesmeyi fark etmek birkaç haftayi alabilir. Sizofreni ilaçlari ciddi yan etkilere neden olabildiginden, sizofreni hastalari bunlari almakta isteksiz olabilmektedir. Iki tür antipsikotik tedavi vardir: birinci nesil antipsikotikler ve ikinci nesil antipsikotikler. Birinci nesil antipsikotikler (tipik) Bu birinci nesil antipsikotiklerin, reversibl olabilen ya da olmayabilen bir hareket bozuklugu (tardif diskinezi) gelistirme olasiligi da dahil olmak üzere, sik ve potansiyel olarak önemli nörolojik yan etkileri vardir. Birinci nesil antipsikotikler sunlari içerir: Klorpromazin, Flufenazin, Haloperidol, Perfenazin. Bu antipsikotikler genellikle ikinci nesil antipsikotiklerden, özellikle de jenerik versiyonlarindan daha ucuz olup, bu durum uzun süreli tedavi gerektiginde önemli bir husus olabilmektedir. Ikinci nesil antipsikotikler (atipik) Bu daha yeni. ikinci nesil ilaçlar, birinci nesil antipsikotiklere göre daha düsük ciddi yan etki riski tasidiklari için genellikle tercih edilirler. Ikinci kusak antipsikotikler sunlari içerir: Aripiprazol, Asenapin, Brexpiprazol, Kariprazin, Klozapin, Iloperidon, Lurasidon, Olanzapin, Paliperidon, Ketiapin, Risperidon, Ziprasidon. Bazi arastirmalara göre, mevcut antipsikotik tedaviye ragmen, sizofreni hastalarinin çogu, kalici pozitif ve negatif semptomlar ve bilissel bozukluklar sergilemeye devam etmektedir. Kalici semptomlarin tedavisi için psikotrop ajanlarin kullanimina alternatif bir yaklasim, hastaligin semptom ve belirtilerinin altinda yatan varsayimsal pro-inflamatuar durumu tersine çevirmek için anti-inflamatuar ajanlarin kullanilmasidir. Arastirmacilarin birincil hipotezi, ek anti-inflamatuar kombinasyon tedavisinin kalici pozitif semptomlar ve bilissel bozukluklar üzerinde önemli faydali etkilere sahip olacagidir. Arastirmacilarin ikincil hipotezleri sunlardir: a) ek anti-inflamatuar kombinasyon tedavisi, depresif ve negatif semptomlarda iyilesmeler ve proinflamatuar sitokinlerde bir azalma ile iliskilendirilecektir. b) plaseboya kiyasla ek anti-inflamatuar kombinasyon tedavisi, yüksek advers risk ile iliskilendirilmeyecektir. Pozitif ve negatif semptomlar Sizofreni semptomlari genellikle su sekilde siniflandirilir: pozitif semptomlar - halüsinasyonlar veya sanrilar gibi davranis veya düsüncelerdeki herhangi bir degisiklik negatif semptomlar - insanlarin o sirada dünyadan uzaklasiyormus gibi göründügü, günlük sosyal etkilesimlere hiç ilgi duymadigi ve çogu zaman duygusuz ve düz göründügü durumlar. Sizofrenisi olan insanlarin deneyimledigi negatif semptomlar sunlari içerir: 0 iliskiler ve seks de dahil olmak üzere hayata ve aktivitelere karsi ilgi ve motivasyonu kaybetmek, o konsantrasyon eksikligi, evden ayrilmak istememe ve uyku düzenlerinde degisiklikler, konusma baslatma olasiliginin azalmasi ve insanlarla birlikteyken rahatsiz hissetme veya söyleyecek hiçbir seyin olmadigini hissetme Sizofreninin negatif semptomlari, bazen kasitli tembellik veya kabalik ile karistirilabileceginden, genellikle arkadaslar ve aile ile iliski sorunlarina yol açabilir. Son yillarda doktorlar tarafindan bilissel semptomlar olarak adlandirilan üçüncü bir semptom kategorisinin ortaya çiktigi da netlik kazanmistir. Bilissel semptomlar, konsantrasyon ve hafiza ile ilgili sorunlari kapsar ve diger semptom tipleri kadar engelleyici olabilir. Sizofreni bu farkli semptomlara sahip oldugundan, çok tarafli bir durum olarak bilinir. Bilissel semptomlar su sekilde özetlenebilir: veya islevi yerine getirmek için kullanma) islevinde bozulma. - Kisa süreli çalisma belleginin bozulmasi - Dikkat eksikligi - Demans Mevcut bulusta, Sizofreni tedavisinin mevcut durumunu iyilestirme stratejisi, terapileri birlestirmektir. Bu bulus, proinflamatuar sitokinlerde ve pozitif semptomlarda, negatif semptomlarda, bilissel bozukluklarda azalmaya yönelik önemli faydali etkilere sahiptir. Bu nedenle, önceki teknikte Ibuprofen'in en az bir atipik antipsikotik ajan ile kombinasyonu bulunmamaktadir. Ibuprofen, nonsteroid antiinflamatuar bir ilaçtir (NSAID). Vücutta inflamasyona ve agriya neden olan hormonlari azaltarak çalisir ve kimyasal adi 2-(4-izobütilfenil) propiyonik asittir ve kimyasal yapisi Formül I'de gösterilmistir. Formül I; ibuprofen U patent basvurusu, ibuprofen molekülünü açiklar. Ibroprofen vücutta inflamasyon ve agriya neden olan hormonlari azaltir ve atesi düsürmek ve bas agrisi, dis agrisi, sirt agrisi, artrit, adet kramplari veya küçük yaralanmalar gibi birçok durumun neden oldugu agri veya iltihabi tedavi etmek için kullanilir. Antipsikotik ilaçlar, sizofreni hastalarini tedavi etmek için kullanilan ana ilaç sinifidir. Ayrica bipolar bozukluk, depresyon ve Alzheimer hastaliginda ortaya çikan psikozlu insanlari tedavi etmek için kullanilirlar. Atipik antipsikotikler, eski veya tipik antipsikotik ilaçlardan farkli bir farmakolojik profile sahip daha yeni antipsikotik ajanlardir. Ikinci nesil antipsikotikler olarak da adlandirilirlar. Bu antipsikotik sinifindaki ilaçlar, dopamin ve serotonin dahil olmak üzere birçok reseptör tipine etki eder, ancak dopamin reseptörleri için daha seçicidirler. Eski tipik antipsikotik ilaçlara kiyasla daha az ekstrapiramidal yan etkilere neden olurlar. Tedaviye dirençli hastalarda daha etkilidirler ve tipik antipsikotiklere kiyasla negatif semptomlari tedavi etmede daha fazla etkinlige sahiptirler. Antipsikotik ajanlar, Aripiprazol (Abilify), Asenapin (Saphris), Brekspiprazol (Rexulti), Kariprazin (Vraylar), Klozapin (Clozaril, Versacloz), Iloperidon (Fanapt), Lurasidon (Latuda), Olanzapin (Zyprexa), Paliperidon (Invega), Ketiapin (Seroquel), Risperidon (Risperdal), Ziprasidon (Geodon) veya bunlarin kombinasyonlarindan seçilir. Tercih edilen antipsikotiklerden biri, benzisotiazol türevlerinin kimyasal sinifina ait olan piperazin-l-ilmetil]sikloheksilmetil}heksahidro-4,7-metano-2H-izoindol-1,S-dion'dur ve kimyasal yapisi Formül Il'de gösterilmistir. Formül II; Lu rasidon Lurasidon hidroklorür, Dainippon Sumitomo tarafindan Latuda® ticari adi altinda gelistirilen ve sizofreni hastalarinin ve bipolar I bozukluk (bipolar depresyon) ile iliskili majör depresif ataklarin tedavisi için endike olan bir Iurasidon tuzudur. Lurasidon hidroklorür, beyaz ila kirli beyaz bir tozdur. Suda çok az çözünür, 0.1 N HCI'de pratik olarak çözünmez veya hiç çözünmez, etanolde az çözünür, metanolde az çözünür, toluende pratik olarak çözünmez veya hiç çözünmez ve asetonda çok az çözünür. Bu bulusta birden fazla molekülün tek dozaj formunda birlestirilmesi hastanin uyumunu artirmaktadir. Ancak bu kombinasyon hastalarin yasam kalitesini arttirirken, birden fazla molekülü tek dozaj formunda birlestirmek ayni zamanda pozitif, negatif, bilissel semptomlar olabilen istenmeyen sizofreni semptomlarini azaltir, hastaligin semptom ve belirti tezahürlerinin altinda yatan varsayimsal proinflamatuar durumu tersine çevirir. Bu nedenle, Ibuprofen'in en az bir atipik antipsikotik ajan ile birlestirilmesine ihtiyaç vardir, tercihen atipik antipsikotik ajan Lurasidon'dur. Bulusun Ayrintili Açiklamasi Mevcut bulusun ana amaci, hizli ve etkili tedavi saglamak adina pozitif, negatif, bilissel semptomlar olabilen istenmeyen sizofreni semptomlarini ortadan kaldirmak, hastaligin semptom ve belirti tezahürlerinin altinda yatan varsayimsal proinflamatuar durumu tersine çevirmek için Ibuprofen'i en az bir atipik antipsikotik ajanla birlestirmektir. Mevcut bulusun bir baska amaci, istenmeyen sizofreni semptomlarinin tedavisinde kullanim için sinerjistik etkiye sahip stabil bir kombinasyon formülasyonu elde etmek ve sizofreni semptomlarinin altinda yatan varsayimsal proinflamatuar durumu tersine çevirmektir. Bu bulus ayrica, istenmeyen sizofreni semptomlarindan mustarip bir insanin tedavisinde kullanim için etkili miktarda Ibuprofen ve etkili bir miktarda atipik antipsikotik ajan, özellikle Lurasidon içeren farmasötik bir kombinasyon saglamakta olup, özelligi Ibuprofen ve atipik antipsikotik ajanin ayni anda, ayri ayri veya sirayla uygulanmasidir. Burada kullanildigi sekliyle "Lurasidon" terimi, serbest baz formunda veya farmasötik olarak kabul edilebilir tuzlar, kristalin polimorf, solvatlar, hidratlar, esterler veya bunlarin karisimi formunda Lurasidon anlamina gelir. Mevcut bulusun bir düzenlemesine göre farmasötik kombinasyon, Ibuprofen ve en az bir atipik antipsikotik ajan içerir. Mevcut bulusun bir düzenlemesine göre, antipsikotik ajanlar, Aripiprazol (Abilify), Asenapin (Saphris), Brekspiprazol (Rexulti), Kariprazin (Vraylar), Klozapin (Clozaril, Versacloz), (Seroquel), Risperidon (Risperdal), Ziprasidon (Geodon) veya bunlarin kombinasyonlarini içeren atipik antipsikotikler grubundan seçilir. Tercihen antipsikotik ajan, sizofreni hastalarinin tedavisi olarak kullanilan Lurasidon veya bunlarin kombinasyonlaridir. Dolayisiyla bu bulusun bir düzenlemesi, Ibuprofen'i Lurasidon ile ayni ve stabil bir dozaj formunda istenen çözünme profilleri ile birlestirmektedir. Mevcut bulusun bir düzenlemesine göre farmasötik kombinasyon, Ibuprofen ve Lurasidon Mevcut bulusun bir düzenlemesine göre, Iurasidon miktari kombinasyonda agirlikça %1.0 ile Mevcut bulusun bir düzenlemesine göre, ibuprofen miktari, kombinasyonda agirlikça %25.0 ile %500 arasindadir. Bu bulus, pozitif, negatif, bilissel semptomlar olabilen istenmeyen sizofreni semptomlarindan mustarip bir insani tedavi etmek, hastaligin semptom ve belirti tezahürlerinin altinda yatan varsayimsal proinflamatuar durumu tersine çevirmek, proinflamatuar sitokinlerde bir azalma saglamak için bir yöntem saglamakta, etkili miktarda ibuprofen ve etkili miktarda atipik antipsikotik ajanin birlikte denege periyodik olarak uygulanmasini içermekte olup, asagida açiklanan bu etkili miktarlar bir insani tedavi etmek için etkilidir. Mevcut bulusun bu düzenlemesine göre farmasötik kombinasyon, 200 mg ile 800 mg arasindaki bir miktarda Ibuprofen ve 20 mg ile 120 mg arasindaki bir miktarda Lurasidon içerir. Mevcut bulusun bir düzenlemesine göre, Lurasidonun Ibuprofene agirlik orani 0.005-1.5, tercihen 0.025-O.6 arasindadir. Mevcut bulusa göre tercih edilen bir düzenlemede, söz konusu kombinasyon ayrica dolgu maddeleri, baglayicilar, dagiticilar, solventler ve yardimci solventler, hiz kontrol polimerleri, direkt baski ajani, sürfaktanlar, lubrikantlar, glidantlar, tatlandiricilar, stabilizatörler, kaplama maddeleri, renklendirme maddeleri, inert maddeler veya bunlarin karisimlarindan seçilen, farmasötik olarak kabul edilebilir en az bir eksipiyan da içerir. Uygun dolgu maddeleri, mikrokristalin selüloz, mannitol, spreyle kurutulmus manitol, Iaktoz, inorganik tuzlar, kalsiyum tuzlari, polisakaritler, dikalsiyum fosfat, sodyum klorür, dekstratlar, bikarbonat, kalsiyum karbonat veya bunlarin karisimlarini içeren gruptan seçilir. Mevcut bulusun bir düzenlemesine göre dolgu maddesi, mikrokristalin selüloz veya manitol veya susuz Iaktoz veya önceden jelatinize edilmis nisasta veya bunlarin karisimlaridir. Uygun baglayicilar, metil selüloz, polivinilpirolidon, polietilen glikol, polivinil alkol, nisasta, glikoz, glikoz surubu, dogal zamklar, sukroz, sodyum aljinat, hidroksipropil metil selüloz, hidroksipropil selüloz, karboksi metil selüloz, metil selüloz gibi selüloz türevleri, Jelatin, karagenan, guar sakizi, karbomer, polimetakrilatlar, metakrilat polimerler, kollajenler, jelatin, agar gibi proteinler, aljinat, aljinik asit, ksantan zamki, hyaluronik asit, pektin, polisakkaritler, karbomer, poloksamer, poliakrilamid, alüminyum hidroksit, laponit, bentonit, polioksietilen-alkil eter, polidekstroz, polietilen oksit veya bunlarin karisimlarini içeren gruptan seçilir. Mevcut bulusun bir düzenlemesine göre, baglayici, metil selüloz veya polivinilpirolidon veya bunlarin karisimlaridir. Uygun dagiticilar, polivinil pirolidon (krospovidon), povidon, çapraz bagli karboksimetil selüloz (kroskarmeloz sodyum), düsük ikameli hidroksipropil selüloz, önceden jelatinize edilmis nisasta, sodyum karboksimetil selüloz, kalsiyum karboksimetil selüloz, karboksimetil selüloz, dokusat sodyum, guar zamki, düsük ikameli hidroksipropil selüloz, poliakrilin potasyum, sodyum aljinat, misir nisastasi, sodyum nisasta glikolat, alginik asit, alginatlar, iyon degisim reçineleri, magnezyum alüminyum silika, sodyum dodesil sülfat, poloksamer, sodyum glisin karbonat, sodyum Iauril sülfat veya karisimlarini içeren gruptan seçilir. Mevcut bulusun bir düzenlemesine göre, dagitici, kroskarmeloz sodyum veya önceden jelatinize edilmis nisasta veya sodyum nisasta glikolat veya bunlarin karisimlaridir. Uygun solventler veya yardimci solventler, su, propilen glikol, gliserin, etanol, polietilen glikol veya bunlarin karisimlarindan olusan gruptan seçilir. Uygun hiz kontrol polimerleri, etil akrilat, etil metakrilat kopolimer, etilselüloz, metilselüloz, hipromelloz ftalat, polidekstroz, polivinilasetat ftalat, zein, polivinilpirolidon, polivinil alkol, polivinil asetat, hidroksipropil selüloz, hidroksipropil metilselüloz, hidroksipropil metilselüloz E4M, hidroksipropil metilselüloz K1OOMCR, hidroksietil selüloz, hidroksimetil selüloz, jelatin, polietilen oksit, akasya, dekstrin, nisasta, polihidroksietilmetakrilat, sodyum karboksimetilselüloz, karboksimetil selüloz, sodyum aljinat, aljinik asit, pektin, poliglukoronik asit, poligalakturonik asit, kondroitik sülfat, karagenan, Iambda carregeenan, iota carregeenan, furcellaran, ksantan zamki, bir akrilik asit polimeri, karbopol, agar, guar zamki, psilyum tohum zamki, gellan zamki, keçiboynuzu zamki, tara zamki, demirhindi zamki, arap zamki, curdlan, galaktomannan, glukomannan, nitroselüloz, metilselüloz, proteoglikan, glikoprotein, aktin, tubulin, hemoglobin, insülin, fibrin, albümin, miyozin, kollajen, kazein, pullulan, kitosan, gliserol, propilen glikol, makrogoller, phfchalate esterler, dibütil sebasetat, sitrat esterler, triasetin, hint yagi, asetillenmis monogliseritler, fraksiyonlu hindistancevizi yagi, hidrojene bitkisel yag, hidrojene hint yagi, karnauba mumu, kandelya mumu, balmumu, parafin mumu, stearik asit, gliseril behenat, setil alkol, setostearil alkol veya bunlarin karisimlarini içeren gruptan seçilir. Uygun direkt baski maddeleri, kalsiyum hidrojen fosfat sodyum aljinat, önceden jelatinize edilmis nisasta, kalsiyum sitrat veya bunlarin karisimlarini içeren gruptan seçilir. Uygun sürfaktanlar, sodyum dokusat, gliseril monooleat, polietilen alkil eter, polioksietilen sorbitan yag asidi esteri, sodyum laurii sülfat, sorbik asit, sorbitan yag asidi esteri, nonoksinol, polioksietilen stearatlar, polietilen glikol, lösin, polaksomer 407, sodyum benzoat, dokusat sodyum, alfa tokoferol, askorbil palmitat, sitrik asit, polietoksile yag asidi esterleri, polioksietilen hidrojene hint yagi veya bunlarin karisimlarini içeren gruptan seçilir. Uygun lubrikantlar, magnezyum stearat, kalsiyum stearat, çinko stearat, talk, vakslar, borik asit, hidrojene bitkisel yag, sodyum klorat, magnezyum Iauril sülfat, sodyum oleat, sodyum asetat, sodyum benzoat, polietilen glikol, stearik asit, yag asidi, fumarik asit, gliseril palmito sülfat, sodyum stearil fumarat, sodyum Iauril sülfat veya bunlarin karisimlarini içeren gruptan seçilir. Mevcut bulusun bir düzenlemesine göre Iubrikant, magnezyum stearattir. Uygun glidantlar, kolloidal susuz silika, kolloidal silikon dioksit, misir nisastasi, talk veya bunlarin karisimlarini içeren gruptan seçilir. Mevcut bulusun bir baska düzenlemesine göre, glidant, kolloidal susuz silikadir. Uygun tatlandiricilar, aspartam, potasyum asesülfam, sodyum sakarinat, neohesperidin dihidrokalkon, sukraloz, sakarin, sakaroz, glikoz, laktoz, fruktoz gibi sekerler veya mannitol, sorbitol, ksilitol, eritritol gibi seker alkolleri veya bunlarin karisimlarindan olusan gruptan seçilir. Uygun stabilizatörler, sitrik asit, fumarik asit, tartarik asit, sodyum sitrat, sodyum benzoat, sodyum dihidroien fosfat, kalsiyum karbonat, magnezyum karbonat, arginin, Iisin, meglamin, askorbik asit, gallik asit esterleri veya bunlarin karisimlarindan ve tercihen sitrik asit, fumarik asit, arginin veya bunlarin karisimlarindan olusan gruptan seçilir. Uygun kaplama maddeleri, polimetakrilatlar, polialkilakrilatlar kopolimerleri, hidroksil propil metil selüloz, laktoz monohidrat, hidroksipropil selüloz, polivinil alkol, polietilen glikol, talk, polivinil alkol-polietilen glikol kopolimerleri (Kollicoat® IR), etilselüloz® dispersiyonlari (Surelease®), polivinilprolidon, polivinilprolidon-vinil asetat kopolimeri (PVP-VA), her türlü Opadry®, pigmentler, boyalar, titanyum dioksit, demir oksit veya bunlarin karisimlarindan olusan gruptan seçilir. Uygun renklendirme maddeleri, demir oksit, titanyum dioksit, Gida, Ilaç ve Kozmetik (FD&C) boyalari (örnegin, FD&C mavisi, FD&C yesili, FD&C kirmizisi, FD&C sarisi, FD&C Iakeleri), poncau, indigo Ilaç ve Kozmetik (D&C) mavisi, indigotin FD&C mavisi, karmoisin indigotin (indigo Karmin); demir oksitler (örnegin, demir oksit kirmizisi, sarisi, siyahi), kinolin sarisi, alevli kirmizi, karmin, karmoisin, gün batimi sarisi veya bunlarin karisimlarindan olusan gruptan seçilir. Iki molekül arasindaki uygun inert maddeler, nisasta, laktoz, seker alkolü benzeri D-manitol, eritritol; düsük ikameli hidroksipropil selüloz, hidroksipropil selüloz, hidroksipropil metilselüloz, polivinilpirrolidon, polivinil alkol, metilselüloz, hidroksietil metilselüloz veya bunlarin karisimlarindan seçilir. Mevcut bulusun bir düzenlemesine göre farmasötik kombinasyon, oral yoldan uygulanir. Farmasötik kombinasyon, tabletler, kapsüller, seritler (strips), suruplar, tozlar, pastiller, torbalar (sachets), efervesan kompozisyonlar, haplar, kaplanmis boncuk sistemleri (coated bead systems), granüller, mikro küreler, drajeler, filmler, oral uygulanabilirfilmler, solüsyonlar, katilar (solids), süspansiyonlar veya emülsiyonlar formundadir. Tercihen farmasötik kombinasyon, tabletler veya kapsüller formundadir. Mevcut bulusun baska bir düzenlemesine göre farmasötik kombinasyon, bir tablet formundadir. Farmasötik kombinasyon, film kapli tabletler, iki katmanli tabletler, iç içe tabletler (inlay tablets), agizda dagilan tabletler, basilmis tabletler, kaplanmis veya kaplanmamis tabletler, çok katmanli tabletler, mini tabletler, bukkal tabletler (buccal tablets), dil alti tabletler, efervesan tabletler, midede dagilan tabletler, çignenebilir tabletler, dispersiyon tabletleri veya Mevcut bulusun bir baska düzenlemesine göre farmasötik kombinasyon, film kaplamali tablet veya iki katmanli tablet olarak formüle edilir. Mevcut bulusun bir baska düzenlemesine göre farmasötik kombinasyon, bir kapsül formundadir. Mevcut bulusun bir düzenlemesine göre, degistirilmis salimli dozaj formu, kontrollü salim, sürekli salim, geciktirilmis salim, uzatilmis salim, tekrar etkili sistem veya bunlarin karisimlarini içeren gruptan seçilir. Bir düzenlemede, degistirilmis salimli dozaj formu, hiz kontrol polimerleri kullanilarak hazirlanir. Kombinasyon, direkt baski, yas veya kuru granülasyon, sicak eriyik granülasyon, sicak eriyik ekstrüzyon, akiskan yatakli granülasyon, ekstrüzyon/sferonizasyon, briket tablet basma (slugging), püskürterek kurutma (Spray drying) veya solvent evaporasyon yöntemi kullanilarak hazirlanir. Bu mevcut bulusta, kombinasyonun istenen bir çözünmesi elde edilmekte ve istenen bir içerik tekdüzeligi ve basit bir hazirlama prosesi endüstriyel üretim lehine olmaktadir. Bu bulusta kombinasyon, istenmeyen sizofreni semptomlarinin tedavisinde kullanim içindir ve insandaki sizofreni semptomlarinin altinda yattigi varsayilan proinflamatuar durumu tersine. TR TR TR
Claims (1)
1.STEMLER Ibuprofen ve en az bir atipik antipsikotik ajan içeren bir farmasötik kombinasyondur. Istem 1'e göre farmasötik kombinasyon olup, özelligi antipsikotik ajanlarin, Aripiprazol, Asenapin, Brekspiprazol, Kariprazin, Klozapin, Iloperidon, Lurasidon, Olanzapin, Paliperidon, Ketiapin, Risperidon, Ziprasidon veya bunlarin kombinasyonlarini içeren atipik antipsikotikler grubundan seçilmesidir. Istem 1'e göre farmasötik kombinasyon olup, özelligi atipik antipsikotik ajanin Lurasidon olmasidir. istem 3'e göre farmasötik kombinasyon olup. özelligi Ibuprofenin 200 mg ile 800 mg arasinda bir miktarda mevcut olmasi ve Lurasidonun 20 mg ile 120 mg arasinda bir miktarda mevcut olmasidir. istem 3'e göre farmasötik kombinasyon olup, özelligi Lurasidonun Ibuprofene agirlik Önceki istemlerden herhangi birine göre farmasötik kombinasyon olup, özelligi ayrica dolgu maddeleri, baglayicilar, dagiticilar, solventler ve yardimci solventler, hiz kontrol polimerleri, direkt baski maddeleri, sürfaktanlar, Iubrikantlar, glidantlar, tatlandiricilar, stabilizatörler, kaplama maddeleri, renklendirme maddeleri, inert maddeler veya bunlarin karisimlarindan seçilen, farmasötik olarak kabul edilebilir en az bir eksipiyan içermesidir. Önceki istemlerden herhangi birine göre farmasötik kombinasyon olup, özelligi kombinasyonun agizdan uygulanmasidir. istem 7'ye göre farmasötik kombinasyon olup, özelligi farmasötik kombinasyonun tabletler, kapsüller. seritler (strips), suruplar. tozlar. pastiller, torbalar (sachets), efervesan kompozisyonlar, haplar, kaplanmis boncuk sistemleri (coated bead systems). granüller, mikro küreler, drajeler, filmler, oral uygulanabilir filmler, solüsyonlar, katilar (solids), süspansiyonlar veya emülsiyonlar formunda olmasidir. istem 8'e göre farmasötik kombinasyon olup, özelligi farmasötik kombinasyonun bir tablet formunda olmasidir. istem 9'a göre farmasötik kombinasyon olup, özelligi farmasötik kombinasyonun film kapli tabletler, iki katmanli tabletler, iç içe tabletler (inlay tablets), agizda dagilan tabletler, basilmis tabletleri kaplanmis veya kaplanmamis tabletler, çok katmanli tabletler, mini tabletler, bukkal tabletler (buccal tablets), dil alti tabletler, efervesan tabletler, midede dagilan tabletler, çignenebilir tabletler, dispersiyon tabletleri veya Iozengeler içeren tabletler olarak formüle edilmesidir. .Istem T'e göre farmasötik kombinasyon olup, özelligi farmasötik kombinasyonun bir kapsül formunda olmasidir. Önceki istemlerden herhangi birine göre farmasötik kombinasyonu hazirlamak için bir yöntem olup, özelligi direkt baski, yas veya kuru granülasyon, sicak eriyik granülasyon, sicak eriyik ekstrüzyon, akiskan yatakli granülasyon. ekstrüzyon/sferonizasyon, briket tablet basma (slugging), püskürterek kurutma (Spray drying) veya solvent evaporasyon tekniklerini içermesidir. Önceki istemlerden herhangi birine göre farmasötik kombinasyon olup, özelligi istenmeyen sizofreni semptomlarinin tedavisinde kullanilmaya yönelik olmasi ve insandaki sizofreni semptomlarinin altinda yattigi varsayilan proinflamatuar durumu tersine çevirmesidir. TR TR TR
Publications (1)
Publication Number | Publication Date |
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TR2021021540A2 true TR2021021540A2 (tr) | 2023-07-21 |
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