Maonero Azvino eOral Thin Films

Mazhinji kugadzirira kwemishonga anoshandiswa muhwendefa, granule, hupfu, uye fomu yemvura.Kazhinji, dhizaini yepiritsi iri muchimiro chinoratidzwa kuvarwere kuti vamedze kana kutsenga chaiyo dose yemishonga.Zvisinei, kunyanya varwere vezera uye vana vane dambudziko rekutsenga kana kumedza mafomu ekuyereswa kwakasimba.4 Nokudaro, vana vakawanda uye vanhu vakwegura vanozeza kutora mafomu aya ekudzivirira akasimba nekuda kwekutya kufema.Mapiritsi ekunyungudutsa nemuromo (ODTs) abuda kuti asangane nechido ichi.Nekudaro, kune vamwe varwere vevarwere, kutya kumedza iyo yakasimba dosage fomu (tablet, capsule), uye njodzi yeasphyxiation inoramba iripo kunyangwe nguva pfupi yekuparara / kuparara.Oral mutete firimu (OTF) zvinodhaka zvekuendesa zvinodhaka ndeimwe inosarudzika pasi pemamiriro aya.Iyo yemuromo bioavailability yemishonga yakawanda haina kukwana nekuda kwema enzymes, yakajairika yekutanga-pass metabolism, uye pH yemudumbu.Mishonga yakadaro yakajairika yakapihwa vabereki uye yakaratidza kuderera kwemurwere.Mamiriro ezvinhu akaita seaya akavhura nzira yekuti indasitiri yemishonga igadzirise mamwe masisitimu ekufambisa kwemishonga kuburikidza nekugadzira mafirimu matete anorasika / anonyungudika mumuromo.Kutya kunyura, iyo inogona kunge iri njodzi neODTs, yakabatanidzwa nemapoka evarwere aya.Kukurumidza kuparara/kupatsanurwa kweOTF dhizaini masisitimu ndiyo inosarudzika imwe kune maODTs muvarwere vane kutya kufefetera.Kana dzaiswa parurimi, maOTF anobva atota nemate.Nekuda kweizvozvo, ivo vanoparadzirwa uye / kana kunyungudika kuti vasunungure mushonga we systemic uye / kana kutorwa kwenzvimbo.

 

Oral distegrating/dissolving films or strips zvinogona kutsanangurwa sezvizvi: “Aya ndiwo masisitimu ekuendesa zvinodhaka ayo ari kukurumidza kuburitsa mushonga nekunyungudutsa kana kunamatira mucosa nemate mukati memasekonzi mashoma nekuda kwekuti ine mapolymer anonyungudika nemvura kana akaiswa. mumukanwa kana parurimi”.Iyo sublingual mucosa ine yakakwirira membrane permeability nekuda kweiyo yakaonda membrane chimiro uye yakakwira vascularization.Nekuda kwekukurumidza kupihwa kweropa uku, inopa yakanaka kwazvo bioavailability.Yakavandudzwa systemic bioavailability imhaka yekusvetuka yekutanga-pass mhedzisiro uye zvirinani kupenya kunokonzerwa nekuwanda kweropa uye kutenderera kwelymphatic.Mukuwedzera, iyo oral mucosa inzira inoshanda zvikuru uye yakasarudzwa yegadziriro yemishonga yekuendesa zvinodhaka nekuda kwenzvimbo yakakura uye nyore nyore kushandiswa kwekutora.6 Kazhinji, OTFs inoratidzirwa sechidimbu uye chinoshanduka chepolymer layer, ine kana isina mapurasitiki mukati. zviri mukati mavo.Vanogona kunzi havanyanyi kunetseka uye vanogamuchirwa nevarwere, sezvo ivo vakaonda uye vanochinja-chinja muchimiro chavo chechisikigo.Mafirimu matete mapolymeric masisitimu anopa zvakawanda zvezvinodiwa zvinotarisirwa kudhizaini system.Muzvidzidzo, mafirimu matete akaratidza kugona kwavo sekuvandudza maitiro ekutanga emushonga uye nguva yechiitiko ichi, kuderedza kuwanda kwedosing, uye kuwedzera kushanda kwemushonga.Ne tekinoroji-yefirimu tekinoroji, zvinogona kubatsira kubvisa mhedzisiro yezvinodhaka uye kuderedza zvakajairika metabolism inotengwa neproteolytic enzymes.Mafirimu akaonda matete anofanirwa kuve neanodikanwa ehurongwa hwekuunza zvinodhaka, senge yakakodzera kutakura zvinodhaka, kukurumidza kupararira / kuparara, kana kushanda kwenguva refu uye kugadzikana kwekugadzirisa.Zvakare, ivo vanofanirwa kunge vasina chepfu, biodegradable uye biocompatible.

 

Maererano neAmerican Food and Drug Administration (FDA), OTF inotsanangurwa se "kusanganisira imwe kana kupfuura inoshanda mishonga yemishonga (APIs), inochinjika uye isina-brittle strip inoiswa parurimi isati yapinda mudumbu remudumbu, ichivavarira kukurumidza kupera kana kuparara mumate”.Yokutanga yakanyorwa OTF yaiva Zuplenz (Ondansetron HCl, 4-8 mg) uye yakagamuchirwa muna 2010. Suboxon (buprenorphine uye naloxan) yakakurumidza kutevera sechipiri yakagamuchirwa.Nhamba dzinoratidza kuti varwere vana kubva kune vashanu vanosarudza nemuromo kunyunguduka / kuparara kweyero mafomu pamusoro pechinyakare muromo yakasimba dosage mafomu.7 Parizvino, mune akawanda emishonga uye epamusoro-the-counter zvigadzirwa mapoka, kunyanya mukukosora, kutonhora, kurwadziwa kwehuro, erectile dysfunction disorders. , allergic reactions, asthma, gastrointestinal disorders, kurwadziwa, kunyunyuta, zvinetso zvekurara, uye kusanganiswa kwevhitamini yakawanda, nezvimwewo OTFs iripo uye inoramba ichiwedzera.13 Mafirimu emuromo anokurumidza kupera ane zvakawanda zvakanakira pane mamwe maitiro akasimba ekuyerwa, zvakadai sekushanduka uye. kuwedzera kushanda kweiyo API.Zvakare, mafirimu emumuromo ane kuparara uye kupatsanurwa nemvura shoma yemate isingasviki miniti imwe kana ichienzaniswa neODTs.1

 

OTF inofanirwa kunge iine zvinotevera zvakanaka maficha

-Inofanira kuravira zvakanaka

-Mishonga inofanira kuva yakanyanya kunyorova uye inonyungudika mumate

-Inofanira kunge iine tension resistance

-Inofanira kuve ionized mumuromo mhango pH

-Inofanira kukwanisa kupinda mukati memukanwa mucosa

-Inofanira kunge ichikwanisa kukurumidza kuita

 

Mabhenefiti eOTF pane mamwe mafomu ekuyedza

-Inoshanda

-Haadi kushandiswa kwemvura

-Inogona kushandiswa zvakachengeteka kunyangwe kuwana mvura kusingaite (senge kufamba)

-Hapana njodzi yekudzipwa

-Kuvandudza kugadzikana

-Easy kushandisa

-Kushandisa nyore kune varwere vepfungwa uye vasingaenderani

-Pane zvishoma kana kusasara mumuromo mushure mekushandisa

-Bypasses gastrointestinal turakiti uye nokudaro kuwedzera bioavailability

-Low dosage uye yakaderera mhedzisiro

-Inopa yakanyanya kurongeka dosage kana ichienzaniswa nemvura dosage mafomu

-Hapana chikonzero chekuyera, icho chakakosha chinokanganisa mune yemvura dosage mafomu

-Kusiya kunzwa kwakanaka mumuromo

-Inopa kukurumidza kutanga kwemhedzisiro mumamiriro ezvinhu anoda kupindira nekukurumidza, semuenzaniso, allergic kurwisa senge asthma uye intraoral zvirwere.

-Inovandudza kutorwa kwehuwandu uye huwandu hwemishonga

-Inopa yakawedzera bioavailability yemishonga isinganyungudike mvura, kunyanya kuburikidza nekupa nzvimbo yakakura yepasi ichikurumidza kunyungudika.

-Hazvidziviriri zvakajairika mabasa akadai sekutaura uye kunwa

-Inopa kutungamirirwa kwemishonga ine ngozi yakawanda yekuvhiringidza mudumbu remudumbu

-Ine musika uri kuwedzera uye zvigadzirwa zvakasiyana

-Inogona kuvandudzwa uye kuiswa pamusika mukati memwedzi ye12-16

 

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Nguva yekutumira: Zvita-01-2021