Amalungiselelo amaningi emithi asetshenziswa kuthebhulethi, i-granule, i-powder, nefomu le-liquid.Ngokuvamile, idizayini yethebhulethi isesimweni esinikezwa iziguli ukuze zigwinye noma zihlafune umthamo oqondile womuthi.Kodwa-ke, ikakhulukazi iziguli ezikhulile nezezingane zinenkinga yokuhlafuna noma ukugwinya amafomu emithamo eqinile.4 Ngakho-ke, izingane eziningi nabantu asebekhulile bayanqikaza ukuthatha lawa mafomu omthamo oqinile ngenxa yokwesaba ukuhogela umoya.Amaphilisi achithwa ngomlomo (ama-ODT) avele ukuze ahlangabezane nalesi sidingo.Kodwa-ke, kwezinye iziguli ezinesiguli, ukwesaba ukugwinya ifomu lesilinganiso esiqinile (ithebhulethi, i-capsule), kanye nengozi yokuphefumula i-asphyxiation naphezu kwezikhathi ezifushane zokuhlakazeka / ukuhlukana.Izinhlelo zokulethwa kwezidakamizwa ze-Oral thin film (OTF) ziyindlela ekhethwayo ngaphansi kwalezi zimo.I-bioavailability yomlomo yezidakamizwa eziningi ayanele ngenxa yama-enzyme, i-metabolism evamile ye-first pass metabolism, ne-pH yesisu.Imithi enjalo evamile iye yanikezwa abazali futhi ibonise ukuthobela kwesiguli okuphansi.Izimo ezinjengalezi zivule indlela yokuthi imboni yemithi ithuthukise ezinye izinhlelo zokuthutha izidakamizwa ngokwenza amafilimu amancane ahlakazekayo/ancibilikayo emlonyeni.Ukwesaba ukuminza, okungase kube yingozi kuma-ODT, kuye kwahlotshaniswa nalamaqembu eziguli.Ukuqedwa ngokushesha/ukuhlakazeka kwezinhlelo zokulethwa kwezidakamizwa ze-OTF kungenye indlela ekhethwayo kune-ODT ezigulini ezinokwesaba ukuphelelwa umoya.Uma ebekwe olimini, ama-OTF asheshe afakwe amathe.Njengomphumela, ziyahlakazwa futhi/noma zihlakazwe ukuze kukhululwe umuthi ukuze umunce wesistimu kanye/noma wendawo.
Amafilimu noma amapheshana ahlakazeka ngomlomo/ahlakazekayo angachazwa kanje: “Lawa amasistimu okulethwa kwezidakamizwa asheshe adedele isidakamizwa ngokuncibilikisa noma ukunamathela kulwelwesi lwamathe ngemizuzwana embalwa ngenxa yokuthi luqukethe ama-polymers ancibilika emanzini lapho ebekwa. emlonyeni noma olimini”.I-sublingual mucosa ine-membrane ephezulu yokungena ngenxa yesakhiwo sayo esincane se-membrane kanye ne-vascularization ephezulu.Ngenxa yalokhu kunikezwa kwegazi okusheshayo, kunikeza i-bioavailability enhle kakhulu.I-systemic bioavailability ethuthukisiwe ngenxa yokweqa umphumela wokudlula kokuqala kanye nokungeneka okungcono kungenxa yokugeleza kwegazi okuphezulu nokujikeleza kwe-lymphatic.Ukwengeza, i-oral mucosa iyindlela ephumelela kakhulu futhi ekhethiwe yokulethwa kwezidakamizwa zesistimu ngenxa yendawo enkulu kanye nokusebenziseka kalula kokumuncwa.6 Ngokuvamile, ama-OTF abonakala njengongqimba oluncane lwe-polymer oluthambile futhi oluguquguqukayo, olunama-plasticizers noma ngaphandle kwawo. okuqukethwe kwabo.Zingashiwo ukuthi aziphazamiseki futhi zamukeleka kakhulu ezigulini, njengoba zincane futhi ziguquguqukayo ekwakhiweni kwazo kwemvelo.Amafilimu azacile ayizinhlelo ze-polymeric ezihlinzeka ngezidingo eziningi ezilindelwe ohlelweni lokulethwa kwezidakamizwa.Ocwaningweni, amafilimu amancanyana abonise amakhono awo njengokuthuthukisa umphumela wokuqala womuthi kanye nobude besikhathi salo mphumela, ukwehlisa imvamisa yokudosa, nokwandisa ukusebenza kahle komuthi.Ngobuchwepheshe befilimu encane, kungaba yinzuzo ukuqeda imiphumela emibi yezidakamizwa nokunciphisa umzimba ovamile otholakala ngama-proteolytic enzymes.Amafilimu afanele azacile kufanele abe nezinto ezifiselekayo zesistimu yokulethwa kwezidakamizwa, njengomthamo ofanele wokulayisha izidakamizwa, ukuhlakazeka okusheshayo/ukuhlakazeka, noma ukusetshenziswa isikhathi eside kanye nokuzinza kokwakheka okunengqondo.Futhi, kufanele zingabi nabuthi, zingaboli futhi zihambisane ne-biocompatible.
Ngokusho kwe-American Food and Drug Administration (FDA), i-OTF ichazwa ngokuthi “kuhlanganise nesithako semithi esisodwa noma eziningi ezisebenzayo (APIs), umugqa oguquguqukayo nongashwabanisi ofakwa olimini ngaphambi kokudlulela emgudwini wamathumbu, okuhloswe ngawo ukuhlakazeka ngokushesha noma ukuhlakazeka ematheni”.I-OTF yokuqala ebekiwe kwakuyi-Zuplenz (Ondansetron HCl, 4-8 mg) futhi yavunywa ngo-2010. I-Suboxon (buprenorphine ne-naloxan) ilandele ngokushesha njengoba eyesibili ivunyiwe.Izibalo zibonisa ukuthi iziguli ezine kweziyisihlanu zikhetha amafomu omthamo wokuhlakazwa/ukuhlakazeka ngomlomo ngaphezu kwamafomu wesilinganiso esiqinile somlomo womlomo.7 Njengamanje, emaqenjini amaningi emikhiqizo kadokotela kanye nalawo athengwayo, ikakhulukazi ekukhwehleleni, emakhazeni, emphinjeni, ekuphazamisekeni kwe-erectile dysfunction. , ukungezwani komzimba, isifuba somoya, ukuphazamiseka kwesisu, ubuhlungu, izikhalazo zokuhona, izinkinga zokulala, nezinhlanganisela zamavithamini amaningi, njll. Ama-OTF ayatholakala futhi ayaqhubeka anda.13 Amafilimu omlomo ancibilika ngokushesha anezinzuzo eziningi kunezinye izinhlobo zemithamo eqinile, njengokuvumelana nezimo kanye ukwanda kokusebenza kwe-API.Futhi, amafilimu omlomo anokuhlakazeka nokuhlakazeka ngoketshezi lwamathe oluncane kakhulu ngaphansi komzuzu owodwa uma kuqhathaniswa nama-ODTs.1
I-OTF kufanele ibe nezici ezinhle ezilandelayo
-Kufanele kunambitheke kahle
-Izidakamizwa kufanele zikwazi ukumelana nomswakama futhi zincibilike ematheni
-Kufanele kube nokumelana nokushuba okufanele
- Kufanele i-ionized ku-pH yomlomo womlomo
-Kufanele ikwazi ukungena ku-mucosa yomlomo
-Kufanele ikwazi ukuba nomphumela osheshayo
Izinzuzo ze-OTF ngaphezu kwamanye amafomu omthamo
-Ongokoqobo
-Ayidingi ukusetshenziswa kwamanzi
-Ingasetshenziswa ngokuphepha ngisho nalapho kungenzeki ukufinyelela emanzini (njengokuhamba)
-Ayikho ingozi yokuphefumula
-Ukuzinza okuthuthukisiwe
-Kulula ukufaka isicelo
Isicelo -Easy ezigulini ezingokwengqondo nezingahambisani
-Kunensalela encane noma engekho emlonyeni ngemva kokufaka isicelo
-Idlula umgudu wamathumbu futhi ngaleyo ndlela ikhulise i-bioavailability
-Umthamo ophansi kanye nemiphumela emibi ephansi
-Inikeza umthamo onembe kakhulu uma uqhathaniswa namafomu omthamo owuketshezi
-Asikho isidingo sokulinganisa, okuyisici esibalulekile kumafomu omthamo we-liquid
-Ishiya umuzwa omuhle emlonyeni
-Inikeza imiphumela esheshayo ezimweni ezidinga ukungenelela okuphuthumayo, isibonelo, ukuhlaselwa kwe-allergic njenge-asthma nezifo ze-intraoral
-Ithuthukisa izinga lokumuncwa kanye nenani lezidakamizwa
-Inikeza i-bioavailability ethuthukisiwe yezidakamizwa ezincane ezincibilika emanzini, ikakhulukazi ngokunikeza indawo enkulu ngenkathi incibilika ngokushesha.
-Ayivimbeli imisebenzi evamile njengokukhuluma nokuphuza
-Inikeza ukuphathwa kwezidakamizwa ngengozi enkulu yokuphazamiseka emgudwini wamathumbu
- Inemakethe ekhulayo kanye nezinhlobonhlobo zemikhiqizo
-Ingathuthukiswa futhi ibekwe emakethe phakathi nezinyanga eziyi-12-16
Lesi sihloko sivela ku-inthanethi, sicela uxhumane nokwephulwa komthetho!
©I-copyright2021 Turk J Pharm Sci, Ishicilelwe yi-Galenos Publishing House.
Isikhathi sokuthumela: Dec-01-2021