Isishwankathelo sangoku seefilimu eziOral Thin

Amalungiselelo amaninzi amayeza asetyenziswa kwithebhulethi, igranule, umgubo, kunye nefom yolwelo.Ngokubanzi, uyilo lwethebhulethi ikwimo enikezelwe kwizigulana ukuba ziginye okanye zihlafune umthamo ochanekileyo wamayeza.Nangona kunjalo, ngakumbi izigulane zabantwana kunye nezigulana zinobunzima bokuhlafuna okanye ukuginya iifom zedosi eqinile.4 Ngoko ke, abantwana abaninzi kunye nabantu abadala bayathandabuza ukuthatha ezi fom zedosi eziqinileyo ngenxa yokoyika ukuphefumla.Iipilisi ezichithwa ngomlomo (ODTs) ziye zavela ukuhlangabezana nale mfuno.Nangona kunjalo, kwezinye izigulane ezigulayo, uloyiko lokuginya ifom yedosi eqinileyo (ithebhulethi, i-capsule), kunye nomngcipheko we-asphyxiation uhlala nangona ixesha elifutshane lokuchithwa / ukuchithwa.Iinkqubo zokuhanjiswa kweziyobisi ngomlomo (OTF) yeyona ndlela ikhethwayo phantsi kwezi meko.I-bioavailability yomlomo yamachiza amaninzi ayanelanga ngenxa ye-enzymes, i-metabolism eqhelekileyo yokuqala, kunye ne-pH yesisu.Amachiza anjalo aqhelekileyo aye alawulwa ngumzali kwaye abonise ukuthotyelwa kwesigulane esisezantsi.Iimeko ezifana nezi zivule indlela yokuba ishishini loxubo-mayeza liphuhlise iindlela ezizezinye zothutho lwamachiza ngokuphuhlisa iifilimu ezicekethekileyo ezihlakazekayo/ezinyibilikayo emlonyeni.Uloyiko lokurhaxwa, olunokuba yingozi kwi-ODTs, ludibene nala maqela ezigulane.Ukupheliswa okukhawulezayo/ukuqhekeka kweenkqubo ze-OTF zokuhanjiswa kwechiza yeyona ndlela ikhethwayo kune-ODTs kwizigulana ezinoloyiko lokuphefumla.Xa zibekwe ngolwimi, ii-OTF zimanziswa ngoko nangoko ngamathe.Ngenxa yoko, ziyahlakazwa kwaye/okanye zinyibilike ukuze kukhululwe iyeza lenkqubo yenkqubo kunye/okanye yokufunxwa kwendawo.

 

Ukuqhekeka komlomo / ukuchithwa kwefilimu okanye imicu ingachazwa ngolu hlobo lulandelayo: "Ezi ziinkqubo zokuhanjiswa kweziyobisi ezithi zikhulule ngokukhawuleza ichiza ngokunyibilika okanye ukunamathela kwi-mucosa ngamathe kwimizuzwana embalwa ngenxa yokuba iqulethe iipolymers ezinyibilikayo emanzini xa zibekwe. emlonyeni okanye elulwimini”.I-mucosa ye-sublingual ine-membrane ephezulu yokugqithisa ngenxa yesakhiwo sayo esincinci se-membrane kunye ne-vascularization ephezulu.Ngenxa yolu nikezelo lwegazi olukhawulezayo, lubonelela nge-bioavailability entle kakhulu.I-bioavailability yenkqubo eyomeleziweyo ngenxa yokutsiba isiphumo sokupasa kokuqala kunye nokungeneka okungcono kungenxa yokuhamba kwegazi okuphezulu kunye nokujikeleza kwe-lymphatic.Ukongezelela, i-oral mucosa yindlela esebenzayo kakhulu kwaye ekhethiweyo yokuhanjiswa kweziyobisi ngokwenkqubo ngenxa yendawo enkulu kunye nokulula kwesicelo sokufunxa.6 Ngokubanzi, ii-OTF zibonakaliswe njengoluhlu oluncinci kunye ne-flexible polymer layer, kunye okanye ngaphandle kweplastiki umxholo wabo.Zinokuthi ziphazamiseke kwaye zamkeleke ngakumbi kwizigulane, njengoko zincinci kwaye ziguquguqukayo kwisakhiwo sabo sendalo.Iifilimu ezincinci ziinkqubo zepolymeric ezibonelela ngeemfuno ezininzi ezilindelekileyo kwinkqubo yokuhanjiswa kweziyobisi.Kuphononongo, iifilimu ezicekethekileyo zibonise izakhono zazo ezinjengokuphucula isiphumo sokuqala sechiza kunye nobude besi siphumo, ukunciphisa ukuphindaphindwa kwedosi, kunye nokwandisa ukusebenza kwechiza.Ngobuchwepheshe befilimu encinci, kunokuba luncedo ukuphelisa imiphumo emibi yeziyobisi kunye nokunciphisa imetabolism eqhelekileyo efunyenwe yi-proteolytic enzymes.Iifilim ezinqwenelekayo ezicekethekileyo kufuneka zibe neempawu ezinqwenelekayo zenkqubo yokuhanjiswa kwechiza, njengomthamo ofanelekileyo wokulayisha ichiza, ukusasazwa okukhawulezayo/ukutshatyalaliswa, okanye ukusetyenziswa ixesha elide kunye nozinzo olufanelekileyo lokuqulunqa.Kwakhona, kufuneka zingabi natyhefu, zikwazi ukubola kwaye zihambelane ne-biocompatible.

 

Ngokutsho kwe-American Food and Drug Administration (FDA), i-OTF ichazwa ngokuthi "kubandakanya enye okanye ngaphezulu kwezithako ezisebenzayo zamachiza (APIs), umcu oguquguqukayo kunye nongekho brittle obekwe elulwimini ngaphambi kokuba udlulele kwi-gastrointestinal tract. ukonakala ngokukhawuleza okanye ukuqhekeka ematheni”.I-OTF yokuqala emiselweyo yi-Zuplenz (i-Ondansetron HCl, 4-8 mg) kwaye yamkelwa kwi-2010. I-Suboxon (i-buprenorphine kunye ne-naloxan) ilandele ngokukhawuleza njengesibini esivunyiweyo.Amanani abonisa ukuba izigulane ezine kwezihlanu zikhetha ukuchithwa ngomlomo / ukuchithwa kweefom zedosi ngaphezu kweefom zedosi eqinile yomlomo. , i-allergic reactions, i-asthma, ukuphazamiseka kwesisu, intlungu, izikhalazo zokurhona, iingxaki zokulala, kunye nokudibanisa i-multivitamin, njl njl. Ii-OTF ziyafumaneka kwaye ziyaqhubeka zikhula.13 Iifilimu zomlomo ezichithwa ngokukhawuleza zineenzuzo ezininzi ngaphezu kwezinye iifom zedosi eqinile, ezifana nokuguquguquka kunye ukwanda kokusebenza kwe-API.Kwakhona, iifilimu zomlomo zinokuchithwa kunye nokuchithwa kunye nolwelo oluncinci lwamathe ngaphantsi komzuzu omnye xa kuthelekiswa ne-ODTs.1

 

I-OTF kufuneka ibenezi mpawu zilandelayo ezifanelekileyo

-Kufuneka incasa kamnandi

-Iziyobisi kufuneka zixhathise ukufuma kwaye zinyibilike ematheni

-Kufuneka ibe noxhathiso olufanelekileyo

-Kufuneka i-ionized kwi-pH yomlomo womlomo

-Kufuneka ikwazi ukungena kwi-mucosa yomlomo

-Kufuneka ikwazi ukuba nefuthe elikhawulezayo

 

Izibonelelo ze-OTF kunezinye iifom zedosi

-Esebenzayo

-Ayifuni ukusetyenziswa kwamanzi

-Inokusetyenziswa ngokukhuselekileyo naxa ukufikelela emanzini kungenzeki (njengokuhamba)

-Akukho mngcipheko wokufunxana

-Uzinzo oluphuculweyo

-Kulula ukuyifaka

-Isicelo esilula kwizigulana zengqondo nezingahambelaniyo

-Kuncinci okanye akukho ntsalela emlonyeni emva kwesicelo

-Idlula indlela yesisu kwaye ngaloo ndlela yandisa i-bioavailability

-Idosi ephantsi kunye neziphumo ebezingalindelekanga eziphantsi

-Ibonelela ngedosi echanekileyo ngakumbi xa kuthelekiswa neefom zedosi yolwelo

-Akukho mfuneko yokulinganisa, eyona nto ibalulekileyo kwiifom zedosi ye-liquid

-Ishiya imvakalelo elungileyo emlonyeni

-Ukubonelela ngokukhawuleza kweempembelelo kwiimeko ezifuna ukungenelela ngokukhawuleza, umzekelo, ukuhlaselwa kwe-allergies njenge-asthma kunye nezifo ze-intraoral.

-Ukuphucula izinga lokufunxa kunye nomthamo wamachiza

-Ibonelela nge-bioavailability eyandisiweyo yamachiza amancinci anyibilikayo emanzini, ngakumbi ngokunika indawo enkulu ngelixa inyibilika ngokukhawuleza.

-Ayikuthinteli imisebenzi eqhelekileyo njengokuthetha nokusela

-Inikezela ngolawulo lweziyobisi ezinomngcipheko omkhulu wokuphazamiseka kwindlela yesisu

-Unentengiso eyandisiweyo kunye nemveliso eyahlukeneyo

-Inokuphuhliswa kwaye ibekwe kwimarike kwiinyanga ezili-12-16

 

Eli nqaku livela kwi-Intanethi, nceda uqhagamshelane nolwaphulo-mthetho!

©Ilungelo lokushicilela2021 Turk J Pharm Sci, Ipapashwe nguGalenos Publishing House.


Ixesha lokuposa: Dec-01-2021