Qhov ncauj dissolving films
Oral dissolving films (ODF) yog ib daim ntawv tshiab ntawm qhov ncauj tawm tam sim ntawd uas tau siv ntau dua nyob rau txawv teb chaws nyob rau xyoo tas los no. Nws tshwm sim thaum xyoo 1970s. Tom qab kev txhim kho, nws tau maj mam hloov zuj zus los ntawm cov khoom siv kho mob yooj yim portal. Txoj kev loj hlob tau nthuav dav mus rau thaj chaw ntawm cov khoom kho mob, cov khoom siv kho mob tus kheej thiab tshuaj, thiab tau nyiam cov kev txaus siab thiab kev saib xyuas zoo vim nws qhov zoo uas lwm hom tshuaj tsis muaj. Nws tau dhau los ua ib qho tseem ceeb ntawm kev siv tshuaj ntau ntxiv rau daim nyias nyias, tshwj xeeb tshaj yog haum rau kev nqos cov neeg mob nyuaj thiab cov tshuaj uas muaj kev cuam tshuam loj dua thawj zaug.
Vim qhov tshwj xeeb npaum li cas daim ntawv kom zoo dua ntawm qhov ncauj dissolving films, nws muaj zoo daim ntawv thov kev cia siab. Raws li daim ntawv noj tshuaj tshiab uas tuaj yeem hloov cov ntsiav tshuaj hauv qhov ncauj, ntau lub tuam txhab loj muaj kev txaus siab rau qhov no, kom txuas ntxiv lub sijhawm patent ntawm qee yam tshuaj los ntawm kev hloov pauv ntau npaum li cas yog lub ntsiab lus tshawb fawb kub tam sim no.
Nta thiab qhov zoo ntawm qhov ncauj dissolving films
Tsis tas yuav haus dej, yooj yim siv. Feem ntau, cov khoom yog tsim los ua qhov loj ntawm lub thwj, uas tuaj yeem yaj sai sai ntawm tus nplaig thiab nqos nrog kev nqos ib txwm; kev tswj hwm sai thiab pib ua haujlwm sai; piv nrog rau txoj kev ntawm qhov ntswg mucosal, txoj kev ntawm qhov ncauj mucosal yog tsawg dua yuav ua rau mucosal puas tsuaj, thiab nws kho muaj zog muaj nuj nqi; kab noj hniav mucosal kev tswj hwm tuaj yeem kho hauv zos raws li cov ntaub so ntswg permeability kom yooj yim tshem tawm thaum muaj xwm ceev; cov tshuaj yog sib npaug ntawm cov khoom siv ua yeeb yaj kiab, cov ntsiab lus yog qhov tseeb, thiab kev ruaj ntseg thiab lub zog zoo. Nws yog tshwj xeeb tshaj yog haum rau cov me nyuam cov kev npaj uas tam sim no nyob rau hauv luv luv nyob rau hauv Tuam Tshoj. Nws tuaj yeem yooj yim daws cov teeb meem tshuaj ntawm cov menyuam yaus thiab cov neeg mob thiab txhim kho kev ua raws li cov menyuam yaus thiab cov neeg laus. Yog li ntawd, ntau lub tuam txhab tshuaj muab lawv cov tshuaj uas twb muaj lawm npaj, tshuaj ntsiav, ntsiav tshuaj thiab lub qhov ncauj kab noj hniav Cov tshuaj disintegrating ntsiav tshuaj yog hloov dua siab tshiab rau hauv lub qhov ncauj ceev-dissolving zaj duab xis mus cuag cov khoom lub neej voj voog.
Disadvantages ntawm qhov ncauj dissolving films
Lub qhov ncauj kab noj hniav tuaj yeem nqus mucosa nrog qhov chaw txwv. Feem ntau, lub qhov ncauj daim nyias nyias yog me me nyob rau hauv ntim thiab cov tshuaj loading tsis loj (feem ntau yog 30-60mg). Tsuas yog qee cov tshuaj nquag tuaj yeem raug xaiv; cov tshuaj tseem ceeb yuav tsum tau saj-masked, thiab saj stimulus ntawm cov tshuaj cuam tshuam rau txoj kev ua raws li txoj cai; involuntary qaub qaub secretion thiab nqos cuam tshuam rau txoj kev ua tau zoo ntawm qhov ncauj mucosa; tsis yog txhua yam khoom tuaj yeem dhau los ntawm qhov ncauj mucosa, thiab lawv qhov nqus tau cuam tshuam los ntawm cov roj solubility; dissociation degree, qhov hnyav molecular, thiab lwm yam; yuav tsum tau siv nyob rau hauv tej yam kev mob Absorption accelerator; Thaum lub sij hawm ua zaj duab xis txheej txheem, cov khoom yog rhuab los yog cov kuab tshuaj evaporates, nws yog ib qho yooj yim mus ua npuas ncauj, thiab nws yog ib qho yooj yim mus poob tawm thaum lub sij hawm txiav, thiab nws yog ib qho yooj yim rau tawg thaum lub sij hawm txiav; zaj duab xis yog nyias, lub teeb, me me, thiab yooj yim nqus dej noo. Yog li ntawd, cov kev xav tau ntawm kev ntim khoom yog qhov siab, uas yuav tsum tsis tsuas yog yooj yim siv, tab sis kuj ua kom cov tshuaj zoo.
Qhov ncauj dissolving zaj duab xis npaj ua lag luam txawv teb chaws
Raws li kev txheeb cais, qhov xwm txheej ntawm kev lag luam zaj duab xis formulations txog tam sim no yog kwv yees li hauv qab no. FDA tau pom zoo 82 kev lag luam ua yeeb yaj kiab formulations (nrog rau cov chaw tsim khoom sib txawv thiab cov lus qhia tshwj xeeb), thiab Nyiv PMDA tau pom zoo 17 cov tshuaj (xws li cov tuam txhab sib txawv thiab cov lus qhia tshwj xeeb), thiab lwm yam, txawm hais tias piv rau cov khoom siv tshuaj niaj hnub tseem muaj qhov sib txawv loj, tab sis qhov zoo thiab cov yam ntxwv. ntawm kev tsim cov yeeb yaj kiab yuav ua lub luag haujlwm tseem ceeb hauv kev txhim kho tshuaj tom ntej.
Hauv xyoo 2004, kev muag khoom thoob ntiaj teb ntawm qhov ncauj siv tshuab thev naus laus zis hauv OTC thiab cov khoom siv kho mob kev lag luam yog US $ 25 lab, uas tau nce mus rau US $ 500 lab hauv xyoo 2007, US $ 2 billion hauv xyoo 2010, thiab US $ 13 billion hauv xyoo 2015.
Cov xwm txheej tam sim no ntawm kev txhim kho hauv tsev thiab kev siv qhov ncauj dissolving film npaj
Tsis muaj qhov ncauj-melting zaj duab xis cov khoom tau pom zoo rau kev lag luam hauv Suav teb, thiab lawv txhua tus nyob hauv lub xeev ntawm kev tshawb fawb. Cov chaw tsim khoom thiab ntau yam uas tau pom zoo rau kev kho mob thiab kev tso npe thov hauv theem tshuaj xyuas yog raws li hauv qab no:
Cov tuam txhab lag luam hauv tsev uas tshaj tawm cov neeg ua kom lub qhov ncauj ntau tshaj plaws yog Qilu (7 ntau yam), Hengrui (4 ntau yam), Shanghai Modern Pharmaceutical (4 ntau yam), thiab Sichuan Baili Pharmaceutical (4 ntau yam).
Feem ntau cov ntawv thov rau qhov ncauj dissolving tus neeg sawv cev yog ondansetron qhov ncauj dissolving agent (4 tshaj tawm), olanzapine, risperidone, montelukast, thiab voglibose txhua tus muaj 2 tshaj tawm.
Tam sim no, kev lag luam sib faib ntawm qhov ncauj daim nyias nyias (tsis suav nrog cov khoom ua pa freshening) feem ntau yog nyob hauv North American lag luam. Nrog rau qhov tob thiab kev loj hlob ntawm ntau yam kev tshawb fawb ntawm qhov ncauj instant membranes, thiab kev txhawb nqa ntawm cov khoom no nyob rau hauv cov teb chaws Europe thiab Asia, kuv ntseeg hais tias ib tug ntau npaum li cas daim ntawv no muaj tej yam kev lag luam muaj peev xwm nyob rau hauv cov tshuaj, cov khoom noj qab haus huv thiab cosmeceuticals.
Post lub sij hawm: May-28-2022
