Mafilimu osungunula pakamwa
Makanema a Oral dissolving (ODF) ndi njira yatsopano yotulutsa yomwe yakhala ikugwiritsidwa ntchito kwambiri kunja kwazaka zaposachedwa. Zinawonekera kumapeto kwa zaka za m'ma 1970. Pambuyo pa chitukuko, chasintha pang'onopang'ono kuchokera ku chinthu chosavuta chachipatala cha portal. Chitukukochi chakulirakulira kuzinthu zamankhwala, zinthu zosamalira anthu komanso mankhwala osokoneza bongo, ndipo zakopa chidwi ndi chidwi chachikulu chifukwa cha zabwino zomwe mitundu ina yamankhwala alibe. Ikukhala njira yofunika kwambiri yoperekera mankhwala kwa nembanemba, makamaka yoyenera kumeza odwala ovuta komanso mankhwala okhala ndi zovuta zowopsa zoyamba.
Chifukwa cha mawonekedwe apadera a mulingo wamakanema osungunula pakamwa, ili ndi chiyembekezo chabwino chogwiritsa ntchito. Monga mawonekedwe atsopano a mlingo omwe angalowe m'malo mwa mapiritsi omwe akusweka pakamwa, makampani akuluakulu ambiri ali ndi chidwi kwambiri ndi izi, kuwonjezera nthawi yovomerezeka ya mankhwala ena kudzera mukusintha mawonekedwe a mlingo ndi mutu wovuta kwambiri wofufuza pakali pano.
Mawonekedwe ndi ubwino wa mafilimu osungunula pakamwa
Palibe chifukwa chomwa madzi, osavuta kugwiritsa ntchito. Kawirikawiri, mankhwalawa amapangidwa kuti akhale kukula kwa sitampu, yomwe imatha kusungunuka mofulumira pa lilime ndi kumeza ndi kayendedwe kabwino ka kumeza; makonzedwe mofulumira ndi mofulumira isanayambike zotsatira; poyerekeza ndi njira ya m'mphuno ya m'mphuno, njira ya m'kamwa ya m'kamwa sichitha kuwononga mucosal, ndi kukonza kwake Kugwira ntchito mwamphamvu; patsekeke mucosal makonzedwe akhoza kusinthidwa kwanuko malinga ndi minofu permeability atsogolere kuchotsa mwadzidzidzi; mankhwalawa amagawidwa mofanana muzinthu zopanga mafilimu, zomwe zili zolondola, ndipo kukhazikika ndi mphamvu ndi zabwino. Ndikoyenera makamaka kukonzekera kwa ana omwe panopa akusowa ku China. Iwo mosavuta kuthetsa mavuto mankhwala ana ndi odwala ndi bwino kutsatira ana ndi odwala okalamba. Chifukwa chake, makampani ambiri opanga mankhwala amaphatikiza zokonzekera zamadzimadzi zomwe zilipo, makapisozi, mapiritsi ndi pakamwa pakamwa Mankhwala osokoneza bongo amasinthidwa kukhala filimu yapakamwa yosungunuka mwachangu kuti atalikitse moyo wazinthu.
Kuipa kwa mafilimu osungunula pakamwa
Pakamwa amatha kuyamwa mucosa ndi malo ochepa. Nthawi zambiri, nembanemba yapakamwa ndi yaying'ono mu voliyumu ndipo kutsitsa kwamankhwala sikuli kwakukulu (nthawi zambiri 30-60mg). Mankhwala ena okha omwe amagwira ntchito kwambiri angasankhidwe; mankhwala aakulu ayenera kulawa-maskitid, ndi kukoma kukondoweza mankhwala amakhudza Pathway kutsatira; kutulutsa malovu mosasamala ndi kumeza kumakhudza mphamvu ya njira ya m'kamwa; sizinthu zonse zomwe zingadutse mucosa wamkamwa, ndipo kuyamwa kwawo kumakhudzidwa ndi kusungunuka kwa mafuta; Digiri ya dissociation, kulemera kwa maselo, etc.; ayenera kugwiritsidwa ntchito pansi pa zinthu zina mayamwidwe accelerator; panthawi yopanga filimuyi, zinthuzo zimatenthedwa kapena zosungunulira zimatuluka, zimakhala zosavuta kutulutsa thovu, ndipo zimakhala zosavuta kugwa panthawi yodula, ndipo zimakhala zosavuta kuswa panthawi yodula; filimuyi ndi yopyapyala, yopepuka, yaying'ono, komanso yosavuta kuyamwa chinyezi. Chifukwa chake, zofunikira pakuyika ndizokwera kwambiri, zomwe siziyenera kukhala zosavuta kugwiritsa ntchito, komanso kuonetsetsa kuti mankhwalawo ndi abwino.
Kukonzekera kwa mafilimu osungunula pakamwa kumagulitsidwa kunja
Malinga ndi ziwerengero, momwe filimu ikugulitsidwa mpaka pano ili motere. FDA yavomereza 82 malonda mafilimu formulations (kuphatikiza opanga osiyana ndi specifications), ndi Japan PMDA anavomereza 17 mankhwala (kuphatikizapo opanga osiyana ndi specifications), etc., ngakhale poyerekeza ndi formulations olimba chikhalidwe Pali kusiyana kwakukulu, koma ubwino ndi makhalidwe kupanga filimuyi kudzakhala ndi gawo lofunikira pakukula kwa mankhwala.
Mu 2004, kugulitsa kwapadziko lonse kwaukadaulo wamakanema amkamwa mu OTC ndi msika wazachipatala kunali US $ 25 miliyoni, yomwe idakwera mpaka US $ 500 miliyoni mu 2007, US $ 2 biliyoni mu 2010, ndi US $ 13 biliyoni mu 2015.
Mkhalidwe wamakono wa chitukuko chapakhomo ndikugwiritsa ntchito kukonzekera filimu yosungunuka m'kamwa
Palibe mafilimu osungunula pakamwa omwe avomerezedwa kuti azigulitsidwa ku China, ndipo onse ali mu kafukufuku. Opanga ndi mitundu yomwe yavomerezedwa kuti igwiritsidwe ntchito pazachipatala ndikulembetsa mu gawo lowunika ndi izi:
Opanga m'nyumba omwe amalengeza kuchuluka kwa mankhwala osungunula pakamwa ndi Qilu (mitundu 7), Hengrui (mitundu 4), Shanghai Modern Pharmaceutical (mitundu 4), ndi Sichuan Baili Pharmaceutical (mitundu ina).
Ntchito yapakhomo ya oral dissolving agent ndi ondansetron oral dissolving agent (4 declarations), olanzapine, risperidone, montelukast, ndi voglibose aliyense ali ndi 2 declarations.
Pakadali pano, gawo lamsika la membrane wamkamwa (kupatula zinthu zotsitsimutsa mpweya) limakhazikika pamsika waku North America. Ndi kuzama ndi chitukuko cha kafukufuku wosiyanasiyana wokhudzana ndi zingwe zapakamwa, komanso kukwezedwa kwa zinthu zotere ku Europe ndi Asia, ndikukhulupirira kuti Fomu iyi ya Mlingo umodzi ili ndi kuthekera kochita malonda muzamankhwala, zamankhwala ndi zodzoladzola.
Nthawi yotumiza: May-28-2022
