Oral dissolving films
Oral dissolving films (ODF) imhando nyowani yemuromo yakasimba-yekukurumidza-kuburitsa dosage fomu iro rave kushandiswa zvakanyanya kunze kwenyika mumakore achangopfuura. Yakaonekwa mukupera kwema1970. Mushure mekuvandudzwa, zvishoma nezvishoma zvakashanduka kubva kune yakapusa portal hutano hwehutano chigadzirwa. Iko kusimukira kwakawedzera kusvika kuminda yezvigadzirwa zvehutano, zvigadzirwa zvekuchengetedza munhu uye zvinodhaka, uye zvakwezva kufarira kwakakura uye kutariswa nekuda kwemabhenefiti ayo asina mamwe mafomu edosi. Iri kuwedzera kukosha membrane dosage dhizaini dhizaini system, kunyanya yakakodzera kumedza varwere vakaoma uye mishonga ine yakanyanya kuoma yekutanga mhedzisiro.
Nekuda kweiyo yakasarudzika dosage fomu mukana wemafirimu ekunyungudutsa nemuromo, ine tarisiro yakanaka yekushandisa. Sechimiro chitsva chedosi chinogona kutsiva mapiritsi ari kuparara nemuromo, makambani makuru mazhinji ane chido chikuru mune izvi, kuwedzera nguva yepetent yemamwe mishonga kuburikidza nekushandurwa kwefomu yedosi inyaya yetsvakiridzo inopisa parizvino.
Zvimiro uye zvakanakira zvemuromo inonyungudutsa mafirimu
Hapana chikonzero chekunwa mvura, nyore kushandisa. Kazhinji, chigadzirwa chacho chakagadzirirwa kuva hukuru hwetampu, inogona kukurumidza kunyungudutswa parurimi uye kumedzwa nemaitiro anowanzomedza; kukurumidza kutonga uye kukurumidza kutanga kwekuita; kana zvichienzaniswa ne nasal mucosal nzira, oral mucosal nzira kashoma kukonzeresa mucosal kukuvara, uye kugadzirisa kwayo Kusimba kushanda; cavity mucosal administration inogona kugadziridzwa munharaunda maererano nehutachiona hwehutachiona hwekuita kuti kubviswa kwekukurumidzira; mushonga wacho wakagovaniswa zvakaenzana mune zvekugadzira firimu, zvirimo ndezvechokwadi, uye kugadzikana uye kusimba kwakanaka. Inonyanya kukodzera kugadzirira kwevana izvo zvino zvishoma nezvishoma muChina. Inogona kugadzirisa zviri nyore matambudziko emishonga evana nevarwere uye kuvandudza kutevedza kwevana nevarwere vakura. Nokudaro, makambani mazhinji emishonga anosanganisa gadziriro dzavo dzemvura dziripo, macapsules, mahwendefa uye oral cavity.
Kuipa kwemafirimu ekunyungudutsa nemuromo
Iyo yemuromo mhango inogona kutora mucosa ine nzvimbo shoma. Kazhinji, membrane yemuromo idiki muhuwandu uye kurodha kwezvinodhaka hakusi kukuru (kazhinji 30-60mg). Zvimwe chete mishonga inoshanda zvakanyanya inogona kusarudzwa; mushonga mukuru unoda kuravira-masked, uye kuravira kunokurudzira kwemushonga kunokanganisa kutevedza kweNzira; involuntary saliva secretion uye kumedza kunokanganisa kushanda kwemuromo mucosa nzira; kwete zvinhu zvose zvinogona kupfuura nemumuromo mucosa, uye kutora kwavo kunokonzerwa nemafuta solubility; dissociation degree, molecular weight, nezvimwewo; inoda kushandiswa pasi pemamwe mamiriro Absorption accelerator; panguva yekugadzira firimu, zvinhu zvinopisa kana kuti solvent inoputika, zviri nyore kupupa, uye zviri nyore kudonha panguva yekucheka, uye zviri nyore kuputsa panguva yekucheka; iyo firimu yakatetepa, yakareruka, diki, uye iri nyore kutora unyoro. Naizvozvo, izvo zvinodiwa pakurongedza zvakakwirira, izvo hazvifanirwe kuve nyore kushandisa chete, asiwo kuve nechokwadi chemhando yemishonga.
Oral dissolving film gadziriro dzinotengeswa kunze kwenyika
Zvinoenderana nenhamba, mamiriro ekugadzirwa kwemafirimu akatengeswa kusvika parizvino akaenzana seanotevera. FDA yakabvumidza makumi masere nemaviri ekugadzirwa kwemafirimu ekuumbwa (kusanganisira vagadziri vakasiyana uye zvakatemwa), uye Japan PMDA yakabvumidza 17 mishonga (kusanganisira vagadziri vakasiyana uye zvakatemwa), nezvimwewo, kunyangwe zvichienzaniswa neyakagadzika magadzirirwo akasimba Pachine mukaha mukuru, asi zvakanakira uye maitiro. yekugadzira firimu ichaita basa rakakosha mukuvandudzwa kwezvinodhaka kunotevera.
Muna 2004, kutengesa kwepasirese kwehunyanzvi hwemufirimu wemuromo muOTC uye musika wezvigadzirwa zvehutano hwaive US$25 miriyoni, iyo yakakwira kusvika kuUS $500 miriyoni muna 2007, US $ 2 bhiriyoni muna 2010, uye US $ 13 bhiriyoni mu2015.
Chimiro chazvino chebudiriro yemba uye kushandiswa kwemuromo kunyungudika firimu gadziriro
Hapana zvigadzirwa zvemafirimu zvinonyungudutsa muromo zvakatenderwa kushambadzira muChina, uye zvese zviri mumamiriro ekutsvaga. Vagadziri uye mhando dzakatenderwa kukiriniki uye kunyoresa zvikumbiro muchikamu chekuongorora ndeaya anotevera:
Vagadziri vepamba vanozivisa huwandu hukuru hweanonyungudika nemuromo ndeye Qilu (7 marudzi), Hengrui (4 marudzi), Shanghai Modern Pharmaceutical (4 marudzi), uye Sichuan Baili Pharmaceutical (4 marudzi).
Chishandiso chemumba cheoral dissolving agent ndeye ondansetron oral dissolving agent (4 declarations), olanzapine, risperidone, montelukast, uye voglibose imwe neimwe ine 2 declaration.
Parizvino, chikamu chemusika chemukanwa membranes (kusingabatanidzi zvigadzirwa zvinofema) chinonyanya kutariswa mumusika weNorth America. Nekudzika uye nekuvandudzwa kwekutsvagisa kwakasiyana-siyana pamusoro pemukanwa pakarepo membrane, uye kusimudzirwa kwezvigadzirwa zvakadaro muEurope neAsia, ndinotenda iyi Imwe dosi fomu ine zvimwe zvekutengeserana zvinogona mumishonga, zvigadzirwa zvehutano uye cosmeceuticals.
Nguva yekutumira: May-28-2022
