Iifilimu ezinyibilikayo ngomlomo
Iifilimu zokunyibilikisa ngomlomo (Oral dissolving films) (ODF) luhlobo olutsha lomlomo oluqinileyo olukhutshwa ngoko nangoko oluye lwasetyenziswa ngokubanzi kumazwe aphesheya kwiminyaka yakutshanje. Yavela ekupheleni kweminyaka yee-1970. Emva kophuhliso, luye lwavela ngokuthe ngcembe kwimveliso yokhathalelo lwempilo ye-portal. Uphuhliso luye lwanda kwimimandla yeemveliso zokhathalelo lwempilo, iimveliso zokhathalelo lomntu kunye neziyobisi, kwaye uye watsala umdla obanzi kunye nengqalelo ngenxa yeenzuzo zayo ezinye iifom zedosi ezingenayo. Iya isiba yinkqubo yonikezelo lweyeza lwe-membrane ebaluleke kakhulu, ngakumbi ilungele ukuginya izigulane ezinzima kunye namachiza aneziphumo ezibi kakhulu zokupasa kuqala.
Ngenxa yenzuzo yefomu yedosi ekhethekileyo yeefilimu ezinyibilikayo ngomlomo, inamathuba amahle okusetyenziswa. Njengohlobo olutsha lwedosi enokutshintsha iipilisi ngomlomo, iinkampani ezininzi ezinkulu zinomdla kakhulu koku, ukwandisa ixesha lelungelo elilodwa lomenzi wechiza athile ngokuguqulwa kwefomu yedosi sisihloko sophando esishushu ngoku.
Iimpawu kunye neenzuzo zeefilimu ezichithwa ngomlomo
Akukho mfuneko yokusela amanzi, kulula ukuyisebenzisa. Ngokuqhelekileyo, imveliso yenzelwe ubungakanani besitampu, esinokuchithwa ngokukhawuleza ngolwimi kwaye siginywe ngeentshukumo eziqhelekileyo zokugwinya; ulawulo olukhawulezayo kunye nokuqalisa ukusebenza ngokukhawuleza; xa kuthelekiswa nomzila we-mucosal yempumlo, indlela yomlomo we-mucosal ayinakwenzeka ukuba ibangele umonakalo we-mucosal, kunye nokulungiswa kwayo Umsebenzi owomeleleyo; Ukulawulwa kwe-cavity mucosal kunokulungiswa kwendawo ngokuhambelana ne-tissue permeability ukuze kube lula ukususwa ngokukhawuleza; iyeza lisasazwa ngokulinganayo kwizinto ezenza ifilimu, umxholo uchanekile, kwaye uzinzo namandla alungile. Ilungele ngokukhethekileyo amalungiselelo abantwana okwangoku anqongopheleyo e-China. Inokusombulula ngokulula iingxaki zamayeza abantwana kunye nezigulane kunye nokuphucula ukuthotyelwa kwabantwana kunye nezigulane ezikhulileyo. Ngoko ke, iinkampani ezininzi zamachiza zidibanisa amalungiselelo akhoyo e-liquid, ii-capsules, iipilisi kunye nomlomo womlomo Imveliso yethebhulethi echithwayo iguqulwa ibe yifilimu yomlomo echithwe ngokukhawuleza ukwandisa umjikelezo wobomi bemveliso.
Ukungalungi kweefilimu ezichithwa ngomlomo
Umlomo womlomo unokufunxa i-mucosa kunye nendawo encinci. Ngokuqhelekileyo, i-membrane yomlomo incinci kumthamo kwaye ukulayishwa kweziyobisi akukhulu (ngokuqhelekileyo i-30-60mg). Kuphela ngamachiza athile asebenzayo kakhulu anokukhethwa; ichiza eliphambili kufuneka lifakwe incasa, kwaye incasa yokuvuselela iyeza ichaphazela ukuthotyelwa kweNdlela; ukukhutshwa kwamathe okungenakuzithandela kunye nokugwinya kuchaphazela ukusebenza kwendlela yomlomo we-mucosa; Azikho zonke izinto ezinokudlula kwi-mucosa yomlomo, kwaye ukuxutywa kwabo kuchaphazeleka kukunyibilika kwamafutha; iqondo lokuhlukana, ubunzima bemolekyuli, njl.; kufuneka isetyenziswe phantsi kweemeko ezithile I-Absorption accelerator; ngexesha lenkqubo yokwenza ifilimu, izinto zifudumala okanye i-solvent iyaphuphuma, kulula ukuphosa i-foam, kwaye kulula ukuwa ngexesha lokusika, kwaye kulula ukuphuka ngexesha lokusika; ifilimu incinci, ilula, incinci, kwaye kulula ukufunxa ukufuma. Ngoko ke, iimfuno zokupakishwa ziphezulu, okungafanele kube lula ukuyisebenzisa, kodwa ziqinisekisa umgangatho wamayeza.
Amalungiselelo omboniso bhanyabhanya anyibilikayo ngomlomo athengiswa kumazwe angaphandle
Ngokwezibalo, imeko yokwenziwa kwefilimu ethengisiweyo ukuza kuthi ga ngoku imalunga noku kulandelayo. I-FDA ivume iifom zefilimu ezithengiswayo ze-82 (kubandakanywa nabavelisi abahlukeneyo kunye neenkcukacha), kunye neJapan PMDA ivume izidakamizwa ze-17 (kubandakanywa nabavelisi abahlukeneyo kunye neenkcukacha), njl., nangona kuthelekiswa nokuqulunqwa okuqinileyo kwendabuko Kusekho i-gap enkulu, kodwa inzuzo kunye neempawu. yokwenziwa kwefilimu iya kudlala indima ebalulekileyo kuphuhliso lwamachiza olulandelayo.
Kwi-2004, ukuthengiswa kwehlabathi jikelele kweteknoloji yefilimu yomlomo kwi-OTC kunye nemarike yeemveliso zokhathalelo lwempilo yayiyi-US $ 25 yezigidi, eyanyuka kwi-US $ 500 yezigidi kwi-2007, i-US $ 2 yezigidigidi kwi-2010, kunye ne-US $ 13 yezigidigidi kwi-2015.
Ubume bangoku bophuhliso lwasekhaya kunye nokusetyenziswa kwamalungiselelo efilimu achithwa ngomlomo
Akukho zimveliso zefilimu ezinyibilikisa umlomo zivunyiweyo ukuba zithengiswe eTshayina, kwaye zonke zikwimeko yophando. Abavelisi kunye neentlobo ezivunyiweyo zeklinikhi kunye nezicelo zobhaliso kwinqanaba lokuphonononga zimi ngolu hlobo lulandelayo:
Abavelisi basekhaya abavakalisa elona nani likhulu lee-arhente zokunyibilikisa ngomlomo yi-Qilu (iintlobo ezi-7), i-Hengrui (iintlobo ezi-4), i-Shanghai Modern Pharmaceutical (iintlobo ezi-4), kunye ne-Sichuan Baili Pharmaceutical (iintlobo ezi-4).
Esona sicelo sasekhaya se-arhente yokunyibilikisa ngomlomo yi-ondansetron i-oral dissolving agent (i-4 declarations), i-olanzapine, i-risperidone, i-montelukast, kunye ne-voglibose nganye inezibhengezo ezi-2.
Okwangoku, isabelo sentengiso yeenwebu zomlomo (ngaphandle kweemveliso zokuphefumla) sigxile kakhulu kwimarike yaseMntla Melika. Ngobunzulu kunye nophuhliso lophando olwahlukeneyo kwiinwebu zomlomo ezikhawulezayo, kunye nokukhuthazwa kweemveliso ezinjalo eYurophu naseAsia, ndiyakholelwa ukuba le fomu yedosi enye inamandla athile orhwebo kumayeza, iimveliso zempilo kunye ne-cosmeceuticals.
Ixesha lokuposa: May-28-2022
