Amafilimu ancibilika ngomlomo
Amafilimu e-Oral dissolving (i-ODF) iyifomu lethamo eliqinile lomlomo elikhishwa ngokushesha elisetshenziswa kabanzi phesheya eminyakeni yamuva nje. Yavela ngasekupheleni kwawo-1970. Ngemva kokuthuthuka, kancane kancane yavela kumkhiqizo wokunakekelwa kwezempilo we-portal olula. Intuthuko iye yanda yafinyelela emikhakheni yemikhiqizo yokunakekelwa kwempilo, imikhiqizo yokunakekelwa komuntu siqu kanye nezidakamizwa, futhi idonse isithakazelo esikhulu nokunaka ngenxa yezinzuzo zayo ezinye izinhlobo zemithamo ezingenazo. Seluba uhlelo lokulethwa kwemithi yolwelwesi olubaluleke kakhulu, ikakhulukazi olufanele ukugwinya iziguli ezinzima kanye nezidakamizwa ezinemiphumela emibi kakhulu yokudlula yokuqala.
Ngenxa yenzuzo yefomu lesilinganiso esiyingqayizivele samafilimu ancibilika ngomlomo, inamathuba amahle okusebenza. Njengefomu elisha lomthamo elingangena esikhundleni samaphilisi ahlakazeka ngomlomo, izinkampani eziningi ezinkulu zinentshisekelo enkulu kulokhu, ukwelula isikhathi selungelo lobunikazi semithi ethile ngokuguqulwa kwefomu lomthamo kuyisihloko socwaningo esishisayo okwamanje.
Izici nezinzuzo zamafilimu ancibilika ngomlomo
Asikho isidingo sokuphuza amanzi, kulula ukuyisebenzisa. Ngokuvamile, umkhiqizo uklanyelwe ukuba usayizi wesitembu, ongaqedwa ngokushesha olimini futhi ugwinywe ngokunyakaza okujwayelekile kokugwinya; ukuphathwa ngokushesha kanye nokuqala ukusebenza ngokushesha; uma kuqhathaniswa nomzila we-mucosal yamakhala, umzila we-mucosal womlomo cishe ungabangela ukulimala kwe-mucosal, kanye nokulungiswa kwayo Ukusebenza okuqinile; Ukuphathwa kwe-cavity mucosal kungalungiswa endaweni ngokusho kwe-tissue permeability ukuze kube lula ukususwa okuphuthumayo; umuthi usatshalaliswa ngokulinganayo ezintweni zokwakha ifilimu, okuqukethwe kunembile, futhi ukuzinza namandla kuhle. Ifaneleka ngokukhethekile amalungiselelo ezingane okwamanje ashodayo e-China. Ingakwazi ukuxazulula kalula izinkinga zemithi yezingane neziguli futhi ithuthukise ukuhambisana kwezingane neziguli esezikhulile. Ngakho-ke, izinkampani eziningi zemithi zihlanganisa amalungiselelo azo akhona oketshezi, amaphilisi, amaphilisi kanye nembobo yomlomo Umkhiqizo wethebhulethi ehlakazekayo uguqulwa ube ifilimu yomlomo ehlakazeka ngokushesha ukuze kunwetshwe umjikelezo wokuphila womkhiqizo.
Ukungalungi kwamafilimu ancibilika ngomlomo
Umgodi womlomo ungamunca i-mucosa ngesikhala esilinganiselwe. Ngokuvamile, ulwelwesi lomlomo luncane ngevolumu futhi ukulayishwa kwezidakamizwa akukukhulu (ngokuvamile ku-30-60mg). Izidakamizwa ezithile ezisebenza kakhulu kuphela ezingakhethwa; umuthi oyinhloko udinga ukumbozwa ukunambitheka, futhi ukunambitheka komuthi kuthinta ukulandelwa kwePathway; ukukhishwa kwamathe okungenakuzikhethela kanye nokugwinya kuthinta ukusebenza kahle kwendlela yomlomo we-mucosa; akuzona zonke izinto ezingadlula ku-mucosa yomlomo, futhi ukumuncwa kwazo kuthinteka ukuncibilika kwamafutha; i-dissociation degree, isisindo samangqamuzana, njll.; idinga ukusetshenziswa ngaphansi kwezimo ezithile I-Absorption accelerator; ngesikhathi senqubo yokwenza ifilimu, izinto ezishisayo ziyafudumala noma i-solvent iyahwamuka, kulula ukwenza igwebu, futhi kulula ukuwa ngesikhathi sokusika, futhi kulula ukuphuka ngesikhathi sokusika; ifilimu incane, ilula, incane, futhi kulula ukumunca umswakama. Ngakho-ke, izidingo zokupakisha ziphakeme kakhulu, okungafanele kube lula ukuyisebenzisa kuphela, kodwa futhi ziqinisekise ikhwalithi yemithi.
Amalungiselelo efilimu ancibilika ngomlomo adayiswa phesheya
Ngokwezibalo, isimo sokumakethwa kwamafilimu kuze kube manje sicishe sibe ngolulandelayo. I-FDA igunyaze ukwakhiwa kwefilimu edayiswayo engama-82 (kuhlanganise nabakhiqizi abahlukene kanye nezici ezibekiwe), futhi i-Japan PMDA igunyaze izidakamizwa eziyi-17 (kuhlanganise nabakhiqizi abahlukene kanye nezicaciso), njll., nakuba kuqhathaniswa nokwakhiwa okuqinile kwendabuko Kusenegebe elikhulu, kodwa izinzuzo nezici. yokwakhiwa kwefilimu izodlala indima ebalulekile ekuthuthukisweni kwezidakamizwa okulandelayo.
Ngo-2004, ukuthengiswa komhlaba wonke kobuchwepheshe befilimu yomlomo emakethe ye-OTC kanye nemikhiqizo yokunakekelwa kwezempilo kwaba amaRandi ayizigidi ezingu-25, okukhuphuke kwafinyelela ku-US$500 million ngo-2007, US$2 billion ngo-2010, kanye ne-US$13 billion ngo-2015.
Isimo samanje sokuthuthukiswa kwasekhaya kanye nokusetshenziswa kwamalungiselelo efilimu ancibilika ngomlomo
Ayikho imikhiqizo yefilimu encibilika emlonyeni evunyelwe ukumakethwa e-China, futhi yonke isesimweni socwaningo. Abakhiqizi nezinhlobonhlobo ezigunyazwe izicelo zomtholampilo nezokubhaliswa esigabeni sokubuyekezwa zimi kanje:
Abakhiqizi basekhaya abamemezela inani elikhulu kakhulu lezinto ezincibilikisa ngomlomo i-Qilu (izinhlobo ezingu-7), i-Hengrui (izinhlobo ezi-4), i-Shanghai Modern Pharmaceutical (izinhlobo ezi-4), kanye ne-Sichuan Baili Pharmaceutical (izinhlobo ezi-4).
Isicelo sasekhaya kakhulu se-ejenti encibilikisa ngomlomo i-odansetron oral dissolving agent (izimemezelo ezi-4), i-olanzapine, i-risperidone, i-montelukast, ne-voglibose ngayinye inezimemezelo ezingu-2.
Njengamanje, isabelo semakethe solwelwesi lomlomo (ngaphandle kwemikhiqizo yokuphefumula umoya) sigxile kakhulu emakethe yaseNyakatho Melika. Ngokujulile nokuthuthukiswa kocwaningo oluhlukahlukene ngolwelwesi olusheshayo lomlomo, kanye nokukhuthazwa kwemikhiqizo enjalo eYurophu nase-Asia, ngikholelwa ukuthi leli fomu lesilinganiso Esilodwa linamandla athile okuhweba emithini, emikhiqizweni yezempilo nasezintweni zokuthambisa.
Isikhathi sokuthumela: May-28-2022
