Ama-caplule aqinile / ama-hpmc ama-caplule / ama-caplule emifino / ama-api zemifino aphezulu / i-api ephezulu kakhulu kanye nezithako ezibucayi zoMswaniso / I-Film Science / Ukulawulwa Kokukhululwa Okugciniwe ....
Ukusebenza kwezindleko okuvelele, ukusebenziseka kalula, nokulula kokulawulwa kweziguli komthamo, imikhiqizo eqinile yomlomo (i-OSD) ihlala iyindlela ethandwayo yokuphatha yabathuthukisi bezidakamizwa.
Kwezinhlangano ezintsha ezingama-38 ama-molecule (nmes) ezivunyelwe yi-US Food Food and Drug Administration ngonyaka ka-2019, 26 zazingu-OSD1. Ngo-2018, imali engenayo yemakethe yemikhiqizo enophawu lwe-OSD ngokusebenza kwama-CMO emakethe yaseNyakatho Melika yayicishe ibe ngama- $ 79 billion e-USD ngo-2093
Amathebulethi asabusa imakethe ye-OSD, kepha ama-caplule anzima abe yindlela eyandayo ebabazekayo. Lokhu kungenxa yokwethenjwa kwama-capsule njengendlela yokuphatha, ikakhulukazi lezo ezinama-apis aphezulu e-potency antitumor apis. Amaphilisi asondelene kakhulu ezigulini, imaski yephunga elingathandeki kanye nokunambitheka, futhi kulula ukugwinya, kungcono kakhulu kunezinye izindlela zama-dosage.
Amalambu kaJulien, umphathi womkhiqizo eLonza Capsule nasezithako zezempilo, axoxa ngezinzuzo ezahlukahlukene zama-caplule anzima ngaphezulu kwamathebulethi. Ubelana ngokuqonda kwakhe ku-hydroxypropyllyllop methylcellulose (HPMC) amakhandlela angenalutho nokuthi angawasiza kanjani abathuthukisi bezidakamizwa ukuthi bakhulise imikhiqizo yabo ngenkathi behlangana nokufunwa kwabathengi kwemithi etholwa ngumthengi.
Ama-caplule anzima: Thuthukisa ukuhambisana kwesiguli futhi usebenze kahle ukusebenza
Iziguli zivame ukuzabalaza nemithi enambitha noma enuka kabi, kunzima ukugwinya, noma kungaba nemiphumela emibi. Unalokhu engqondweni, ukuthuthukisa amafomu we-dosage asebenziseka kalula angathuthukisa ukulandelwa kweziguli ngamarejimu wokwelashwa. Ama-caplule anzima ayindlela ekhangayo yeziguli ngoba, ngaphezu kokunambitheka kanye nephunga, lingathathwa kaningi, linciphise kaningi, linciphise umthwalo wethebhulethi, futhi sikhululwe ngokushesha, ukukhishwa okulawulwa ngokushesha ukuze uzuze.
Ukulawula okungcono kokukhishwa kwesidakamizwa, ngokwesibonelo nge-micropelleting the api, kungavimbela ukulahla umthamo futhi kunciphise imiphumela emibi. Abathuthukisi bezidakamizwa bathola ukuthi ukuhlanganisa ubuchwepheshe obuhlukahlukene ngama-caplule kukhulisa ukuguquguquka nokusebenza ngempumelelo kokusebenza kwe-API okulawulwa okulawulwayo. Kungasekela ngisho ama-pellets aqukethe ama-apis ahlukile kwi-capsule efanayo, okusho ukuthi izidakamizwa eziningi zingalawulwa ngasikhathi sinye emithanjeni ehlukene, ziphinde zinciphise imvamisa ye-dosing.
Ukuziphatha kwe-Pharmacokinetic kanye ne-Pharmacodynamic kwalezi zinhlaka, kufaka phakathi uhlelo lwe-MultiParticate API3, kanye nohlelo lokuhlanganiswa kwethamo olungahleliwe, futhi kukhombise ukuzala okungcono kuqhathaniswa nokwakhiwa okujwayelekile.
Kungenxa yalokhu kuthuthukiswa okungaba khona ekulandelweni kweziguli kanye nokusebenza ngempumelelo okufunwa kwemakethe yama-apis ama-granursed kuma-caplule alukhuni kuyaqhubeka ukukhula.
Ukuthandwa kwe-polymer:
Isidingo samaphilisi wemifino ukuze ungene esikhundleni se-hard gelatin caplules
Ama-caplule anzima endabuko enziwe nge-gelatin, nokho, ama-gelatin aqinile amaphilisi angaveza izinselelo lapho ehlangabezana ne-hygroscopic noma okuqukethwe okubucayi komswakama. I-Gelatin ngumkhiqizo owenziwe ngesilwane owenziwayo othambekele ekuphendukeni okuxhumanisayo okuthinta isenzo sokuchitheka, futhi unokuqukethwe kwamanzi okuphezulu ukuze ulondoloze ukuguquguquka kwawo, kodwa futhi kungashintshana ngamanzi nge-API kanye nama-excipie.
Ngaphezu komthelela we-capsule impahla ekusebenzeni komkhiqizo, iziguli eziningi ziyamangaza ukungenisa imikhiqizo yezilwane ngezizathu zenhlalo noma zamasiko futhi zifuna imishanguzo ethathwe izitshalo noma vegan. Ukuhlangabezana nalesi sidingo, izinkampani ezenza imithi nazo ziyaqhubeka nokutshala imali kuma-regimens amasha e-dosing ukuthuthukisa ezinye izindlela ezenzelwe izitshalo eziphephile futhi ezisebenzayo. Intuthuko ku-Material Science yenze ama-caplule anezitshalo atholwe, anikeze iziguli inketho ethathwe njengezilwane ngaphezu kwezinzuzo ze-gelatin caplules-swilwability, ukuphumelela izindleko.
Ukuze uthole ukuqedwa okungcono nokuhambisana:
Ukusetshenziswa kwe-HPMC
Njengamanje, enye yezindlela ezinhle kakhulu ku-gelatin yi-hydroxypropyllylylylylylylylylylylylylyllose (HPMC), i-polymer ethathwe emicu yezihlahla.
I-HPMC ayinamehlo amancane kune-gelatin futhi ithola namanzi amancane kune-gelatin6. Okuqukethwe kwamanzi okuphansi kwama-HPMC capsule kunciphisa ukushintshaniswa kwamanzi phakathi kwe-capsule nokuqukethwe, okukhona kwezinye izimo kungathuthukisa ukuqina kwamakhemikhali nangokomzimba kokwakhiwa, ukunwebeka kalula izinselelo ze-hygroscopic apis nama-excipients. Ama-HPMC azwakala ama-caplule awazwela ekushiseni futhi kulula ukuyigcina nokuhambisa.
Ngokukhuphuka kwama-API asebenza kahle, izidingo zokwakheka ziba yinkimbinkimbi ngokwengeziwe. Kuze kube manje, abathuthukisi bezidakamizwa bathole imiphumela emihle kakhulu kwinqubo yokuhlola ukusetshenziswa kwama-HPMC capsule ukuze athathe isikhundla sendabuko ye-gelatin. Eqinisweni, ama-HPMC capsule njengamanje ancanyelwa izivivinyo zomtholampilo ngenxa yokuvumelana kwawo okuhle nezidakamizwa eziningi kanye ne-excipients7.
Ukuthuthuka okuqhubekayo kubuchwepheshe be-HPMC capsule kubuye kusho ukuthi abathuthukisi bezidakamizwa bakwazi kangcono ukusebenzisa amapharamitha aso okuchithwa kanye nokuhambisana nobubanzi be-NMES, kufaka phakathi amakhompiyutha anamandla kakhulu.
Ama-HPMC caps ngaphandle kwe-ejenti ye-gelling anezindawo ezinhle zokuqothula ngaphandle kwe-ion kanye nokuncika kwe-ph, ukuze iziguli zizothola umuthi ofanayo wezokwelapha lapho ethatha umuthi esiswini esingenalutho noma ngokudla. Njengoba kukhonjisiwe kuMfanekiso 1. 8
Ngenxa yalokhu, ukuthuthuka ekuchitheni kungavumela iziguli ukuthi zingabi nazinqumba ngokuhlela imithamo yazo, ngaleyo ndlela kwandise ukuhambisana.
Ngaphezu kwalokho, izinto ezintsha eziqhubekayo ku-HPMC Capsule Membrane Solutions nazo zingavumela ukuvikelwa kwamathumbu kanye nokukhululwa okusheshayo ezindaweni ezithile zepheshana lokugaya ukudla, ukulethwa kwezidakamizwa okuhlosiwe kwezindlela ezithile zokwelapha, futhi kuthuthukiswe kabusha ukusetshenziswa okungenzeka kwe-HPMC Caplules.
Olunye ukuqondiswa kwesicelo kwama-HPMC caplules kumadivayisi wokuphefumula wokuphatha ama-pulmonary. Isidingo semakethe siyaqhubeka ukukhula ngenxa yokuthuthuka kwe-bioavailability ngokugwema ukusebenza kwe-hepatic pass kanye nokuhlinzeka ngendlela eqondile yokuphatha lapho kubhekiswa khona izifo ezinjengesifo se-pulthma kanye nesifo esingama-pulmonary sokuphatha.
Abakhiqizi bezidakamizwa bahlala befuna ukuthuthukisa izindlela ezisebenzayo, ezinobungane nezisebenzayo nezisebenzayo zezifo zokuphefumula, futhi bahlole ukwelashwa kwezidakamizwa okuholwa kwezifo zesistimu ye-Central Nervor (CNS). funa kuyanda.
Okuqukethwe kwamanzi okuphansi kwama-HPMC capsule kubenza balungele ama-hygroscopic noma ama-apis abucayi amanzi, yize izindawo zikagesi phakathi kokwakheka namakhandlela eziyize kufanele futhi kubhekwe kuyo yonke intuthuko8.
Imicabango yokugcina
Ukuthuthukiswa kwe-membrane Science kanye ne-OSD Engineering Technology kubeke isisekelo se-HPMC capsules ukuthola indawo ye-gelatin kwezinye izindlela, ukuhlinzeka ngezinketho eziningi ekwakheni ukusebenza komkhiqizo. Ngaphezu kwalokho, ukugcizelelwa okwandayo kokuthandwa kwabathengi kanye nesidingo esikhulayo sezidakamizwa ezishibhile ezingabizi kakhulu kuthuthukise isidingo samakhabethe angenalutho ngokuhambisana okungcono nama-molecule athambile anomswakama.
Kodwa-ke, ukukhethwa kwezinto zokufumbane kubalulekile ekuqinisekiseni impumelelo yomkhiqizo, kanye nokukhetha okulungile phakathi kwe-gelatin ne-HPMC kungenziwa kuphela ngobuchwepheshe obufanele. Ukukhetha okuyikho kwezinto zokulwa nolwelwesi akunakuthuthukisa ukusebenza ngempumelelo futhi kunciphise ukuphendula okunzima, kepha futhi kusiza ukunqoba izinselelo ezithile zokwakhiwa.
Isikhathi sePosi: Feb-20-2025