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I-HME (I-Hot Melt Extrusion) Iimpawu eziNxulumeneyo

Ukujikeleziswa kwezikrufu, Kukho iintsapho ezimbini ze-screw extruders, ukhetho lwemathiriyeli lubalulekile kuphuhliso lwemveliso eyimpumelelo…

I-Hot Melt Extrusion

Ukujikeleza kwe-screws kudala ukuxuba kunye nokusabalalisa.Ukuxuba ukusabalalisa kwandisa ulwahlulo kunye nokudityaniswa kwakhona kwezixhobo ngelixa unciphisa igalelo lamandla ngokuxuba kunye nemiphumo ephantsi yokwandisa kunye neplani-shear.Oku kudibanisa ngokulinganayo izixhobo kodwa akunciphisi kakhulu ubungakanani bamasuntswana ezinto ezisasazekileyo kwaye kuvelise ukuthotywa okuncinci kwe-thermal kunye nokucheba kwemathiriyeli ebuthathaka.

Ukuxutywa kwe-dispersive kusebenza imihlaba eyandisiweyo kunye neplani yokucheba ukophula imathiriyeli esasaziweyo ukuya kubukhulu obuncinci, ngokufanelekileyo kusetyenziswa amandla okanye ngaphezulu kancinane kwinqanaba lomgubasi ofunekayo ukuzophula.

Ukusetyenziswa kwezinto ezahlukeneyo zokuxuba kuvumela i-twin screw extruder ukuba yenze zombini ukunciphisa ubungakanani be-particle kunye nokuxuba ukuze i-APIs ifakwe kwi-polymer kwifom ehlakaziweyo okanye, ukuba i-API ye-solubility kwi-polymer iphezulu ngokwaneleyo, kwifom echithwe.Ekubeni i-extrudate ipholisa ngokukhawuleza ekuphumeni kwe-extruder, nayiphi na i-API echithwa kwi-polymer kwiqondo lokushisa elixutywayo lingakwazi ukuphinda lihlaziye ekupholiseni, okukhokelela kwizisombululo eziqinileyo eziphezulu.Kwiimeko ezinjalo ukuzinza kwemveliso kufuneka kulandelwe ngokusondeleyo njengoko i-recrystallization ye-API ngaphezu kwexesha elide linokwenzeka, ngokukodwa kubushushu obuphezulu bokugcina kunye nokulayisha okuphezulu kwe-API, kwaye kunokuchaphazela ubomi beshelufu yemveliso yokugqibela.

Kukho iintsapho ezimbini ze-twin screw extruders: i-high-speed energy input (i-HSEI) i-twin-screw extruders, esetyenziselwa ikakhulu ukudibanisa, ukusetyenzwa okusebenzayo kunye / okanye ukuchithwa, kunye ne-speed-speed late fusion (LSLF) i-twin-screw extruders, yenzelwe ukuxuba kwi-chear ephantsi kunye nokumpompa kwiingcinezelo ezifanayo.Izikrweqe zinokujikeleza ngokudibeneyo (ukuzosula ngokwakho), okanye ukujikeleziswa kwekhawunta (isithuba sekhalenda), uninzi lwezikrweqe ezisetyenziselwa ukuxuba zijikeleza ngokudibeneyo.

Iindidi ezahlukeneyo zokuphuma zisetyenziselwa ukubumba i-extrudate kwiprofayili efunekayo.Oku kufa kuquka i-sheet kunye neefilim ezifayo ezisetyenziswa kwi-transdermal film applications, i-strand dies esetyenziselwa iityhubhu yezonyango kunye nezinye izixhobo ezikhupha amachiza, imilo iyafa esetyenziswa ekubumbeni ukuvuthela, kunye ne-co-extrusion dies esetyenziswa kuyilo lwesixhobo sokugcina amanzi.Amacandelo ancedisayo ahlukeneyo asezantsi asetyenziswa kwakhona kwinkqubo yokugqiba, kubandakanywa ukuhlamba kwamanzi kunye neemela zomoya zokupholisa, amabhanti okuhambisa ukuhambisa imveliso ekhutshiweyo ukusuka kwifa ukuya ekupheleni komgca, i-strand-cutters yokusika i-extrudate kwi-tubing okanye iintonga. kunye ne-spoolers yokuqokelelwa kwe-extrudate.Iipelletizers zisetyenziselwa ukusika i-extrudate ibe ngamaqhekeza amancinci ukuzaliswa ngokuthe ngqo kwe-capsule kwaye kwimeko yezinye izixhobo zokubumba inaliti ukwenza imveliso yokugqibela.

Njengalo naluphi na uhlobo lwedosi, ukhetho lwemathiriyeli lubalulekile kuphuhliso lwemveliso eyimpumelelo.Kwizicelo ezininzi, i-polymer kufuneka ibe yi-thermoplastic, izinzile kumaqondo okushisa asetyenziswe kwinkqubo, kwaye i-chemically ihambelana ne-API ngexesha lokukhupha.Kwiifomu eziqinileyo zedosi yomlomo, iipholima ezinyibilikayo zamanzi zihlala zikhethwa phakathi kweepolima esele zisetyenziswa kwiimveliso zamayeza ezifana nepoly(ethylene glycol) kunye nepoly(vinylpyrrolidinone).Ngomdla owandisiweyo wokusebenzisa i-HME kwiimveliso zamayeza, ababoneleli abakhulu bepolymer nabo baqala ukubonelela ngeepolima ezilungiselelwe ngokukodwa usetyenziso lwamayeza.Kwizixhobo zokucoca amachiza, iipolima azinakunyibilika emanzini, kwaye uninzi lweemveliso eziphantsi kophuhliso zisebenzisa nokuba yi-ethylene vinyl acetate copolymers (EVAs) okanye iipolyurethanes.

I-HME ivumela i-API ukuba ixutywe kunye ne-polymer phantsi kobuncinci be-shear kunye noxinzelelo lwe-thermal kwaye ngoko ke ngokuqulunqwa kwezinto ezincinci ezinxulumene nenkqubo ye-API.Ii-Antioxidants zihlala zibandakanyiwe ngaphakathi kokuqulunqwa, kwaye ixesha elifutshane lokuhlala kwi-barrel (ngokuqhelekileyo ngokomyalelo wemizuzu) kunceda ukunciphisa ukuthotywa kwe-thermal ngokukodwa xa kuthelekiswa nokuxuba ibhetshi kunye nezinye iinkqubo zokudibanisa.

Esinye isicwangciso-qhinga sokulawula i-kinetics ye-elution ye-chiza kwizixhobo ezifana ne-intravaginal rings ibandakanya ukwandiswa kwe-extrusion technique.I-extrusion edibeneyo kunye ne-chiza ye-core strand ene-release-control-polymer sheath edibanisa i-core kwinkqubo ye-co-extrusion eyodwa ivelisa i-strand ye-core-sheath strand.Intloko ye-extrusion eyenzelwe ngokukodwa yondliwa ngama-extruders amabini e-perpendicular - enye ibonelela ngokubunjwa okungundoqo, enye inikezela ngempahla ye-sheath.I-core-sheath strand iyasikwa kwaye iziphelo zixhunyiwe ukwenza isixhobo sokugqibela.

I-HME inikezela abaphuhlisi bemveliso yezixhobo zonyango, ukuchithwa kweefom zedosi yomlomo kunye nezixhobo zokucoca iziyobisi kunye nenkqubo yokukhetha ukwandisa i-API yokuxuba kunye ne-polymer, ngelixa inciphisa ukuthotywa kwe-API, kwaye ide ivule umnyango kwiimveliso ezingenakulungiswa ngezinye iindlela.


Ixesha lokuposa: Aug-01-2017