UJoseph Brama wasungula inkqubo yokukhutshwa kokuveliswa kwemibhobho ekhokelayo ngasekupheleni kwenkulungwane ye-18.Kwakungekho phakathi kwenkulungwane ye-19 apho iteknoloji ye-hot-melt extrusion yaqala ukusetyenziswa kwishishini leplastiki.Yaqala ukusetyenziswa kwimveliso ye-polymer yokugquma i-coatings kwiingcingo zombane.Namhlanje iteknoloji ye-extrusion ye-hot melt extrusion isetyenziswa ngokubanzi kungekuphela nje kwimveliso yeepolymer, kodwa nakwimveliso kunye nokuxuba iipolymers ngokwazo.Okwangoku, ngaphezu kwesiqingatha seemveliso zeplastiki, kubandakanywa iingxowa zeplastiki, amaphepha eplastiki kunye nemibhobho yeplastiki, ziveliswa ngokusebenzisa le nkqubo.
Emva kwexesha, le teknoloji yavela ngokuthe ngcembe kwicandelo lamayeza kwaye ngokuthe ngcembe yaba yitekhnoloji eyimfuneko.Ngoku abantu basebenzisa itekhnoloji ye-hot-melt extrusion ukuze balungiselele iigranules, iipilisi ezizinzileyo, i-transdermal kunye ne-transmucosal drug delivery system etc. Kutheni abantu bekhetha le teknoloji ngoku?Isizathu ikakhulu kukuba xa kuthelekiswa nenkqubo yemveli yemveliso kwixesha elidlulileyo, itekhnoloji yokunyibilika eshushu enyibilikayo inezi nzuzo zilandelayo:
Ukuphucula izinga lokuchithwa kwamachiza anganyibiliki kakuhle
Kukho izinto eziluncedo ekulungiseleleni imixube ekhutshwa ngokuzinzileyo
Ukulungiswa kwama-agent okukhululwa kwesisu kunye nokubeka ngokuchanekileyo
Phucula i-excipient compressibility
Inkqubo yokuqhawula iyenzeka kwinqanaba elinye
Vula indlela entsha yokulungiswa kwee-micropellets
Phakathi kwabo, i-cellulose ether idlala indima ebalulekileyo kule nkqubo, makhe sijonge ukusetyenziswa kwe-ether cellulose yethu kuyo!
Ukusetyenziswa kwe-ethyl cellulose
I-Ethyl cellulose luhlobo lwe-hydrophobic ether cellulose.Kwintsimi yamachiza, ngoku isetyenziselwa i-microencapsulation yezinto ezisebenzayo, i-solvent kunye ne-extrusion granulation, i-tablet piping kunye ne-coating for controlled release tablets and beads.I-Ethyl cellulose inokunyusa ubunzima obuhlukeneyo beemolekyuli.Iqondo lobushushu beglasi yalo liyi-129-133 degrees celcius, kwaye indawo yayo yokunyibilika kwekristale yi-180 degrees Celsius.I-Ethyl cellulose lukhetho olulungileyo lwe-extrusion kuba ibonisa iipropati ze-thermoplastic ngaphezu kobushushu beglasi yokutshintsha kunye nangaphantsi kobushushu bayo bokuthotywa.
Ukuze unciphise iqondo lokushisa lokutshintsha kweglasi yeepolymers, eyona ndlela ixhaphakileyo kukongeza iiplasticizers, ngoko inokucutshungulwa kwiqondo lokushisa eliphantsi.Amanye amachiza anokusebenza njenge-plasticizers ngokwawo, ngoko akukho mfuneko yokongeza i-plasticizers ngexesha lenkqubo yokuqulunqa ichiza.Ngokomzekelo, kwafunyaniswa ukuba iifilimu ezikhutshiweyo eziqulethe ibuprofen kunye ne-ethyl cellulose zineqondo lokushisa elisezantsi leglasi kuneefilimu eziqulethe i-ethyl cellulose kuphela.Ezi filimu zingenziwa kwibhubhoratri kunye ne-twin-screw extruders ezijikelezayo.Abaphandi baphinda bayigalela ibe ngumgubo baze bahlalutye i-thermal.Kwavela ukuba ukwandisa inani le-ibuprofen kunokunciphisa ubushushu beglasi.
Olunye uvavanyo lwalukukongeza i-hydrophilic excipients, i-hypromellose, kunye ne-xanthan gum kwi-ethylcellulose kunye ne-ibuprofen micromatrices.Kwagqitywa ekubeni i-micromatrix eveliswe ngobuchule be-hot-melt extrusion yayinepateni ethe gqolo yokufunxa ichiza kuneemveliso ezikhoyo kurhwebo.Abaphandi bavelise i-micromatrix ngokusebenzisa ukusekwa kwebhubhoratri ejikelezayo kunye ne-twin-screw extruder kunye ne-3-mm cylindrical die.Amaphepha akhutshiweyo asikwe ngesandla ayezi-2 mm ubude.
Ukusetyenziswa kwe-Hypromelose
IHydroxypropyl methylcellulose yi-hydrophilic cellulose ether ethi idumbe ibe sisinyibiliko esicacileyo okanye esinamafu kancinane kwi-colloidal kumanzi abandayo.Isisombululo samanzi sinomsebenzi ongaphezulu, ukukhanya okuphezulu kunye nokusebenza okuzinzileyo.Ukunyibilika kuyahluka kunye ne-viscosity.I-viscosity ephantsi, i-solubility enkulu.Iimpawu ze-hydroxypropyl methylcellulose ezineenkcazo ezahlukeneyo ziyahluka, kwaye ukuchithwa kwayo emanzini akuchaphazeli ixabiso le-pH.
Kwishishini lamachiza, lihlala lisetyenziswa kwi-matrix yokukhululwa elawulwayo, i-tablet coating processing, i-adhesive granulation, njl. Ukushisa kweglasi ye-hydroxypropyl methylcellulose yi-160-210 degrees Celsius, oku kuthetha ukuba ukuba ithembele kwezinye iindawo, ukushisa kwayo. ngaphezu kwama-250 degrees Celsius.Ngenxa yobushushu obuphezulu beglasi yokutshintsha kunye nobushushu obuphantsi bokuthotywa, ayisetyenziswa kakhulu kwitekhnoloji ye-hot melt extrusion.Ukuze kwandiswe ubungakanani bayo bokusetyenziswa, enye indlela kukudibanisa kuphela isixa esikhulu seplasticizer kwinkqubo yokuqulunqa njengoko abaphengululi babini batshoyo, kwaye usebenzise i-extrusion matrix formulation obunzima bayo beplastiizer buyi-30%.
I-Ethylcellulose kunye ne-hydroxypropylmethylcellulose inokudibaniswa ngendlela ekhethekileyo ekuhanjisweni kweziyobisi.Enye yezi fom zedosi kukusebenzisa i-ethylcellulose njengetyhubhu yangaphandle, kwaye emva koko ulungiselele i-hypromellose grade A ngokwahlukileyo.Isiseko se-cellulose core.
Iityhubhu ye-ethylcellulose iveliswa kusetyenziswa i-hot-melt extrusion kumatshini ojikelezayo kwilabhoratri efaka i-tube yentsimbi yokufa, ingundoqo eyenziwa ngesandla ngokufudumeza indibano ide inyibilike, ilandelwa yi-homogenization.Izinto ezingundoqo ke ngoko zondliwa ngesandla kumbhobho.Injongo yolu phononongo yayikukuphelisa impembelelo yokuphuma eyenzeka ngamanye amaxesha kwi-hydroxypropyl methylcellulose matrix tablets.Abaphandi abafumananga mahluko kwireyithi yokukhutshwa kwe-hydroxypropyl methylcellulose ye-viscosity efanayo, nangona kunjalo, ukubuyisela i-hydroxypropyl methylcellulose nge-methylcellulose kubangele ukukhutshwa ngokukhawuleza.
Outlook
Nangona i-hot melt extrusion ibuchwephesha obutsha kushishino loxubo lwamayeza, itsale umdla omkhulu kwaye isetyenziselwa ukuphucula imveliso yeendlela ezininzi ezahlukeneyo zedosi kunye neenkqubo.Itekhnoloji ye-Hot-melt extrusion iye yaba yeyona teknoloji iphambili yokulungiselela ukusasazwa okuqinileyo phesheya.Ngenxa yokuba imigaqo yayo yobugcisa ifana neendlela ezininzi zokulungiselela, kwaye isetyenziswe kwamanye amashishini iminyaka emininzi kwaye iqokelele amava amaninzi, inethuba elibanzi lophuhliso.Ngokunzulu kophando, kukholelwa ukuba isicelo salo siya kwandiswa ngakumbi.Ngelo xesha, iteknoloji ye-hot-melt extrusion inoqhagamshelwano oluncinci kunye neziyobisi kunye neqondo eliphezulu lokuzenzekelayo.Emva kokutshintshela kwishishini lamayeza, kukholelwa ukuba ukuguqulwa kwayo kwe-GMP kuya kukhawuleza.
Ixesha lokuposa: Dec-16-2022