UJoseph Brama wasungula inqubo yokukhishwa kwamapayipi okuhola ngasekupheleni kwekhulu le-18.Kwaze kwaba maphakathi nekhulu le-19 lapho ubuchwepheshe be-hot-melt extrusion baqala ukusetshenziswa embonini yepulasitiki.Yaqala ukusetshenziswa ekukhiqizeni i-polymer coatings yezintambo zikagesi.Namuhla ubuchwepheshe be-hot melt extrusion busetshenziswa kabanzi hhayi kuphela ekukhiqizeni imikhiqizo ye-polymer, kodwa futhi ekukhiqizeni nasekuxubeni ama-polymers ngokwawo.Njengamanje, ngaphezu kwengxenye yemikhiqizo yepulasitiki, okuhlanganisa izikhwama zepulasitiki, amashidi epulasitiki namapayipi epulasitiki, akhiqizwa kusetshenziswa le nqubo.
Kamuva, lobu buchwepheshe bavela kancane kancane emkhakheni wezokwelapha futhi kancane kancane baba ubuchwepheshe obubalulekile.Manje abantu basebenzisa ubuchwepheshe be-hot-melt extrusion ukuze balungise ama-granules, amaphilisi akhishwa njalo, isistimu yokulethwa kwezidakamizwa e-transdermal kanye ne-transmucosal njll. Kungani abantu bekhetha lobu buchwepheshe manje?Isizathu ngokuyinhloko yingoba uma kuqhathaniswa nenqubo yokukhiqiza yendabuko esikhathini esidlule, ubuchwepheshe be-hot melt extrusion bunalezi zinzuzo ezilandelayo:
Thuthukisa izinga lokuqedwa kwezidakamizwa ezingancibiliki kahle
Kunezinzuzo zokulungiselela ukwakheka kokukhishwa okuqhubekayo
Ukulungiswa kwama-agent okukhululwa kwamathumbu ngokuma okunembile
Thuthukisa ukucindezelwa kwe-excipient
Inqubo yokusika yenziwa ngesinyathelo esisodwa
Vula indlela entsha yokulungiswa kwama-micropellets
Phakathi kwabo, i-cellulose ether idlala indima ebalulekile kule nqubo, ake sibheke ukusetshenziswa kwe-cellulose ether yethu kuyo!
Ukusetshenziswa kwe-ethyl cellulose
I-Ethyl cellulose iwuhlobo lwe-hydrophobic ether cellulose.Emkhakheni wezokwelapha, manje usesetshenziswa ku-microencapsulation yezinto ezisebenzayo, i-solvent kanye ne-extrusion granulation, i-tablet piping kanye njengendawo yokumboza amaphilisi okukhululwa okulawulwayo kanye nobuhlalu.I-Ethyl cellulose ingandisa izisindo zamangqamuzana ahlukahlukene.Izinga lokushisa lokushintsha kwengilazi yalo lingu-129-133 degrees Celsius, futhi indawo yayo yokuncibilika kwekristalu ingaphansi kuka-180 degrees Celsius.I-Ethyl cellulose iyisinqumo esihle se-extrusion ngoba ikhombisa izakhiwo ze-thermoplastic ngaphezu kwezinga lokushisa lokushintsha kwengilazi nangaphansi kwezinga lokushisa eliwohlokayo.
Ukuze wehlise izinga lokushisa lokuguqulwa kwengilazi lama-polymers, indlela ejwayelekile kakhulu yokwengeza ama-plasticizers, ngakho-ke ingacutshungulwa ekushiseni okuphansi.Ezinye izidakamizwa zingasebenza njengama-plasticizers ngokwazo, ngakho-ke asikho isidingo sokuphinda wengeze ama-plasticizers ngesikhathi senqubo yokwakhiwa kwezidakamizwa.Isibonelo, kwatholakala ukuthi amafilimu akhishiwe aqukethe ibuprofen ne-ethyl cellulose anezinga lokushisa eliphansi lokushintsha kwengilazi kunamafilimu aqukethe i-ethyl cellulose kuphela.Lawa mafilimu angenziwa elabhorethri ngama-tn-screw extruder ajikelezayo.Abacwaningi babuye bayigaya yaba yimpushana base benza ukuhlaziya okushisayo.Kwavela ukuthi ukwandisa inani le-ibuprofen kunganciphisa izinga lokushisa lokushintsha kwengilazi.
Okunye ukuhlola kwakuwukwengeza izisiza ze-hydrophilic, i-hypromellose, ne-xanthan gum ku-ethylcellulose ne-ibuprofen micromatrices.Kwaphethwa ngokuthi i-micromatrix ekhiqizwa indlela ye-hot-melt extrusion inephethini ehlala njalo yokumunca izidakamizwa kunemikhiqizo etholakalayo ethengiswayo.Abacwaningi bakhiqize i-micromatrix besebenzisa ukusethwa kwelabhorethri ejikelezayo kanye ne-twin-screw extruder ene-3-mm cylindrical die.Amashidi akhishwe ngesandla asikwe ngesandla abengu-2 mm ubude.
Ukusetshenziswa kwe-Hypromellose
IHydroxypropyl methylcellulose i-hydrophilic cellulose ether ekhukhumala ibe yisisombululo se-colloidal esicacile noma esinamafu kancane emanzini abandayo.Isixazululo esinamanzi sinomsebenzi ongaphezulu, ukukhanya okuphezulu nokusebenza okuzinzile.I-Solubility iyahlukahluka ngokuya nge-viscosity.I-viscosity ephansi, i-solubility enkulu.Izakhiwo ze-hydroxypropyl methylcellulose ezinemininingwane ehlukene zihlukile, futhi ukuchithwa kwayo emanzini akuthintwa inani le-pH.
Embonini yezemithi, kuvame ukusetshenziswa ekukhishweni kwe-matrix okulawulwayo, ekucubunguleni i-tablet coating, i-adhesive granulation, njll. Izinga lokushisa lokushintsha kwengilazi le-hydroxypropyl methylcellulose liyi-160-210 degrees Celsius, okusho ukuthi uma lincike kwezinye izinto ezithatha indawo, izinga lokushisa layo lokuwohloka. ingaphezu kuka-250 degrees Celsius.Ngenxa yokushisa kwayo okuphezulu kokuguqulwa kwengilazi kanye nezinga lokushisa eliphansi lokuwohloka, ayisetshenziswa kakhulu kubuchwepheshe be-hot melt extrusion.Ukuze kwandiswe ububanzi bayo bokusetshenziswa, enye indlela iwukuhlanganisa kuphela inani elikhulu le-plasticizer enqubweni yokwakhiwa njengoba izazi ezimbili zasho, futhi usebenzise ukwakheka kwe-extrusion matrix isisindo sayo se-plasticizer okungenani singu-30%.
I-Ethylcellulose ne-hydroxypropylmethylcellulose ingahlanganiswa ngendlela eyingqayizivele ekulethweni kwezidakamizwa.Elinye lalawa mafomu omthamo ukusebenzisa i-ethylcellulose njengeshubhu langaphandle, bese ulungiselela i-hypromellose grade A ngokwehlukana.Isisekelo se-cellulose core.
Ishubhu ye-ethylcellulose ikhiqizwa kusetshenziswa i-hot-melt extrusion emshinini ojikelezayo endaweni yokucwaninga efaka i-tube yensimbi yokufa yensimbi, umnyombo wayo owenziwe ngesandla ngokushisa umhlangano kuze kube yilapho uncibilika, kulandelwa i-homogenization.Izinto eziwumgogodla zibe sezifakwa ngesandla epayipini.Inhloso yalolu cwaningo bekuwukuqeda umphumela wokuvela kwesinye isikhathi okwenzeka kumathebhulethi e-hydroxypropyl methylcellulose matrix.Abacwaningi abatholanga mehluko esilinganisweni sokukhululwa kwe-hydroxypropyl methylcellulose ye-viscosity efanayo, nokho, ukufaka esikhundleni se-hydroxypropyl methylcellulose nge-methylcellulose kuholele esilinganisweni sokukhululwa ngokushesha.
I-Outlook
Nakuba i-hot melt extrusion kuwubuchwepheshe obusha embonini yezemithi, idonse ukunakwa okuningi futhi isetshenziselwa ukuthuthukisa ukukhiqizwa kwamafomu nezinhlelo eziningi zemithamo ehlukene.Ubuchwepheshe be-hot-melt extrusion buye baba ubuchwepheshe obuhamba phambili ekulungiseleleni ukuhlakazeka okuqinile phesheya.Ngenxa yokuthi izimiso zayo zobuchwepheshe zifana nezindlela eziningi zokulungiselela, futhi iye yasetshenziswa kwezinye izimboni iminyaka eminingi futhi yaqongelela ulwazi oluningi, inamathemba entuthuko abanzi.Ngokujula kocwaningo, kukholakala ukuthi ukusetshenziswa kwalo kuzosandiswa.Ngesikhathi esifanayo, ubuchwepheshe be-hot-melt extrusion bunokuxhumana okuncane nezidakamizwa kanye nezinga eliphezulu lokuzenzekelayo.Ngemuva kokuguqukela embonini yezemithi, kukholakala ukuthi ukuguqulwa kwayo kwe-GMP kuzoshesha kakhulu.
Isikhathi sokuthumela: Dec-16-2022