UJoseph Brama wasungula inqubo yokukhishwa kwe-Extrusion yokukhiqizwa kwamapayipi okuhola ngasekupheleni kwekhulu le-18. Kwakungekho kuze kube maphakathi nekhulu le-19 lelo phepha le-Hot-Melt Extt liqale ukusetshenziswa embonini yePlastics. Yaqala ukusetshenziselwa ukukhiqizwa kokufakwa kwe-polymer izigqoko zokufaka izintambo zikagesi. Namuhla ubuchwepheshe bokukhishwa okushisayo busetshenziswa kabanzi hhayi kuphela ekukhiqizweni kwemikhiqizo ye-polymer, kodwa futhi nasekukhiqizweni nasekuxubeni kwama-polymers ngokwawo. Njengamanje, ngaphezu kwengxenye yemikhiqizo yepulasitiki, kufaka phakathi izikhwama zepulasitiki, amashidi epulasitiki namapayipi epulasitiki, akhiqizwa kusetshenziswa le nqubo.
Kamuva, lobu buchwepheshe buvele kancane emkhakheni wezemithi futhi kancane kancane baba ubuchwepheshe obusemqoka. Manje abantu basebenzisa ubuchwepheshe bokukhishwa okushisayo kwe-Hot-Melt ukulungiselela ama-granules, amaphilisi wokukhishwa kwezidakamizwa, uhlelo lokulethwa kwezidakamizwa kanye ne-transmucosal nezidakamizwa njll Kungani abantu bekhetha lobu buchwepheshe manje? Isizathu ikakhulukazi siqhathaniswa nenqubo yokukhiqiza yendabuko esikhathini esedlule, ubuchwepheshe bokukhishwa okushisayo okushisayo bunezinzuzo ezilandelayo:
Thuthukisa izinga lokuchithwa kwezidakamizwa ezingenampilo kabi
Kunezinzuzo zokulungiselela ukwakheka kokukhishwa okuqhubekayo
Ukulungiselela ama-gastrointestinal agents agents anokuma okunembile
Thuthukisa ukucindezelwa kwe-exepunt
Inqubo yokusika itholwa ngesinyathelo esisodwa
Vula indlela entsha yokulungiswa kwama-micropellets
Phakathi kwazo, i-ether ye-cellulose idlala indima ebalulekile kule nqubo, ake sibheke ukusetshenziswa kwe-ether yethu ye-cellulose kuyo!
Ukusetshenziswa kwe-ethyl cellulose
I-Ethyl cellulose uhlobo lwe-hydrophobic ether cellulose. Ensimini yezemithi, manje usesetshenziswa ku-microancekalation yezinto ezisebenzayo, i-solvent kanye ne-detlence granution, amapayipi wethebulethi kanye nokuhlanganiswa kwamathebulethi okukhishwa alawulwayo kanye nobuhlalu. I-Ethyl cellulose ingakhuphula izinsimbi ezahlukahlukene zamangqamuzana. Amazinga okushisa alo wokuguqula ama-glass angu-129-133 degrees Celsius, kanye nephuzu lawo le-crystal incity lisusa ama-degree angama-180. I-Ethyl cellulose iyisinqumo esihle sokukhishwa ngoba ikhombisa izakhiwo ze-thermoplastic ngaphezulu kwamazinga okushisa alo okushisa futhi ngaphansi kokushisa kwayo kokuwohloka kwayo.
Ukuze wehlise izinga lokushisa le-glass lama-polymers, indlela evame kakhulu ukwengeza amapulasitiki, ngakho-ke kungacutshungulwa emazingeni okushisa aphansi. Ezinye izidakamizwa zingasebenza njengamapulasitiki ngokwazo, ngakho-ke asikho isidingo sokufaka kabusha amapulasitiki ngesikhathi senqubo yokwakhiwa kwezidakamizwa. Isibonelo, kutholakale ukuthi amafilimu anwebekayo aqukethe i-ibuprofen ne-ethyl cellulose ayenokushisa okuphansi kwengilazi okuphansi kunamafilimu aqukethe kuphela ama-ethyl cellulose. Lawa mafilimu angenziwa ebhulathri nge-Twin-Screw Extuders ejikelezayo. Abaphenyi baphinde bayithobe ibe yimpuphu bese benza ukuhlaziya okushisayo. Kwavela ukuthi ukwandisa inani le-Ibuprofen kunganciphisa izinga lokushisa kwengilazi.
Okunye ukuhlola kwakuwukufaka ama-hydrophilic excipients, i-hypromeellose, kanye ne-xanthan gum ku-ethylcellose kanye ne-ibuprofen ama-mistratfs. Kwaphethwa ngokuthi i-micromatrix ekhiqizwe yinqubo eshisayo eshisayo eshisayo yayinephethini lokufakwa kwezidakamizwa njalo kunemikhiqizo etholakala kwezohwebo. Abaphenyi bakhiqiza i-Micromatrix besebenzisa ukusetha kwelebhu okujikelezayo kanye ne-twin-screw extruder nge-3-mm cylindrical die. Amashidi asikiwe ngesandla ayengama-2 mm ubude.
Ukusetshenziswa kwe-Hypromellose
I-Hydroxypropylm methylcellulose iyi-hydrophilic cellulose ether evuvukala ibe yisixazululo esicacile noma esinamafu kancane emanzi abandayo. Isixazululo samanzi sinomsebenzi ongaphezulu, ukucaca okuphezulu nokusebenza okuzinzile. I-Solubolity iyahlukahluka nge-viscosity. Ukwehlisa ukubonakala, kukhudlwana ukubola. Izakhiwo ze-hydroxypropyll methylcellose ezinokucaciswa okuhlukile zihlukile, futhi ukuchithwa kwalo emanzini akuphazamiseki ngenani le-PH.
Embonini yezemithi, imvamisa isetshenziswa ku-matrix elawulwa ukukhishwa, ukucubungula amathebhulethi, njll. Ukushisa kwengilazi kwe-methylcellulose, okusho ukuthi uma kuncike kwamanye ama-degrees angama-250 Celsius. Ngenxa yokushisa kwayo okuphezulu kwengilazi okushisa nokushisa okuwohloka okuphansi, akusetshenziswa kabanzi kubuchwepheshe bokukhishwa okushisayo okushisayo. Ukuze wandise ububanzi bawo bokusebenzisa, indlela eyodwa ukuhlanganisa inani elikhulu lesenzi enqubweni yokwakhiwa njengoba izazi ezimbili zisho, futhi zisebenzisa ukwakheka kwe-matrix yesisindo esingu-30%.
Ethylcellose kanye hydroxypropylethlellellellellellellulose kungahlanganiswa ngendlela ehlukile ekulethweni kwezidakamizwa. Enye yalezi zinhlobo zama-dosage ukusebenzisa i-ethylcellose njenge-tube yangaphandle, bese ilungiselela i-hypromellose grade yodwa. Isisekelo umnyombo we-cellulose.
I-ethylcellose tubing ikhiqizwa kusetshenziswa ukukhishwa okushisayo emshinini wokujikeleza kwelabhoratri afaka indandatho yensimbi die tube, umnyombo owenziwe ngesandla ngokushisa umhlangano kuze kube yilapho kuncibilika, kulandelwa yi-homogenization. Izinto ezibalulekile zizondla ngesandla ngepayipi. Inhloso yalolu cwaningo bekuwukuqeda umphumela wokuphuma kwesinye isikhathi kwenzeka kuma-hydroxypropylyllyllose matrix amaphilisi matrix. Abaphenyi bathola umehluko ngezinga lokukhishwa kwe-hydroxypropyllll methylcellulose ngokubonakala okufanayo, noma kunjalo, ukufaka esikhundleni i-hydroxyproty methylcellulose nge-methylcellulose kuholele esilinganisweni sokukhululwa esisheshayo.
Okuzayo
Yize ukukhishwa okushisayo kuncibilika ubuchwepheshe obusha emkhakheni wezemithi, kudonsele ukunakwa okuningi futhi kusetshenziselwa ukwenza ngcono ukukhiqizwa kwamafomu amaningi nezinhlelo ezahlukahlukene. Ubuchwepheshe bokukhishwa okushisayo buye baba ubuchwepheshe obuphambili bokulungiselela ukuhlukahluka okuqinile phesheya. Ngoba izimiso zayo zobuchwepheshe zifana nezindlela eziningi zokulungiselela, futhi kusetshenziswe kwezinye izimboni iminyaka eminingi futhi kwaqongelela okuhlangenwe nakho okuningi, kunamathuba okuthuthuka okubanzi. Ngokujula kocwaningo, kukholelwa ukuthi uhlelo lwayo luzokwandiswa futhi. Ngasikhathi sinye, ubuchwepheshe bokukhishwa okushisayo buye bakwazi ukuxhumana okuncane nezidakamizwa kanye nezinga eliphakeme lokuzenzakalela. Ngemuva kokuguqukela embonini yezemithi, kukholakala ukuthi ushintsho lwayo lwe-GMP luzoshesha.
Isikhathi sePosi: Feb-14-2025