Joseph Brama tau tsim cov txheej txheem extrusion rau kev tsim cov kav hlau lead hauv xyoo pua 18th.Nws tsis yog txog thaum nruab nrab ntawm lub xyoo pua 19th uas kub-melt extrusion tshuab pib siv nyob rau hauv kev lag luam yas.Nws yog thawj zaug siv nyob rau hauv zus tau tej cov insulating polymer coatings rau hluav taws xob nyob ntawm tej.Niaj hnub no kub yaj extrusion tshuab yog dav siv tsis tsuas yog nyob rau hauv zus tau tej cov polymer cov khoom, tab sis kuj nyob rau hauv zus tau tej cov thiab sib tov ntawm polymers lawv tus kheej.Tam sim no, ntau tshaj li ib nrab ntawm cov khoom siv yas, suav nrog cov hnab yas, cov ntawv yas thiab cov kav dej yas, tau tsim los siv cov txheej txheem no.
Tom qab ntawd, cov cuab yeej no maj mam tshwm sim hauv thaj chaw kws tshuaj thiab maj mam dhau los ua cov cuab yeej siv tsis tau.Tam sim no tib neeg siv cov tshuab kub-melt extrusion los npaj granules, sustained-tso ntsiav tshuaj, transdermal thiab transmucosal tshuaj xa system thiab lwm yam. Vim li cas tib neeg nyiam cov tshuab tam sim no?Qhov laj thawj yog vim li cas piv nrog cov txheej txheem ntau lawm yav dhau los, kub yaj extrusion tshuab muaj qhov zoo hauv qab no:
Txhim kho tus nqi dissolution ntawm cov tshuaj tsis zoo soluble
Muaj qhov zoo rau kev npaj cov qauv tsim tawm-tso tawm
Kev npaj cov tshuaj tua kab mob hauv plab nrog rau qhov tseeb
Txhim kho excipient compressibility
Cov txheej txheem slicing yog paub nyob rau hauv ib kauj ruam
Qhib txoj kev tshiab rau kev npaj ntawm micropellets
Ntawm lawv, cellulose ether plays lub luag haujlwm tseem ceeb hauv cov txheej txheem no, cia peb saib ntawm daim ntawv thov ntawm peb cov cellulose ether hauv nws!
Kev siv ethyl cellulose
Ethyl cellulose yog ib hom hydrophobic ether cellulose.Hauv kev lag luam tshuaj, tam sim no nws tau siv rau hauv microencapsulation ntawm cov tshuaj nquag, hnyav thiab extrusion granulation, ntsiav tshuaj piping thiab ua cov txheej txheem rau cov ntsiav tshuaj tso tawm thiab cov hlaws dai.Ethyl cellulose tuaj yeem nce ntau qhov hnyav molecular.Nws cov iav hloov pauv kub yog 129-133 degrees Celsius, thiab nws cov crystal melting point yog rho tawm 180 degrees Celsius.Ethyl cellulose yog ib qho kev xaiv zoo rau extrusion vim nws nthuav tawm cov khoom siv thermoplastic saum nws cov iav hloov kub thiab qis dua nws qhov kub degradation.
Txhawm rau txo cov iav hloov pauv kub ntawm cov polymers, txoj kev siv ntau tshaj yog ntxiv cov yas yas, yog li nws tuaj yeem ua tiav ntawm qhov kub thiab txias.Qee cov tshuaj muaj peev xwm ua tau raws li plasticizers lawv tus kheej, yog li tsis tas yuav rov ntxiv cov yas yas thaum lub sij hawm tsim cov tshuaj.Piv txwv li, nws tau pom tias cov yeeb yaj kiab extruded uas muaj ibuprofen thiab ethyl cellulose muaj qhov hloov pauv iav qis dua li cov yeeb yaj kiab uas muaj ethyl cellulose nkaus xwb.Cov yeeb yaj kiab no tuaj yeem ua rau hauv chav kuaj nrog kev sib koom ua ke ntxaib-ntsia hlau extruders.Cov kws tshawb fawb kuj tau muab nws tso rau hauv cov hmoov thiab tom qab ntawd ua qhov ntsuas cua sov.Nws tau muab tawm tias nce tus nqi ntawm ibuprofen tuaj yeem txo cov iav hloov pauv kub.
Lwm qhov kev sim yog ntxiv hydrophilic excipients, hypromellose, thiab xanthan gum rau ethylcellulose thiab ibuprofen micromatrices.Nws tau txiav txim siab tias cov micromatrix uas tsim los ntawm cov txheej txheem kub-melt extrusion muaj cov qauv kev nqus tshuaj ntau dua li cov khoom lag luam.Cov kws tshawb fawb tau tsim cov micromatrix siv cov kev sib koom ua ke ntawm kev sim teeb tsa thiab lub ntxaib-ntsia hlau extruder nrog 3-mm cylindrical tuag.Tes txiav extruded nplooj ntawv yog 2 hli ntev.
Kev siv hypromellose
Hydroxypropyl methylcellulose yog hydrophilic cellulose ether uas swells mus rau hauv ib qho ntshiab los yog me ntsis cloudy colloidal tov nyob rau hauv dej txias.Cov tshuaj aqueous muaj cov dej num saum npoo av, siab pob tshab thiab kev ua haujlwm ruaj khov.Solubility sib txawv nrog viscosity.Qhov qis dua qhov viscosity, qhov ntau dua qhov solubility.Cov khoom ntawm hydroxypropyl methylcellulose nrog cov kev qhia tshwj xeeb sib txawv yog qhov sib txawv, thiab nws qhov kev sib cais hauv dej tsis cuam tshuam los ntawm tus nqi pH.
Hauv kev lag luam kws tshuaj, feem ntau yog siv rau hauv kev tswj kev tso tawm matrix, ntsiav tshuaj txheej ua, nplaum granulation, thiab lwm yam. Lub iav hloov kub ntawm hydroxypropyl methylcellulose yog 160-210 degrees Celsius, uas txhais tau hais tias yog nws tso siab rau lwm yam hloov, nws qhov kub thiab txias degradation. kub tshaj 250 degrees Celsius.Vim nws qhov kub hloov pauv ntawm iav siab thiab qis degradation kub, nws tsis yog dav siv nyob rau hauv kub yaj extrusion tshuab.Txhawm rau nthuav dav nws txoj kev siv, ib txoj hauv kev tsuas yog ua ke ntau ntawm cov yas yas hauv cov txheej txheem tsim raws li ob tus kws tshawb fawb tau hais, thiab siv cov txheej txheem extrusion matrix uas nws qhov hnyav ntawm plasticizer tsawg kawg yog 30%.
Ethylcellulose thiab hydroxypropylmethylcellulose tuaj yeem ua ke hauv ib txoj hauv kev tshwj xeeb hauv kev xa cov tshuaj.Ib qho ntawm cov ntaub ntawv no yog siv ethylcellulose raws li lub raj sab nrauv, thiab tom qab ntawd npaj hypromellose qib A cais.Base cellulose core.
Lub ethylcellulose tubing yog tsim los siv kub-melt extrusion nyob rau hauv lub co-rotating tshuab nyob rau hauv lub laboratory inserting ib tug hlau nplhaib tuag raj, cov tub ntxhais ntawm uas yog ua manually los ntawm cua sov lub rooj sib txoos kom txog rau thaum nws melts, ua raws li los ntawm homogenization.Tom qab ntawd cov khoom tseem ceeb yog manually pub rau hauv lub raj xa dej.Lub hom phiaj ntawm txoj kev tshawb no yog txhawm rau tshem tawm cov nyhuv ntawm popping uas qee zaum tshwm sim hauv cov ntsiav tshuaj hydroxypropyl methylcellulose matrix.Cov kws tshawb nrhiav pom tsis muaj qhov sib txawv ntawm qhov tso tawm rau hydroxypropyl methylcellulose ntawm tib lub viscosity, txawm li cas los xij, hloov hydroxypropyl methylcellulose nrog methylcellulose ua rau muaj kev tso tawm sai dua.
Outlook
Txawm hais tias kub yaj extrusion yog ib qho tshiab thev naus laus zis hauv kev lag luam kws tshuaj, nws tau nyiam ntau cov xim thiab siv los txhim kho cov khoom ntawm ntau ntau hom tshuaj thiab tshuab.Kub-melt extrusion tshuab tau dhau los ua cov thev naus laus zis rau kev npaj cov khoom dispersion txawv teb chaws.Vim tias nws cov txheej txheem kev ua haujlwm zoo ib yam li ntau txoj hauv kev npaj, thiab nws tau siv rau hauv lwm qhov kev lag luam rau ntau xyoo thiab tau txais kev paub ntau, nws muaj kev loj hlob dav dav.Nrog rau kev tshawb fawb tob zuj zus, nws ntseeg tias nws daim ntawv thov yuav nthuav dav ntxiv.Nyob rau tib lub sijhawm, cov tshuab kub-melt extrusion tshuab muaj kev sib cuag nrog cov tshuaj tsawg thiab muaj kev ua haujlwm siab.Tom qab kev hloov pauv mus rau kev lag luam tshuaj, nws ntseeg tias nws qhov kev hloov pauv ntawm GMP yuav nrawm heev.
Post lub sij hawm: Dec-16-2022