Joseph Brama akagadzira extrusion process yekugadzirwa kwepombi dze lead mukupera kwezana ramakore rechi 18.Yakanga isiri kusvika pakati pezana ramakore rechi 19 apo tekinoroji yekupisa yakanyunguduka yakatanga kushandiswa muindasitiri yepurasitiki.Yakatanga kushandiswa mukugadzira insulating polymer coatings yewaya dzemagetsi.Nhasi inopisa melt extrusion tekinoroji inoshandiswa zvakanyanya kwete chete mukugadzirwa kwezvigadzirwa zvepolymer, asiwo mukugadzira nekusanganiswa kwemapolymer pachavo.Parizvino, inopfuura hafu yezvigadzirwa zvepurasitiki, kusanganisira mabhegi epurasitiki, mapepa epurasitiki uye mapaipi epurasitiki, anogadzirwa achishandisa nzira iyi.
Gare gare, tekinoroji iyi yakabuda zvishoma nezvishoma mumunda wemishonga uye zvishoma nezvishoma yakava tekinoroji yakakosha.Iye zvino vanhu vanoshandisa tekinoroji yekupisa-yakanyungudika kugadzirira magranules, mahwendefa akaburitswa, transdermal uye transmucosal drug delivery system etc. Sei vanhu vachifarira tekinoroji iyi ikozvino?Chikonzero chikuru ndechekuti kana tichienzanisa neyechinyakare kugadzirwa maitiro munguva yakapfuura, inopisa melt extrusion tekinoroji ine zvinotevera zvakanakira:
Kuvandudza mwero wekuparara kwemishonga isinganyungudika
Pane zvakanakira kugadzirira kuenderera-kuburitswa mafomu
Kugadzirira kwegastrointestinal release agents vane nzvimbo yakarurama
Kuvandudza excipient compressibility
Iyo slicing process inowanikwa mune imwe nhanho
Vhura nzira itsva yekugadzirira kwema micropellets
Pakati pavo, cellulose ether inoita basa rakakosha mukuita uku, ngatitarisei mashandisirwo eether cellulose yedu mairi!
Kushandisa ethyl cellulose
Ethyl cellulose imhando yehydrophobic ether cellulose.Mumunda wemishonga, iye zvino ari kushandiswa mu microencapsulation yezvinhu zvinoshanda, solvent uye extrusion granulation, tablet piping uye sejasi rekudzivirira kusunungurwa mapiritsi uye mabhesi.Ethyl cellulose inogona kuwedzera akasiyana ma molecular uremu.Tembiricha yaro yekuchinja kwegirazi ndeye 129-133 madhigirii celsius, uye nzvimbo yayo yekunyungudika iri minus 180 degrees Celsius.Ethyl cellulose isarudzo yakanaka yeextrusion nekuti inoratidza thermoplastic zvivakwa pamusoro pegirazi rekuchinja tembiricha uye pasi pekushisa kwayo.
Kuti uderedze tembiricha yekuchinja kwegirazi yemapolymers, nzira yakajairika ndeyekuwedzera mapurasitiki, saka inogona kugadziriswa nekudzika kwakadzika.Mimwe mishonga inogona kuita seplasticizers pachavo, saka hapana chikonzero chekuwedzerazve mapurasitiki panguva yekugadzira mishonga.Semuyenzaniso, zvakaonekwa kuti mafirimu eextruded ane ibuprofen uye ethyl cellulose aive netembiricha yakaderera yegirazi pane mafirimu ane ethyl cellulose chete.Aya mafirimu anogona kugadzirwa murabhoritari ane anotenderedza mapatya-screw extruders.Vatsvakurudzi vakaikuyawo kuita hupfu uye vozoita kuongorora kupisa.Zvakazoitika kuti kuwedzera huwandu hwe ibuprofen kunogona kuderedza tembiricha yekuchinja kwegirazi.
Chimwe chiedzo chaive chekuwedzera hydrophilic excipients, hypromellose, uye xanthan chingamu kune ethylcellulose uye ibuprofen micromatrices.Izvo zvakagumiswa kuti iyo micromatrix inogadzirwa neiyo inopisa-yakanyungudika extrusion nzira yaive neyakagadzika zvinodhaka yekunyudza zvinodhaka pane zvigadzirwa zvinotengeswa.Vatsvakurudzi vakagadzira micromatrix vachishandisa co-inotenderera laboratory setup uye mapatya-screw extruder ine 3-mm cylindrical die.Mashizha akachekwa nemaoko aive akareba 2 mm.
Hypromellose kushandiswa
Hydroxypropyl methylcellulose is hydrophilic cellulose ether inozvimba kuita yakajeka kana kuti zvishoma ine makore colloidal solution mumvura inotonhora.Mushonga wemvura une basa repamusoro, kujeka kwepamusoro uye kushanda kwakagadzikana.Solubility inosiyana ne viscosity.Iyo yakaderera viscosity, iyo yakakura solubility.Izvo zvimiro zvehydroxypropyl methylcellulose zvine zvirevo zvakasiyana zvakasiyana, uye kunyungudika kwayo mumvura hakukanganiswe neiyo pH kukosha.
Muindasitiri yemishonga, inowanzoshandiswa mukudzorwa kusunungurwa matrix, tablet coating processing, adhesive granulation, etc. The glass transition tembiricha yehydroxypropyl methylcellulose is 160-210 degrees Celsius, zvinoreva kuti kana ikavimba nezvimwe zvinotsiva, kushatisa kwayo tembiricha. inopfuura 250 degrees Celsius.Nekuda kweiyo yakakwirira girazi tembiricha tembiricha uye yakaderera degradation tembiricha, haina kunyanya kushandiswa mukupisa melt extrusion tekinoroji.Kuti uwedzere huwandu hwayo hwekushandisa, imwe nzira ndeyekungobatanidza huwandu hukuru hweplasticizer mukugadzira sezvakataurwa nenyanzvi mbiri, uye kushandisa extrusion matrix formula iyo huremu hweplasticizer hunosvika makumi matatu muzana.
Ethylcellulose uye hydroxypropylmethylcellulose inogona kusanganiswa nenzira yakasarudzika mukuunza zvinodhaka.Imwe yeaya mafomu ekuyedza ndeye kushandisa ethylcellulose sechubhu yekunze, uye wozogadzira hypromellose giredhi A zvakasiyana.Base cellulose core.
Iyo ethylcellulose tubing inogadzirwa uchishandisa inopisa-yakanyunguduka extrusion mumuchina unotenderedza murabhoritari uchipinza simbi mhete kufa chubhu, iyo musimboti inogadzirwa nemaoko nekupisa gungano kusvika yanyungudika, ichiteverwa nehomogenization.Iyo yakakosha zvinhu zvinobva zvapinzwa nemaoko mupombi.Chinangwa chechidzidzo ichi chaive chekubvisa mhedzisiro yekubuda iyo dzimwe nguva inoitika muhydroxypropyl methylcellulose matrix mapiritsi.Vatsvagiri havana kuwana mutsauko mukuburitswa kwehydroxypropyl methylcellulose yeiyo viscosity yakafanana, zvisinei, kutsiva hydroxypropyl methylcellulose nemethylcellulose kwakakonzera kukurumidza kuburitswa.
Outlook
Kunyangwe kupisa kunyungudika extrusion iri tekinoroji nyowani muindasitiri yemishonga, yakakwezva kutarisisa kwakawanda uye inoshandiswa kuvandudza kugadzirwa kweakawanda akasiyana dosage mafomu uye masisitimu.Hot-melt extrusion tekinoroji yave inotungamira tekinoroji yekugadzirira kupararira kwakasimba kunze kwenyika.Nekuti misimboti yayo yehunyanzvi yakafanana nenzira dzakawanda dzekugadzirira, uye yakashandiswa mune mamwe maindasitiri kwemakore mazhinji uye yakaunganidza ruzivo rwakawanda, ine tarisiro yakakura yebudiriro.Nekudzika kwetsvagiridzo, zvinotendwa kuti mashandisirwo ayo achazowedzerwa.Panguva imwecheteyo, iyo inopisa-yakanyunguduka extrusion tekinoroji ine zvishoma kusangana nemishonga uye yakakwirira yeautomation.Mushure mekuchinja kuenda kuindasitiri yemishonga, zvinotendwa kuti shanduko yayo yeGMP ichave yakakurumidza.
Nguva yekutumira: Zvita-16-2022