Joseph Brama o ile a qapa mokhoa oa extrusion bakeng sa tlhahiso ea liphaephe tsa loto qetellong ea lekholo la bo18 la lilemo. E bile bohareng ba lekholo la bo19 la lilemo moo theknoloji ea extrusion ea hot-melt e ileng ea qala ho sebelisoa indastering ea polasetiki. E ile ea sebelisoa ka lekhetlo la pele ha ho etsoa liaparo tsa polymer tsa insulating bakeng sa lithapo tsa motlakase. Kajeno theknoloji ea hot melt extrusion e sebelisoa haholo eseng feela tlhahiso ea lihlahisoa tsa polymer, empa hape le tlhahiso le ho kopanya li-polymer ka botsona. Hona joale, ho feta halofo ea lihlahisoa tsa polasetiki, ho kenyelletsa le mekotla ea polasetiki, liphaephe tsa polasetiki le liphaephe tsa polasetiki li hlahisoa ka mokhoa ona.
Hamorao, theknoloji ena e ile ea hlaha butle-butle lefapheng la meriana 'me butle-butle ea fetoha theknoloji ea bohlokoahali. Hona joale batho ba sebelisa theknoloji ea hot-melt extrusion ho lokisa li-granules, matlapa a tsoelang pele a lokolloa, tsamaiso ea transdermal le transmucosal drug delivery etc. Ke hobane'ng ha batho ba khetha theknoloji ee hona joale? Lebaka ke hobane ha ho bapisoa le mokhoa oa khale oa tlhahiso ea nakong e fetileng, theknoloji ea hot melt extrusion e na le melemo e latelang:
Ntlafatsa sekhahla sa ho qhala ha lithethefatsi tse sa qhibiliheng hantle
Ho na le melemo ea ho lokisa li-formulation tse sa khaotseng
Tokisetso ea li-agent tsa ho lokolloa ha gastrointestinal tse nang le boemo bo nepahetseng
Ntlafatsa compressibility ea bohlokoa
Ts'ebetso ea slicing e phethahala ka mohato o le mong
Bula tsela e ncha ea ho lokisa li-micropellets
Har'a bona, cellulose ether e phetha karolo ea bohlokoa ts'ebetsong ena, a re ke re hlahlobeng tšebeliso ea cellulose ether ea rona ho eona!
Tšebeliso ea ethyl cellulose
Ethyl cellulose ke mofuta oa hydrophobic ether cellulose. Lefapheng la meriana, hona joale o sebelisoa ho microencapsulation ea lintho tse sebetsang, solvent le extrusion granulation, piping ea letlapa le ho roala bakeng sa matlapa a laoloang le lifaha. Ethyl cellulose e ka eketsa boima ba limolek'hule tse fapaneng. Thempereichara ea phetoho ea khalase ea eona ke likhato tse 129-133 tsa Celsius, 'me sebaka sa eona sa ho qhibiliha sa kristale ke likhato tse 180 tsa Celsius. Ethyl cellulose ke khetho e ntle bakeng sa extrusion hobane e bonts'a thepa ea thermoplastic ka holim'a mocheso oa eona oa phetoho ea khalase le ka tlase ho mocheso oa eona oa ho senyeha.
E le ho fokotsa mocheso oa phetoho ea khalase ea li-polymers, mokhoa o tloaelehileng ka ho fetisisa ke ho eketsa li-plasticizers, kahoo li ka sebetsoa ka mocheso o tlaase. Lithethefatsi tse ling li ka sebetsa e le li-plasticizers ka botsona, ka hona ha ho hlokahale ho eketsa li-plasticizers nakong ea ts'ebetso ea ho etsa lithethefatsi. Ka mohlala, ho ile ha fumanoa hore lifilimi tse fetisitsoeng tse nang le ibuprofen le ethyl cellulose li na le mocheso o fokolang oa phetoho ea khalase ho feta lifilimi tse nang le ethyl cellulose feela. Lifilimi tsena li ka etsoa ka laboratoring ka li-extruder tse potolohang mafahla. Bafuputsi le bona ba ile ba e sila hore e be phofo ebe ba etsa tlhahlobo ea mocheso. Ho ile ha fumaneha hore ho eketsa bongata ba ibuprofen ho ka fokotsa mocheso oa phetoho ea khalase.
Teko e 'ngoe e ne e le ho eketsa li-excipients tsa hydrophilic, hypromellose, le xanthan gum ho ethylcellulose le ibuprofen micromatrices. Ho ile ha fihleloa qeto ea hore micromatrix e hlahisoang ke mokhoa oa ho chesa-hot-melt extrusion o ne o e-na le mokhoa o tsitsitseng oa ho monya lithethefatsi ho feta lihlahisoa tse fumanehang khoebong. Bafuputsi ba hlahisitse micromatrix ba sebelisa setupo sa laboratori e potolohang le "twin-screw extruder" e nang le "cylindrical die" ea 3-mm. Maqephe a khaotsoeng ka letsoho a ne a le bolelele ba 2 mm.
Tšebeliso ea hypromellose
Hydroxypropyl methylcellulose ke hydrophilic cellulose ether e ruruhileng ho ba tharollo ea colloidal e hlakileng kapa e nang le maru hanyane metsing a batang. Tharollo ea metsi e na le mosebetsi oa holim'a metsi, pepeneneng e phahameng le ts'ebetso e tsitsitseng. Sollubility e fapana ho ea ka viscosity. The viscosity e ka tlaase, e kholoanyane ea ho qhibiliha. Thepa ea hydroxypropyl methylcellulose e nang le litlhaloso tse fapaneng e fapane, 'me ho qhibiliha ha eona metsing ha ho amehe ke boleng ba pH.
Ka indasteri ea meriana, e atisa ho sebelisoa ka matrix a lokolloang a laoloang, ts'ebetso ea ho roala letlapa, granulation ea sekhomaretsi, joalo-joalo Mocheso oa phetoho ea khalase ea hydroxypropyl methylcellulose ke 160-210 likhato tsa Celsius, e bolelang hore haeba e itšetlehile ka tse ling tse ling, mocheso oa eona oa ho senyeha. ho feta likhato tse 250 tsa Celsius. Ka lebaka la mocheso oa eona o phahameng oa phetoho ea likhalase le mocheso o tlaase oa ho senyeha, ha e sebelisoe haholo theknoloji ea hot melt extrusion. E le ho atolosa sebaka sa eona sa tšebeliso, mokhoa o le mong ke ho kopanya feela palo e kholo ea polasetiki ka mokhoa oa ho etsoa ha litsebi tse peli li boletse, 'me u sebelise tlhahiso ea matrix ea extrusion eo boima ba eona ba plasticizer e leng bonyane 30%.
Ethylcellulose le hydroxypropylmethylcellulose li ka kopanngoa ka tsela e ikhethang ha ho fanoa ka lithethefatsi. E 'ngoe ea mefuta ena ea litekanyetso ke ho sebelisa ethylcellulose e le tube e ka ntle, ebe o lokisa hypromellose grade A ka thoko. Base cellulose core.
The ethylcellulose tubing e hlahisoa ka ho sebelisa extrusion e chesang-e qhibilihang ka mochine o potolohang ka laboratoring e kenyang lesale la tšepe la tšepe, e leng motheo oa eona o entsoeng ka letsoho ka ho futhumatsa kopano ho fihlela e qhibiliha, e lateloa ke homogenization. Thepa ea mantlha e feptjoa ka letsoho ka har'a phaephe. Sepheo sa thuto ena e ne e le ho felisa phello ea popping eo ka linako tse ling e hlahang matlapeng a matrix a hydroxypropyl methylcellulose. Bafuputsi ha ba fumane phapang ea sekhahla sa tokollo bakeng sa hydroxypropyl methylcellulose ea viscosity e tšoanang, leha ho le joalo, ho nkela hydroxypropyl methylcellulose ka methylcellulose ho felletse ka sekhahla sa tokollo ka potlako.
Maikutlo
Le hoja hot melt extrusion e le thekenoloji e batlang e le ncha indastering ea meriana, e hohetse tlhokomelo e ngata 'me e sebelisetsoa ho ntlafatsa tlhahiso ea mefuta le mekhoa e mengata e fapaneng ea litekanyetso. Theknoloji ea extrusion ea hot-melt e fetohile theknoloji e ka sehloohong ea ho lokisetsa ho hasana ho tiileng linaheng tse ling. Hobane melao-motheo ea eona ea tekheniki e tšoana le mekhoa e mengata ea ho itokisa, 'me e sebelisitsoe liindasteri tse ling ka lilemo tse ngata' me e bokelletse boiphihlelo bo bongata, e na le litebello tse pharaletseng tsa nts'etsopele. Ka ho teba ha lipatlisiso, ho lumeloa hore ts'ebeliso ea eona e tla atolosoa le ho feta. Ka nako e ts'oanang, theknoloji ea hot-melt extrusion e na le kamano e fokolang le lithethefatsi le tekanyo e phahameng ea ho iketsetsa. Kamora phetoho ho indasteri ea meriana, ho lumeloa hore phetoho ea eona ea GMP e tla ba kapele.
Nako ea poso: Dec-16-2022