Film Coating Process for Tablets

Iinkqubo yokwaleka tabletiguqula iipilisi ezikrwada zibe yimveliso ephucukileyo elungelelanisa ukusebenza kakuhle, ukuzinza, kunye nesibheno sesigulane.Ukugquma ifilimu, inyathelo elibalulekileyo, lifakela iipilisi ezinobumba obuncinci, obufanayo ukukhusela izithako ezisebenzayo zonyango (APIs), ukulawula ukukhutshwa kweziyobisi, ukuphucula i-aesthetics, kunye nokuphucula ukuthotyelwa kwesigulane.

I. UkuqondaIitafile ezigqunywe ngefilimu

Aifilimu icwecwe tabletluhlobo oluqinileyo lwedosi yomlomo egutyungelwe kuluhlu olucekethekileyo, olusekwe kwipolymer esebenza imisebenzi emininzi, ukusuka ekukhuseleni i-API ukuya ekwandiseni ukuginywa. Ngokungafaniyo neetafile ezingagqunywanga, ezisesichengeni sokonakala kwendalo.ifilimu yokwalekaibonelela ngomqobo okhuselayo, iphucula isibheno esibonakalayo ngombala kunye neglosi, kwaye inokuguqula iiprofayili zokukhutshwa kweziyobisi. Le nkqubo ayiyonto nje yokuthambisa; lutyando olukwinqanaba eliphezulu lobuchwepheshe oluqinisekisa ukuba iipilisi ziyahlangabezana nemigangatho engqongqo yolawulo ngelixa kujongwa iimfuno zezigulane. Iinkqubo yokugquma ifilimu kwiipilisiyamkelwa ngokubanzi ngenxa yokuguquguquka kwayo, ukuxhasa ukukhutshwa ngokukhawuleza (IR), ukulibaziseka-ukukhutshwa, okanye ukukhutshwa okuzinzileyo okwenziwa kwiinjongo ezithile zonyango.

II. IiNjongo eziManinzi zeItheyibhile Coating

Iinkqubo yokwaleka tabletIbaluleke kakhulu kwimveliso yamayeza, ebonelela ngeenzuzo ezifumaneka kwixesha elide, ukusebenza kwamachiza kunye namava esigulane. Nasi isizathu sokuba kubalulekile:

Imveliso kunye noZinzo loGcino:

Ukugquma ifilimuIkhusela ii-APIs kuxinzelelo lokusingqongileyo njengomswakama, ukukhanya, kunye neoksijini, enokubangela i-hydrolysis, i-oxidation, okanye i-photodegradation. Kwiziyobisi ezingevani nokufuma njenge-ranitidine hydrochloride, ii-polymers ezifana ne-polyvinyl alcohol (PVA) okanye i-Eudragit ziphucula uzinzo, zandisa ubomi beshelufu kunye nokugcina ukusebenza kakuhle ngexesha lokugcinwa.
Ngokuthintela utshintsho lomzimba njengokuvuvukala okanye ukuqhekeka, iingubo ziqinisekisa ukuba iipilisi zihlala zilungile ngaphakathi kokupakishwa, zigcina ingqibelelo yemveliso.

Iipateni eziLawulwayo zokukhutshwa kweziyobisi:

Iingubo zivumela ulawulo oluchanekileyo kwisiza, izinga, kunye nexesha lokukhutshwa kwe-API. Iingubo ezikhutshwa ngokukhawuleza zichithwa ngokukhawuleza kwisisu, ngelixa i-enteric coatings, eyenzelwe iziyobisi ezifana ne-proton pump inhibitors (umzekelo, i-omeprazole), ukulibazisa ukukhululwa de amathumbu amancinci ukukhusela i-APIs kwi-asidi yesisu okanye ukuthintela ukucaphuka kwesisu.
Ukukhutshwa okuzinzileyo, ukusebenzisa iipolima ezinganyibilikiyo ngamanzi njenge-ethyl cellulose, ukwandisa ixesha lokukhutshwa kweziyobisi, ukunciphisa ukuphindaphinda kwedosi kunye nokuphucula iziphumo zonyango.

Ukuthotyelwa kweSigulana okongeziweyo:

Ukugquma ifilimuiphucula ukuginywa ngokudala umphezulu ogudileyo, omenyezelayo, ukwenza ukuba iipilisi zigatywe lula, ingakumbi kubantwana kunye nabemi babantwana. Iimpawu zokugubungela i-taste-masking zifihla i-flavour ekrakra okanye engathandekiyo, ekhuthaza ukubambelela.
Iingubo ezinombala ezinemibala zincedisa ukuchongwa, ukunciphisa iimpazamo zamayeza, kunye neempawu ezicacileyo, ezicacileyo ziqinisekisa ukulandeleka, ukuhlangabezana neemfuno zokulawula ukhuseleko kunye nokuthotyelwa.

Ubuhle kunye noMgangatho wokuSebenza:

Ingubo efanayo, engenaziphene yongeza inkangeleko yethebhulethi, yomeleza uphawu lwegama kunye nokuthembana kwabathengi. Ikwanciphisa iziphene ezinje ngebhulorho, ukuqhekeka, okanye uburhabaxa be-orenji-peel, ukuqinisekisa ukuthotyelwa kwemigangatho efunekayo.

Inkqubo yoKugquma iThebhulethi

I-Pan Tablet Coater

III. NjaniInkqubo yoKugquma iFilimu yezamayezaIyasebenza

Iinkqubo yokugquma ifilimu kwiipilisiLumsebenzi ophucukileyo, onamanyathelo amaninzi ofuna ukuchaneka ukufezekisa iziphumo ezihambelanayo, ezikumgangatho ophezulu. Nalu ucazululo oluneenkcukacha:

Ukulungiselela Uqulunqo:

Ukuqulunqwa kwe-coating kudibanisa iipolymers ezenza ifilimu (umzekelo, i-hydroxypropyl methylcellulose [HPMC], i-Eudragit), i-plasticizers, ii-pigments, kunye nezongezo zokufumana izinto ezinqwenelekayo ezifana nombala, isicwebezelisi, kunye nokumelana nokufuma. Ukukhethwa kwepolymer kuchaphazela kakhulu i-viscosity, echaphazela ukutshiza kunye nomgangatho wefilimu.

ULungiselelo lweSisombululo sokugquma:

I-powder eyenziwe kwangaphambili ixutywe namanzi okanye i-solvent ye-organic, ngokuqhelekileyo ifuna imizuzu engama-45 ukwenza isisombululo esilinganayo. Iviscometer yokwalekaIbaluleke kakhulu apha, njengoko i-viscosity ichaphazela ngokuthe ngqo ukwakheka kwamathontsi kunye nokufana kwefilimu. Izisombululo eziphezulu ze-viscosity zengozi yokubunjwa kweqhuma, ngelixa i-viscosity ephantsi iqinisekisa ukulungiswa ngokukhawuleza kunye nomgangatho ongcono womphezulu.

Ukusetyenziswa koKutyabeka:

Iyalayisha: Iipilisi zifakwe kumatshini wokugquma, njenge-pan coater okanye i-fluidized bed coater, apho zijikeleza khona ukuze ziqinisekise ukuba zichanekile kwisisombululo sokugquma.
Ukutshiza: Isisombululo sokugquma i-atomized ngokusebenzisa umbhobho wokutshiza, kunye ne-atomization kunye nepateni yokulawula umoya we-droplet kunye nokusabalalisa. Umlinganiselo olungelelanisiweyo womoya wokutshiza (ngokufanelekileyo 1:1) uqinisekisa amathontsi amancinci kunye nokugubungela okufanayo.
Ukomisa: Umoya oshushu ukhupha isinyibilikisi, wenze ifilimu egudileyo, eqhubekayo. Ukomisa okulawulwayo kuthintela ukomisa ngokugqithisileyo (okubangela imiphezulu erhabaxa) okanye ukomiswa ngaphantsi (okukhokelela ekudibaniseni okanye ukudityaniswa).

Ulawulo lwemeko:

Ukujongwa ngokungqongqo kobunzima bokugquma, ukufana, umbala, kunye nokuthungwa kuqinisekisa ukuthotyelwa kweendlela ezilungileyo zokuvelisa (GMPs). Imilinganiselo engaphakathi, ngakumbi ye-viscosity kunye noxinaniso, ibalulekile ukuthintela iziphene ezinjengokubopha ibhulorho, ukuqhekeka, okanye ukuxobula, njengoko kubonisiwe kwiingxoxo zolawulo lwenkqubo.

Ziziphi ezona zilungileyoTablet Coating Solutions?

Ukukhetha isisombululo esifanelekileyo sokugquma kuxhomekeke kwiipropati zechiza, iinjongo zonyango, kunye nemiqobo yokuvelisa. Iindlela ezimbini eziphambili zilawula:

Organic Solvent Film Coating:

Efanelekileyo kwi-APIs evakalelwa ngumswakama, i-organic solvent coatings zisebenzisa iipolymers ezifana ne-cellulose acetate phthalate ukubonelela ngezithintelo eziqinileyo zokufuma, ukukhusela i-hydrolysis. Nangona kunjalo, zibiza kakhulu, zibeka imingcipheko yokhuseleko ngenxa yokutsha, kwaye zinemiqobo yokusingqongileyo, efuna ukuphathwa kunye nokulahlwa okukhethekileyo.

I-Aqueous Film Coating:

Olona khetho lukhethwayo kuninzi lwezicelo, iingubo zokugquma kwamanzi zisebenzisa iipolymers ezinyibilikayo emanzini njenge-HPMC okanye i-PVA, enikezela ngobunzima, ukhuseleko, kunye nokunciphisa impembelelo yokusingqongileyo. Imixube ekwinqanaba eliphezulu iphucula ukusebenza kakuhle kuzo zonke iintlobo zezixhobo, izenza zibenendleko kwaye zihambelane neendlela zolawulo, ezifana nezithintelo kwi-titanium dioxide (TiO2).

IV. Usetyenziso lwezamayeza lweUkugquma ifilimu

Iinkqubo yokwaleka tabletibonelela ngezicelo ezahlukeneyo, nganye ijongana nemiceli mngeni ethile yamayeza:

Ukukhutshwa kweziyobisi okuGuquliweyo:

Ukulibaziseka ukukhutshwa kweziyobisi:

Iingubo ze-Enteric zikhusela amachiza e-asidi-labile (umzekelo, i-esomeprazole) okanye ukunciphisa ukucaphuka kwesisu (umzekelo, i-pantoprazole) ngokunyibilika kwi-pH yamathumbu amancinci. Iifomyula ezimbini zokulibaziseka-ukukhutshwa, njenge-dexlansoprazole, zidibanisa iigranules ezineeprofayili ezahlukeneyo zokuchithwa kwe-pH ezixhomekeke kwi-pH ukwenzela ukufunxa okwandisiweyo.
Iingubo ezijoliswe kwikholoni, zisebenzisa i-pH-ezixhomekeke kwi-pH okanye i-polymers ezonakaliswa yi-enzymatically, zinyange iimeko ezifana nesifo sika-Crohn okanye ukuphucula i-peptide bioavailability. Ubuchwephesha obufana ne-ColoPulse budibanisa i-pH kunye ne-bacterial triggers ukuhanjiswa okuchanekileyo.
Iingubo ze-Chronotherapeutic zilungelelanisa ukukhutshwa kwechiza kunye nezingqisho ze-circadian, njengoko kubonwa kwiipilisi ze-enteric-coated bilayer ye-telmisartan kunye ne-pravastatin, iphucula unyango lwe-hypertension kunye ne-cholesterol synthesis.

Umfanekiso woku-1

I-caplet egqunyiweyo yayinganyangeki kwiimeko ze-acidic kwaye ibonise iprofayili yokukhutshwa kwechiza exhomekeke kwi-pH. Kwaqala ukukhutshwa kweziyobisi emva kwe-1 h kwimeko encinci yamathumbu kwaye emva koko waqhubeka nokukhululwa kweziyobisi ngendlela eqhubekayo kuzo zonke iimeko ze-distal intestine kunye nekholoni.

Ukukhutshwa kweziyobisi okuZinzileyo:

Iipolymers ezinganyibilikiyo ngamanzi njenge-ethyl cellulose okanye iipolymethacrylates zenza iiprofayili ezikhutshwa ngokuzinzileyo, zinciphisa amaxesha okudosa kumachiza afana ne-venlafaxine. Iinkqubo zepompo ze-Osmotic, ezifakwe nge-cellulose acetate, ukukhululwa kokulawula ngokungena kwamanzi kunye nobukhulu be-orifice, njengoko kuboniswe kwi-efisone hydrochloride formulations.

Umfanekiso wesi-2

Kuthetha ukugxininiswa kweplasma ngokubhekiselele kwiiprofayili zexesha ezifunyenwe emva kokulawulwa kwe-Eperisone 150 mg CR (ukukhululwa okulawulwayo) iipilisi ze-osmotic kunye nokukhululwa ngokukhawuleza.

Ukuphuculwa kozinzo lweziyobisi:

Ukugquma ifilimuikhusela umswakama-obuthathaka (umzekelo, i-ranitidine) okanye iziyobisi ezilula ukukhanya (umzekelo, i-nifedipine) usebenzisa i-hydrophobic polymers, i-lipids, okanye i-opacifiers. Ukudibanisa iipolymers ezifana ne-HPMC kunye ne-suberin fatty acids kwandisa imiqobo yomphunga wamanzi, iqinisekisa ukuzinza kwexesha elide.

Taste Masking:

Kubalulekile ekuthotyelweni kwabantwana kunye ne-geriatric, iingubo zokufihla incasa zisebenzisa iipolymers ezifana ne-ethylcellulose okanye i-hypromellose ukuthintela ukukhutshwa kwechiza elikrakra emlonyeni womlomo. Ulungelelwaniso olulungiselelweyo lwepolymers ezinyibilikayo emanzini kunye nezinganyibilikiyo zilungelelanisa incasa yokufihla kunye ne-bioavailability.

I-Active Film Coating:

Le ndlela yokuvuselela idibanisa ii-APIs kumqolo wokugquma, eyenza indibaniselwano yedosi esisigxina (umzekelo, i-metformin kunye ne-glimepiride) okanye ukuphuculwa kozinzo kumachiza afana ne-peliglitazar. Imingeni ibandakanya ukufezekisa ukuhanjiswa kwe-API efanayo kunye nolawulo oluchanekileyo lwendawo yokugqibela, efuna ukubekwa esweni kwenkqubo eyomeleleyo.

V. Inkqubo Imingeni kwiItheyibhile Coating

Iinkqubo yokugquma ifilimu kwiipilisiiyaguquguquka, ngokutshiza, ukwabiwa kokugquma, kunye nokomisa okwenzeka ngaxeshanye. Imingeni ephambili ibandakanya:

Ilahleko yokuSombulula kunye noTshintsho lweViscosity: I-solvent evaporation inyusa i-viscosity, ichaphazela ukubunjwa kwamaconsi kunye nomgangatho wefilimu. Izongezo zexesha elincinci ziyimfuneko ukuze kugcinwe i-viscosity efanelekileyo.
Ulwakhiwo lwesiphene: Imiba efana nebhulorho, ukuqhekeka, uburhabaxa be-orenji-peel, okanye i-twinning ivela kwiiparamitha zenkqubo engafanelekanga, efana nomoya wokutshiza ongalungelelananga, ubungakanani bethontsi obungalunganga, okanye ukomiswa ngokwaneleyo.
Unyino lweMilinganiselo yesiNtu: Izixhobo ezingasebenzi kwi-intanethi njengeekomityi ze-efflux okanye ii-viscometers zaselabhorethri azichanekanga kwaye zidla ixesha, ziyasilela ukubamba iimeko zenkqubo ezifana neqondo lobushushu, izinga lokucheba, okanye ukuguquguquka kwamandla.
Ukuthotyelwa koMgaqo: Imigangatho engqongqo ifuna umbala ongaguqukiyo, ukufaneleka, kunye neengubo ezingenasiphene, ezifuna ulawulo lwexesha lokwenene ukuhlangabezana ne-GMP kunye neemfuno zokulandeleka.

VI. IiParameters zeNkqubo kunye neMiba echaphazelayoUmgangatho Wokugquma ifilimu

Ukuphumeza iyunifomu, umgangatho ophezulu wokutyabeka kufuna ulawulo olucokisekileyo lweeparamitha zenkqubo, njengoko kuchaziwe ngezantsi:

Ukutshiza ireyithi yokuHamba koMoya:

I-Atomization kunye nephethini yomoya ichitha isisombululo sokugquma sibe ngamaconsi. Umlinganiselo we-1: 1 unciphisa ubungakanani be-droplet, ukwandisa ukufana kwe-coating kunye nokusebenza kakuhle. Ukuhamba komoya okungalungelelananga kukhokelela ekuhleni okungalinganiyo kunye neziphene.

Izinga lokutshiza:

Amazinga aphezulu okutshiza anyusa ubungakanani bamathontsi kwaye anciphise isantya, oko kuchaphazela umgangatho wokugquma. Umlinganiselo weqondo le-atomization yomoya wokutshiza ubalulekile ekugcineni ubungakanani bethontsi engaguqukiyo kunye nomthamo wokomisa.

I-Inlet kunye ne-Outlet Air:

Ubushushu bomoya wokungena kunye nokufuma kuchaphazela ukomisa ukusebenza kakuhle. Ukomisa ngokugqithisileyo kubangela imiphezulu erhabaxa, ngelixa ukomisa ngaphantsi kukhokelela kwi-agglomeration. Ubushushu bomoya obuphumayo, buqhele ukuba yi-2–3°C ngaphezu kobushushu bebhedi yethebhulethi, bukhokela uhlengahlengiso lokomisa.

Ubungakanani beDrooplet:

Amaconsi amancinci, aphunyezwe ngokulingana komoya kunye ne-viscosity ephantsi, aqinisekisa ifilimu ye-homogenous. Amathontsi amakhulu anyusa uburhabaxa bomphezulu, ebeka esichengeni umgangatho.

Umxholo oqinileyo kunye neViscosity:

Umxholo oqinileyo ophakamileyo ukhawuleza ukuzuza ubunzima kodwa ukwandisa i-viscosity, ukudibanisa ukutshiza. Ukufudumeza isisombululo okanye ukulungelelanisa umxholo wepolymer kunciphisa i-viscosity, ukuphucula inkqubo kunye nokunciphisa iindleko.

Umgama wompu ukuya ebhedini:

Umgama ofanelekileyo uqinisekisa ukuba amathontsi afikelela kumphezulu wethebhulethi ngaphandle kokoma kwangaphambi kwexesha okanye ubumanzi obugqithisileyo. Ukude kakhulu, kwaye amathontsi oma phakathi emoyeni, ebangela uburhabaxa; isondele kakhulu, kwaye imiphezulu emanzi ikhokelela ekuthandeni.

Ixesha lokuphumla:

I-Post-coating curing (1-iiyure ezininzi) isusa i-solvent eseleyo kwaye ilukhuni ifilimu, ichaphazela iiprofayili zokuchithwa. Imingcipheko engonelanga yokunyanga ayiphelelanga kwi-polymer coalescence.

Isantya sePan kunye nokuhamba kweThebhulethi:

Ukujikeleza okufanelekileyo kwe-pan kuqinisekisa ukuba iipilisi zijikeleza kwindawo yokutshiza ngeendlela ezahlukeneyo, ukukhuthaza ukugquma okufanayo. Izantya ezicothayo zibangela ukhuselo olungalinganiyo, ngelixa isantya esigqithisileyo sisenokonakalisa iipilisi.

Ukubunjwa kwesisombululo sokwaleka:

Ukhetho lweepolymers, ii-pigments, kunye ne-plasticizers zinefuthe kwi-viscosity, ukuxinana komphezulu, kunye nomgangatho wefilimu. Iipolymers ezinyibilikayo zamanzi zandisa i-viscosity, zifuna ukuqulunqwa ngokucophelela ukuphepha iziphene.

VII. Indima yeLonnmeter Inline Coating Viscometer

ILonnmeter Inline Coating Viscometeriguqula inguquushicilelo lwamayezakunye nokugquma ngokubonelela ngokujongwa kwexesha langempela le-viscosity, ukujongana nemida yezixhobo zemveli. Oku phambilii-viscometer yokugqokailinganisa i-viscosity ngokuthe ngqo kumjelo wenkqubo, ukubalwa kwezinto eziguquguqukayo ezifana nobushushu, izinga lokucheba, kunye neemeko zokuhamba.

Izinto ezilungileyo zeLonnmeter Inline Coating Viscometer

Ukuchaneka kwexesha lokwenyani: Ukubeka iliso ngokuqhubekayo utshintsho lwe-viscosity ukusuka kwisiseko, okwenza uhlengahlengiso olukhawulezileyo kumanqanaba e-solvent okanye ubushushu, ukuqinisekisa ukubunjwa kwe-droplet ehambelanayo kunye nomgangatho wefilimu.
UkuNcitshiswa kwesiphene: Igcina i-viscosity egqwesileyo ukunciphisa imiba efana nebhuloho, ukuqhekeka, okanye uburhabaxa be-orenji-peel, ukuqinisekisa ukuthotyelwa kwemimiselo yemveliso egqityiweyo.
UkuSebenza kweendleko: Ukunciphisa i-pigment kunye nokusetyenziswa kwe-solvent ngokulungisa umxholo oqinileyo, ukunciphisa iindleko zempahla kunye nenkunkuma, kunye nokunciphisa amaxesha okucubungula.
IiNzuzo zokusiNgqongileyo: Ukunciphisa ukusetyenziswa kwemithombo, ukuhambelana neendlela ezizinzileyo zokwenziwa kwemveliso.
Ukuthotyelwa okuPhuculweyo: Iqinisekisa ukuxinana kombala okuhambelanayo kunye nokumakishwa okucacileyo, okubalulekileyo ekulandeleni ukulandelwa kunye nokhuseleko lwesigulane.
Ukusebenza kakuhle koMsebenzisi: Yenza ngokuzenzekelayo ulawulo lwe-viscosity, ukukhulula abaqhubi ukuba bagxininise kweminye imisebenzi, ngokungafaniyo neendlela zezandla ezichitha ixesha kunye nezingahambelani.
Ukubaleka: Ukulungelelanisa kwizixhobo ezahlukeneyo zokugquma (i-pan coaters, i-fluidized bed coaters) kunye nokuqulunqwa, ukuxhasa iinkqubo zombini ze-aqueous kunye ne-organic solvent.

Ukufundisa iinkqubo yokugquma ifilimu kwiipilisiifuna ukuchaneka, itekhnoloji ephezulu, kunye nokuqonda okunzulu kweeparamitha zenkqubo. ILonnmeter Inline Coating Viscometerixhobisa abavelisi ukuba boyise imiceli mngeni, bandise umgangatho, kwaye bafezekise ukuthotyelwa ngokulula.Cela ikhowuti namhlanjeukuqonda indlela esi sigqiboviscometer yokwalekainokuphucula ukusebenza kakuhle, ukunciphisa iindleko, kunye nokuhambisa iipilisi eziphezulu ezihlangabezana neemfuno zesigulane kunye nokulawula.

Thatha Inyathelo Ngoku

Ixesha lokuposa: Aug-22-2025