Film Coating Process for Tablets

UwitekaIgikoresho cyo gutwikiraihindura ibinini bibisi mubicuruzwa bihanitse biringaniza imikorere, ituze, hamwe no kwitabaza abarwayi.Gufata amashusho, intambwe ikomeye, ikubiyemo ibinini bifite urwego ruto, ruringaniye kugirango rukingire ibikoresho bya farumasi bikora (APIs), kugenzura irekurwa ryibiyobyabwenge, kuzamura ubwiza, no kunoza kubahiriza abarwayi.

I. GusobanukirwaIbikoresho bya firime

A.firime yubatsweni ifishi ikomeye yo munwa ifunitse muburyo buto, bushingiye kuri polymer bukora imirimo myinshi, kuva kurinda API kugeza kongera imbaraga zo kumira. Bitandukanye n'ibinini bidafunze, bibangamiwe no kwangiza ibidukikije,firimeitanga inzitizi ikingira, itezimbere uburyo bwo kureba binyuze mumabara nuburabyo, kandi irashobora guhindura imyirondoro irekura ibiyobyabwenge. Iyi nzira ntabwo kwisiga gusa; nigikorwa cyiterambere cyikoranabuhanga cyemeza ko ibinini byujuje ubuziranenge bukomeye mugihe gikemura ibibazo byumurwayi. Uwitekagutunganya firime ya tabletiiremewe cyane kubera guhuza kwinshi, gushyigikira ako kanya-kurekura (IR), gutinda-kurekurwa, cyangwa gukomeza-kurekura bihoraho bigamije intego zihariye zo kuvura.

II. Intego zinyuranye Intego yaIgikoresho cya Tablet

UwitekaIgikoresho cyo gutwikirani ingenzi mu gukora imiti, itanga inyungu zirenze umusaruro, imikorere yibiyobyabwenge, nuburambe bwabarwayi. Dore impamvu ari ngombwa:

Gukora no guhunika neza:

Gufata amashushoikingira APIs ihangayikishije ibidukikije nkubushuhe, urumuri, na ogisijeni, bishobora gutera hydrolysis, okiside, cyangwa gufotora. Ku biyobyabwenge byangiza amazi nka hydrochloride ya ranitidine, gutwikira hamwe na polymers nka alcool ya polyvinyl (PVA) cyangwa Eudragit byongera umutekano, bikongerera igihe cyo kubaho kandi bikomeza gukora neza mugihe cyo kubika.
Mu gukumira impinduka zifatika nko kubyimba cyangwa guturika, impuzu zemeza ko ibinini bikomeza kuba byiza mubipfunyika, bikarinda ubusugire bwibicuruzwa.

Kugenzura Ibiyobyabwenge Birekura:

Ipitingi ituma igenzura neza kurubuga, igipimo, nigihe cyo gusohora API. Ako kanya-kurekura ibishishwa bishonga vuba mu gifu, mugihe imyenda ya enteric, yagenewe imiti nka inhibitori ya proton pompe (urugero, omeprazole), itinda kurekurwa kugeza amara mato kugirango irinde APIs aside aside cyangwa ikingira igifu.
Kurekura-kurekura neza, ukoresheje polymers zidashobora gushonga nka Ethyl selulose, kumara igihe kinini kurekura ibiyobyabwenge, kugabanya inshuro nyinshi no kunoza imiti ivura.

Kongera abarwayi:

Gufata amashushoitezimbere kumira mugukora ubuso bworoshye, burabagirana, bigatuma ibinini byoroha kuribwa, cyane cyane kubantu babana naba bakuze. Kuryoha-guhisha ibintu bihisha uburyohe busharira cyangwa budashimishije, butera inkunga kubahiriza.
Ibara ryanditseho amabara yerekana imfashanyo, kugabanya amakosa yimiti, nibimenyetso bisobanutse, byumvikana neza byerekana neza, byujuje ibisabwa kugirango umutekano ube wubahirizwa.

Ubwiza nubwiza:

Igifuniko kimwe, kitagira inenge cyongera isura ya tablet, gishimangira ikiranga no kwizerana kwabaguzi. Iragabanya kandi inenge nko kuraro, guturika, cyangwa orange-igishishwa gikabije, byemeza kubahiriza ibipimo ngenderwaho.

Uburyo bwo gutwikira ibinini

Isahani ya Tablet

III. UburyoImiti ya farumasi yububikoImirimo

Uwitekagutunganya firime ya tabletini imikorere ihanitse, intambwe-ntambwe isaba ibisobanuro kugirango igere ku bisubizo bihamye, byujuje ubuziranenge. Dore gusenyuka birambuye:

Gutegura:

Ipitingi ihuza polimeri ikora firime (urugero, hydroxypropyl methylcellulose [HPMC], Eudragit), plasitike, pigment, ninyongeramusaruro kugirango ugere kubintu byifuzwa nkibara, ububengerane, hamwe no kurwanya ubushuhe. Guhitamo polymer bigira uruhare runini mubwiza, bigira ingaruka kumiti no kumiterere ya firime.

Gutegura igisubizo:

Ifu yabanje gutegurwa ivangwa namazi cyangwa ibimera kama, mubisanzwe bisaba iminota 45 kugirango habeho igisubizo kimwe. Uwitekaviscometer yo gutwikirani ingenzi hano, nkuko viscosity igira ingaruka itaziguye no gushiraho film. Igisubizo cyinshi-cyinshi gishobora kwibasirwa nibibyimba, mugihe ubukonje buke butuma imyiteguro yihuse hamwe nubuziranenge bwubutaka.

Gukoresha Igipfukisho:

Kuremera.
Gutera. Ikigereranyo cyuzuye cyo guhumeka ikirere (nibyiza 1: 1) cyemeza ibitonyanga bito hamwe no gukwirakwiza kimwe.
Kuma: Umuyaga ushyushye uhumeka umusemburo, ukora firime yoroshye, ikomeza. Kwumisha kugenzurwa birinda gukama cyane (bitera ubuso bubi) cyangwa gukama munsi (biganisha ku mpanga cyangwa agglomeration).

Kugenzura ubuziranenge:

Gukurikirana cyane igipfundikizo cy'ubunini, uburinganire, ibara, n'imiterere byerekana kubahiriza imikorere myiza yo gukora (GMP). Ibipimo byimbitse, cyane cyane ubwiza nubucucike, nibyingenzi kugirango wirinde inenge nko kuraro, gucamo, cyangwa gukuramo, nkuko bigaragara mubiganiro byo kugenzura inzira.

Niki Cyiza CyizaIbisubizo bya Tablet?

Guhitamo igisubizo kiboneye biterwa nibiyobyabwenge, intego zo kuvura, hamwe nimbogamizi zakozwe. Uburyo bubiri bwibanze bwiganje:

Organic Solvent Film Coating:

Nibyiza kuri APIs yubushyuhe bukabije, ibishishwa bya organic solvent ikoresha polymers nka selulose acetate phthalate kugirango itange inzitizi zikomeye zubushuhe, zirinda hydrolysis. Nyamara, birahenze cyane, biteza umutekano muke kubera gucanwa, kandi bifite ingaruka mbi kubidukikije, bisaba gufata neza no kujugunya.

Amazi ya firime:

Guhitamo guhitamo kubisabwa byinshi, ibishishwa byamazi bifashisha amazi ya elegitoronike nka HPMC cyangwa PVA, bitanga ubunini, umutekano, kandi bigabanya ingaruka kubidukikije. Iterambere ryambere ryongera imikorere muburyo bwibikoresho, bigatuma bidahenze kandi bikurikiza inzira zigenga, nkibibujijwe kuri dioxyde de titanium (TiO2).

IV. Imiti ya farumasi yaGufata amashusho

UwitekaIgikoresho cyo gutwikiraikora porogaramu zitandukanye, buri kimwe gikemura ibibazo byihariye bya farumasi:

Guhindura ibiyobyabwenge:

Gutinda kurekura ibiyobyabwenge:

Kwinjiza munda birinda imiti ya acide-labile (urugero, esomeprazole) cyangwa kugabanya uburakari bwo mu gifu (urugero, pantoprazole) mu gushonga mu mara mato y'ibanze ya pH. Kabiri yatinze-kurekura ibyakozwe, nka dexlansoprazole, komatanya granules hamwe na pH zitandukanye zishingiye kumyirondoro kugirango ishobore kwaguka.
Ipitingi yibasiwe na colon, ukoresheje pH-iterwa na polymer cyangwa yangirika cyane, bivura indwara nkindwara ya Crohn cyangwa kunoza peptide bioavailable. Tekinoroji nka ColoPulse ihuza pH na bagiteri itera kubyara neza.
Chronotherapeutic coatings ihuza irekurwa ryibiyobyabwenge nindirimbo za circadian, nkuko bigaragara muri taberi ya biliyeri yometse kuri telmisartan na pravastatin, igabanya uburyo bwo kuvura hypertension na synthesis ya cholesterol.

Igishushanyo 1

Igipfundikizo gipfundikijwe cyarwanaga na acide kandi cyerekanaga umwirondoro w’ibiyobyabwenge pH. Yatangiye kurekura ibiyobyabwenge nyuma yisaha 1 h mumiterere mito mito hanyuma ikomeza kurekura ibiyobyabwenge muburyo burambye mugihe cyose amara ya kure na colon

Kurekura ibiyobyabwenge birambye:

Amazi adashobora gushonga polymers nka Ethyl selulose cyangwa polymethacrylates ikora imyirondoro irambye-igabanya, kugabanya inshuro zikoreshwa kumiti nka venlafaxine. Sisitemu ya pompe ya Osmotic, yashizwemo na selile ya selile, igenzura irekura binyuze mumazi yinjira nubunini bwa orifice, nkuko bigaragara mumashanyarazi ya eperisone hydrochloride.

Igishushanyo 2

Hagati ya plasma yibanze hamwe nigihe cyumwirondoro wabonetse nyuma yubuyobozi bwa Eperisone 150 mg CR (kugenzurwa kugenzurwa) osmotic no guhita bisohora ibinini.

Kunoza ibiyobyabwenge:

Gufata amashushoirinda ubushuhe (urugero, ranitidine) cyangwa imiti yorohereza urumuri (urugero, nifedipine) ukoresheje polymers hydrophobique, lipide, cyangwa opacifiers. Guhuza polymers nka HPMC hamwe na acide ya ferine acide byongera inzitizi zamazi zamazi, bigatuma umutekano uramba.

Kuryoha:

Ni ngombwa mu kubahiriza abana no gukura mu gihe, gutwikira uburyohe-bifashisha polymers nka Ethylcellulose cyangwa hypromellose kugirango wirinde gusohora ibiyobyabwenge bikabije mu kanwa. Ikigereranyo cyiza cya water-soluble na polymer zidashonga kuringaniza uburyohe bwo guhisha hamwe na bioavailability.

Gufata Amashusho:

Ubu buryo bushya bushyiramo APIs murwego rwo gutwikira, bigafasha guhuza ibipimo bifatika (urugero, metformin na glimepiride) cyangwa kunoza ituze ryibiyobyabwenge nka peliglitazar. Inzitizi zirimo kugera ku gukwirakwiza API imwe hamwe no kugenzura neza-ingingo ya nyuma, bisaba kugenzura neza.

V. Gukemura ibibazo muriIgikoresho cya Tablet

Uwitekagutunganya firime ya tabletini imbaraga, hamwe no gutera, gukwirakwiza, no gukama bibera icyarimwe. Inzitizi z'ingenzi zirimo:

Igihombo cya Solvent hamwe na Viscosity Impinduka: Guhumeka kumashanyarazi byongera ubwiza, bigira ingaruka kumiterere yigitonyanga nubwiza bwa firime. Ibihe byoroheje byongeweho birakenewe kugirango ubungabunge neza.
Imiterere itunganye: Ibibazo nkikiraro, guturika, ububobere bwa orange-peel, cyangwa impanga biva mubintu bidakwiye, nkumwuka wa spray utaringaniye, ingano yigitonyanga kitari cyo, cyangwa gukama bidahagije.
Imipaka yo gupima imipaka.
Kubahiriza amabwiriza: Ibipimo bikaze bisaba ibara rihoraho, byemewe, hamwe nubusembwa butagira inenge, bisaba kugenzura igihe nyacyo kugirango byuzuze GMP nibisabwa.

VI. Inzira Ibipimo nibintu bigira ingarukaUbwiza bwa Firime

Kugera ku kintu kimwe, cyiza cyo hejuru bisaba kugenzura neza ibipimo ngenderwaho, nkuko bigaragara hano:

Shira igipimo cyumuyaga:

Atomisiyoneri hamwe nikirere gisenya igisubizo cyo gutonyanga mubitonyanga. Ikigereranyo cya 1: 1 kigabanya ingano yigitonyanga, kongerera uburinganire no gukora neza. Imyuka idahwitse iganisha ku guta hamwe nudusembwa.

Igipimo cya Spay:

Igipimo cyo hejuru cya spray cyongera ingano yigitonyanga kandi kigabanya umuvuduko, bigira ingaruka kumiterere. Ikigereranyo cya atomisiyasi yikigereranyo cya spray ningirakamaro mugukomeza ubunini bwigitonyanga nubushobozi bwo gukama.

Umwuka winjira:

Ubushyuhe bwikirere bwinjira nubushuhe bigira ingaruka kumisha. Kuma cyane bitera ubuso bubi, mugihe kutumisha biganisha kuri agglomeration. Ubushyuhe bwo mu kirere busohoka, ubusanzwe 2-3 ° C hejuru yubushyuhe bwo kuryama, buyobora gukama.

Ingano yigitonyanga:

Ibitonyanga bito, bigerwaho hifashishijwe ibipimo byikirere byuzuye hamwe nubukonje buke, byemeza firime imwe. Ibitonyanga binini byongera ubuso bukabije, byangiza ubuziranenge.

Ibirimo bikomeye hamwe na Viscosity:

Ibintu byinshi bikomeye byihutisha kongera ibiro ariko byongera ubukonje, bigoye gutera. Gushyushya igisubizo cyangwa gutezimbere ibirimo polymer bigabanya ubukonje, kunoza imikorere no kugabanya ibiciro.

Intera kugeza ku buriri:

Intera nziza ituma ibitonyanga bigera hejuru ya tablet nta gukama imburagihe cyangwa ubushuhe bukabije. Kure cyane, kandi ibitonyanga byumye hagati yumuyaga, bitera ubukana; hafi cyane, kandi ubuso butose buganisha ku mpanga.

Gukiza Igihe:

Gukiza nyuma yo gukiza (1 - amasaha menshi) bikuraho ibishishwa bisigaye kandi bigakomera firime, bigira ingaruka kumwirondoro. Gukiza bidahagije ibyago byuzuye polymer coalescence.

Umuvuduko wihuta na Tablet:

Guhinduranya neza neza bituma ibizunguruka bizenguruka muri spray zone hamwe nicyerekezo gitandukanye, biteza imbere umwenda umwe. Umuvuduko gahoro utera ubwuzuzanye, mugihe umuvuduko ukabije ushobora kwangiza ibinini.

Igikoresho cyo gukemura:

Guhitamo polymers, pigment, hamwe na plasitike bigira ingaruka kumyambarire, guhagarara hejuru, hamwe nubwiza bwa firime. Amazi ashonga polymers yongerera ubwiza, bisaba gukora neza kugirango wirinde inenge.

VII. Uruhare rwaLonnmeter Inline Coating Viscometer

UwitekaLonnmeter Inline Coating ViscometerImpinduramatwaraicapiro rya farumasino gutwikira mugutanga igihe-nyacyo cyo kugenzura, gukemura ibibazo byibikoresho gakondo. Ibi byateye imbereibara rya viscometerapima viscosity mu buryo butaziguye, akabara impinduka nkubushyuhe, igipimo cyogosha, nuburyo ibintu bitemba.

Ibyiza byaLonnmeter Inline Coating Viscometer

Igihe nyacyo: Gukomeza gukurikirana impinduka zijimye ziva kumurongo wibanze, bigafasha guhita uhindura urwego rwumubyimba cyangwa ubushyuhe, bigatuma imiterere yibitonyanga hamwe nubwiza bwa firime.
Kugabanuka neza: Igumana ubwiza bwiza kugirango ugabanye ibibazo nkikiraro, guturika, cyangwa ububobere bwa orange-ibishishwa, byemeza kubahiriza ibicuruzwa byarangiye.
Ikiguzi Cyiza: Kugabanya pigment no gukoresha ibishishwa mugutezimbere ibintu bikomeye, kugabanya ibiciro byimyanda n imyanda, no kugabanya igihe cyo gutunganya.
Inyungu zidukikije: Kugabanya imikoreshereze yumutungo, guhuza nibikorwa birambye byo gukora.
Kuzuza kubahiriza: Iremeza ibara ryuzuye hamwe nibimenyetso byemewe, nibyingenzi mugukurikirana amabwiriza n'umutekano w'abarwayi.
Gukora neza: Ihindura igenzura ryijimye, kubohora abashoramari kwibanda kubindi bikorwa, bitandukanye nuburyo bwintoki butwara igihe kandi budahuye.
Ubunini.

Kumenya Uwitekagutunganya firime ya tabletibisaba neza, tekinoroji igezweho, hamwe no gusobanukirwa byimbitse ibipimo. UwitekaLonnmeter Inline Coating Viscometeriha imbaraga abayikora gutsinda ibibazo, kunoza ubuziranenge, no kugera ku kubahiriza byoroshye.Saba amagambo uyu munsikuvumbura uburyo iyi nteraviscometer yo gutwikirairashobora kuzamura imikorere, kugabanya ibiciro, no gutanga ibinini bisumba byose byujuje ibyifuzo byabarwayi nubuyobozi.

Fata ingamba nonaha

Igihe cyo kohereza: Kanama-22-2025