Capsules ikomeye / HPMC hollow capsules / capsules yimboga / ikora neza cyane API hamwe nibikoresho byangiza amazi / ubumenyi bwa firime / kugenzura kurekura / tekinoroji yubuhanga bwa OSD….
Ikiguzi cyiza-cyiza, ugereranije no koroshya ibicuruzwa, no koroshya kugenzura abarwayi kugipimo, ibicuruzwa bikomeye byo mu kanwa (OSD) bikomeza kuba uburyo bwatoranijwe bwo kuyobora abategura ibiyobyabwenge.
Mu bigo 38 bishya bya molekile bito (NMEs) byemejwe n’ikigo cy’Amerika gishinzwe ibiryo n’ibiyobyabwenge muri 2019, 26 byari OSD1.Muri 2018, isoko ryinjiza ibicuruzwa byanditswemo na OSD hamwe no gutunganya kabiri byakozwe na CMO ku isoko ry’Amerika y'Amajyaruguru byari hafi miliyari 7.2 z'amadolari ya Amerika 2. Biteganijwe ko isoko rito rya molekile ryohereza hanze rizarenga miliyari 69 USD mu 20243. Aya makuru yose yerekana ko mu kanwa Ifishi ikomeye ya dosiye (OSDs) izakomeza gutsinda.
Tableti iracyiganje ku isoko rya OSD, ariko capsules zikomeye ziragenda ziba nziza cyane.Ibi biterwa ahanini nubwizerwe bwa capsules nkuburyo bwubuyobozi, cyane cyane abafite imbaraga nyinshi za antitumor APIs.Capsules yegereye abarwayi, mask impumuro mbi nuburyohe, kandi biroroshye kuyimira, nziza cyane kurenza izindi dosiye.
Julien Lamps, Umuyobozi wibicuruzwa muri Lonza Capsules nibikoresho byubuzima, araganira ku nyungu zitandukanye za capsules zikomeye kuruta ibinini.Asangira ibitekerezo bye kuri hydroxypropyl methylcellulose (HPMC) capsules yuzuye nuburyo bashobora gufasha abashinzwe gufata imiti kunoza ibicuruzwa byabo mugihe abakiriya bakeneye imiti ikomoka ku bimera.
Capsules ikomeye: Kunoza kubahiriza abarwayi no kunoza imikorere
Akenshi abarwayi barwana n'imiti iryoshye cyangwa ihumura nabi, biragoye kuyimira, cyangwa ishobora kugira ingaruka mbi.Hamwe nibitekerezo, guteza imbere ifishi ikoreshwa nabakoresha irashobora kunoza kubahiriza abarwayi uburyo bwo kuvura.Capsules ikomeye ni amahitamo ashimishije kubarwayi kuko, usibye guhisha uburyohe numunuko, birashobora gufatwa gake cyane, kugabanya umutwaro wibinini, kandi bikagira ibihe byiza byo kurekura, binyuze mugukoresha vuba-kurekurwa, kugenzurwa-kurekurwa no gutinda buhoro kuri kugeraho.
Kugenzura neza imyitwarire yo kurekura ibiyobyabwenge, kurugero ukoresheje micropelletizing API, birashobora gukumira guta ibiyobyabwenge no kugabanya ingaruka.Abashinzwe gufata ibiyobyabwenge basanga guhuza ikorana buhanga ryinshi na capsules byongera ubworoherane nuburyo bwiza bwo kugenzura-kurekura API gutunganya.Irashobora no gushyigikira pellet zirimo API zitandukanye muri capsule imwe, bivuze ko imiti myinshi ishobora gutangwa icyarimwe mubipimo bitandukanye, bikagabanya inshuro yo kunywa.
Imyitwarire ya pharmacokinetic na pharmacodynamic yiyi formulaire, harimo sisitemu igizwe na sisitemu4, extrusion spheronisation API3, hamwe na sisitemu ihamye ya dose5, nayo yerekanye imyororokere myiza ugereranije nibisanzwe.
Ni ukubera iri terambere rishobora kunozwa mukubahiriza abarwayi no gukora neza nibisabwa ku isoko rya granular APIs zikubiye muri capsules zikomeye zikomeje kwiyongera.
Ibyifuzo bya polymer:
Gukenera capsules yimboga kugirango isimbuze gelatine ikomeye
Imikorere gakondo ya capsules ikozwe muri gelatine, nyamara, gelatine ikomeye ya capsules irashobora kwerekana ingorane mugihe uhuye na hygroscopique cyangwa ibiyikubiyemo.Gelatin ni inyamanswa ikomoka ku bicuruzwa bikunda guhura n’ibisubizo bigira ingaruka ku myitwarire y’iseswa, kandi bifite amazi menshi ugereranije n’amazi kugira ngo bikomeze guhinduka, ariko birashobora no guhana amazi hamwe na API hamwe n’ibisohoka.
Usibye ingaruka z'ibikoresho bya capsule ku mikorere y'ibicuruzwa, abarwayi benshi kandi ntibashaka gufata ibikomoka ku nyamaswa kubera impamvu z'imibereho cyangwa umuco kandi bashaka imiti ikomoka ku bimera cyangwa ibikomoka ku bimera.Kugira ngo iki kibazo gikemuke, uruganda rukora imiti narwo rukomeje gushora imari mu buryo bushya bwo gukoresha imiti igamije guteza imbere ubundi buryo bushingiye ku bimera bifite umutekano kandi byiza.Iterambere ryibikoresho siyanse yatumye capsules ikomoka ku bimera ishoboka, iha abarwayi amahitamo adakomoka ku nyamaswa hiyongereyeho ibyiza bya capsules ya gelatine - kumira, koroshya ibicuruzwa, no gukoresha neza.
Kugira ngo iseswa ryiza kandi rihuze:
Ikoreshwa rya HPMC
Kugeza ubu, bumwe mu buryo bwiza bwo gukoresha gelatine ni hydroxypropyl methylcellulose (HPMC), polymer ikomoka ku mitsi y'ibiti.
HPMC ntigizwe na chimique kurusha gelatine kandi ikurura amazi make ugereranije na gelatine6.Amazi make ya capsules ya HPMC agabanya guhanahana amazi hagati ya capsule nibirimo, ibyo hamwe na hamwe bishobora guteza imbere imiti n’imiterere yumubiri, bikongerera igihe cyo kubaho, kandi byoroshye gukemura ibibazo bya hygroscopique APIs nibisohoka.HPMC yuzuye capsules ntabwo yunva ubushyuhe kandi byoroshye kubika no gutwara.
Hamwe no kwiyongera kwa APIs-nziza cyane, ibisabwa kubisobanuro biragenda birushaho kuba ingorabahizi.Kugeza ubu, abashinzwe ibiyobyabwenge bageze ku musaruro ushimishije mugikorwa cyo gushakisha ikoreshwa rya capsules ya HPMC kugirango basimbuze gelatine gakondo.Mubyukuri, capsules ya HPMC isanzwe ikundwa mubigeragezo byamavuriro kubera guhuza neza nibiyobyabwenge nibisohoka7.
Gukomeza kunoza ikoranabuhanga rya HPMC capsule bisobanura kandi ko abategura ibiyobyabwenge bashoboye gukoresha neza ibipimo byo gusesa no guhuza hamwe na NMEs zitandukanye, harimo nimbaraga zikomeye.
HPMC capsules idafite imiti ya gelling ifite imiterere myiza yo gusesa idafite ion na pH biterwa, kuburyo abarwayi bazabona ingaruka zimwe zo kuvura mugihe bafashe imiti kumara yubusa cyangwa hamwe nifunguro.Nkuko bigaragara ku gishushanyo 1. 8
Kubera iyo mpamvu, kunoza iseswa birashobora gutuma abarwayi badafite ubushake bwo guteganya dosiye zabo, bityo bikubahirizwa.
Byongeye kandi, gukomeza guhanga udushya muri HPMC capsule membrane ibisubizo birashobora kandi gutuma kurinda amara no kurekurwa byihuse mubice byihariye byinzira yigifu, gutanga imiti igamije uburyo bumwe na bumwe bwo kuvura, kandi bikarushaho kunoza uburyo bwo gukoresha capsules ya HPMC.
Ubundi buryo bwo gusaba icyerekezo cya HPMC kiri mubikoresho byo guhumeka kubuyobozi bwibihaha.Isoko ryamasoko rikomeje kwiyongera bitewe na bioavailability yatewe no kwirinda ingaruka ya hepatike ya mbere no gutanga inzira itaziguye yubuyobozi mugihe yibasiye indwara nka asima nindwara zidakira zifata ibihaha (COPD) hamwe nubuyobozi.
Abakora ibiyobyabwenge bahora bashakisha uburyo bunoze buhendutse, bworohereza abarwayi, kandi bunoze bwo kuvura indwara zubuhumekero, no gushakisha uburyo bwo kuvura imiti ihumeka kuburwayi bumwe na bumwe bwo hagati (CNS).ibisabwa biriyongera.
Amazi make ya capsules ya HPMC atuma biba byiza kuri APIs ya hygroscopique cyangwa yita kumazi, nubwo imiterere ya electrostatike hagati yimikorere na capsules yuzuye nayo igomba kwitabwaho mugutezimbere8.
ibitekerezo byanyuma
Iterambere rya siyanse yubumenyi na tekinoroji ya OSD yashyizeho urufatiro rwa HPMC capsules yo gusimbuza gelatine capsules muburyo bumwe, itanga amahitamo menshi mugutezimbere imikorere yibicuruzwa.Byongeye kandi, kongera kwibanda ku byo abaguzi bakunda no kwiyongera ku biyobyabwenge bidahenze byongerewe imbaraga byongereye icyifuzo cya capsules idafite aho ihuriye neza na molekile zumva neza.
Nyamara, guhitamo ibikoresho bya membrane ni urufunguzo rwo kwemeza ko ibicuruzwa bigenda neza, kandi guhitamo neza hagati ya gelatine na HPMC birashobora gukorwa gusa nubuhanga bukwiye.Guhitamo neza ibikoresho bya membrane ntibishobora kunoza imikorere no kugabanya ingaruka mbi, ariko kandi bifasha gutsinda ibibazo bimwe na bimwe.
Igihe cyo kohereza: Nzeri-23-2022