Hard capsules/HPMC hollow capsules/vegetable capsules/high-efficiency API uye mwando-sensitive ingredients/film sainzi/inosimudzira kuburitsa/OSD engineering tekinoroji….
Kunyanya kudhura-kushanda, kureruka kwekugadzira, uye kureruka kwemurwere kudzora dosi, oral solid dosage (OSD) zvigadzirwa zvinoramba zviri iyo nzira yakasarudzika yekutonga kune vanogadzira zvinodhaka.
Pamakumi matatu nemasere madiki mamorekuru masangano (NMEs) akatenderwa neUS Food and Drug Administration muna 38, makumi maviri nematanhatu aive OSD1.Muna 2018, mari yemusika yezvigadzirwa zveOSD-branded nesecond processing by CMOs muNorth America market yaisvika $7.2 bhiriyoni USD 2. The small molecule outsourcing market inotarisirwa kudarika USD 69 bhiriyoni muna 20243. Zvose izvi data zvinoratidza kuti oral yakasimba dosage mafomu (OSDs) acharamba achikunda.
Mapiritsi achiri kutonga musika weOSD, asi macapsules akaomarara ari kuramba achiwedzera kunaka.Izvi zvinokonzerwa nekuvimbika kwema capsules senzira yekutonga, kunyanya avo vane high potency antitumor APIs.Macapsules ane hukama hwepedyo nevarwere, mask kunhuhwirira kusingafadzi uye kuravira, uye ari nyore kumedza, zvakanyanya nani pane mamwe mafomu ekuyerwa.
Julien Lamps, Product Manager kuLonza Capsules uye Health Ingredients, anokurukura zvakanakira zvakasiyana-siyana zvemakapisi akaomarara pamusoro pemapiritsi.Anogovera manzwisisiro ake muhydroxypropyl methylcellulose (HPMC) hollow capsules uye mabatiro avanogona kubatsira vanogadzira zvinodhaka kukwirisa zvigadzirwa zvavo vachisangana nezvinodiwa nevatengi zvemishonga inotorwa nechirimwa.
Hard capsules: Kuvandudza kutevedza kwemurwere uye kukwidziridza mashandiro
Varwere vanowanzonetseka nemishonga inoravira kana kunhuwa zvakaipa, yakaoma kumedza, kana inogona kuva nemigumisiro yakaipa.Tichifunga izvi, kugadzira mafomu emushandisi-ane hushamwari edosi anogona kuvandudza kutevedza kwemurwere nemishonga yekurapa.Hard capsules inzira inokwezva kune varwere nekuti, kunze kwekunakirwa nekunhuhwirira, vanogona kutorwa zvishoma kazhinji, kuderedza mutoro wehwendefa, uye kuva nenguva yekuburitsa zviri nani, kuburikidza nekushandiswa kwekukurumidza-kuburitswa, kudzorwa-kuburitswa uye kunonoka kuburitswa achieve.
Kudzora kurinani pamusoro pekuburitswa kwemushonga, semuenzaniso ne micropelletizing iyo API, inogona kudzivirira kuraswa kwedosi uye kuderedza mhedzisiro.Vagadziri vezvinodhaka vari kuona kuti kusanganisa multiparticulate tekinoroji nemakapisi kunowedzera kushanduka uye kushanda kweinodzorwa-kuburitsa API kugadzirisa.Inogona kutsigira mapepa ane maAPI akasiyana mune imwechete capsule, zvinoreva kuti mishonga yakawanda inogona kushandiswa panguva imwe chete mumhando dzakasiyana-siyana, zvichiwedzera kuderedza kuwanda kwedosing.
Iyo pharmacokinetic uye pharmacodynamic maitiro ezvigadziriso izvi, kusanganisira multiparticulate system4, extrusion spheronization API3, uye yakatarwa-dose musanganiswa system5, yakaratidzawo kuberekana kuri nani kana kuchienzaniswa neyakajairwa magadzirirwo.
Imhaka yeiyi mukana wekuvandudza mukuteerera kwevarwere uye kushanda nesimba uko kudiwa kwemusika kwegranular APIs akavharidzirwa mumakapisi akaomarara kunoramba kuchikura.
Polymer inodiwa:
Kudiwa kwemiriwo capsules kutsiva yakaoma gelatin capsules
Traditional hard capsules yakagadzirwa negelatin, zvisinei, gelatin yakaoma capsules inogona kupa matambudziko paunosangana nehygroscopic kana mwando-sensitive content.Gelatin imhuka-yakagadzirwa ne-chigadzirwa chinowanzoita kuyambuka-kubatanidza maitiro anokanganisa maitiro ekuparara, uye ine mvura ine mvura yakawanda kuti ichengetedze kushanduka kwayo, asi inogonawo kuchinjana mvura neAPIs uye zvinobatsira.
Pamusoro pekukanganisa kwecapsule material pakuita kwechigadzirwa, varwere vakawanda vanozeza kunwa zvigadzirwa zvemhuka nekuda kwezvikonzero zvemagariro kana tsika uye vari kutsvaga mishonga inotorwa nezvirimwa kana vegan.Kuti zvizadzise chinodikanwa ichi, makambani emishonga ari kuenderera mberi nekudyara mari mumichina yedosing regimens kugadzira dzimwe nzira dzekudyara dzakachengeteka uye dzinoshanda.Kufambira mberi mune zvesainzi zvesainzi kwakaita kuti zvinomera-zvakagadzirwa hollow capsules zvigoneke, zvichipa varwere sarudzo isiri yemhuka mukuwedzera kune zvakanakira gelatin capsules-kumedza, nyore kugadzira, uye mutengo-unoshanda.
Kuti zvigadziriswe zvirinani uye kuenderana:
Kushandiswa kweHPMC
Parizvino, imwe yenzira dzakanakisa dzegelatin ndeye hydroxypropyl methylcellulose (HPMC), polymer inotorwa kubva mumiti fibers.
HPMC haina kemikari inert shoma pane gelatin uye zvakare inotora mvura shoma pane gelatin6.Mvura yakaderera yeHPMC capsules inoderedza kuchinjana kwemvura pakati pe capsule uye zviri mukati, izvo mune dzimwe nguva zvinogona kuvandudza kemikari uye kugadzikana kwemuviri wekugadzirisa, kuwedzera hupenyu hwesherufu, uye nyore nyore kusangana nematambudziko e hygroscopic APIs uye excipients.HPMC hollow capsules hainzwi tembiricha uye iri nyore kuchengeta nekutakura.
Nekuwedzera kwe-high-effect APIs, zvinodiwa zvekugadzirisa zviri kuwedzera uye zvakanyanya kuoma.Kusvika pari zvino, vanogadzira zvinodhaka vakawana mhedzisiro yakanaka mukuita kwekuongorora kushandiswa kweHPMC capsules kutsiva echinyakare gelatin capsules.Muchokwadi, macapsules eHPMC parizvino anowanzo kufarirwa mumakiriniki ekuyedzwa nekuda kwekuenderana kwawo nemishonga yakawanda uye anobatsira7.
Kuenderera mberi kwekuvandudzwa kweHPMC capsule tekinoroji kunorevawo kuti vanogadzira zvinodhaka vari nani kutora mukana wekuparara kwayo paramita uye kuenderana nehupamhi hweNMEs, kusanganisira makomisheni ane simba.
HPMC capsules isina gelling agent ine yakanakisa dissolution zvivakwa pasina ion uye pH kutsamira, kuitira kuti varwere vawane yakafanana yekurapa maitiro kana vachitora mushonga usina chinhu mudumbu kana nekudya.Sezvinoratidzwa Mufananidzo 1.8
Nekuda kweizvozvo, kuvandudzwa kwekuparara kunogona kubvumira varwere kuti vasanetseka nezve kuronga madosi avo, nekudaro vachiwedzera kutevedzera.
Pamusoro pezvo, kuenderera mberi kwehunyanzvi muHPMC capsule membrane mhinduro kunogona zvakare kugonesa kuchengetedzwa kwemukati uye nekukasira kusunungurwa munzvimbo dzakanangana dzegavhuna, inonangwa kuendesa zvinodhaka kune dzimwe nzira dzekurapa, uye kuwedzera kuwedzera kushandiswa kweHPMC capsules.
Imwe nzira yekushandisa yeHPMC capsules iri mune inhalation zvishandiso zvepulmonary administration.Kudiwa kwemusika kuri kuramba kuchikura nekuda kwekuvandudzwa kwebioavailability nekudzivirira iyo hepatic yekutanga-pass mhedzisiro uye nekupa yakananga nzira yekutonga kana yakanangana nezvirwere zvakaita seasthma uye chisingaperi chinodzivirira pulmonary chirwere (COPD) neiyi fomu yekutonga.
Vagadziri vezvinodhaka vanogara vachitsvaga kuvandudza kurapa kusingadhuri, kushivirira, uye kunoshanda kwezvirwere zvekufema, uye kuongorora kurapa kwekufemerwa kwemishonga yezvimwe zvirwere zvepakati tsinga (CNS).kudiwa kuri kuwedzera.
Iyo yakaderera mvura yemukati yeHPMC capsules inoita kuti ive yakakodzera kune hygroscopic kana mvura-inonzwa APIs, kunyangwe electrostatic zvivakwa pakati pekugadzira uye hollow capsules inofanirwawo kutariswa mukati mekukura8.
pfungwa dzekupedzisira
Kuvandudzwa kwesainzi yemembrane uye OSD engineering tekinoroji yakateya hwaro hweHPMC capsules kutsiva gelatin capsules mune mamwe magadzirirwo, ichipa dzimwe sarudzo mukugadzirisa kuita kwechigadzirwa.Pamusoro pezvo, kuwedzera kukoshesa zvinofarirwa nevatengi uye kukwira kuri kudiwa kwemishonga isingadhure inofemerwa kwakawedzera kudiwa kwemakapisi asina hovhorosi anoenderana zvirinani nemamorekuru anonzwa mwando.
Zvisinei, kusarudzwa kwe membrane zvinhu zvakakosha pakubudirira kwechigadzirwa, uye sarudzo yakarurama pakati pegelatin neHPMC inogona kuitwa chete neunyanzvi hwakakodzera.Sarudzo chaiyo yemembrane zvinhu haingogone kuvandudza mashandiro uye kuderedza maitiro akashata, asi zvakare kubatsira kukunda mamwe matambudziko ekugadzira.
Nguva yekutumira: Sep-23-2022