Cov tshuaj ntsiav nyuaj / HPMC hollow capsules / zaub capsules / high-efficiency API thiab noo noo-rhiab cov khoom xyaw / zaj duab xis science / sustained tso tawm tswj / OSD engineering technology ....
Kev ua tau zoo ntawm tus nqi zoo, tus txheeb ze yooj yim ntawm kev tsim khoom, thiab kev yooj yim ntawm tus neeg mob tswj kev noj ntau npaum li cas, cov khoom siv hauv qhov ncauj (OSD) tseem yog daim ntawv nyiam ntawm kev tswj hwm rau cov neeg tsim tshuaj.
Ntawm 38 lub koom haum me me tshiab (NMEs) tau pom zoo los ntawm US Food and Drug Administration hauv 2019, 26 yog OSD1.Hauv 2018, cov nyiaj tau los ntawm kev lag luam ntawm OSD-branded cov khoom lag luam nrog kev ua haujlwm thib ob los ntawm CMOs hauv North American lag luam yog kwv yees li $ 7.2 billion USD 2. Cov khoom lag luam me me yuav tsum tau tshaj $ 69 billion hauv 20243. Tag nrho cov ntaub ntawv no qhia tias qhov ncauj Cov ntaub ntawv ntau npaum li cas (OSDs) yuav muaj yeej.
Cov ntsiav tshuaj tseem tseem nyob hauv OSD kev ua lag luam, tab sis cov tshuaj ntsiav nyuaj tau dhau los ua lwm txoj hauv kev txaus nyiam.Qhov no yog ib feem los ntawm kev ntseeg siab ntawm cov tshuaj ntsiav raws li hom kev tswj hwm, tshwj xeeb tshaj yog cov uas muaj zog antitumor APIs.Capsules muaj kev sib raug zoo rau cov neeg mob, npog cov ntxhiab tsw thiab saj, thiab yooj yim rau nqos, zoo dua li lwm hom tshuaj.
Julien Lamps, Tus Thawj Saib Xyuas Khoom Muag ntawm Lonza Capsules thiab Cov Khoom Siv Noj Qab Haus Huv, tham txog ntau yam zoo ntawm cov tshuaj ntsiav nyuaj dua cov ntsiav tshuaj.Nws qhia nws txoj kev nkag siab rau hydroxypropyl methylcellulose (HPMC) hollow capsules thiab yuav ua li cas lawv tuaj yeem pab cov neeg tsim tshuaj kho kom zoo dua lawv cov khoom thaum ntsib cov neeg siv khoom xav tau cov tshuaj cog qoob loo.
Cov tshuaj ntsiav nyuaj: Txhim kho cov neeg mob ua raws cai thiab ua kom zoo dua
Cov neeg mob feem ntau tawm tsam nrog cov tshuaj uas saj los yog tsw tsw phem, nyuaj rau nqos, los yog tej zaum yuav muaj kev phiv.Nrog rau qhov no hauv siab, tsim cov ntaub ntawv siv tau zoo rau cov neeg siv tuaj yeem txhim kho cov neeg mob ua raws li kev kho mob.Cov tshuaj ntsiav nyuaj yog qhov kev xaiv zoo rau cov neeg mob vim tias, ntxiv rau qhov npog qhov ncauj thiab tsw, lawv tuaj yeem noj tsawg dua, txo cov ntsiav tshuaj lub nra, thiab muaj lub sijhawm tso tawm zoo dua, los ntawm kev siv tam sim-tso, tswj-tso tawm thiab tso tawm qeeb rau. ua tiav.
Kev tswj hwm zoo dua ntawm kev tso tawm tus cwj pwm ntawm cov tshuaj, piv txwv li los ntawm micropelletizing API, tuaj yeem tiv thaiv cov tshuaj pov tseg thiab txo cov kev mob tshwm sim.Cov neeg tsim tshuaj yeeb tau pom tias kev sib txuas cov cuab yeej siv ntau yam nrog cov tshuaj ntsiav ua rau kom yooj yim thiab ua tau zoo ntawm kev tswj-tso API ua.Nws tuaj yeem txhawb nqa cov pellets uas muaj cov APIs sib txawv hauv tib lub tshuaj ntsiav, uas txhais tau hais tias ntau cov tshuaj tuaj yeem siv tau ib txhij hauv cov koob tshuaj sib txawv, ntxiv kom txo qhov zaus ntawm kev noj tshuaj.
Cov tshuaj pharmacokinetic thiab pharmacodynamic tus cwj pwm ntawm cov formulations no, nrog rau cov multiparticulate system4, extrusion spheronization API3, thiab cov taag-dose ua ke system5, kuj pom zoo reproducibility piv rau cov pa formulations.
Nws yog vim qhov no muaj peev xwm txhim kho nyob rau hauv cov neeg mob ua raws cai thiab kev ua tau zoo uas lub khw xav tau rau granular APIs encapsulated hauv cov tshuaj ntsiav nyuaj txuas ntxiv mus.
Polymer nyiam:
Qhov xav tau zaub capsules los hloov tawv gelatin capsules
Cov tshuaj ntsiav nyuaj yog ua los ntawm gelatin, txawm li cas los xij, gelatin nyuaj capsules tuaj yeem nthuav tawm cov teeb meem thaum ntsib cov ntsiab lus hygroscopic lossis noo noo-rhiab.Gelatin yog cov khoom tsim los ntawm cov tsiaj txhu uas muaj feem cuam tshuam rau kev sib txuas sib txuas uas cuam tshuam rau tus cwj pwm kev sib cais, thiab muaj cov ntsiab lus dej siab los tswj nws qhov yooj yim, tab sis kuj tseem tuaj yeem pauv dej nrog APIs thiab excipients.
Ntxiv rau qhov cuam tshuam ntawm cov khoom siv tshuaj ntsiav ntawm cov khoom lag luam, ntau thiab ntau tus neeg mob tsis kam noj cov khoom tsiaj rau kev sib raug zoo lossis kev coj noj coj ua thiab tab tom nrhiav cov tshuaj cog qoob loo lossis vegan tshuaj.Txhawm rau ua kom tau raws li qhov xav tau no, cov tuam txhab tshuaj tseem tab tom nqis peev hauv kev siv tshuaj kho tshiab los tsim cov kev hloov pauv cog uas muaj kev nyab xeeb thiab siv tau zoo.Kev nce qib hauv cov ntaub ntawv kev kawm tau tsim cov tshuaj ntsiav tshuaj cog qoob loo tau, muab cov neeg mob uas tsis muaj tsiaj txhu ntxiv, muab cov khoom noj uas tsis muaj tsiaj txhu ntxiv, yooj yim ntawm kev tsim khoom, thiab cov nqi tau zoo.
Txhawm rau kom zoo dua dissolution thiab compatibility:
Kev siv HPMC
Tam sim no, ib qho kev xaiv zoo tshaj plaws rau gelatin yog hydroxypropyl methylcellulose (HPMC), ib qho polymer muab tau los ntawm cov ntoo fibers.
HPMC tsis muaj tshuaj lom neeg tsawg dua gelatin thiab tseem nqus dej tsawg dua gelatin6.Cov ntsiab lus dej tsawg ntawm HPMC capsules txo cov dej pauv ntawm cov tshuaj ntsiav thiab cov ntsiab lus, uas qee zaum tuaj yeem txhim kho cov tshuaj lom neeg thiab lub cev ruaj khov ntawm cov qauv, txuas lub neej txee, thiab yooj yim ua tau raws li cov teeb meem ntawm hygroscopic APIs thiab excipients.HPMC hollow capsules yog insensitive rau kub thiab yooj yim rau khaws thiab thauj.
Nrog rau kev nce qib ntawm cov txiaj ntsig zoo APIs, cov kev cai rau kev tsim qauv tau dhau los ua ntau thiab nyuaj.Txog tam sim no, cov neeg tsim tshuaj tau ua tiav cov txiaj ntsig zoo hauv cov txheej txheem tshawb nrhiav kev siv HPMC capsules los hloov tshuaj gelatin capsules.Qhov tseeb, HPMC capsules tam sim no feem ntau nyiam nyob rau hauv kev sim tshuaj vim lawv zoo sib xws nrog feem ntau cov tshuaj thiab excipients7.
Kev txhim kho txuas ntxiv hauv HPMC capsule thev naus laus zis kuj txhais tau tias cov neeg tsim tshuaj muaj peev xwm ua tau zoo dua ntawm nws qhov kev sib cais thiab kev sib raug zoo nrog ntau yam NMEs, suav nrog cov tshuaj muaj zog heev.
HPMC capsules yam tsis muaj tus neeg sawv cev gelling muaj cov khoom tawg zoo heev yam tsis muaj ion thiab pH dependence, yog li cov neeg mob yuav tau txais kev kho mob tib yam thaum noj cov tshuaj ntawm lub plab khoob lossis noj mov.Raws li pom hauv daim duab 1. 8
Yog li ntawd, kev txhim kho hauv kev sib cais tuaj yeem tso cai rau cov neeg mob tsis muaj kev cuam tshuam txog kev teem sijhawm lawv cov koob tshuaj, yog li ua raws li kev ua raws cai.
Tsis tas li ntawd, txuas ntxiv kev tsim kho tshiab hauv HPMC capsule membrane cov kev daws teeb meem tseem tuaj yeem ua rau muaj kev tiv thaiv plab hnyuv thiab tso tawm sai rau hauv cov chaw ntawm lub plab zom mov, tsom cov tshuaj xa mus rau qee qhov kev kho mob, thiab ntxiv dag zog rau cov kev siv ntawm HPMC capsules.
Lwm daim ntawv thov kev taw qhia rau HPMC capsules yog nyob rau hauv cov khoom nqus nqus pa rau kev tswj xyuas pulmonary.Kev lag luam kev lag luam tseem nce ntxiv vim kev txhim kho bioavailability los ntawm kev zam cov kab mob hepatic first-pass effect thiab muab txoj hauv kev ncaj nraim ntawm kev tswj hwm thaum tsom cov kab mob xws li mob hawb pob thiab mob ntsws ntsws (COPD) nrog rau daim ntawv tswj hwm no.
Cov tuam txhab tshuaj ib txwm saib xyuas kom tsim tau tus nqi zoo, tus neeg mob tus phooj ywg, thiab kev kho mob zoo rau cov kab mob ua pa, thiab tshawb nrhiav kev kho cov tshuaj nqus tau rau qee cov kab mob hauv nruab nrab paj hlwb (CNS).kev thov yog nce.
Cov ntsiab lus dej tsawg ntawm HPMC capsules ua rau lawv zoo tagnrho rau hygroscopic lossis dej-sensitive APIs, txawm hais tias electrostatic zog ntawm formulation thiab hollow capsules yuav tsum tau txiav txim siab thoob plaws hauv kev loj hlob8.
kev xav kawg
Txoj kev loj hlob ntawm membrane science thiab OSD engineering technology tau tso lub hauv paus rau HPMC capsules los hloov gelatin capsules nyob rau hauv ib co formulations, muab ntau txoj kev xaiv nyob rau hauv optimizing cov khoom ua tau zoo.Tsis tas li ntawd, kev nce ntxiv ntawm kev nyiam ntawm cov neeg siv khoom thiab kev xav tau nce rau cov tshuaj nqus tau pheej yig tau txhawb nqa qhov kev thov rau hollow capsules nrog kev sib raug zoo nrog cov molecules noo noo-rhiab heev.
Txawm li cas los xij, kev xaiv ntawm cov khoom siv membrane yog qhov tseem ceeb rau kev ua kom cov khoom tiav, thiab kev xaiv zoo ntawm gelatin thiab HPMC tsuas yog ua tau nrog cov kws tshaj lij.Kev xaiv kom raug ntawm cov khoom siv membrane tuaj yeem tsis tsuas yog txhim kho kev ua tau zoo thiab txo cov kev cuam tshuam tsis zoo, tab sis kuj pab kov yeej qee yam teeb meem kev tsim.
Post lub sij hawm: Sep-23-2022