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Highly soluble drugs directly granulated by water dispersions of insoluble EUDRAGIT polymers as a part of hypromellose K100M matrix systems

Identifikátory výsledku

  • Kód výsledku v IS VaVaI

    <a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00027162%3A_____%2F19%3AN0000204" target="_blank" >RIV/00027162:_____/19:N0000204 - isvavai.cz</a>

  • Nalezeny alternativní kódy

    RIV/61389013:_____/19:00503798

  • Výsledek na webu

    <a href="https://www.hindawi.com/journals/bmri/2019/8043415/" target="_blank" >https://www.hindawi.com/journals/bmri/2019/8043415/</a>

  • DOI - Digital Object Identifier

    <a href="http://dx.doi.org/10.1155/2019/8043415" target="_blank" >10.1155/2019/8043415</a>

Alternativní jazyky

  • Jazyk výsledku

    angličtina

  • Název v původním jazyce

    Highly soluble drugs directly granulated by water dispersions of insoluble EUDRAGIT polymers as a part of hypromellose K100M matrix systems

  • Popis výsledku v původním jazyce

    The aim of the present study was to investigate the suitability of insoluble Eudragit® water dispersions (NE, NM, RL and RS) for direct high-shear granulation of very soluble levetiracetam in order to decrease its burst effect from HPMC K100M matrices. The process characteristics, ss-NMR analysis, in-vitro dissolution behavior, drug release mechanism and kinetics, texture profile analysis of the gel layer and PCA analysis were explored. An application of water dispersions directly on levetiracetam was feasible only in a multistep process. All prepared formulations exhibited a 12-hour sustained release profile characterized by a reduced burst effect in a concentration-dependent manner. No effect on swelling extent of HPMC K100M was observed in the presence of Eudragit®. Contrary, higher rigidity of formed gel layer was observed using combination of HPMC and Eudragit®. Not only the type and concentration of Eudragit®, but also the presence of the surfactant in water dispersions played a key role in the dissolution characteristics. The dissolution profile close to zero-order kinetic was achieved from the sample containing levetiracetam directly granulated by the water dispersion of Eudragit® NE (5% of solid polymer per tablet) with a relatively high amount of surfactant nonoxynol 100 (1.5%). The initial burst release of drug was reduced to 8.04% in 30 min (a 64.2% decrease) while the total amount of the released drug was retained (97.02%).

  • Název v anglickém jazyce

    Highly soluble drugs directly granulated by water dispersions of insoluble EUDRAGIT polymers as a part of hypromellose K100M matrix systems

  • Popis výsledku anglicky

    The aim of the present study was to investigate the suitability of insoluble Eudragit® water dispersions (NE, NM, RL and RS) for direct high-shear granulation of very soluble levetiracetam in order to decrease its burst effect from HPMC K100M matrices. The process characteristics, ss-NMR analysis, in-vitro dissolution behavior, drug release mechanism and kinetics, texture profile analysis of the gel layer and PCA analysis were explored. An application of water dispersions directly on levetiracetam was feasible only in a multistep process. All prepared formulations exhibited a 12-hour sustained release profile characterized by a reduced burst effect in a concentration-dependent manner. No effect on swelling extent of HPMC K100M was observed in the presence of Eudragit®. Contrary, higher rigidity of formed gel layer was observed using combination of HPMC and Eudragit®. Not only the type and concentration of Eudragit®, but also the presence of the surfactant in water dispersions played a key role in the dissolution characteristics. The dissolution profile close to zero-order kinetic was achieved from the sample containing levetiracetam directly granulated by the water dispersion of Eudragit® NE (5% of solid polymer per tablet) with a relatively high amount of surfactant nonoxynol 100 (1.5%). The initial burst release of drug was reduced to 8.04% in 30 min (a 64.2% decrease) while the total amount of the released drug was retained (97.02%).

Klasifikace

  • Druh

    J<sub>imp</sub> - Článek v periodiku v databázi Web of Science

  • CEP obor

  • OECD FORD obor

    30104 - Pharmacology and pharmacy

Návaznosti výsledku

  • Projekt

    <a href="/cs/project/EF15_003%2F0000495" target="_blank" >EF15_003/0000495: FIT (Farmakologie, Imunoterapie, nanoToxikologie)</a><br>

  • Návaznosti

    P - Projekt vyzkumu a vyvoje financovany z verejnych zdroju (s odkazem do CEP)<br>I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Ostatní

  • Rok uplatnění

    2019

  • Kód důvěrnosti údajů

    S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Údaje specifické pro druh výsledku

  • Název periodika

    Biomed Research International

  • ISSN

    2314-6133

  • e-ISSN

    2314-6141

  • Svazek periodika

  • Číslo periodika v rámci svazku

    MAR 2019

  • Stát vydavatele periodika

    GB - Spojené království Velké Británie a Severního Irska

  • Počet stran výsledku

    13

  • Strana od-do

    8043415

  • Kód UT WoS článku

    000461616600001

  • EID výsledku v databázi Scopus