Investigation of pharmaceutical wet granulation in a high-shear mixer and its scale-up with respect to dissolution behaviour

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F60461373%3A22340%2F15%3A43900436" target="_blank" >RIV/60461373:22340/15:43900436 - isvavai.cz</a>

Výsledek na webu

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DOI - Digital Object Identifier

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Jazyk výsledku

angličtina

Název v původním jazyce

Investigation of pharmaceutical wet granulation in a high-shear mixer and its scale-up with respect to dissolution behaviour

Popis výsledku v původním jazyce

This work was focused on a high-shear wet granulation process handling formulation containing over 50 % by weight of a hydrophobic Active Pharmaceutical Ingredient (API). This formulation was subjected to parametric sensitivity study and robustness of scale-up was investigated. Effect of both formulation (liquid/solid ratio) and process parameters (agitation rate, chopper rate and wet massing time) was determined at three different scales (0.5, 4.0 and 25 L) with respect to bulk properties of granulatesuch as bulk density and particle size distribution as well as dissolution profiles. Product properties were strongly dependent on the agitation rate, while the chopper rate was a distinctly less important parameter. When agitation rate at a given scalewas fixed, the bulk properties were an increasing function of wet massing time and a steady state was observed. Dissolution rate was a decreasing function of wet massing time. Using the Froude number during scale-up, the bulk density was

Název v anglickém jazyce

Investigation of pharmaceutical wet granulation in a high-shear mixer and its scale-up with respect to dissolution behaviour

Popis výsledku anglicky

This work was focused on a high-shear wet granulation process handling formulation containing over 50 % by weight of a hydrophobic Active Pharmaceutical Ingredient (API). This formulation was subjected to parametric sensitivity study and robustness of scale-up was investigated. Effect of both formulation (liquid/solid ratio) and process parameters (agitation rate, chopper rate and wet massing time) was determined at three different scales (0.5, 4.0 and 25 L) with respect to bulk properties of granulatesuch as bulk density and particle size distribution as well as dissolution profiles. Product properties were strongly dependent on the agitation rate, while the chopper rate was a distinctly less important parameter. When agitation rate at a given scalewas fixed, the bulk properties were an increasing function of wet massing time and a steady state was observed. Dissolution rate was a decreasing function of wet massing time. Using the Froude number during scale-up, the bulk density was

Druh

D - Stať ve sborníku

CEP obor

CI - Průmyslová chemie a chemické inženýrství

OECD FORD obor

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Projekt

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Návaznosti

S - Specificky vyzkum na vysokych skolach

Rok uplatnění

2015

Kód důvěrnosti údajů

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

Název statě ve sborníku

Proceedings of 42nd International Conference of Slovak Society of Chemical Engineering

ISBN

978-80-89475-14-8

ISSN

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e-ISSN

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Počet stran výsledku

9

Strana od-do

"233-1"-"233-9"

Název nakladatele

J. Markoš, V. Štefuca

Místo vydání

Bratislava

Místo konání akce

Tatranské Matliare

Datum konání akce

25. 5. 2015

Typ akce podle státní příslušnosti

WRD - Celosvětová akce

Kód UT WoS článku

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