Effect of process scale-up on the dissolution of granules with a high content of active pharmaceutical ingredient

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F60461373%3A22340%2F15%3A43899914" target="_blank" >RIV/60461373:22340/15:43899914 - isvavai.cz</a>

Výsledek na webu

<a href="http://apps.webofknowledge.com/full_record.do?product=WOS&search_mode=GeneralSearch&qid=4&SID=S2K2CD6AfClgauzA9GP&page=1&doc=1" target="_blank" >http://apps.webofknowledge.com/full_record.do?product=WOS&search_mode=GeneralSearch&qid=4&SID=S2K2CD6AfClgauzA9GP&page=1&doc=1</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1016/j.powtec.2015.04.028" target="_blank" >10.1016/j.powtec.2015.04.028</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Effect of process scale-up on the dissolution of granules with a high content of active pharmaceutical ingredient

Popis výsledku v původním jazyce

The robustness and parametric sensitivity of a high-shear wet granulation process during scale-up were investigated for a formulation containing over 50% by weight of a hydrophobic active pharmaceutical ingredient (API). The sensitivity of granule properties-such as particle site distribution, bulk density and dissolution rate with respect to both formulation (binder/solids ratio) and process parameters (agitation rate and wet massing time) was determined at three different scales (0.5, 4.0 and 25.0 L).For a fixed impeller speed at a given granulator scale, the dissolution rate was found to be strongly correlated with bulk density, and both parameters could be controlled relatively precisely by the wet massing time. However, during scale-up and for variable agitation rates (expressed by the dimensionless Froude number) dissolution rate was found to be a non-trivial function of both granule size distribution and granule density. A set of process parameters for which the formulation was

Název v anglickém jazyce

Effect of process scale-up on the dissolution of granules with a high content of active pharmaceutical ingredient

Popis výsledku anglicky

The robustness and parametric sensitivity of a high-shear wet granulation process during scale-up were investigated for a formulation containing over 50% by weight of a hydrophobic active pharmaceutical ingredient (API). The sensitivity of granule properties-such as particle site distribution, bulk density and dissolution rate with respect to both formulation (binder/solids ratio) and process parameters (agitation rate and wet massing time) was determined at three different scales (0.5, 4.0 and 25.0 L).For a fixed impeller speed at a given granulator scale, the dissolution rate was found to be strongly correlated with bulk density, and both parameters could be controlled relatively precisely by the wet massing time. However, during scale-up and for variable agitation rates (expressed by the dimensionless Froude number) dissolution rate was found to be a non-trivial function of both granule size distribution and granule density. A set of process parameters for which the formulation was

Druh

J_x - Nezařazeno - Článek v odborném periodiku (Jimp, Jsc a Jost)

CEP obor

CI - Průmyslová chemie a chemické inženýrství

OECD FORD obor

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Projekt

<a href="/cs/project/LH12115" target="_blank" >LH12115: Víceúrovňová analýza a návrh granulačních procesů</a><br>

Návaznosti

P - Projekt vyzkumu a vyvoje financovany z verejnych zdroju (s odkazem do CEP)<br>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 periodika

Powder Technology

ISSN

0032-5910

e-ISSN

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Svazek periodika

285

Číslo periodika v rámci svazku

NOV 2015

Stát vydavatele periodika

NL - Nizozemsko

Počet stran výsledku

8

Strana od-do

88-95

Kód UT WoS článku

000362605200012

EID výsledku v databázi Scopus

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