Experimental analysis of inter- and intra-batch variation of granule porosity, stiffness and dissolution rate

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F60461373%3A22340%2F18%3A43916259" target="_blank" >RIV/60461373:22340/18:43916259 - isvavai.cz</a>

Výsledek na webu

<a href="https://www.sciencedirect.com/science/article/pii/S0263876218300790?via%3Dihub" target="_blank" >https://www.sciencedirect.com/science/article/pii/S0263876218300790?via%3Dihub</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1016/j.cherd.2018.02.014" target="_blank" >10.1016/j.cherd.2018.02.014</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Experimental analysis of inter- and intra-batch variation of granule porosity, stiffness and dissolution rate

Popis výsledku v původním jazyce

Using a pharmaceutical formulation, granule batches were produced at a range of granulator volumes from 0.5 L to 400 L and process conditions, characterised by the Froude number in the range from Fr = 0.26 to Fr = 1.63. The mean values and the standard deviations of granule porosity, granule stiffness and granule dissolution rate evaluated from each batch using the 400–1000 μm sieve fraction were compared in order to establish structure–property correlations. Both granule stiffness and granule dissolution rate were found linearly correlated with the Froude number. A significant intra-batch variability of all investigated granule properties was observed. The relative standard deviation of granule stiffness also increased linearly with the Froude number. Coupled experiments relating the microstructure of granules with their individual compression and dissolution curves were carried out for the first time. A surprising diversity of intra-batch granule structures and their associated dissolution rates was found in batches produced at both low and high Froude numbers, highlighting the importance of avoiding granule segregation in downstream unit operations in order to maintain consistent drug release profiles from the investigated formulation. © 2018 Institution of Chemical Engineers

Název v anglickém jazyce

Experimental analysis of inter- and intra-batch variation of granule porosity, stiffness and dissolution rate

Popis výsledku anglicky

Using a pharmaceutical formulation, granule batches were produced at a range of granulator volumes from 0.5 L to 400 L and process conditions, characterised by the Froude number in the range from Fr = 0.26 to Fr = 1.63. The mean values and the standard deviations of granule porosity, granule stiffness and granule dissolution rate evaluated from each batch using the 400–1000 μm sieve fraction were compared in order to establish structure–property correlations. Both granule stiffness and granule dissolution rate were found linearly correlated with the Froude number. A significant intra-batch variability of all investigated granule properties was observed. The relative standard deviation of granule stiffness also increased linearly with the Froude number. Coupled experiments relating the microstructure of granules with their individual compression and dissolution curves were carried out for the first time. A surprising diversity of intra-batch granule structures and their associated dissolution rates was found in batches produced at both low and high Froude numbers, highlighting the importance of avoiding granule segregation in downstream unit operations in order to maintain consistent drug release profiles from the investigated formulation. © 2018 Institution of Chemical Engineers

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

20402 - Chemical process engineering

Projekt

<a href="/cs/project/GA15-05534S" target="_blank" >GA15-05534S: Studie vztahu mezi strukturou a vlastnostmi složitých granulárních systémů a dynamiky jejich lámání</a><br>

Návaznosti

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

Rok uplatnění

2018

Kód důvěrnosti údajů

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

Název periodika

Chemical Engineering Research and Design

ISSN

0263-8762

e-ISSN

—

Svazek periodika

132

Číslo periodika v rámci svazku

Neuveden

Stát vydavatele periodika

SG - Singapurská republika

Počet stran výsledku

12

Strana od-do

1131-1142

Kód UT WoS článku

000430522300096

EID výsledku v databázi Scopus

2-s2.0-85042636273