Influence of process parameters on content uniformity of a low dose active pharmaceutical ingredient in a tablet formulation according to GMP

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F62157124%3A16370%2F14%3A43873114" target="_blank" >RIV/62157124:16370/14:43873114 - isvavai.cz</a>

Výsledek na webu

<a href="http://dx.doi.org/10.2478/acph-2014-0022" target="_blank" >http://dx.doi.org/10.2478/acph-2014-0022</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.2478/acph-2014-0022" target="_blank" >10.2478/acph-2014-0022</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Influence of process parameters on content uniformity of a low dose active pharmaceutical ingredient in a tablet formulation according to GMP

Popis výsledku v původním jazyce

The article describes the development and production of tablets using direct compression of powder mixtures. The aim was to describe the impact of filler particle size and the time of lubricant addition during mixing on content uniformity according to the Good Manufacturing Practice (GMP) process validation requirements. Processes are regulated by complex directives, forcing the producers to validate, using sophisticated methods, the content uniformity of intermediates as well as final products. Cuttingdown of production time and material, shortening of analyses, and fast and reliable statistic evaluation of results can reduce the final price without affecting product quality. The manufacturing process of directly compressed tablets containing the lowdose active pharmaceutical ingredient (API) warfarin, with content uniformity passing validation criteria, is used as a model example. Statistic methods have proved that the manufacturing process is reproducible. Methods suitable for elu

Název v anglickém jazyce

Influence of process parameters on content uniformity of a low dose active pharmaceutical ingredient in a tablet formulation according to GMP

Popis výsledku anglicky

The article describes the development and production of tablets using direct compression of powder mixtures. The aim was to describe the impact of filler particle size and the time of lubricant addition during mixing on content uniformity according to the Good Manufacturing Practice (GMP) process validation requirements. Processes are regulated by complex directives, forcing the producers to validate, using sophisticated methods, the content uniformity of intermediates as well as final products. Cuttingdown of production time and material, shortening of analyses, and fast and reliable statistic evaluation of results can reduce the final price without affecting product quality. The manufacturing process of directly compressed tablets containing the lowdose active pharmaceutical ingredient (API) warfarin, with content uniformity passing validation criteria, is used as a model example. Statistic methods have proved that the manufacturing process is reproducible. Methods suitable for elu

Druh

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

CEP obor

FR - Farmakologie a lékárnická chemie

OECD FORD obor

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Projekt

—

Návaznosti

S - Specificky vyzkum na vysokych skolach

Rok uplatnění

2014

Kód důvěrnosti údajů

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

Název periodika

Acta pharmaceutica

ISSN

1330-0075

e-ISSN

—

Svazek periodika

64

Číslo periodika v rámci svazku

3

Stát vydavatele periodika

HR - Chorvatská republika

Počet stran výsledku

13

Strana od-do

355-367

Kód UT WoS článku

000342726300008

EID výsledku v databázi Scopus

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