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

Result code in 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>

Result on the web

<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>

Result language

angličtina

Original language name

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

Original language description

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

Czech name

—

Czech description

—

Type

J_x - Unclassified - Peer-reviewed scientific article (Jimp, Jsc and Jost)

CEP classification

FR - Pharmacology and apothecary chemistry

OECD FORD branch

—

Project

—

Continuities

S - Specificky vyzkum na vysokych skolach

Publication year

2014

Confidentiality

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

Name of the periodical

Acta pharmaceutica

ISSN

1330-0075

e-ISSN

—

Volume of the periodical

64

Issue of the periodical within the volume

3

Country of publishing house

HR - CROATIA

Number of pages

13

Pages from-to

355-367

UT code for WoS article

000342726300008

EID of the result in the Scopus database

—