Improvement of content uniformity in low-dose powder blends: critical formulation and process variables

Makraduli, Liljana and Makreski, Petre and Geskovski, Nikola (2022) Improvement of content uniformity in low-dose powder blends: critical formulation and process variables. Macedonian Pharmaceutical Bulletin -7th Congress of Pharmacy in North Macedonia with International participation, 68 (03). pp. 221-222. ISSN 1857 - 8969

Text 68_3_105.pdf - Published Version Download (161kB)

Abstract

The safety and efficacy of solid oral drug products, as
well as their robust performance, are ensured by meeting
the specified values of critical quality attributes (CQAs).
Blend homogeneity and content uniformity in drug
products are CQAs of primary importance, especially for
direct compression (Crouter, Briens, 2019; Jakubowska,
Ciepluch, 2021; Zheng, 2008).
Drug product development
and manufacturing should align with Quality by Design
(QbD) principles, where critical material attributes
(CMAs) and critical process parameters (CPPs) are taken
into consideration in regards to their impact on product
CQAs (Fukuda et al., 2018; ICH Q8 (R2), 2017; Roy, 2012).
According to the Product Quality Research Institute
(PQRI) Blend Uniformity Working Group (BUWG)
survey the blend-uniformity variation was always less
than 10% for direct compression processes, used routinely
to manufacture low-dosage solid forms (Hancock and
Garcia-Munoz, 2013).

Item Type:	Article
Subjects:	Engineering and Technology > Other engineering and technologies Medical and Health Sciences > Other medical sciences Natural sciences > Other natural sciences
Divisions:	Faculty of Medical Science
Depositing User:	Liljana Makraduli
Date Deposited:	29 Mar 2024 09:24
Last Modified:	29 Mar 2024 09:24
URI:	https://eprints.ugd.edu.mk/id/eprint/33899

Actions (login required)

View Item