The particle size distribution is one of the most critical parameters in drug product quality. Real time understanding and control of particles ensures Quality by Design (QbD) in solid and liquid dosage formulation. FBRM® and PVM® Process Analytical Technologies (PAT) provide in-process real time measurements of particle dimension, particle shape, and particle count. FBRM® and PVM® are used to promote faster formulation development, improve process confidence, and control batch-to-batch consistency.
- Dissolution Testing - FBRM® tracks tablet, capsule, and granule disintegration and dissolution mechanisms in real time to uncover the root cause of dissolution performance inconsistencies
- Granulation - FBRM® and PVM® provide immediate feedback for batch control and repeatability, without the need for offline sampling. Optimize granulation development and scale-up by directly monitoring the granule distribution in real time
- Fluid Bed - FBRM® and PVM® detect and control attrition, breakage, and agglomeration in the fluid bed. Ensure a repeatable endpoint particle size distribution
- Milling - Monitor the real-time particle distribution at the outlet of the mill to further control batch repeatability
- Liquid Suspensions - Ensure particle stability and homogeneity by tracking the particle distribution in real time
After purchasing Lasentec® in 2001, METTLER TOLEDO has become the world leader for in-line particle/droplet size, shape, and count characterization.
Applikationer
Udvikling af fast oral doseringsform
Undersøg, hvordan partikelstørrelse og -antal ændres, når tabletter og kapsler går i opløsning under opløsningstest.
Automatiserede løsninger og in-situ PAT til understøttelse af LNP-formulering
Få mere at vide om, hvordan automatiserede laboratoriereaktorer og in-situ PAT muliggjorde hurtig procesopskalering af PEG-lipid nanopartikelformulering (LNP) til mRNA-vacciner under COVID-19-pandemien.
Publikationer
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Analysatorer til partikelstørrelse
Forstå, optimer og kontroller partikler og dråber i realtid med inline-partikelstørrelsesanalysatorer.