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
Utveckling av fast oral doseringsform
Studera hur partikelstorlek och antal förändras när tabletter och kapslar sönderfaller under upplösningstestning.
Automatiserade lösningar och in-situ PAT för att stödja LNP-formulering
Lär dig hur automatiserade laboratoriereaktorer och in-situ PAT möjliggjorde snabb processuppskalning av formuleringen PEG-lipid nanoparticle (LNP) för mRNA-vacciner under covid-19-pandemin.
Trycksaker
Relaterade produkter
Analysatorer för partikelstorlek
Förstå, optimera och kontrollera partiklar och droppar i realtid med inbyggda partikelstorleksanalysatorer.