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.
Aplikace
Vývoj pevných perorálních lékových forem
Studujte, jak se mění velikost a počet částic, když se tablety a kapsle rozpadají během testování rozpouštění.
Automatizovaná řešení a in-situ PAT pro podporu formulace LNP
Zjistěte, jak automatizované laboratorní reaktory a in-situ PAT umožnily rychlé škálování procesu formulace lipidových nanočástic (LNP) PEG pro mRNA vakcíny během pandemie COVID-19.
Publikace ke stažení
Podobné produkty
Analyzátory velikosti částic
Pochopte, optimalizujte a kontrolujte částice a kapičky v reálném čase pomocí inline analyzátorů velikosti částic.