Tag Archives: 7th World Meeting on Pharmaceutics Biopharmaceutics and Pharmaceutical Technology

Optimization and Scale-up of Fluid Bed Processes

Fluid Bed Granulation and Coating from GEA and Niro Pharma SystemsSpray layering is increasingly being used to produce spherical pellets of a target particle distribution – often with engineered dissolution profiles for time-release formulations.

This extended abstract summarizes collaborative research between GEA (Niro) Pharma Systems and METTLER TOLEDO in the application of process analytical technologies (PAT) to the monitoring, optimization and control of Precision Fluid Bed Granulation and Fluid Bed Coating.

Download the extended abstract from the presentation given at the 7th World Meeting on Pharmaceutics, Biopharmaceutics, and Pharmaceutical Technology.

Authors:
Andrew Birkmire, Dr. Kim Walters, GEA (Niro) Pharma
Dr. Mario Hubert, BMS
Eric Dycus, Terry Redman, Ben Smith, METTLER TOLEDO
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Understanding Dissolution Inconsistency Through In Situ Particle Characterization and Root Cause Analysis

Dissolution-Disintegration-Distek-METTLER-TOLEDO-FBRM

METTLER TOLEDO FBRM and Opt Diss Fiber Optic UV for Dissolution Testing in Distek Evolution 6100

USP tablet dissolution testing is recognized as the standard analytical method used in the pharmaceutical industry.

Traditionally, dissolution has been performed in the analytical laboratory and tests were conducted with the final product. But in recent years dissolution testing has become a development tool for Quality by Design (QbD), and testing has expanded to include dissolution and disintegration tests which screen product performance during drug product development.
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Roller Compaction Process Optimization Using At Line Particle Characterization

roller-compaction-dry-granulation-FBRM-C35-METTLER-TOLEDO

METTLER TOLEDO C35 FBRM probe monitors roller compaction in real time

A successful process based on roller compaction followed by milling should produce a granule with consistent particle size distribution, density, and porosity control. Inconsistencies often occur during granulation scale-up due to changing raw materials or changing process dynamics.
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Optimization and Scale-up of High Shear Wet Granulation Processes

GlaxoSmithKline-GSK-granulation-measurement-FBRM-C35

FBRM® C35 with mechanical wiper for in situ granulation measurement

One goal of high shear granulation is to yield repeatable endpoint granule size, shape, and density distributions. This is necessary for consistent downstream flow properties, tablet consistency, and content uniformity. Quality by Design (QbD) is a concept applied to gain true process understanding through tools such as Design of Experiment (DoE), risk management, and Process Analytical Technology (PAT).

This extended abstract summarizes collaborative research between GlaxoSmithKline (GSK) and METTLER TOLEDO in the application of process analytical technologies (PAT) to the monitoring, optimization and control of High Shear Wet Granulation.

Download the extended abstract for this upcoming conference presentation.

Authors:
Zane Arp, GSK
Eric Dycus, Ben Smith, METTLER TOLEDO
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