Often, I hear questions surrounding what are liquid dosage formulations. I thought I might take the opportunity to provide a short introduction to liquid dosage formulations. Liquid dosage formulations may be in the form of suspensions or syrups, metered dosed inhalers (MDIs), or creams or lotions. All of these systems would typically have particles present or droplets present in their formulations. There could also be parentals, such as injections or intravenous infusions, which may be particle free. Continue reading
Last month, Steve Mehrman of Johnson & Johnson gave a presentation on using Fluid Bed Granulation as a predictor of dissolution performance. Continue reading
A couple of weeks ago, I posted an article about my colleagues’ attendance at POWTECH in Nuremberg. I was recently informed that while in Nuremberg, they accepted an award for this year’s most outstanding innovation in the field of Particle Characterization and Material Science at POWTECH. I thought I would share some of the details with you:
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.
Andrew Birkmire, Dr. Kim Walters, GEA (Niro) Pharma
Dr. Mario Hubert, BMS
Eric Dycus, Terry Redman, Ben Smith, METTLER TOLEDO
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.
The particle size distribution is a critical parameter in process efficiency and product quality in many pharmaceutical, chemical and industrial processes. The real-time measurement of particle count, dimension and shape of particles as they actually exist in process provides critical process information that speeds up process understanding and enables a better means of real-time measurement and control.
At next week’s World Congress on Particle Technology in Nuremburg, two of my colleagues will be presenting papers covering research and case studies covering a variety of applications of real-time measurement of particle systems using on-line particle characterization tools.
The titles of the four papers that will be presented are listed below :
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.
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.
Zane Arp, GSK
Eric Dycus, Ben Smith, METTLER TOLEDO