Tag Archives: Ben Smith

Why Measure Particle or Droplet Distribution in Process or Development?

After last week’s introduction to liquid dosage formulations, I wanted to follow-up with: why measure the particle or droplet distribution in process or in development? Continue reading

What are Liquid Dosage Formulations?

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

用流化床成粒预测溶解质量

上个月, 强生公司的Steve Mehrman做了一个“关于用流化床成粒作为溶解结果的一个预测方法”的报告. 如果您没能参加Steve在新泽西作的这一报告,他将在本月二十七日的网络研讨会上谈同一论题:配有在线FBRM C35的流化床:一个溶解质量预测法Continue reading

Predicting Dissolution Quality With Fluid Bed Granulation

Last month, Steve Mehrman of Johnson & Johnson gave a presentation on using Fluid Bed Granulation as a predictor of dissolution performanceContinue reading

METTLER TOLEDO receives POWTECH award for Top Innovation in Particle Characterization and Material Sciences

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Dr. Markus Adamczyk, representing METTLER TOLEDO, accepts the award for top innovation in particle characterization and material science from Frank Jablonski and Gerd Kielburger

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:
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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

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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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World Congress on Particle Technology 6: FBRM and PVM real-time particle system characterization at WCPT6 in Nuremburg, Germany (26-29 April, 2010)

POWTECH-WCPT6-Nuremburg-METTLER-TOLEDO-FBRM-C35The 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 :

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Roller Compaction Process Optimization Using At Line Particle Characterization

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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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