USP dissolution testing is a standard method in pharmaceutical industry to characterize dissolution performance of solid dosage forms. Continue reading
Three speakers from the 2010 In-Process Particle Forum will present at IFPAC [International Forum Process Analytical Technology] on January 21, 2011 in Baltimore, MD. Steve Mehrman of Johnson & Johnson and James Butz of Merck & Co. are scheduled to present during the Particle Characterization/Analysis-Ultrasound Spectroscopy Friday AM V session at IFPAC. Kevin Macias of Bristol-Myers Squibb will present during the Control Strategies for Drug Product Development and Manufacturing Friday AM VII session. Continue reading
At the 2010 American Institute of Chemical Engineers (AIChE) Annual Meeting in Salt Lake City, there were a number of well-attended sessions dealing with the related topics of Quality by Design (QbD) and Process Analytical Technologies (PAT). Continue reading
In July, I announced that I would be chairing next week’s In Process Particle Forum being held in Iselin, NJ. Today, I want to highlight one of the papers that will be presented at In Process Particle Forum. Steve Mehrman of Johnson & Johnson will present on using FBRM C35 during fluid bed granulation development and scale-up.
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.