Meeting the Challenges of Excipient Variability
The physical and chemical properties of an excipient can have an impact on the manufacture and performance of the pharmaceutical products. With regulators placing increasing emphasis on quality by design (QbD) in product development, the industry is now paying closer attention to the role of excipients in the formulation of drugs and the impact of excipient variability on the quality of the final drug product. Representatives of excipient development organizations addressed key aspects of excipient variability with Pharmaceutical Technology.
Participants of this roundtable discussion include Bernhard Fussnegger, global development and technical marketing, BASF Pharma Ingredients; Dora Meissner, regulatory manager and Rick Mutchler, president, BioSpectra; Carl Mroz, director–global regulatory affairs, Colorcon; True Rogers, R&D pharma technology leader, Dow Pharma and Food Solutions; and Ann Gray, market segment manager oral excipients, Evonik Pharma Polymers & Services.
Multiple causes of variabilityPharmTech: What are common sources of excipient variability?
Sep 1, 2014, By: Adeline Siew, PhD, Rita Peters, PHARMACEUTICAL TECHNOLOGY, https://www.pharmtech.com/view/meeting-challenges-excipient-variability