The Quality by Design concept as generally understood within the pharmaceutical industry relates to the development of medicinal products. Excipients are one of these major inputs that are combined to produce a formulation:
API + Excipient + Process + Interactions = Formulation
The key to success in developing robust medicinal products is to understand the variability in these components and how it influences the design space for finished products. Excipients are just one component of the variability but a very important one. The excipient user needs to understand excipient variability and how it influences the products. This in turn requires that the key parameters influencing functional performance are understood and how the variability in the raw materials and processing can affect the excipient performance.
QbD is much broader in scope than just pharmaceutical finished products. In principle it can be applied to any manufactured goods or services. It can thus be applied to the design and development of both new and existing excipients. When used in this way QbD and the design space concept is a powerful tool that can facilitate understanding of excipient functionality.
Chris has written a regular column on Functionality and Performance of Excipients in a Quality–by-Design World, in American Pharmaceutical Review published as follows:
Part 1: Functionality and Performance of Excipients in a Quality-by-Design World: (2009), 12, (1), 40 – 44
Part 2: Functionality and Performance of Excipients in a Quality-by-Design World: Excipient Variability, QbD and Robust Formulations, (2009), 12, (2), 24 – 27.
Part 3: Functionality and Performance of Excipients in a Quality-by-Design World. (2009), 12, (4), 22 – 26
Part 4: Functionality and Performance of Excipients in a Quality-by-Design World: Obtaining Information on Excipient Variability for Formulation Design Space, (2009), Jul/Aug, 28-33
Part 5: Functionality and Performance of Excipients in a Quality-by-Design World: Changes in the Sourcing and Supply of Pharmaceutical Excipients, (2009), Sep/Oct, 12-17
Online subscriptions to the American Pharmaceutical Review are free worldwide.
You can also watch an interview on YouTube that Chris gave at the USP International Excipients Workshop 2009 responding to the question of the challenges that the pharmaceutical industry faces with the introduction of Quality by Design.
FinnBrit Consulting can advise clients on Quality by Design applications and design space for both medicinal finished products and excipients.
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