Managing excipients for Quality-by-Design projects
KEYWORDS: excipients, QbD, performance, composition, variability, communication.
ABSTRACT: In order to develop the enhanced understanding necessary to demonstrate an acceptable Design Space and Control Strategy required for Quality by Design (QbD) marketing applications, it will be necessary to incorporate the variability in potentially critical excipient parameters into the Design of Experiments (DoE). Methods are described that allow samples to be engineered such that potentially critical excipient parameters can be included in the DoE. However, it must be acknowledged that not all such excipient parameters will be amenable to sample engineering. The excipient manufacturer may be able to provide non-GMP samples which help define the necessary limits for the formulation. The nature of QbD as it relates to excipients is such that communication under a confidentiality agreement between excipient users and excipient makers will be necessary. The necessity for good communication between the excipient user and manufacturer is also emphasized.
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