Incorporating excipients into a quality by design formulation project Using the opportunities available through Quality by Design

Pharmaceutical excipients are important components of most pharmaceutical formulations. Among other things, understanding excipient variability is essential for developing a Design Space under Quality by Design. Obtaining excipients manufactured to be at the extremes of specification is likely to be very difficult, and not required on regulatory or scientific grounds. The excipient manufacturers are simply not set up to do this. QbD offers the flexibility to use other means to investigate excipient variability. There are options for both single grade excipients and multiple grade excipients which use existing materials and will therefore be quicker and more cost effective.