Abstract

Pharmaceutical excipients are important componentsof most pharmaceutical formulations. Among otherthings, understanding excipient variability is essential fordeveloping a Design Space under Quality by Design.Obtaining excipients manufactured to be at the extremes ofspecification is likely to be very difficult, and not required onregulatory or scientific grounds. The excipient manufacturersare simply not set up to do this. QbD offers the flexibility to useother means to investigate excipient variability. There areoptions for both single grade excipients and multiple gradeexcipients which use existing materials and will therefore bequicker and more cost effective.