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

Christian Moreton
FinnBrit Consulting, Waltham, United States

Corresponding Author

Christian Moreton:
FinnBrit Consulting, 29 Shawmut Road, MA 02452, Waltham, United States
, email:

consulting@finnbrit.com


Moreton C.,

(2011

Incorporating excipients into a quality by design formulation project Using the opportunities available through Quality by Design,
Chemistry Today 
Excipients – Vol. 29(5) September/October 2011

, 7-9

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.