Functionality and Performance of Excipients in a Quality-by-Design World: Part III-Excipient Quality in a QbD Context

摘要

As I wrote in my earlier columns, excipients are going to be a major part of pharmaceutical formulation Quality by Design (QbD). It thus follows that excipient quality will also be an important part of QbD and Design Space. We therefore need to consider excipient quality in all its aspect very carefully to get the most out of pharmaceutical formulation QbD and Design Space. But first we should define what we mean by quality, and then examine what it means in the context of excipients in a QbD world.