Key themes that will shape the excipient landscape in the near future will include regulations, innovation, economics and sustainability, says Dr Iain Moore, Head of Global Quality Assurance, Croda International, in this year’s CPhI Annual Report.
Excipients have always played a critical role in the safe and effective use of medicinal products. Their functions range from acting simply as a bulking agent to allow a tiny quantity of an active to be picked up by the patient right through to being responsible for forming the lipid nanoparticles that deliver the mRNA in several COVID-19 vaccines.
And, whereas they are pharmacologically inactive, in that they have no therapeutic effect on their own, the oversight applied to them in the drug product approval process can be as rigorous as the active substance.
In the developed world, the ways of using and approving excipients are well established and have changed very little in the past decade. The newly emerging economies, however, are now introducing new and more demanding ways of approving the manufacture and use of excipients — and these developments are driving changes throughout the industry.
This article was originally published in the CPhI Annual Report 2021 and is reproduced with kind permission.