Premier Design for Formulations – Is it Really Worth it?

By David Calvert, May 2016

As the football Premier League in England came to a conclusion, I asked myself the question “what system would be considered the “Leicester City” of formulation design?”. To most of those in the pharmaceutical industry, then Quality by Design (QbD) is considered best practice. One of the main drivers for QbD was to try and minimise the time taken to get a dossier through the regulatory process and I was interested therefore in a  presentation at the recent QbD symposium organised by De Montfort University (based by chance in the very same “Premier City”).

In his presentation, Colm Reddington of the MHRA (the UK medicines regulator) examined 69 applications made to the Chemistry, Pharmacy and Standards (CPS) expert advisory group which advises the Commission on Human Medicines (CHM) on matters relating to a range of quality issues. He classified the applications by the extent to which they demonstrated enhanced Quality by Design approaches. The applications were ranked with those at the lower having a mainly empirical approach and those at the top which had established a design space and used process analytical tools (PAT) amongst other QbD techniques. Interestingly around half of the applications were considered to still use the traditional empirical approach but around 20% were towards the higher end of the spectrum. During the examination process, the majority of the major objections came where the empirical approach was taken with only one major objection in the top two categories.

Whilst the sample size was small, it does offer some proof towards the logical conclusion that a good design will lead to a better defined product. Even in this study though it is worth considering if a full blown QbD approach is always the best approach. In our training course on “Design for Formulation” which we ran last year, Ian Jolliffe and our other speakers demonstrated how a structured approach to the formulation design process is the best one, but that this must be tailored towards each specific industry – and a risk management approach is key. You can view a webinar recording of Ian discussing what you need to do before you go in the lab on our web-site  and Ian’s forthcoming webinar “iFormulate introduces Powderology – An Introduction to the Mysteries of Powders”, you will also hear how this approach can be key in working with powders in all types of formulations. You can register for this on the webinar page.