Speech: Functional Related Chemical Profiling (FRCP) of excipients during formulation development

Description

Watch Hans Platteeuw’s presentation from the ExciPerience 2021 here!

Functional Chemical testing is nowhere to be found on an ordinary CoA or in Pharmacopeal test procedures, yet it makes or breaks a product development when changing from a supplier, when changing from R&D samples to cGMP, or from batch to batch of an excipient from the same supplier.

If during QBD it is identified that changing an excipient is a risk, FRCP is there to understand what is the cause of this risk and then can be used to control it. For example if during a stability it appears that compound X is not compatible with excipient Y, we can shift to excipient Z and start again without having any real understanding of the cause of the incompatibility, or we can investigate first with FRCP, which parameter of excipient Y causes the incompatibility and then include a control/limit for that parameter in the product sourcing specifications.

Another example would be a formula with highly variable dissolution profiles from one lot to the next and the identification of the root cause being differences in the substitution degree of the rate controlling polymer from batch to batch. Completely different functional grades of an excipient can all comply to the same EP monograph, yet act completely different in a formula in terms of stability and/or dissolution.

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The Exciperience covered all areas from basic or advanced research and formulation to manufacturing and regulatory. It was the intersection between all the different perspectives and people in the excipient community.