European Pharmacopoeia (Ph. Eur.) Supplement 11.2, which comes into force in 39 European countries on 1 July 2023, contains five excipient monographs that have been revised to include a section on functionality-related characteristics (FRCs), boosting the total of Ph. Eur. monographs that include such a section to more than 100. This important milestone highlights the significant work done since the Ph. Eur. took the pioneering step to include the first FRC section in a monograph back in 2008.
The FRC section outlines the physical or chemical characteristics of an excipient that influence one or more of its functions when used in specific applications in the final product. It is not a mandatory part of the monograph but provides extremely useful information – particularly for manufacturers during product development – on the attributes that can influence medicinal product quality. For example, the FRC section added to Polysorbate 80 (0428) – used as an emulsifier or solubiliser in both parenteral and non parenteral liquid dosage forms and in semi-solid preparations – includes a cross-reference to the tests for composition of fatty acids and hydroxyl value.
The Excipient Performance Working Party (EXP WP), which is responsible for defining the FRCs and test procedures, has carried out extensive work to ensure that the many ways these excipients are used in medicinal products on the European market are reflected in the monographs, but has also focussed on identifying the tests most relevant for defining their key characteristics. Given that excipients have multiple uses and that new uses are constantly being developed, the experts of the EXP WP will continue to assess existing FRC sections to ensure that these new uses are covered. They will, of course, also examine the excipient monographs that do not yet have an FRC section, with a view to including new uses and grades of the substances that reflect the market in Europe today.
General considerations for FRCs are presented in general chapter 5.15. Functionality-related characteristics of excipients. Users are also encouraged to familiarise themselves with the FRC sections already published in the Ph. Eur. and to check the Pharmeuropa website regularly for new texts published for public consultation that contain an FRC section.