IPEC calls for inclusion of excipient compound monographs in Ph. Eur.

The call came from Roquette’s Lore Vignoli who told delegates at the European Directorate for the Quality of Medicines (EDQM) 50^th​ anniversary conference in Strasbourg, France that industry and regulators would benefit from the inclusion of such standards.

“It is the case in some countries that pharmacopoeias allow the development of monographs for excipient compounds and we know that this is not the rule in the European Pharmacopoeia, but this is something that could be very helpful to manufacturers.”​

Vignoli, who represented IPEC at the event, added that: “For the European Pharmacopoeia it could also be a way of continuously improve its position as the leading global pharmacopoeia and further its acceptance by countries outside Europe​.”

Compounds​

Excipient compounds, or co-processed excipients, are a mixture of two or more excipients combined to create a mixture with improved properties without a significant chemical change.

At present monographs covering such combinations are not included in the European Pharmacopoeia.

Part of the reason for this is that the European Pharmacopoeal Commission, which governs development of Ph. Eur., has had close ties with European regulatory authorities that at present prefer to define the quality of individual components of medicinal products rather than of mixtures.

However, this may soon change and IPEC may get its wish as, at a meeting held in June, the Commission decided to add the elaboration of a general monograph on co-processed excipients on the work program.

Other requests​

Vignoli also called for other modifications to the Ph. Eur. suggesting that, among other things, the formation of a network for global pharmacopoeias, the development of good pharmacopoeial practices (GPP) would be welcomed by IPEC members.

“Another need and expectation from manufacturers of excipients a general update of monographs” she said, explaining that some IPEC members have pointed to the need to include more modern analysis methods in monographs.

“They [IPEC members] refer to the USP modernisation programme and say that some [European] monographs may need to be updated or to include new tests because they do not match the general chapters and maybe sometimes the users are confused​.”