Critical comments from TriPEC, the three regions that make up the International Pharmaceutical Excipients Council, on the
general draft chapter on FRC work have claimed that the European work jeopardizes international harmonization of excipient
monographs. The presentation of the European monograph differs from the presentation of the USP monograph. Apart from labeling requirements, the content of the PDF sign-off texts have been reproduced exactly in the European
monograph.
The different formats have no implications on manufacturers' ability to specify excipient characteristics, which, according
to regulatory guidance, should focus on the characteristics critical for actual formulation and manufacture. European legislation
requires that compliance testing include every test in a monograph. The presentation of physical characteristics in the nonmandatory
FRC section should therefore be seen as a pragmatic solution to a legal problem.
Extra testing?
The new format of excipient monographs in PhEur was discussed at the European Directorate for the Quality of Medicines Conference on Excipients in 2002. Although there was
support among many participants, some raised the question: Is this just additional testing? It should not be considered as
such because the testing to be done is dictated by the pharmaceutical development work, not by the pharmacopoeia. This criticism
has been voiced several times since then (6). TriPEC has recently expressed that there is great potential for extra, unnecessary
testing for all listed FRCs when the user of an excipient does not fully understand which FRCs are appropriate for the intended
use and application. This argument is supported by excipient manufacturers reporting that customers with reference to the
listed FRCs have asked for data. This seems to be the essence of much of the criticism that has been raised against the FRC
project. There is a significant need for information and training of all parties involved in the supply, uses, and assessments
of excipients. The problems can be overcome once users of the pharmacopoeia have become familiar with the aim and uses of
the new FRC section.
Henning G. Kristensen, DSc, is chair of the Working Party on Functionality-Related Characteristics at the European Pharmacopoeia Commission and a professor
of pharmaceutical sciences at the University of Copenhagen, Universitetsparken 2, DK-2100 Copenhagen, Denmark, hgk@farma.ku.dk
Submitted: Feb. 13, 2007. Accepted Mar. 27, 2007.
References
1. M. Rios, "Debating Excipient Functionality," Pharm. Technol. 30 (9), 50–60 (2006).
2. "Functionality-related Characteristics of Excipients (5.15)," Draft General Chapter, Pharmeuropa
18 (3), 434–435 (2006).
3. Council of Europe, "Supplement 6.1, Chapter 5.14," PhEur (2007).
4. ICH Q8 Pharmaceutical Development (Brussels, Belgium, November 2005).
5. EMEA Committee for Medicinal Products for Human Use, Guideline on Excipients in the Dossier for Application for Marketing Authorization of Medicinal Product (London, November 2006).
6. R.C. Moreton, "Functionality and Performance of Excipients," Excipient Performance Supp. to Pharm. Technol.
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(Excipient Performance Suppl.), s4–s14 (2006).
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