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European Pharmacopoeia Commission adopts revised dosage form monographs on patches and medicated plasters

European Pharmacopoeia
Ph. Eur. Commission
29 September 2020
Strasbourg, France

At its 167th session in June 2020, the European Pharmacopoeia Commission adopted revised dosage form monographs on transdermal patches, cutaneous patches and medicated plasters, as well as the related test method for dissolution testing.

The new version of Patches (1011) now groups together both cutaneous and transdermal patches since they have similar manufacturing and quality control requirements. Prior to the revision, cutaneous patches were covered in the monograph on Semi-solid preparations for cutaneous application (0132).

As a result of these changes, general chapter 2.9.4 Dissolution test for transdermal patches has also been revised to ensure that it applies to both cutaneous and transdermal patches and the title has been changed accordingly. Details on the possible preparation of the patches before the test have been transferred from the dosage form monograph Patches (1011) to this general chapter. Lastly, a number of the dimensions described for the cell method (figure 2.9.4.-3) have been corrected to ensure they match the dimensions given elsewhere in the text.

In addition, medicated plasters – also initially covered in Semi-solid preparations for cutaneous application (0132) – are now dealt with in a new and dedicated general monograph entitled Plasters, medicated (3032).

These chapters will be published in Supplement 10.5 of the European Pharmacopoeia by 1 January 2021 with the implementation date of 1 July 2021.

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