Europe – Dosage Form Monographs for Public Consultation

The European Pharmacopoeia (Ph. Eur.) Commission is undertaking a review of the mandatory dosage form monographs. As part of this process, its Group of experts 12 has revised or elaborated several texts involving preparations which are applied to the skin and one involving intravesical preparations. These proposed revisions have been published in Pharmeuropa 31.3 and concern the following texts:

  • Patches, transdermal (1011) with the new name Patches
  • Semi-solid preparations for cutaneous application (0132)
  • Dissolution test for transdermal patches (2.9.4) changed to Dissolution test for patches
  • a new general monograph on Plasters, medicated (3032)
  • a new general monograph on Intravesical preparations (2811)

The general monograph Patches, transdermal (1011) has been completely revised to include the description and requirements for cutaneous patches. The title of the monograph will therefore be changed to reflect this revision. A dissolution test will now be required for both cutaneous and transdermal patches; consequently, the general chapter Dissolution test for transdermal patches (2.9.4) has been revised to include the test for cutaneous patches. It is also proposed to rename this chapter to reflect this change. For transdermal patches, the requirement to comply with the Test on uniformity of dosage units (2.9.40) or the Uniformity of content (2.9.6) remains unchanged.