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.
With the inclusion of cutaneous patches in general monograph 1011, this section has been deleted from the general monograph Semi-solid preparations for cutaneous application (0132). Additionally, due to the creation of a new general monograph on Plasters, medicated (3032), the section referring to this pharmaceutical preparation has been deleted from monograph 0132. Further revisions to this monograph reflect changes to the uniformity requirements. For metered-dose preparations which are intended for systemic effect, an inter-container test for the uniformity of delivered dose has been added to the Production section and an intra-container test to the Tests section.
In addition to changes to these texts, a new monograph on Intravesical preparations (2811) has been published in Pharmeuropa 31.3. Intravesical preparations are aqueous preparations intended to be instilled into the urinary bladder, and the requirements for different intravesical preparations are given in this monograph.
The commenting period for the public ends on 30 September 2019. All interested parties are strongly encouraged to review the pertinent documents and submit their comments before the deadline. For more information on how to comment, please see: How to comment.