Following the recently revised USP general chapter <3> TOPICAL AND TRANSDERMAL DRUG PRODUCTS – PRODUCT QUALITY TESTS, the European Pharmacopeia (Ph. Eur.) proposes to amend the Ph. Eur. Monograph on Semi-solid preparations for cutaneous application. The draft chapter has been published in Pharmeuropa 31.3 and is open for comment until 30 September 2019. The Ph. Eur. draft now introduces the following changes:
Updated definitions of Creams, Gels, Pastes
- Creams are semi-solid preparations of homogeneous appearance consisting of a lipophilic phase and an aqueous phase, one of which is finely dispersed in the other.
- Gels are semi-solid preparations consisting of a single-phase liquid basis gelled by a suitable gelling agent. Active substance(s) are dissolved or dispersed in the basis.
- Pastes are semi-solid preparations containing a large proportion of finely or very finely (2.9.35) divided solids dispersed in the basis, intended for cutaneous application.
Creams, Gels and Pastes are supplied in single-dose or multidose containers.
Restructured and changed uniformity requirements
- For metered-dose preparations intended for systemic effect, an inter-container test for uniformity of delivered dose has been added to the Production section and an intra-container test to the Tests section.
- The test for uniformity of dosage units for preparations intended for systemic effect that are supplied in single-dose containers has been clarified and the possibility of a test for Uniformity of content has been added.
Transferred Medicated plasters and Cutaneous patches sections
The sections have been transferred to separate dosage form monographs published in the same issue of Pharmeuropa:
- The monograph “Patches” has been entirely revised to ensure that it is applicable to both transdermal and cutaneous patches. The title has been modified to reflect the change.
- The title and the wording of chapter 2.9.4. Dissolution test for patches have been modified to ensure that it is applicable to both transdermal and cutaneous patches. In section 2. Cell method, the calculated volume of the support and the calculated area for the cover of the extraction cell have been corrected.
- In addition, a new monograph for Plasters, medicated has been proposed.