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Consultation deadline for revised dosage form monographs and general chapters drawing near

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European Pharmacopoeia
Ph. Eur. Commission
News
10 December 2019
Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) Commission is undertaking a review of the dosage form monographs and related general chapters. Five different texts finalised by Ph. Eur. Group of Experts 12 have been launched for public consultation in Pharmeuropa 31.4 until 31 December 2019.

The general monograph Eye preparations (1163) has been revised to include the additional requirements and mandatory test for sub-visible particle contamination described in the proposed new general chapter 2.9.53. This test will need to be performed for all eye drops and lotions intended for use in surgical procedures or for application to injured eyes. The section on ophthalmic inserts has also been revised to include a test ensuring that the release of the active substance is suitable.

The new general chapter, Particulate contamination: sub-visible particles in non-injectable liquid preparations (2.9.53), describes two methods for evaluating the presence of sub-visible particles in non-parenteral liquid preparations. This chapter provides additional information on other test methods which may be referred to in other monographs in the future. For parenteral preparations, testing for sub-visible particle contamination will continue according to chapter 2.9.19.

Uniformity and accuracy of delivered doses from multidose containers (2.9.27), already submitted for public consultation in Pharmeuropa 29.4, has been revised on the basis of the feedback received. The reference to oral dosage forms has been deleted (tests are applicable when referred to in dosage form monographs) and the test has been modified to allow volume-based measurement of the accuracy and uniformity of the delivered dose. Acceptance criteria for accuracy will be given in the individual monographs, which refer to this general method, and are not included in the chapter itself. 

Ear preparations (0652) has been revised to clarify that these dosage forms are intended for a local effect. The applicability of the test for uniformity of mass for ear preparation solutions supplied in single-dose containers has also been clarified. Other improvements include the separation of ear drops from ear sprays, since these two dosage forms are very distinct and require different tests. For ear sprays, tests for uniformity of delivered dose (intra-container testing), number of deliveries per container and leak rate have also been added.

Lastly, Liquid preparations for cutaneous application (0927) has been revised to add requirements and tests for the uniformity of the delivered dose (intra-container testing), as well as for the number of deliveries per container for metered-dose liquid preparations for cutaneous application intended for a systemic effect. A definition of “cutaneous foams” is also proposed.

These texts are available for public comments in Pharmeuropa 31.4 until 31 December 2019. All interested parties are encouraged to review the documents and submit their comments before the deadline. Find more information on how to comment here: How to Comment.

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