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Ph. Eur. Supplement 10.6: updated dosage form monographs and general chapters

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04 February 2021
Strasbourg, France

At its 168th session in November 2020, the European Pharmacopoeia (Ph. Eur.) Commission adopted revised versions of three dosage form monographs and two related general chapters, together with one new general chapter. While the revised texts cover a large number of medicinal products including all eye and ear preparations, and all large oral tablets and capsules above 18 mm in size, the new general chapter, Particulate contamination: sub-visible particles in non-injectable liquid preparations (2.9.53), mainly applies to certain eye preparations.

A brief description of the main changes to the following dosage form monographs is given below:

  • Eye preparations (1163) – New requirements concerning the test for sub-visible particle contamination have been added for eye drops and eye lotions. These requirements apply specifically for preparations used in a surgical setting or for the treatment of the injured eye. Where ophthalmic inserts are concerned, the text now stipulates that a suitable test to demonstrate the appropriate release of the active substances must be performed.
  • Ear preparations (0652) – A new section on ear sprays has been created in order to specify clearly the tests to carry out for this category of ear preparations. Thus, uniformity of delivered dose (intra-container testing), number of deliveries per container and, for pressurised preparations, the leak rate test have been included as requirements for metered-dose ear sprays that are supplied in multidose containers.
  • Foams, medicated (1105) – The sterility test and the labelling section have been deleted in order to avoid duplication of information from the dosage form monographs that refer to this text.

The main changes undertaken for the general chapters are:

  • Disintegration of tablets and capsules (2.9.1) – The section concerning Test B applicable for tablets and capsules larger than 18 mm has been revised. Test B is currently specific to the European Pharmacopoeia and, unlike Test A, is not harmonised with either the Japanese Pharmacopoeia (JP) or the US Pharmacopeia (USP). The wording of Test B has been aligned with that of the harmonised text and, again in accordance with the latter, staged testing is now described.
    The Ph. Eur., JP and USP will continue their efforts to further harmonise Test B within the Pharmacopoeial Discussion Group (PDG).
  • Uniformity and accuracy of delivered doses from multidose containers (2.9.27) – The revised text makes it possible to conduct the test based on volume measurements.

All these texts will be published in July 2021 in Supplement 10.6 of the European Pharmacopeia and will become legally binding in the member states of the European Pharmacopoeia on 1 January 2022.

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