Europe – New policy for dissolution and disintegration testing in Ph. Eur. monographs

Over the last few years, the European Pharmacopoeia (Ph. Eur.) has been elaborating monographs on medicinal products containing chemically defined active substances, applicable to immediate-release solid dosage forms (tablets, capsules).

These monographs include a mandatory test for dissolution or disintegration. However, in justified and authorised cases, manufacturers may propose another procedure and/or, where appropriate, different acceptance criteria as part of their marketing authorisation application. This is indicated in the monographs by the sentence:

The tablets comply with the test and the acceptance criterion described below, unless otherwise justified and authorised.

Since the result of the dissolution test may be affected by the formulation and/or the manufacturing process, the Ph. Eur. Commission launched a substantive examination of users’ expectations with regard to this test in medicinal product monographs.

Users in the pharmaceutical industry, the licensing authorities, national pharmacopoeias and OMCLs, for example, were therefore invited to participate in a survey in January 2019.

Three options were proposed:

  1. keep a mandatory dissolution test in the monographs;
  2. include a dissolution test as an example in the monographs;
  3. do not include a dissolution test since the dosage form monographs on Tablets (0478) and Capsules (0016) contain the requirement to carry out such a test, in addition to the prescriptions of guideline ICH Q6A…