The revised European Pharmacopoeia (Ph. Eur.) Monograph Tablets (0478) has been published in Ph. Eur. Supplement 9.3. New and revised texts of Supplement 9.3 will be implemented on January 1, 2018 (unless otherwise indicated). Additionally, from the 9th Edition, corrections are to be taken into account as soon as possible and not later than the end of the month following the month of publication (i.e. August 31, 2017, for Supplement 9.3).
The details of the revised Monograph Tablets are the following:
Subdivision of tablets: Break-marks must be functional, either to ease the intake of the medicinal product or to deliver fractional doses; in cases where fractions of tablets are necessary to deliver the intended dose stated in the labelling, the efficacy of the breakmark is assessed with respect to uniformity of mass of the subdivided parts. The tests have to be performed during product development or for validation purposes usingthe test provided in the monograph in section Production.
Tests: Wording clarified for dissolution test: Unless otherwise justified and authorized, a suitable test is carried out, for example one of the tests described in Ph. Eur. general chapter 2.9.3. Dissolution test for solid dosage forms.
Gastro-resistant tablets: Dissolution test deleted as already listed in general Tests section; Definition amended: Usually they are prepared by covering tablets with a gastro-resistant coating or from granules or particles already covered with a gastro-resistant coating (previous definition: "Usually they are prepared from granules or particles already covered with a gastro-resistant coating, in certain cases they are prepared by covering tablets with a gastro-resistant coating); Production section deleted as covered by dissolution test in general Tests section.
Modified-release tablets: Production section deleted as covered by dissolution test in general Tests section.
Tablets for use in the mouth: Section deleted as it is within the scope of Oromucosal preparations (1807).
Oral lyophilisates: Definition amended: Oral lyophilisates are solid single-dose preparations made by freeze-drying of a liquid or semi-solid preparation. These fast-releasing preparations are intended to be placed in the mouth where their contents are released in saliva and swallowed or, alternatively, are intended to be dissolved or dispersed in water before oral administration.