European Pharmacopoeia Ph Eur Monograph Tablets 0478 Better
: There has been increased scrutiny on tablet divisibility, with studies showing many marketed tablets struggle to meet the strict Ph. Eur. mass uniformity requirements for subdivided parts. Harmonisation : Ongoing efforts by the Pharmacopoeial Discussion Group (PDG)
: Testing is performed on 10 tablets to measure the force (in Newtons) required to disrupt them. Functional Break-Marks (Subdivision) european pharmacopoeia ph eur monograph tablets 0478 better
: Standard uncoated tablets must typically disintegrate within 15 minutes : There has been increased scrutiny on tablet
These are critical performance tests.
Many commercial tablets feature break-marks (scores) designed to facilitate dose splitting or ease swallowing. Monograph 0478 dictates the quality rules for these features: Specific monographs: Finished products Monograph 0478 dictates the quality rules for these
If you are filing a Marketing Authorization Application (MAA) in Europe, your dossier must reference the current version of 0478 (updated annually in April). The EDQM frequently revises 0478 to include new dosage forms like orodispersible films and mini-tablets.