The European Pharmacopoeia (Ph. Eur.) provides common standards to ensure the quality of medicines across Europe and beyond. Monographs describe tests, assays, and specifications that pharmaceutical dosage forms, active substances, and excipients must meet. Ph. Eur. monograph 0478 covers tablets — a widely used solid oral dosage form — and prescribes criteria for identity, uniformity, content, dissolution, disintegration, hardness, friability, and other quality attributes. This article summarizes the monograph’s key elements, technical rationale, practical implementation, challenges in compliance, and recommended improvements to make the monograph clearer, more robust, and better aligned with contemporary regulatory science and manufacturing practices.
Orodispersible Tablets: Uncoated tablets that disperse rapidly in the mouth before being swallowed. european pharmacopoeia ph eur monograph tablets 0478 better
Compared to older or non-harmonised standards, Ph. Eur. 0478 offers several “better” features: European Pharmacopoeia (Ph
Subdivision of Scored Tablets: For tablets with break-marks, the Ph. Eur. requirements for scored tablets dictate that the break-marks must be functional and ensure the uniformity of mass of the subdivided parts. monograph 0478 covers tablets — a widely used
What is the European Pharmacopoeia (Ph. Eur.)?
Test Method: 30 tablets are broken by hand; one part from each is weighed. Acceptance Criteria: