Uncoated tablets that disperse rapidly in the mouth before being swallowed.

Must resist acidic medium (0.1 M HCl) for 2 to 3 hours without cracking or disintegrating before being tested in a buffer solution. 2. Dissolution (Chapter 2.9.3)

The monograph categorizes tablets based on their intended use and release characteristics: Standard oral dosage forms.

The serves as the authoritative general standard for tablets within the European regulatory framework. It defines the production methods, quality control requirements, and classification for various tablet types, ensuring that finished medicinal products are safe and effective for patient use. Classification of Tablets under Ph. Eur. 0478

Must disintegrate within 5 minutes or less.

Designed to dissolve or disperse in water with the release of carbon dioxide.

Typically must disintegrate within 15 minutes in water.