To comply with Ph. Eur. 0478, tablets must pass a rigorous battery of tests. These tests ensure that the physical characteristics of the tablet translate into reliable therapeutic performance. 1. Uniformity of Dosage Units
: Ensures each tablet contains the correct amount of active ingredient. This is generally verified through Uniformity of Mass or Uniformity of Content .
If you need a deep dive into the for tests like the Uniformity of Dosage Units (2.9.40)? European Pharmacopoeia -ph. Eur.- Monograph Tablets -0478-
Monograph 0478 was first published in 1969 (as "Tabulettae") and last revised in (Ph. Eur. 11.3).
is a general dosage form monograph that establishes the mandatory quality standards for tablets intended for oral administration in the European Union. It covers a wide range of tablet types, including uncoated, coated, effervescent, gastro-resistant, and orodispersible tablets. www.edqm.eu Core Definitions & Scope Definition To comply with Ph
The Ph. Eur. monograph for Tablets - 0478 specifies a range of testing requirements to ensure the quality of tablets, including:
Ensures the tablet is firm enough to be handled but not so hard that it fails to dissolve. Manufacturing and Production Standards These tests ensure that the physical characteristics of
The "Tablets -0478-" monograph covers tablets intended for oral administration, including immediate-release, modified-release, and prolonged-release formulations. The monograph applies to tablets containing one or more APIs, with or without excipients.
: Designed to dissolve in water with the release of carbon dioxide.
The monograph begins with a precise definition of what constitutes a "tablet." According to Ph. Eur. 0478, , obtained by compressing uniform volumes of particles or by another suitable manufacturing technique, such as extrusion, moulding or freeze-drying (lyophilisation).