: Includes prolonged-release and pulsatile-release tablets designed to alter the rate or timing of drug delivery.
If a tablet has a break-mark for dose splitting, the monograph requires a specific test for the Uniformity of Mass of the subdivided parts to ensure patients get the correct fractional dose. Why It Matters
The container label must include (per Ph. Eur. general notices and individual monograph): European Pharmacopoeia -ph. Eur.- Monograph Tablets -0478-
According to the EDQM standards, tablets are defined as . They are primarily produced by compressing uniform volumes of particles but can also be manufactured using advanced techniques like extrusion, molding, or freeze-drying (lyophilization). Covered Formulations
30 tablets are broken by hand. One part from each is weighed. Covered Formulations 30 tablets are broken by hand
: The formulation must exhibit sufficient mechanical strength to withstand the physical friction of packaging, shipping, and automated dispensing without fracturing. Strict Requirements for Scored Tablets (Subdivision) The Ph.Eur. approach to tablet splitting
If a tablet has a "break-mark" (score line) intended for delivering fractional doses, the efficacy of this mark must be validated. and automated dispensing without fracturing.
Tablets are solid preparations each containing a single dose of one or more active substances. They are obtained by compressing uniform volumes of particles or by another suitable manufacturing process (e.g., compaction, granulation followed by compression).
Understanding European Pharmacopoeia (Ph. Eur.) Monograph 0478: A Comprehensive Guide to Tablet Quality Standards