European Pharmacopoeia -ph. Eur.- Monograph Tablets -0478- Best Online
The monograph distinguishes several categories of tablets based on their intended use or design. A summary of these categories, their definitions, and key considerations is provided in the table below:
Ph. Eur. 2.9.3 While Disintegration tests physical breakdown, Dissolution tests bioavailability. Monograph 0478 states: "For conventional-release tablets, a dissolution test is carried out... unless a disintegration test is specified in the individual monograph."
Designed to resist gastric fluid for 2–3 hours but disintegrate in intestinal fluid within 60 minutes. European Pharmacopoeia -ph. Eur.- Monograph Tablets -0478-
The monograph distinguishes between several specialized tablet types, each with specific requirements:
At the heart of oral solid dosage regulation lies . While it may seem like a generic entry, Monograph 0478 is the foundational legal text defining what a tablet is, how it must behave, and the tests it must pass before it is deemed safe for human use. Unlike active substance monographs (e.g., Paracetamol or Aspirin), this is a general monograph . It applies to all tablet formulations unless specifically waived or modified by an individual product monograph. and cross-border distribution
30 tablets are broken by hand. One part from each is weighed.
: Manufacturers must take rigorous preventative measures to prevent contamination during processing, storage, and cross-border distribution, adhering directly to the guidelines set in Ph. Eur. General Chapter 5.1 . how it must behave
Monograph 0478 also provides additional requirements for specialized tablet types:
Intended to be dissolved or dispersed in water before administration; must disintegrate within 5 minutes.
A soft tablet (low hardness) might disintegrate in 12 minutes, but a hard tablet (high compression force) might take 25 minutes, failing 0478. Formulators must balance hardness and disintegration.
Monograph 0478 does not specify which chemical identity test to use (that is left to the individual active substance monograph). However, it mandates that the must be capable of distinguishing the tablet from placebo.