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European Pharmacopoeia -ph. Eur.- Monograph Tablets -0478- -

Guide to Ph. Eur. Monograph 0478: Tablets

1. Introduction

Monograph 0478, Tablets, is a general monograph in the European Pharmacopoeia (Ph. Eur.) that lays down mandatory quality standards for all solid oral dosage forms defined as tablets. It applies to uncoated, film-coated, and sugar-coated tablets, unless otherwise specified in an individual monograph.

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 European Pharmacopoeia -ph. Eur.- Monograph Tablets -0478-

  • Limits for specified and unspecified impurities per API monograph and general impurities chapters; stability-indicating assay required.

9. Revision History and Future Trends

Monograph 0478 was first published in 1969 (as "Tabulettae") and last revised in January 2023 (Ph. Eur. 11.3). Guide to Ph

Key Exclusions and Nuances

  • Lozenges and pastilles are covered under a separate monograph (Lozenges, 1792).
  • Effervescent tablets are included but have additional specifications (see section 2.9.1).
  • Oral lyophilisates (freeze-dried wafers) are included but require specific hardness/porosity assessments.
  • Gastro-resistant tablets (enteric coated) are included but require specific acid-stage disintegration testing.

Uniformity of Dosage Units

This test is critical for safety. It ensures that the strength of each individual tablet does not vary significantly from the others. It is performed via two methods: Limits for specified and unspecified impurities per API

B. Uniformity of Content (Low-dose tablets)

Reference: Ph. Eur. 2.9.6 (or 2.9.40) If a tablet contains less than 2 mg or less than 2% (w/w) of an active substance, Uniformity of Mass is not sufficient. You must perform Uniformity of Content via an assay (usually HPLC) on 10 individual tablets.

The Shape of Innovation

Perhaps the most intriguing part of Monograph 0478 is its flexibility regarding form. It legally defines various tablet types that modern patients take for granted:

  • Paddle apparatus (Apparatus 2): Most common. 50-100 RPM.
  • Basket apparatus (Apparatus 1): 100 RPM.
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