: Allowed up to 60 minutes (excluding film-coated, which are 30 minutes). Soluble/Dispersible : Must break down within 3 minutes . 2. Dissolution (General Chapter 2.9.3)
To optimize drug delivery and processing, APIs are combined with several functional excipient categories:
The disintegration test evaluates whether tablets can break apart into smaller fragments within a specified liquid medium and timeframe. European Pharmacopoeia -ph. Eur.- Monograph Tablets -0478-
Includes film-coated (disintegration < 30 min) and other coated types (disintegration < 60 min).
A monograph is a detailed description of a specific medicinal product, including its composition, manufacturing process, and testing requirements. Monographs are an essential part of the Ph. Eur., as they provide a standardized approach to ensuring the quality of medicines. The monograph for Tablets - 0478 is one such monograph that sets standards for the quality of tablets. : Allowed up to 60 minutes (excluding film-coated,
Monograph 0478 defines as solid preparations containing a single dose of one or more active substances, obtained by compressing uniform volumes of particles or by other techniques like extrusion, moulding, or freeze-drying (lyophilisation). It applies primarily to tablets for oral administration but excludes lozenges, oral pastes, and oral gums. In some cases, the requirements may not apply to tablets for veterinary use when justified and authorised.
The is the definitive, legally binding regulatory standard that governs the quality, manufacturing, and testing of tablets for oral administration across Europe . Maintained by the European Directorate for the Quality of Medicines & Healthcare (EDQM) , this general dosage form monograph establishes the foundational compliance blueprint for pharmaceutical manufacturers worldwide. Dissolution (General Chapter 2
The Ph. Eur. monograph for Tablets - 0478 specifies a range of testing requirements to ensure the quality of tablets, including:
The Ph. Eur. monograph for Tablets - 0478 provides a comprehensive description of the requirements for tablets, including their definition, composition, manufacturing process, and testing requirements. The monograph applies to tablets that are intended for oral administration, and it covers a wide range of tablet types, including immediate-release, modified-release, and extended-release tablets.
If a tablet has a "break-mark" (score line) intended for delivering fractional doses, the efficacy of this mark must be validated.