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

| Category | Key Characteristics | | :--- | :--- | | | Single layer or multi-layer tablets without a coating. The most basic category. | | Coated Tablets | Covered with a coating (e.g., sugar, film) to protect ingredients or improve swallowability. | | Effervescent Tablets | Contain acids and carbonates; release gas when dissolved in water. Intended to be dissolved before administration. | | Soluble Tablets | Designed to dissolve completely in water, forming a clear or slightly opalescent solution. | | Dispersible Tablets | Intended to be dispersed in water to form a homogeneous dispersion before administration. | | Orodispersible Tablets | Designed to disintegrate rapidly (typically within 3 minutes) when placed on the tongue, releasing the active substance in saliva. | | Gastro-resistant Tablets | Also known as enteric-coated tablets. Their coating resists stomach acid and releases the active substance in the intestine. | | Modified-release Tablets | Formulated to release the active substance at a specific rate, over an extended period, or at a specific location in the GI tract. | | Tablets for Use in the Mouth | A broad category including buccal and sublingual tablets, designed to be retained in the mouth. Note: The Ph. Eur. has redefined this category to be within the scope of the Oromucosal preparations monograph (1807). | | Oral Lyophilisates | Freeze-dried, single-dose preparations that rapidly disintegrate in the mouth. The monograph's definition of this category has been clarified as "solid single-dose preparations made by freeze-drying of a liquid or semi-solid preparation". |

: To ensure the tablet breaks apart in the digestive tract. European Pharmacopoeia -ph. Eur.- Monograph Tablets -0478-

: Since January 2018, revised standards mandate a suitable dissolution test for immediate-release forms unless otherwise justified. | Category | Key Characteristics | | :---

: Formulated with carbonates to react in water and release carbon dioxide for rapid dispersion. | | Effervescent Tablets | Contain acids and

A "monograph" in this context is a collection of quality standards for a specific type of product. Monograph 0478 is a "general" monograph, meaning its requirements apply to all tablets that fall under its definition, regardless of their specific active ingredient. These requirements are legally binding within the European Union, mandated by EU Directives 2001/82/EC and 2001/83/EC, which state that marketing authorization applications must comply with Ph. Eur. texts. Consequently, the standards set forth in monograph 0478 are legally enforceable for any tablet product marketed within the EU, a fact that underscores its critical importance for pharmaceutical manufacturers.

General Monograph 0478, titled "Tablets," is a foundational quality standard within the European Pharmacopoeia (Ph. Eur.). The European Pharmacopoeia is the primary source of official quality standards for medicines and their ingredients in Europe, providing a legal and scientific basis for quality control throughout a product's lifecycle.

Control active substance release behavior throughout the digestive tract. Key Quality Control and Physical Testing Requirements