European Pharmacopoeia -ph. Eur.- Monograph Tablets -0478- ((new)) — Instant

: Delayed-release formulations designed to resist gastric fluid breakdown and release the active drug inside the intestinal fluid. They are typically coated with acid-resistant polymers.

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

The monograph dictates that the excipients used must be safe, non-toxic, and must not adversely affect the therapeutic efficacy or bioavailability of the active pharmaceutical ingredient (API). Excipients typically include diluents, binders, disintegrants, glidants, lubricants, and coloring or flavoring agents. Minimizing Microbial Contamination The most basic category