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Monograph 0478 defines tablets as solid preparations containing a single dose of one or more active substances. They are primarily produced by compressing particles but can also be made through extrusion or freeze-drying (oral lyophilisates). This general monograph covers various categories, including: . Gastro-resistant and Modified-release Tablets . Effervescent, Soluble, and Dispersible Tablets .
Understanding European Pharmacopoeia (Ph. Eur.) Monograph: Tablets -0478-
“Patient acceptability,” argued Marta, the clinical liaison, “is twofold — safety and usability. Faster disintegration for children reduces choking risk and improves dosing accuracy.”
(prolonged, delayed, or pulsatile release) Gastrorisistant tablets (enteric-coated)
The container label must include (per Ph. Eur. general notices and individual monograph):