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Extended Release Film Coated Capsule Dosage Form
Definition 1
A capsule covered with a thin layer of water soluble or insoluble polymer and is designed to release active and/or inert ingredient(s) at a controlled, prolonged rate so as to reduce dosing frequency. (NCI Thesaurus)
Definition 2
A solid dosage form in which the drug is enclosed within either a hard or soft soluble container or 'shell' made from a suitable form of gelatin; additionally, the capsule is covered in a designated film coating, and which releases a drug (or drugs) in such a manner to allow at least a reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional dosage form. (NCI Thesaurus/CDISC)
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