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  • Solid single-dose preparation consisting of a hard shell containing a solid or semi-solid formulation, showing a rate, a place and/or a time of release different from that of a conventional-release capsule. This deliberate modification is achieved by a special formulation design and/or manufacturing method. Hard modified-release capsules are intended for oral use, and include prolonged-release, delayed-release and pulsatile-release preparations. The generic term \'modified-release capsule, hard\' is used only when the more specific terms \'gastro-resistant capsule, hard\' or \'prolonged-release capsule, hard\' do not apply.
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Metadata

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