Oral controlled release tablet with reduced burst effect
The present invention refers to an oral controlled release tablet providing a reduced risk of alcohol induced dose dumping; said tablet comprising: a core comprising a first compressed layer comprising a swelling agent, a second compressed layer comprising at least one therapeutically active ingredi...
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Format: | Patent |
Sprache: | chi ; eng |
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Zusammenfassung: | The present invention refers to an oral controlled release tablet providing a reduced risk of alcohol induced dose dumping; said tablet comprising: a core comprising a first compressed layer comprising a swelling agent, a second compressed layer comprising at least one therapeutically active ingredient, and pharmaceutically acceptable excipient wherein at least one excipient is a release rate controlling excipient and wherein the percent by weight of excipients that are soluble in alcohol does not exceed 35 % by weight of the layer, optionally a third compressed layer comprising a swelling agent; and a coating surrounding the said core, the coating comprising a polymer insoluble in an aqueous medium comprising from 0 % v/v to 40 % v/v of alcohol, whereby upon contact with aqueous gastrointestinal fluids, the upper compressed layer swells to cause removal of the coating from the upper surface of the upper compressed layer and then said upper layer disintegrates allowing the release of the active ingredient fro |
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