Importance

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Abstract

A method of reducing the risk of alcohol-induced dose-dumping of a therapeutically active ingredient comprising administering to human subjects who have ingested alcohol an oral controlled release tablet; said tablet comprising: a core comprising an upper compressed layer comprising a swelling agent, and a lower 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 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 from the defined surface area of the upper surface of said lower compressed layer with the coating covering its bottom and side surfaces.

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First Claim