Multi-stage oral drug controlled-release system
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United States of America Patent
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Issued Date -
Sep 25, 2003
app pub date -
Feb 3, 2003
filing date -
Feb 1, 2002
priority date (Note) -
Abandoned
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Abstract
A multi-stage oral drug controlled-release system is disclosed, as well as a preparation for maintaining the drug blood concentration at a desired level for a prolonged time. The system operates by releasing the drug at a constant rate through stepwise control of drug release following administration of the preparation. More specifically, the multi-stage oral drug controlled-release system involves the stepwise release of drug-containing granules from an inner matrix, which is surrounded by a coating or release-modifying layer. The granules contain an active drug and a carrier material in size of 0.1.about.1 mm. The carrier material is hydrophobic when the drug has a water-solubility of 1 mg/ml or more, and is hydrophilic when the drug has a water-solubility of less than 1 mg/ml. The inner matrix, in which the drug-containing granules are embedded, is formed from swelling and erodible polymer(s) and swelling-regulating material(s). The release-modifying layer is composed of a hydrophobic release-modifying polymer, a hydrophilic release-modifying polymer, pH-dependent release-modifying polymer or mixtures thereof.
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