Controlled-release formulations coated with aqueous dispersions of ethylcellulose

摘要

The invention concerns a controlled release hydromorphone dosage form comprising a multiparticulate system substrate comprising an amount of a hydromorphone salt, the substrate being coated with an aqueous dispersion of at least one hydrophobic polymer, whereby the coating provides controlled release, the substrate including an additional dose of a hydromorphone salt included in either the controlled release coating or in an additional overcoating coated on the outer surface of the controlled release coating, whereby the dosage form, comprising the cured, coated substrate, comprises an effective amount of a hydromorphone salt and provides a therapeutic effect for at least 12 hours when administered to a patient.