Immediate Release Abuse-Deterrent Granulated Dosage Forms

摘要

Described are immediate release oral dosage forms that contain abuse-deterrent features. In particular, the disclosed dosage forms provide deterrence of abuse by ingestion of multiple individual doses. In addition, the disclosed dosage forms provide protection from overdose in the event of accidental or intentional ingestion of multiple individual doses.

主权项

1. An immediate release abuse deterrent dosage form comprising:
a) core-shell particles, the core-shell particles comprising: a core, the core comprising a gelling polymer, wherein the gelling polymer in the core is selected from a natural starch, a synthetic starch, a natural cellulose, a synthetic cellulose, an acrylate, a polyalkylene oxide, a carbomer and combinations thereof; an active pharmaceutical layer surrounding the core, the active pharmaceutical layer comprising a narcotic analgesic; at least one layer surrounding the active pharmaceutical layer, the at least one layer comprising a pH-sensitive film comprising pH-sensitive polymer that is insoluble in water at a pH greater than 5 and is soluble in water at a pH below 5; and b) a matrix comprising a disintegrant and a gelling polymer; wherein the gelling polymer in the matrix is selected from a natural starch, a synthetic starch, a natural cellulose, a synthetic cellulose, an acrylate, a polyalkylene oxide, a carbomer, and combinations thereof.