Patent ID: 9707224
Date: 2017-07-18
CPC Classifications: A61K,A61P

Claim:
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 and a wax, wherein the gelling polymer in the core is selected from ethylcellulose, aminoalkyl methacrylate copolymer, hydroxypropyl methyl cellulose, hydroxy methyl cellulose, methyl cellulose, hydroxyethylmethyl cellulose, sodium carboxymethyl cellulose, a carbomer polymer, polyethylene oxide, and combinations thereof; wherein the core does not contain a sugar sphere or microcrystalline cellulose sphere; an active pharmaceutical layer surrounding the core, the active pharmaceutical layer comprising an active pharmaceutical ingredient (API) that is 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 ethylcellulose, aminoalkyl methacrylate copolymer, hydroxypropyl methyl cellulose, hydroxy methyl cellulose, methyl cellulose, hydroxyethylmethyl cellulose, sodium carboxymethyl cellulose, a carbomer polymer, polyethylene oxide, and combinations thereof; wherein the dosage form demonstrates an immediate release profile when administered in therapeutic doses, but demonstrates an extended release profile when administered in supratherapeutic doses, wherein a supratherapeutic dose refers to administering multiple individual dose units simultaneously; and wherein the immediate release profile is defined as not less than 75% of API released in 30 minutes, and the extended release profile is defined as not more than 95% released in 60 minutes, wherein the release profiles may be evaluated by dissolution in 300 mL of 0.1N HCl media using USP II apparatus at 50 RPM paddle speed and 37° C.