Pharmaceutical Formulation Containing Gelling Agent
Disclosed in certain embodiments is a controlled release oral dosage form comprising a therapeutically effective amount of a drug susceptible to abuse together with one or more pharmaceutically acceptable excipients; the dosage form further including a gelling agent in an effective amount to impart a viscosity unsuitable for administration selected from the group consisting of parenteral and nasal administration to a solubilized mixture formed when the dosage form is crushed and mixed with from about 0.5 to about 10 ml of an aqueous liquid; the dosage form providing a therapeutic effect for at least about 12 hours when orally administered to a human patient.
1 - 40 . (canceled)
41 . An abuse deterrent controlled release dosage form comprising:
particles comprising oxycodone or a pharmaceutically acceptable salt thereof, polyglycolyzed glycerides, a C 8 to C 50 fatty acid or a mixture thereof, carnauba wax and beeswax; and
a capsule containing the particles;
wherein the oxycodone or pharmaceutically acceptable salt thereof is the sole active agent in the abuse deterrent controlled release dosage form, and
the abuse deterrent controlled release dosage form providing a therapeutic effect for about 12 hours or longer when orally administered to a human patient.
42 . The abuse deterrent controlled release dosage form of claim 41 , wherein the particles comprise an organic acid salt of oxycodone.
43 . The abuse deterrent controlled release dosage form of claim 41 , wherein the particles comprise oxycodone base.
44 . The abuse deterrent controlled release dosage form of claim 41 , wherein the C 8 to C 50 fatty acid comprises C 12 -C 40 fatty acid.
45 . The abuse deterrent controlled release dosage form of claim 41 , wherein the C 12 to C 40 fatty acid comprises C 14 fatty acid.
46 . The abuse deterrent controlled release dosage form of claim 41 , wherein the C 8 to C 50 fatty acid comprises stearic acid.
47 . The abuse deterrent controlled release dosage form of claim 41 , wherein the C 8 to C 50 fatty acid comprises C 14 fatty acid and stearic acid.
48 . The abuse deterrent controlled release dosage form of claim 41 , wherein the particles have a diameter from about 0.1 mm to about 2.5 mm.
49 . The abuse deterrent controlled release dosage form of claim 41 , wherein the particles comprise a mixture comprising the oxycodone or a pharmaceutically acceptable salt thereof, the polyglycolyzed glycerides, the C 8 to C 50 fatty acid or mixture thereof, the carnauba wax and the beeswax.
50 . An abuse deterrent controlled release dosage form comprising:
particles comprising an organic acid salt of oxycodone, polyglycolyzed glycerides, a C 12 to C 40 fatty acid, or a mixture thereof, carnauba wax and beeswax; and
a capsule containing the particles;
wherein the organic acid salt of oxycodone is the sole active agent in the abuse deterrent controlled release dosage form, and
the abuse deterrent controlled release dosage form providing a therapeutic effect for about 12 hours or longer when orally administered to a human patient.
51 . The abuse deterrent controlled release dosage form of claim 50 , wherein the C 12 to C 40 fatty acid comprises C 14 fatty acid.