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 . A method of preparing an abuse deterrent controlled release dosage form comprising:
combining oxycodone or a pharmaceutically acceptable salt thereof, a surfactant, a C 12 to C 40 fatty acid or a mixture thereof, and a wax comprising carnauba wax or beeswax or a mixture thereof, to form a combination;
preparing particles from the combination; and
containing the particles in a capsule;
the abuse deterrent dosage form providing a therapeutic effect for about 12 hours or longer when orally administered to a human patient, and
the abuse deterrent dosage form being abuse deterrent when subjected to tampering comprising heating at a temperature greater than about 45° C.
42 . The method of claim 41 , wherein the particles comprise an organic acid salt of oxycodone.
43 . The method of claim 41 , wherein the oxycodone or pharmaceutically acceptable salt thereof is oxycodone base.
44 . The method of claim 41 , wherein the wax comprises carnauba wax.
45 . The method of claim 41 , wherein the wax comprises beeswax.
46 . The method of claim 41 , wherein the wax comprises carnauba wax and beeswax.
47 . A method of preparing an abuse deterrent controlled release dosage form comprising:
combining oxycodone or a pharmaceutically acceptable salt thereof, polyethylene glycol, a fatty acid glyceride, a C 12 to C 40 fatty acid or a mixture thereof, and a wax comprising carnauba wax or beeswax or a mixture thereof, to form a combination;
preparing particles from the combination; and
containing the particles in a capsule;
the abuse deterrent dosage form providing a therapeutic effect for about 12 hours or longer when orally administered to a human patient, and
the abuse deterrent dosage form being abuse deterrent when subjected to tampering comprising heating at a temperature greater than about 45° C.
48 . The method of claim 47 , wherein the particles comprise an organic acid salt of oxycodone.
49 . The method of claim 47 , wherein the oxycodone or pharmaceutically acceptable salt thereof is oxycodone base.
50 . The method of claim 47 , wherein the wax comprises carnauba wax.
51 . The method of claim 47 , wherein the wax comprises beeswax.
52 . The method of claim 47 , wherein the wax comprises carnauba wax and beeswax.
53 . A method of preparing an abuse deterrent controlled release dosage form comprising:
combining oxycodone or a pharmaceutically acceptable salt thereof, a fatty acid ester, a fatty acid glyceride, a C 12 to C 40 fatty acid or a mixture thereof, and a wax comprising carnauba wax or beeswax or a mixture thereof, to form a combination;
preparing particles from the combination; and
containing the particles in a capsule;
the abuse deterrent dosage form providing a therapeutic effect for about 12 hours or longer when orally administered to a human patient, and
the abuse deterrent dosage form being abuse deterrent when subjected to tampering comprising heating at a temperature greater than about 45° C.
54 . The method of claim 53 , wherein the particles comprise an organic acid salt of oxycodone.
55 . The method of claim 53 , wherein the oxycodone or pharmaceutically acceptable salt thereof is oxycodone base.
56 . The method of claim 53 , wherein the wax comprises carnauba wax.
57 . The method of claim 53 , wherein the wax comprises beeswax.
58 . The method of claim 53 , wherein the wax comprises carnauba wax and beeswax.
59 . The method of claim 53 , wherein the fatty acid ester comprises sorbitan fatty acid ester, polyoxyethylene sorbitan fatty acid ester, fatty acid ester of polyhydric alcohol or polyglycerol fatty acid ester.
60 . The method of claim 53 , wherein the fatty acid ester comprises fatty acid ester of polyhydric alcohol.