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. A method of preparing an abuse deterrent controlled release dosage form comprising:
combining oxycodone or a pharmaceutically acceptable salt thereof as active agent, polyglycolyzed glycerides, a C 12 to C 40 fatty acid or a mixture thereof, carnauba wax and beeswax, to form a homogenous mixture, wherein the oxycodone or pharmaceutically acceptable salt thereof is the sole active agent in the dosage form;
preparing particles from the homogenous mixture; 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.
2. The method of claim 1 , wherein the particles comprise an organic acid salt of oxycodone.
3. The method of claim 1 , wherein the oxycodone or pharmaceutically acceptable salt thereof is oxycodone base.
4. The method of claim 1 , wherein the fatty acid comprises C 14 fatty acid.
5. The method of claim 1 , wherein the fatty acid comprises stearic acid.
6. The method of claim 1 , wherein the fatty acid comprises C 14 fatty acid and stearic acid.
7. The method of claim 1 , wherein the combining comprises melting the C 12 to C 40 fatty acid or mixture thereof and incorporating oxycodone base therein.
8. The method of claim 7 , wherein the fatty acid comprises C 14 fatty acid.
9. The method of claim 7 , wherein the fatty acid comprises stearic acid.
10. The method of claim 7 , wherein the fatty acid comprises C 14 fatty acid and stearic acid.
11. The method of claim 1 , wherein the homogenous mixture comprises melted C 12 to C 40 fatty acid, melted carnauba wax, melted beeswax and oxycodone base.
12. The method of claim 11 , wherein the fatty acid comprises C 14 fatty acid.
13. The method of claim 11 , wherein the fatty acid comprises stearic acid.
14. The method of claim 11 , wherein the fatty acid comprises C 14 fatty acid and stearic acid.
15. The method of claim 1 , wherein the particles have a diameter from about 0.1 mm to about 2.5 mm.
16. A method of preparing an abuse deterrent controlled release dosage form comprising:
combining oxycodone base as active agent, polyglycolyzed glycerides, C 12 to C 40 fatty acid or a mixture thereof, carnauba wax, and beeswax to form a homogenous mixture, wherein the oxycodone base is the sole active agent in the dosage form;
preparing particles from the homogenous mixture; 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,
the abuse deterrent dosage form having a viscosity of about 10 cP or more when subjected to tampering comprising heating at a temperature greater than about 45° C.
17. The method of claim 16 , wherein the particles have a diameter from about 0.1 mm to about 2.5 mm.