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. An oral dosage form comprising:
a therapeutically effective amount of an active agent comprising an opioid analgesic selected from hydrocodone, morphine, oxycodone or pharmaceutically acceptable salts thereof;
a gelling agent comprising xanthan gum, mannitol, alginate and hydroxypropylmethylcellulose, the gelling agent in an effective amount to impart a viscosity unsuitable for parenteral administration to a solubilized mixture formed when the dosage form is subject to tampering by dissolution in from about 0.5 to about 10 ml of an aqueous liquid; and
a copolymer comprising ethyl acrylate and methyl methacrylate;
wherein the oral dosage form is a solid dosage form,
wherein the opioid analgesic is the sole active agent in the dosage form,
wherein the ratio of the gelling agent to the opioid analgesic is from about 1:15 to about 15:1; and
the dosage form providing a sustained release of the opioid analgesic and providing a therapeutic effect for 12 hours or more when orally administered to a human patient.
2. The oral dosage form of claim 1 , wherein the ratio of the gelling agent to the opioid analgesic is from about 2:1 to about 10:1.
3. The oral dosage form of claim 1 , wherein the aqueous liquid is water.
4. The oral dosage form of claim 1 , wherein the unsuitable viscosity is attained when about 1 to about 3 ml of aqueous liquid is mixed with the dosage form.
5. The oral dosage form of claim 1 , wherein the addition of from about 0.5 to about 10 ml of the aqueous liquid causes the solubilized mixture to have a viscosity of at least about 10 cP.
6. The oral dosage form of claim 1 , wherein the addition of from about 0.5 to about 10 ml of the aqueous liquid causes the solubilized mixture to have a viscosity of at least about 60 cP.
7. The oral dosage form of claim 1 , further comprising an effective amount of an irritant to impart an irritating or burning sensation upon administration of a tampered dosage form.
8. The oral dosage form of claim 1 , in the form of a tablet.
9. The oral dosage form of claim 1 , wherein the solubilized mixture has a viscosity of 120 cP or greater.
10. The oral dosage form of claim 1 , wherein the solubilized mixture has a viscosity of from 120 cP to 5,000 cP.
11. The oral dosage form of claim 1 , comprising hydrocodone bitartrate.
12. The oral dosage form of claim 1 , comprising morphine sulfate.
13. The oral dosage form of claim 1 , comprising oxycodone hydrochloride.
14. An oral dosage form comprising:
an active agent comprising from about 2.5 mg to about 800 mg morphine sulfate;
a gelling agent comprising xanthan gum, mannitol, alginate and hydroxypropylmethylcellulose; and
a copolymer comprising ethyl acrylate and methyl methacrylate,
wherein the oral dosage form is a solid dosage form,
wherein the morphine sulfate is the sole active agent in the dosage form,
wherein the ratio of the gelling agent to the morphine sulfate is from about 1:15 to about 15:1; and
the dosage form providing a sustained release of the morphine sulfate and providing a therapeutic effect for 12 hours or more when orally administered to a human patient.
15. An oral dosage form comprising:
an active agent comprising from about 2.5 mg to about 320 mg oxycodone hydrochloride;
a gelling agent comprising xanthan gum, mannitol, alginate and hydroxypropylmethylcellulose; and
a copolymer comprising ethyl acrylate and methyl methacrylate,
wherein the oral dosage form is a solid dosage form,
wherein the oxycodone hydrochloride is the sole active agent in the dosage form,
wherein the ratio of the gelling agent to the oxycodone hydrochloride is from about 1:15 to about 15:1; and
the dosage form providing a sustained release of the oxycodone hydrochloride and providing a therapeutic effect for 12 hours or more when orally administered to a human patient.