Pharmaceutical formulation containing gelling agent
AssigneesPurdue Pharma L.P., The P.F. Laboratories, Inc., Purdue Pharmaceuticals L.P.
InventorsCurtis Wright, Benjamin Oshlack, Christopher Breder
Life of this patent
Estimating the term…
Abstract
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.
Claims15
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.
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.
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.
Dependencies are inferred from the claim text.