Pharmaceutical formulation containing opioid agonist, opioid antagonist and gelling agent
AssigneesPurdue Pharma L.P., The P.F. Laboratories, Inc., Purdue Pharmaceuticals L.P.
InventorsBenjamin Oshlack, Curtis Wright, Christopher Breder
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Abstract
Disclosed in certain embodiments is an oral dosage form comprising a therapeutically effective amount of an opioid analgesic, an opioid antagonist and 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.
Claims20
A controlled release oral dosage form comprising:
- a therapeutically effective amount of an opioid analgesic,
- from about 10 ng to 275 mg of an opioid antagonist, and
- particles consisting of a gelling agent, one or more pharmaceutically acceptable hydrophobic material(s) selected from the group consisting of cellulose polymers, acrylic polymers, polylactic acid, polyglycolic acid and a co-polymer of the polylactic acid and polyglycolic acid, and one or more additional pharmaceutically acceptable excipient(s),
- wherein the gelling agent is releasable from said particles and a solubilized mixture having a viscosity unsuitable for injection is formed when the dosage form is crushed and dissolved in from about 1 to about 5 ml of water,
- a weight ratio of the gelling agent to the opioid analgesic is from about 1:40 to about 40:1, and
- the gelling agent is a gum.
A controlled release oral dosage form comprising:
- a therapeutically effective amount of an opioid analgesic selected from the group consisting of oxycodone, codeine, hydrocodone, hydromorphone, levorphanol, meperidine, morphine, pharmaceutically acceptable salts thereof, and mixtures thereof,
- an opioid antagonist, and
- particles consisting of a gelling agent, one or more pharmaceutically acceptable hydrophobic material(s) selected from the group consisting of cellulose polymers, acrylic polymers, polylactic acid, polyglycolic acid and a co-polymer of the polylactic acid and polyglycolic acid, and one or more additional pharmaceutically acceptable excipient(s),
- wherein the gelling agent is releasable from said particles in an effective amount such that syringeability is hindered when the dosage form is crushed and dissolved in from about 1 to about 5 ml of water,
- a weight ratio of the gelling agent to the opioid analgesic is from about 1:40 to about 40:1, and
- the gelling agent is a gum.
A controlled release oral dosage form comprising:
- a therapeutically effective amount of an opioid analgesic selected from the group consisting of oxycodone, codeine, hydrocodone, hydromorphone, levorphanol, meperidine, morphine, pharmaceutically acceptable salts thereof, and mixtures thereof,
- an opioid antagonist, and
- particles consisting of a gelling agent, one or more pharmaceutically acceptable hydrophobic material(s) selected from the group consisting of cellulose polymers, acrylic polymers, polylactic acid, polyglycolic acid and a co-polymer of the polylactic acid and polyglycolic acid, and one or more additional pharmaceutically acceptable excipient(s),
- wherein the gelling agent is releasable from said particles in an effective amount such that the dosage form forms a gel that cannot be drawn into an insulin syringe without picking up pockets of air when the dosage form is crushed and dissolved in from about 1 to about 5 ml of water,
- a weight ratio of the gelling agent to the opioid analgesic is from about 1:40 to about 40:1, and
- the gelling agent is a gum.
Dependencies are inferred from the claim text.