Pharmaceutical formulation containing gelling agent
AssigneesPurdue Pharma L.P., The P.F. Laboratories, Inc., Purdue Pharmaceuticals L.P.
InventorsCurtis Wright, Benjamin Oshlack, Christopher Breder
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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.
Claims17
A method of preparing an abuse deterrent immediate release dosage form comprising:
- (i) preparing a mixture comprising an opioid agonist and a gelling agent comprising microcrystalline cellulose and sodium carboxymethylcellulose;
- (ii) compressing the mixture into a tablet;
- and
- (iii) coating the tablet with a coating comprising polyvinyl alcohol and polyethylene glycol,
- wherein the abuse deterrent dosage form forms a gel unsuitable for parenteral administration when the dosage form is subjected to tampering comprising dissolution in from about 0.5 ml to about 10 ml of an aqueous liquid;
- the dosage form having a ratio of gelling agent to opioid agonist from about 1:1 to about 8:1;
- the dosage form providing an immediate release of the opioid agonist when orally administered to a human patient;
- and
- wherein the opioid agonist is the sole active agent in the dosage form.
Dependencies are inferred from the claim text.