Details for Patent: 9,861,583

Title:	Pharmaceutical formulation containing gelling agent
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.
Inventor(s):	Wright; Curtis (Rockport, MA), Oshlack; Benjamin (Boca Raton, FL), Breder; Christopher (Bethesda, MD)
Assignee:	Purdue Pharma L.P. (Stamford, CT) The P.F. Laboratories, Inc. (Totowa, NJ) Purdue Pharmaceuticals L.P. (Wilson, NC)
Filing Date:	Nov 17, 2016
Application Number:	15/354,538
Claims:	1. A method of preparing an oral dosage form comprising: preparing a mixture comprising: (i) an opioid agonist; and (ii) a gelling agent comprising microcrystalline cellulose, a cellulosic polymer and polyvinyl pyrrolidone, the gelling agent in an effective amount to impart a viscosity unsuitable for parenteral administration when the dosage form is subjected to tampering by dissolution in from about 0.5 ml to about 10 ml of an aqueous liquid; (iii) lactose; and (vi) magnesium stearate; compressing the mixture into a tablet; and coating the tablet with a coating comprising polyvinyl alcohol, polyethylene glycol and talc, the oral dosage form having a ratio of gelling agent to opioid agonist from about 8:1 to about 1:8; the oral dosage form providing an immediate release when orally administered to a human patient. 2. The method of claim 1, wherein the cellulosic polymer comprises sodium carboxymethylcellulose. 3. The method of claim 1, wherein the coating is a seal coat. 4. The method of claim 1, wherein the aqueous liquid is water. 5. The method of claim 1, wherein the viscosity is imparted when the dosage form is subjected to tampering by crushing and dissolution in the aqueous liquid. 6. The method of claim 1, wherein the viscosity is imparted when the dosage form is subjected to tampering by dissolution in the aqueous liquid with heating greater than 45.degree. C. 7. A method of preparing an oral dosage form comprising: preparing a mixture comprising: (i) an opioid agonist; and (ii) a gelling agent comprising microcrystalline cellulose, sodium carboxymethylcellulose and polyvinyl pyrrolidone, the gelling agent in an effective amount to impart a viscosity unsuitable for parenteral administration when the dosage form is subjected to tampering by dissolution in from about 0.5 ml to about 10 ml of an aqueous liquid; (iii) lactose; and (iv) magnesium stearate; compressing the mixture into a tablet; and coating the tablet with a film comprising polyvinyl alcohol, polyethylene glycol and talc, the oral dosage form having a ratio of gelling agent to opioid agonist from about 8:1 to about 1:8; the oral dosage form providing an immediate release when orally administered to a human patient.