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Details for Patent: 9,308,170

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Details for Patent: 9,308,170

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 (Greenwich, CT)
Assignee: Purdue Pharma L.P. (Stamford, CT) The P.F. Laboratories, Inc. (Totowa, NJ) Purdue Pharmaceuticals L.P. (Wilson, NC)
Filing Date:May 09, 2013
Application Number:13/890,874
Claims:1. An immediate release oral dosage form comprising: a mixture of (i) a central nervous system stimulant; (ii) a gelling agent comprising hydroxypropylcellulose, the gelling agent in an effective amount to impart a viscosity of at least 10 cP when the dosage form is subjected to tampering by dissolution in from about 0.5 to about 10 ml of an aqueous liquid; and wherein the weight ratio of the hydroxypropylcellulose to the central nervous system stimulant is about 1:1 to about 8:1; (iii) microcrystalline cellulose; (iv) a material selected from a group consisting of polyethylene glycol, polyethylene oxide, and mixtures thereof; (v) silicon dioxide; (vi) a disintegrant; and (vii) a lubricant; the dosage form providing an immediate release of the central nervous system stimulant.

2. The immediate release oral dosage form of claim 1, wherein the solubilized mixture has a viscosity of at least 60 cP.

3. The immediate release oral dosage form of claim 1, wherein the solubilized mixture has a viscosity of 120 cP or greater.

4. The immediate release oral dosage form of claim 1, wherein the solubilized mixture has a viscosity of from 120 cP to 5,000 cP.

5. The controlled release oral dosage form of claim 1, wherein the imparted viscosity makes the tampered dosage form difficult to pull into an insulin syringe.

6. The controlled release oral dosage form of claim 1, wherein the imparted viscosity makes the tampered dosage form difficult to pull into an insulin syringe as compared to the same dosage form having an inert pharmaceutically acceptable excipient in place of the gelling agent.

7. The controlled release oral dosage form of claim 1, wherein a tampered dosage form cannot be filled into an insulin syringe without picking up pockets of air.

8. The controlled release oral dosage form of claim 1, wherein a tampered dosage form has a milk like color.

9. The controlled release oral dosage form of claim 1, wherein the aqueous liquid is water.

10. The controlled release oral dosage form of claim 1, wherein tampering further comprises crushing the dosage form.

11. The controlled release oral dosage form of claim 1, wherein the viscosity is imparted when the dosage form is subjected to tampering by dissolution in the aqueous liquid at ambient temperature.

12. The controlled release oral dosage form 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.

13. The controlled release dosage form of claim 1, wherein the material comprises polyethylene oxide and has a weight average molecular weight of about 100,000 daltons to about 1,000,000 daltons.

14. The controlled release dosage form of claim 1, wherein the material comprises polyethylene oxide and has a weight average molecular weight of about 1,000,000 daltons to about 10,000,000 daltons.

15. An immediate release oral dosage form comprising: a mixture of (i) a central nervous system stimulant; (ii) a gelling agent comprising hydroxypropylcellulose, the gelling agent in an effective amount to impart a viscosity of about 10 cP or greater when the dosage form is subjected to tampering by dissolution in about 0.5 ml to about 10 ml of an aqueous liquid; and wherein the weight ratio of the hydroxypropylcellulose to the central nervous system stimulant is about 1:1 to about 8:1; (iii) microcrystalline cellulose; (iv) polyethylene oxide with a weight average molecular weight of about 100,000 daltons to about 10,000,000 daltons; (v) silicon dioxide; (vi) a disintegrant; and (vii) a lubricant; the dosage form providing an immediate release of the central nervous system stimulant.

16. An immediate release oral dosage form comprising: a mixture of (i) a central nervous system stimulant; (ii) hydroxypropylcellulose, wherein the weight ratio of the hydroxypropylcellulose to the central nervous system stimulant is about 1:1 to about 8:1; (iii) microcrystalline cellulose; (iv) polyethylene oxide, polyethylene glycol or a mixture thereof; (v) silicon dioxide; (vi) a disintegrant; and (vii) a lubricant; wherein the dosage form provides an immediate release of the central nervous system stimulant.

17. The immediate release dosage form of claim 16, wherein when the dosage form is subjected to tampering by dissolution in about 0.5 ml to about 10 ml of an aqueous liquid, the tampered dosage form comprises a viscosity that makes the tampered dosage form difficult to pull into an insulin syringe.
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