IP Library › Patent Application 14611716
Patent Application
App. No. 14/611,716

Pharmaceutical Formulation Containing Gelling Agent

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Quick Facts
Patent No.
US None
App. No.
14/611,716
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.

Claims (49)

1 - 40 . (canceled)

41 . A controlled release oral solid dosage form comprising:

matrix multiparticulates comprising (i) oxycodone base, an organic acid salt of oxycodone, or a combination thereof;

(ii) a gelling agent comprising a surfactant, an emulsifier or a mixture thereof;

(iii) a C 12 -C 40 fatty acid; and

(iv) a wax;

the matrix multiparticulates providing a therapeutic effect for at least about 12 hours when orally administered to a human patient, having a viscosity of at least about 10 cP when subjected to tampering by heating at a temperature greater than about 45° C., and contained in a pharmaceutically acceptable capsule.

42 . The controlled release oral solid dosage form of claim 41 , wherein the matrix multiparticulates comprise an organic acid salt of oxycodone.

43 . The controlled release oral solid dosage form of claim 41 , wherein the matrix multiparticulates comprise oxycodone base.

44 . The controlled release oral solid dosage form of claim 41 , wherein the wax is selected from the group consisting of carnauba wax, beeswax and a combination thereof.

45 . The controlled release oral solid dosage form of claim 41 , wherein the wax comprises carnauba wax.

46 . The controlled release oral solid dosage form of claim 41 , wherein the wax comprises beeswax.

47 . The controlled release oral solid dosage form of claim 41 , wherein the fatty acid comprises C 12 fatty acid.

48 . The controlled release oral solid dosage form of claim 41 , wherein the fatty acid comprises stearic acid.

49 . The controlled release oral solid dosage form of claim 41 , wherein the fatty acid comprises C 12 fatty acid and stearic acid.

50 . The controlled release oral solid dosage form of claim 41 , wherein the matrix multiparticulates are prepared by melting the C 12 -C 40 fatty acid and incorporating oxycodone base therein.

51 . The controlled release oral solid dosage form of claim 50 , wherein the fatty acid comprises C 12 fatty acid.

52 . The controlled release oral solid dosage form of claim 50 , wherein the fatty acid comprises stearic acid.

53 . The controlled release oral solid dosage form of claim 50 , wherein the fatty acid comprises C 12 fatty acid and stearic acid.

54 . The controlled release oral solid dosage form of claim 41 , wherein the matrix multiparticulates are prepared by combining melted C 12 -C 40 fatty acid, melted wax and oxycodone base.

55 . The controlled release oral solid dosage form of claim 54 , wherein the wax is selected from the group consisting of carnauba wax, beeswax and a combination thereof.

56 . The controlled release oral solid dosage form of claim 54 , wherein the wax comprises carnauba wax.

57 . The controlled release oral solid dosage form of claim 54 , wherein the wax comprises beeswax.

58 . The controlled release oral solid dosage form of claim 54 , wherein the fatty acid comprises C 12 fatty acid.

59 . The controlled release oral solid dosage form of claim 54 , wherein the fatty acid comprises stearic acid.

60 . The controlled release oral solid dosage form of claim 54 , wherein the fatty acid comprises C 12 fatty acid and stearic acid.

61 . A controlled release oral solid dosage form comprising:

matrix multiparticulates prepared by combining (i) oxycodone base;

(ii) a gelling agent comprising a surfactant, an emulsifier or a mixture thereof;

(iii) a C 12 -C 40 fatty acid; and

(iv) a wax selected from the group consisting of carnauba wax, beeswax and a combination thereof;

the matrix multiparticulates providing a therapeutic effect for at least about 12 hours when orally administered to a human patient, having a viscosity of at least about 10 cP when subjected to tampering by heating at a temperature greater than about 45° C., and contained in a pharmaceutically acceptable capsule.

62 . The controlled release oral solid dosage form of claim 61 , wherein the fatty acid comprises C 12 fatty acid, stearic acid or a combination thereof.

63 . A controlled release oral solid dosage form comprising:

matrix multiparticulates comprising (i) oxycodone base, an organic acid salt of oxycodone, or a combination thereof;

(ii) a gelling agent comprising a surfactant, an emulsifier or a mixture thereof;

(iii) a C 12 -C 40 fatty acid; and

(iv) a wax selected from the group consisting of carnauba wax, beeswax and a combination thereof;

the matrix multiparticulates providing a therapeutic effect for at least about 12 hours when orally administered to a human patient, being unsuitable for injection when subjected to tampering by heating at a temperature greater than about 45° C., and contained in a pharmaceutically acceptable capsule.

64 . A controlled release oral solid dosage form comprising:

matrix multiparticulates comprising (i) oxycodone base, an organic acid salt of oxycodone, or a combination thereof;

(ii) polyglycolized glycerides;

(iii) a C 12 -C 40 fatty acid; and

(iv) a wax;

the matrix multiparticulates providing a therapeutic effect for at least about 12 hours when orally administered to a human patient, having a viscosity of at least about 10 cP when subjected to tampering by heating at a temperature greater than about 45° C., and contained in a pharmaceutically acceptable capsule.

65 . The controlled release dosage form of claim 41 , wherein the surfactant is polyglycolized glycerides.

66 . The controlled release dosage form of claim 61 , wherein the surfactant is polyglycolized glycerides.

67 . The controlled release dosage form of claim 63 , wherein the surfactant is polyglycolized glycerides.

68 . The controlled release dosage form of claim 41 , further comprising polyethylene glycol.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 17, 2019
From: THE P.F. LABORATORIES, INC.; PURDUE PHARMA TECHNOLOGIES, INC.
To: PURDUE PHARMA L.P.
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