Oral Pharmaceutical Dosage Forms

• US 20130337059A1
• Filed: 03/05/2013
• Published: 12/19/2013
• Est. Priority Date: 12/06/2007
• Status: Active Grant

• Current Assignee: DURECT Corporation
• Original Assignee: DURECT Corporation
• Inventors: Yum, Su Il, Chao, Wendy, Su, Huey-Ching, Fu, Roger, Zamloot, Michael
• Granted Patent: US 9,592,204 B2
• Time in Patent Office: Days
• US Class Current: 424/456
• CPC Class Codes: A61K 31/137 Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
• CPC Class Codes: A61K 31/4402 only substituted in position 2, e.g. pheniramine, bisacodyl
• CPC Class Codes: A61K 31/4458 only substituted in position 2, e.g. methylphenidate
• CPC Class Codes: A61K 31/485 Morphinan derivatives, e.g. morphine, codeine
• CPC Class Codes: A61K 9/48 Preparations in capsules, e.g. of gelatin, of chocolate A61K9/0004 takes precedence; bite capsules A61K9/0056
• CPC Class Codes: A61K 9/4858 Organic compounds
• CPC Class Codes: A61K 9/4866 Organic macromolecular compounds
• CPC Class Codes: A61P 19/00 Drugs for skeletal disorders
• CPC Class Codes: A61P 19/02 for joint disorders, e.g. arthritis, arthrosis
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 25/04 Centrally acting analgesics, e.g. opioids
• CPC Class Codes: A61P 25/20 Hypnotics; Sedatives
• CPC Class Codes: A61P 25/24 Antidepressants
• CPC Class Codes: A61P 25/26 Psychostimulants, e.g. nicotine, cocaine
• CPC Class Codes: A61P 25/36 Opioid-abuse
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

Abuse-resistant oral dosage forms suitable for administration of pharmacologically active agents are provided.

Claims

1-34. -34. (canceled)

35. A composition comprising:

opioid,

about 30 wt % to about 60 wt % of sucrose acetate isobutyrate,

about 0.1 wt % to about 20 wt % of a cellulose acetate butyrate,

about 0.1 wt % to about 10 wt % of hydroxyethylcellulose, and

solvent.

36. The composition of claim 35, wherein the opioid comprises a member selected from oxycodone, oxymorphone, hydrocodone, hydromorphone, levorphanol, morphine, either in free base form or a pharmaceutically acceptable salt thereof.

37. The composition of claim 35, wherein the opioid is oxycodone.

38. The composition of claim 35, wherein the opioid is present in an amount ranging from about 1.3 wt % to about 35 wt %.

39. The composition of claim 35, further comprising a surfactant.

40. The composition of claim 35, further comprising a viscosity enhancing agent.

41. The composition of claim 40, wherein the viscosity enhancing agent comprises a stiffening agent.

42. The composition of claim 40, wherein the viscosity enhancing agent comprises silicon dioxide.

43. The composition of claim 35, wherein the solvent comprises triacetin.

44. The composition of claim 35, wherein the solvent is present in an amount ranging from about 0.1 wt % to about 40 wt %.

45. The composition of claim 35, further comprising a hydrophobic solvent.

46. The composition of claim 35, wherein the cellulose acetate butyrate has a number average molecular weight ranging from 66,000 to 83,000.

47. The composition of claim 35, wherein the hydroxyethylcellulose is present in an amount ranging from about 3 wt % to about 10 wt %.

48. The composition of claim 35, further comprising a rheology modifier.

49. The composition of claim 48, wherein the rheology modifier is selected from isopropyl myristate, caprylic/capric triglyceride, ethyl oleate, triethyl citrate, dimethyl phthalate, and benzyl benzoate.

50. The composition of claim 48, wherein the rheology modifier is present in an amount ranging from about 0.1 wt % to about 20 wt %.

51. The composition of claim 35, further comprising saturated polyglycolized glyceride.

52. The composition of claim 51, wherein the saturated polyglycolized glyceride is present in an amount ranging from about 0.01 wt % to about 5 wt %.

53. The composition of claim 35, wherein the composition is in the form of a suspension.

54. The composition of claim 35, wherein the composition is encapsulated within a capsule.

55. The composition of claim 54, wherein the capsule comprises gelatin, hydroxyethylcellulose, or hydroxypropylmethylcellulose.

56. A pharmaceutical dosage form comprising the composition of claim 35.