METHODS AND DEVICES FOR PROVIDING PROLONGED DRUG THERAPY

• US 20100093796A1
• Filed: 10/19/2009
• Published: 04/15/2010
• Est. Priority Date: 11/12/1996
• Status: Active Grant

• Current Assignee: Carol A. Christopher, Diane R. Guinta, Lawrence G. Hamel, Samuel R. Saks, Suneel K. Gupta
• Original Assignee: Carol A. Christopher, Diane R. Guinta, Lawrence G. Hamel, Samuel R. Saks, Suneel K. Gupta
• Inventors: Gupta, Suneel K., Saks, Samuel R., Guinta, Diane R., Christopher, Carol A., Hamel, Lawrence G.
• Granted Patent: US 8,629,179 B2
• Time in Patent Office: Days
• US Class Current: 514/317
• CPC Class Codes: A61K 31/00 Medicinal preparations containing organic active ingredients
• CPC Class Codes: A61K 31/137 Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
• CPC Class Codes: A61K 31/421 1,3-Oxazoles, e.g. pemoline, trimethadione
• CPC Class Codes: A61K 31/4422 1,4-Dihydropyridines, e.g. nifedipine, nicardipine
• CPC Class Codes: A61K 31/4458 only substituted in position 2, e.g. methylphenidate
• CPC Class Codes: A61K 9/0002 Galenical forms characterised by the drug release technique; Application systems commanded by energy
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
• CPC Class Codes: A61K 9/2072 characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms A61K9/0004, A61K9/0056, A61K9/0065 take precedence
• CPC Class Codes: A61K 9/2086 Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat active cores with a complete drug-free outer coat A61K9/28
• CPC Class Codes: A61K 9/209 containing drug in at least two layers or in the core and in at least one outer layer
• CPC Class Codes: A61K 9/5084 Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs tablets containing such a mixture A61K9/2077
• CPC Class Codes: A61K 9/70 Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug hollow drug-filled fibres A61K9/0092

Abstract

Methods and devices for maintaining a desired therapeutic drug effect over a prolonged therapy period are provided. In particular, oral dosage forms that release drug within the gastrointestinal tract at an ascending release rate over an extended time period are provided. The dosage forms may additionally comprise an immediate-release dose of drug.

Claims

1-34. -34. (canceled)

35. A method that comprises administering a pharmaceutically acceptable composition comprising methylphenidate or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable carrier to a patient in a manner that achieves an ascending release rate of said methylphenidate beginning with a first periodic interval that begins at time t=0 and continuing through about 5.5 hours following said administration.

36. A method for effectively treating Attention Deficit Disorder or Attention Deficit Hyperactivity Disorder in a subject comprising orally administering a dosage form to said subject, wherein said dosage form comprises

an immediate release coating comprising methylphenidate hydrochloride;

and

a sustained release portion comprising methylphenidate hydrochloride and a pharmaceutically acceptable carrier,

wherein;

said dosage form provides release of said methylphenidate hydrochloride over a period comprising first, second, third, and fourth sequential one-hour time intervals;

said sustained release portion releases more of said methylphenidate hydrochloride during said second interval than during said first interval, more of said methylphenidate hydrochloride during said third interval than during said second interval, and more of said methylphenidate hydrochloride during said fourth interval than during said third interval; and

the methylphenidate hydrochloride released during said first interval only includes methylphenidate hydrochloride released from said immediate release coating.

37. The method according to claim 36 wherein said dosage form is administered one time per day for multiple days.

38. The method according to claim 36 wherein said dosage form is administered to a non-adult subject.

39. A method for effectively treating Attention Deficit Disorder or Attention Deficit Hyperactivity Disorder in a subject comprising orally administering a dosage form to said subject, wherein said dosage form comprises

an immediate release portion comprising methylphenidate or a pharmaceutically effective salt thereof;

and

a sustained release portion comprising methylphenidate or a pharmaceutically effective salt thereof and a pharmaceutically acceptable carrier,

wherein;

said dosage form releases said methylphenidate over a period comprising first, second, and third sequential one-hour time intervals, and

said sustained release portion releases more of said methylphenidate during said second interval than during said first interval, and more of said methylphenidate during said third interval than during said second interval.

40. The method according to claim 39 wherein said period of release comprises a fourth sequential time interval, and wherein the sustained release portion releases more of said methylphenidate during said fourth interval than during said third interval.

41. The method according to claim 39 wherein the methylphenidate released during said first interval only includes methylphenidate released from said immediate release portion.

42. The method according to claim 39 wherein said immediate release portion is applied as a coating on an outer surface of the dosage form.

43. The method according to claim 42 wherein the dosage form releases more of said methylphenidate during said second interval than during said first interval, not including methylphenidate released from said coating during said first interval.

44. The method according to claim 43 wherein the methylphenidate released during said first interval only includes methylphenidate released from said coating.

45. The method according to claim 39 wherein said immediate release portion and said sustained release portion comprise methylphenidate hydrochloride.

46. A method for effectively treating Attention Deficit Disorder or Attention Deficit Hyperactivity Disorder in a subject comprising orally administering a dosage form to said subject, wherein said dosage form comprises:

an immediate release portion comprising methylphenidate or a pharmaceutically effective salt thereof; and

a sustained release portion comprising methylphenidate or a pharmaceutically effective salt thereof and a pharmaceutically acceptable carrier,

wherein said dosage form provides a substantially ascending blood plasma concentration of said methylphenidate or pharmaceutically effective salt thereof up to about 8 hours following administration.

47. The method according to claim 46 wherein said immediate release portion and said sustained release portion each comprise D-methylphenidate.

48. The method according to claim 46 wherein said immediate release portion and said sustained release portion each comprise methylphenidate hydrochloride.

49. The method according to claim 46 wherein said dosage form provides a blood plasma concentration of said methylphenidate or pharmaceutically effective salt thereof that is greater at 4 hours following administration than at 2 hours following administration, and is greater at 5.5 hours following administration than at 4 hours following administration.

50. The method according to claim 49 wherein said dosage form provides a blood plasma concentration of said methylphenidate or pharmaceutically effective salt thereof that is greater at about 8 hours following administration than at 5.5 hours following administration.

51. The method according to claim 46 wherein said blood plasma at a time up to 4 hours following administration comprises said methylphenidate or pharmaceutically effective salt thereof from said immediate release portion.

52. The method according to claim 46 wherein said blood plasma at a time after 4 hours following administration does not comprise methylphenidate or pharmaceutically effective salt thereof from said immediate release portion.

53. A method for effectively treating Attention Deficit Disorder or Attention Deficit Hyperactivity Disorder in a subject comprising orally administering a dosage form to said subject, wherein said dosage form comprises:

an immediate release portion comprising methylphenidate or a pharmaceutically effective salt thereof; and

a sustained release portion comprising methylphenidate or a pharmaceutically effective salt thereof and a pharmaceutically acceptable carrier,

wherein said dosage form provides a substantially ascending blood plasma concentration of said methylphenidate or pharmaceutically effective salt thereof up to about 8 hours following administration;

wherein said dosage form provides a blood plasma concentration of said methylphenidate or pharmaceutically effective salt thereof that is greater at 4 hours following administration than at 2 hours following administration, and is greater at 5.5 hours following administration than at 4 hours following administration;

wherein said blood plasma at a time up to 4 hours following administration comprises said methylphenidate or pharmaceutically effective salt thereof from said immediate release portion; and

,

wherein said blood plasma at a time after 4 hours following administration does not comprise methylphenidate or pharmaceutically effective salt thereof from said immediate release portion.

54. The method according to claim 53 wherein said dosage form provides a blood plasma concentration of said methylphenidate or pharmaceutically effective salt thereof that is greater at about 8 hours following administration than at 5.5 hours following administration

55. The method according to claim 53 wherein said immediate release portion and said sustained release portion each comprise D-methylphenidate.

56. The method according to claim 53 wherein said immediate release portion and said sustained release portion each comprise methylphenidate hydrochloride.

57. A dosage form for effectively treating Attention Deficit Disorder or Attention Deficit Hyperactivity Disorder in a subject comprising:

an immediate release portion comprising methylphenidate or a pharmaceutically effective salt thereof; and

a sustained release portion comprising methylphenidate or a pharmaceutically effective salt thereof and a pharmaceutically acceptable carrier,

wherein said dosage form provides a substantially ascending blood plasma concentration of said methylphenidate or pharmaceutically effective salt thereof up to about 8 hours following administration.

58. The dosage form according to claim 57 wherein said immediate release portion and said sustained release portion each comprise D-methylphenidate.

59. The dosage form according to claim 57 wherein said immediate release portion and said sustained release portion each comprise methylphenidate hydrochloride.

60. The dosage form according to claim 57 wherein said dosage form provides a blood plasma concentration of said methylphenidate or pharmaceutically effective salt thereof that is greater at 4 hours following administration than at 2 hours following administration, and is greater at 5.5 hours following administration than at 4 hours following administration.

61. The dosage form according to claim 60 wherein said dosage form provides a blood plasma concentration of said methylphenidate or pharmaceutically effective salt thereof that is greater at about 8 hours following administration than at 5.5 hours following administration.

62. The dosage form according to claim 57 wherein said blood plasma at a time up to 4 hours following administration comprises said methylphenidate or pharmaceutically effective salt thereof from said immediate release portion.

63. The dosage form according to claim 57 wherein said blood plasma at a time after 4 hours following administration does not comprise said methylphenidate or pharmaceutically effective salt thereof from said immediate release portion.

64. A dosage form for effectively treating Attention Deficit Disorder or Attention Deficit Hyperactivity Disorder in a subject comprising:

an immediate release portion comprising methylphenidate or a pharmaceutically effective salt thereof; and

a sustained release portion comprising methylphenidate or a pharmaceutically effective salt thereof and a pharmaceutically acceptable carrier,

wherein said dosage form provides a substantially ascending blood plasma concentration of said methylphenidate or pharmaceutically effective salt thereof up to about 8 hours following administration;

wherein said dosage form provides a blood plasma concentration of said methylphenidate or pharmaceutically effective salt thereof that is greater at 4 hours following administration than at 2 hours following administration, and is greater at 5.5 hours following administration than at 4 hours following administration;

wherein said blood plasma at a time up to 4 hours following administration comprises said methylphenidate or pharmaceutically effective salt thereof from said immediate release portion; and

,

wherein said blood plasma at a time after 4 hours following administration does not comprise methylphenidate or pharmaceutically effective salt thereof from said immediate release portion.

65. The dosage form according to claim 64 wherein said dosage form provides a blood plasma concentration of said methylphenidate or pharmaceutically effective salt thereof that is greater at about 8 hours following administration than at 5.5 hours following administration.

66. The dosage form according to claim 64 wherein said immediate release portion and said sustained release portion each comprise D-methylphenidate.

67. The dosage form according to claim 64 wherein said immediate release portion and said sustained release portion each comprise methylphenidate hydrochloride.