COMPOSITIONS AND METHODS FOR TREATMENT OF ATTENTION DEFICIT DISORDER AND ATTENTION DEFICIT/HYPERACTIVITY DISORDER WITH METHYLPHENIDATE

• US 20110160245A1
• Filed: 12/29/2010
• Published: 06/30/2011
• Est. Priority Date: 12/15/1997
• Status: Abandoned Application

• Current Assignee: Noven Pharmaceuticals (Hisamitsu Pharmaceutical Company Incorporated)
• Original Assignee: Noven Pharmaceuticals (Hisamitsu Pharmaceutical Company Incorporated)
• Inventors: Mantelle, Juan, Dixon, Terese A.
• Application Number:
  US12/981,154
• Publication Number:
  US 20110160245A1
• Time in Patent Office: Days
• US Class Current: 514/317
• CPC Class Codes: A61K 31/445 Non condensed piperidines, e.g. piperocaine
• CPC Class Codes: A61K 31/4458 only substituted in position 2, e.g. methylphenidate
• CPC Class Codes: A61K 47/32 Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers , poly(meth)acrylates, or polyvinyl pyrrolidone
• CPC Class Codes: A61K 9/7061 Polyacrylates
• CPC Class Codes: A61K 9/7069 obtained otherwise than by reactions only involving carbon to carbon unsaturated bonds, e.g. polysiloxane, polyesters, polyurethane, polyethylene oxide
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system

Abstract

The invention relates to a method of treating Attention Deficit Disorder (ADD) and Attention Deficit/Hyperactivity Disorder (ADHD) and compositions for topical application of methylphenidate comprising methylphenidate in a flexible, finite system wherein said composition comprises about 10 to 30 wt % methylphenidate, about 30 to 50 wt % acrylic adhesive, and about 30 to 50 wt % silicone adhesive and wherein said methylphenidate is delivered to a subject in need thereof such that the plasma concentration of methylphenidate increases over a period of about 6-16 hours, and more preferably over a period of about 6-12 hours followed by a steady decrease in plasma concentration of methylphenidate.

Claims

1-38. -38. (canceled)

39. A composition for topical application of methylphenidate, comprising methylphenidate in a polymer carrier of a flexible finite, system, wherein the composition comprises 5 to 35 wt % methylphenidate based on the total weight of the composition and a non-functional acrylic polymer.

40. The composition according to claim 39, wherein the methylphenidate is methylphenidate base.

41. The composition according to claim 39, wherein the methylphenidate comprises the d-threo-methylphenidate enantiomer.

42. The composition according to claim 39, wherein the composition does not include vinyl acetate or vinyl acetate monomers.

43. The composition according to claim 39, wherein the composition contains an amount of methylphenidate effective to achieve delivery over a period of at least 10 hours.

44. The composition according to claim 39, consisting essentially of said methylphenidate and said non-functional acrylic polymer.

45. The composition according to claim 39, further comprising a capped or amine-compatible polysiloxane polymer.

46. The composition according to claim 45, consisting essentially of said methylphenidate, said non-functional acrylic polymer and said capped or amine-compatible polysiloxane polymer.

47. The composition according to claim 39, wherein the composition does not include an enhancer.

48. The composition according to claim 39, wherein the composition comprises 10 to 30 wt % methylphenidate based on the total weight of the composition.