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Claims for Patent: 6,348,211

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Claims for Patent: 6,348,211

Title: Compositions and methods for treatment of attention deficit disorder and attention deficit/hyperactivity disorder with methylphenidate
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 the methylphenidate is present in an amount sufficient to achieve substantially zero order kinetics for delivery to the skin or mucosa of a patient in need thereof over a period of time at least 10 hours.
Inventor(s): Mantelle; Juan (Miami, FL), Dixon; Terese A. (Miami, FL)
Assignee: Noven Pharmaceuticals, Inc. (Miami, FL)
Application Number:09/618,626
Patent Claims: 1. A composition for topical application of methylphenidate comprising methylphenidate and a pharmaceutically acceptable adhesive carrier in a flexible, finite system,

wherein the methylphenidate is present in an amount sufficient to achieve substantially zero order kinetics for delivery to the skin or mucosa of a patient in need thereof over a period of time at least 10 hours,

wherein the proportion of methylphenidate:silicone adhesive:acrylic adhesive (wt % dry) is about 5-30:0-70:0-70, respectively, and

wherein the composition is substantially free of ritalinic acid at the time of manufacture.

2. The composition according to claim 1, wherein methylphenidate is in the base form.

3. The composition according to claim 2, wherein the methylphenidate base is present within the composition in an amount of at least 26.4 mg per about 10 cm2.

4. The composition according to claim 1, wherein methylphenidate is in the form of a base/basic salt combination or an ester.

5. The composition according to claim 1, wherein the methylphenidate substantially comprises the d-threo-methylphenidate enantiomer.

6. The composition according to claim 1, further comprising an adhesive.

7. The composition according to claim 6, wherein the adhesive is selected from the group consisting of acrylics, natural and synthetic rubbers, bioadhesives, polysiloxanes, polyacrylates, polyvinylpyrrolidones, vinylpyrrolidone copolymers, styrene block polymers and mixtures thereof.

8. The composition according to claim 7, wherein the adhesive includes a bioadhesive which is selected from the group consisting of natural or synthetic polysaccharides and polyacrylic acid polymers.

9. The composition according to claim 8, wherein the natural polysaccharide is a natural gum.

10. The composition according to claim 7, wherein the adhesive includes a polysiloxane which is a capped or amine-compatible polysiloxane polymer.

11. The composition according to claim 7, wherein the adhesive includes an acrylic which is a nonfunctional or minimally functional polymer.

12. The composition according to claim 7, wherein the adhesive includes a polyacrylate which is a non-vinyl acetate containing polymer.

13. The composition according to claim 1, wherein the delivery rate to the skin or mucosa is over a period of time of about 12 to about 20 hours.

14. The composition according to claim 1, wherein the delivery to the skin or mucosa is over a period of time of about 14 to about 16 hours.

15. The composition according to claim 1, wherein the proportion of methylphenidate:silicone adhesive:acrylic adhesive (wt % dry) is 20-30:30-70:10-40, respectively.

16. A composition for topical application of methylphenidate comprising methylphenidate in a flexible, finite system

wherein the methylphenidate is present in an amount sufficient to permit a delivery rate from about 0.5 mg/24 hours to about 100 mg/24 hours in order to achieve a therapeutically effective dose in a patient,

wherein the proportion of methylphenidate:silicone adhesive:acrylic adhesive (wt % dry) is about 5-30:0-70:0-70, respectively, and

wherein the composition is substantially free of ritalinic acid at the time of manufacture.

17. The composition according to claim 16, wherein the delivery rate is from about 2.5 mg/24 hours to about 20 mg/24 hours.

18. The composition according to claim 17, wherein the therapeutically effective dose is from about 0.05 mg/kg/day to about 1.0 mg/kg/day.

19. The composition according to claim 17, wherein the therapeutically effective dose is from about 0.075 mg/kg/day to about 0.3 mg/kg/day.

20. The composition according to claim 16, wherein the therapeutically effective dose is from about 0.05 mg/kg/day to about 1.0 mg/kg/day.

21. The composition according to claim 16, wherein the therapeutically effective dose is from about 0.075 mg/kg/day to about 0.3 mg/kg/day.

22. A composition for transdermal delivery of methylphenidate, comprising methylphenidate or a pharmaceutically acceptable salt thereof in an amount sufficient to provide a flux of at least 5 .mu.g/cm.sup.2 /hr to achieve therapeutic blood levels of methylphenidate for at least 10 hours.

23. A composition according to claim 22, wherein the methylphenidate is present in a therapeutically effective amount for children.

24. A composition for transdermal delivery of methylphenidate, comprising methylphenidate or a pharmaceutically acceptable salt thereof in an amount to provide a dose of at least 0.5 mg to a patient over 24 hours with a flux of at least 5 .mu.g/cm.sup.2 /hr for at least 10 hours.

25. A composition for transdermal delivery of methylphenidate, comprising methylphenidate or a pharmaceutically acceptable salt thereof in an amount sufficient to achieve blood levels of methylphenidate in the range of 1 ng/ml to 6 ng/ml for at least 10 hours.

26. The composition of claim 25, wherein said blood levels of methylphenidate are in the range of 1 ng/ml to 6 ng/ml for at least 20 hours.

27. A composition for topical application of methylphenidate comprising methylphenidate and a pharmaceutically acceptable adhesive carrier in a flexible, finite system,

wherein the methylphenidate is present in an amount sufficient to achieve substantially zero order kinetics for delivery to the skin or mucosa of a patient in need thereof over a period of time at least 10 hours,

wherein the methylphenidate is present at a therapeutically effective amount that is substantially free of crystals, and

wherein the composition is substantially free of ritalinic acid at the time of manufacture.

28. A method of treating attention deficit disorder and attention deficit/hyperactivity disorder comprising topically administering methylphenidate in a flexible, finite system

wherein the methylphenidate is present in an amount sufficient to achieve substantially zero order kinetics for delivery to the skin or mucosa of a patient in need thereof over a period of time at least 10 hours,

wherein the proportion of methylphenidate:silicone adhesive:acrylic adhesive (wt % dry) is about 5-30:0-70:0-70, respectively, and

wherein the composition is substantially free of ritalinic acid at the time of manufacture.

29. A method of treating attention defict disorder and attention deficit/hyperactivity disorder comprising topically administering methylphenidate in a flexible, finite system wherein the methylphenidate is present in an amount sufficient to permit a delivery rate from about 0.5 mg/24 hours to about 100 mg/24 hours in order to achieve a therapeutically effective dose in a patient.

30. A method of treating attention deficit disorder (ADD) or attention deficit/hyperactivity disorder (ADHD), comprising transdermal administration of methylphenidate or a pharmaceutically acceptable salt thereof to an individual with ADD or ADHD, at a rate in excess of 5 .mu.g/cm.sup.2 /hr.

31. A method of treating attention deficit disorder (ADD) or attention deficit/hyperactivity disorder (ADHD), comprising transdermal administration of methylphenidate or a pharmaceutically acceptable salt thereof to an individual with ADD or ADHD, at a rate in excess of 0.05 mg/kg/day.
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