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Claims for Patent: 6,210,705

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Claims for Patent: 6,210,705

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, NC. (Miami, FL)
Application Number:09/163,351
Patent Claims: 1. A composition for topical application of methylphenidate comprising methylphenidate in a flexible, finite system, wherein the methylphenidate is present in a therapeutically effective 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 than at least 10 hours, and wherein the composition comprises no more than about 5 wt % of acid functional monomers.

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 composition comprises no more than about 1 wt % of acid functional monomers.

16. 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 a therapeutically effective 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, and wherein acid functional monomers are present in an amount of no more than about 5 wt %.

17. The method according to claim 16, wherein the acid functional monomers are present in an amount of no more than about 1 wt %.

18. 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 therapeutically effective dose in a patient over a total duration of 24 hours, wherein the total delivered amount of methylphenidate is from about 0.5 mg to about 100 mg, and wherein acid functional monomers are present in an amount of no more than about 5 wt %.

19. The composition according to claim 18, wherein the delivery rate is from about 2.5 mg/24 hours to about 20 mg/24 hours.

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

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

23. The composition according to claim 18, wherein the therapeutically effective dose is from about 0.075 mg/kg/day to about 0.3 mg/kg/day.

24. The composition according to claim 18, wherein the composition comprises no more than about 1 wt % of acid functional monomers.

25. 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 permit a therapeutically effective dose in a patient over a total duration of 24 hours, wherein the total delivered amount of methylphenidate is from about 0.5 mg to about 100 mg, and wherein acid functional monomers are present in an amount of no more than about 5 wt %.

26. The method according to claim 25, wherein the acid functional monomers are present in an amount of no more than about 1 wt %.
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