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Claims for Patent: RE37516

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Claims for Patent: RE37516

Title: Acetamide derivative having defined particle size
Abstract:Pharmaceutical compositions comprising modafinil in the form of particles of defined size. The particle size of modafinil can have a significant effect on the potency and safety profile of the drug.
Inventor(s): Grebow; Peter E. (Penllyn, PA), Corvari; Vincent (Nahua, NH), Stong; David (Coatesville, PA)
Assignee: Cephalon, Inc. (West Chester, PA)
Application Number:09/285,166
Patent Claims: 1. A pharmaceutical composition comprising a substantially homogeneous mixture of modafinil particles, wherein at least about 95% of the cumulative total of modafinil particles in said composition have a diameter of less than about 200 microns (.mu.m).

2. The composition of claim 1 wherein said particles have a median diameter range of between about 2.mu.m and about 60 .mu.m.

3. The composition of claim 1, wherein said composition comprises between about 50 milligrams and about 700 milligrams of said modafinil.

4. A method of altering the somnolent state of a mammal, said method comprising administering an effective amount of the composition of claim 1 to said mammal.

5. The method of claim 4, wherein said somnolent state is narcolepsy.

6. The method of claim 4, wherein said effective amount comprises between about 50 milligrams/day and about 700 milligrams/day of said composition..Iadd.

7. A pharmaceutical composition in an oral unit dose form comprising:

an amount of modafinil effective to alter a somnolent state of a mammal upon oral administration,

said amount of modafinil being in the form of solid modafinil particles,

said particles having a size distribution wherein at least about 95% of the cumulative total of said particles have a diameter of less than about 200 microns (.mu.m). .Iaddend..Iadd.

8. The composition in unit dose form of claim 7 wherein said effective amount comprises particles have a medium diameter range of between about 2 .mu.m and about 60 .mu.m. .Iaddend..Iadd.

9. The composition in unit dose form of claim 7, wherein said effective amount comprises between about 100 milligrams and about 200 milligrams of said modafinil. .Iaddend..Iadd.

10. A method of altering the somnolent state of a mammal, said method comprising administering one or more unit doses of the composition of claim 7 to said mammal. .Iaddend..Iadd.

11. The method of claim 10, wherein said somnolent state is narcolepsy. .Iaddend..Iadd.

12. The method of claim 10, wherein between about 100 milligrams/day and about 200 milligrams/day of said of modafinil are administered to said mammal. .Iaddend..Iadd.

13. A pharmaceutical composition according to claim 7, further comprising additional modafinil particles in excess of said effective amount. .Iaddend..Iadd.

14. A pharmaceutical composition according to claim 13 wherein said additional modafinil particles represent about 10-15% of said effective amount of modafinil. .Iaddend..Iadd.

15. A method for enhancing alertness or increasing regularity of sleep rhythms in a mammal

said method comprising administering an amount of modafinil, as one or more oral unit doses, to said mammal,

said oral unit doses comprising:

an amount of modafinil effective to treat said modafinil-response disease or condition of said mammal upon oral administration,

said amount of modafinil being in the form of solid modafinil particles,

said particles having a size distribution wherein at least about 95% of the cumulative total of said particles have a diameter of less than about 200 microns (.mu.m). .Iaddend..Iadd.

16. A method of treating a mammal diagnosed with a modafinil-responsive disease or condition selected from the group consisting of narcolepsy, Parkinson's disease, urinary incontinence, or Alzheimer's disorder,

said method comprising administering an amount of modafinil, as one or more oral unit doses, to said mammal,

said oral unit doses comprising:

an amount of modafinil effective to treat said modafinil-response disease or condition of said mammal upon oral administration,

said amount of modafinil being in the form of solid modafinil particles,

said particles having a size distribution wherein at least about 95% of the cumulative total of said particles have a diameter of less than about 200 microns (.mu.m). .Iaddend..Iadd.

17. A method or composition according to one of claims 7-16 wherein said modafinil particles are in the form of a modafinil salt. .Iaddend..Iadd.

18. A pharmaceutical composition comprising modafinil in unit dose form, wherein:

a) said modafinil is present in an amount effective to alter the somnolent state of a mammal upon oral administration;

b) said modafinil is in the form of solid particles, or is converted to solid particles after oral administration; and

c) said modafinil has a size distribution such that at least about 95% of the cumulative total of said particles have a diameter of less than about 200 microns (.mu.m). .Iaddend..Iadd.

19. The composition in unit dose form of claim 18, wherein said particles in paragraph c) have a median diameter range of between about 2 .mu.m and 60 .mu.m. .Iaddend..Iadd.

20. The composition in unit dose form of claim 18 wherein said effective amount comprises between about 100 milligrams and about 200 milligrams of said modafinil. .Iaddend..Iadd.

21. A method of altering the somnolent state of a mammal, said method comprising administering one or more unit doses of the composition of claim 18 to said mammal. .Iaddend..Iadd.

22. The method of claim 21, wherein said somnolent sate is narcolepsy. .Iaddend..Iadd.

23. The method of claim 21, wherein between about 100 milligrams/day and about 200 milligrams/day of said modafinil are administered to said mammal. .Iaddend..Iadd.

24. A method for enhancing alertness or increasing regularity of sleep rhythms in a mammal comprising orally administering modafinil to said mammal, wherein:

a) said modafinil is present in an amount effective to treat said modafinil-response disease or condition;

b) said modafinil is in the form of said solid particles, or is converted to solid particles after oral administration; and

c) said modafinil has a size distribution such that at least about 95% of the cumulative total of said particles have a diameter of less than about 200 microns (.mu.m). .Iaddend..Iadd.

25. A method of treating a mammal diagnosed with a modafinil-responsive disease or condition selected from the group consisting of: narcolepsy; Parkinson's disease; urinary incontinence; and Alzheimer's disorder; comprising orally administering modafinil to said mammal, wherein:

a) said modafinil is present in an amount effective to treat said modafinil-responsive disease or condition;

b) said modafinil is in the form of solid particles, or is converted to solid particles after oral administration; and

c) said modafinil has a size distribution such that at least about 95% of the cumulative total of said particles have a diameter of less than about 200 microns (.mu.m). .Iaddend..Iadd.

26. A method or composition according to any one of claims 18-25, wherein said modafinil particles are in the form of a modafinil salt. .Iaddend.
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