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Claims for Patent: 8,039,009

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Claims for Patent: 8,039,009

Title:Modified release formulations of memantine oral dosage forms
Abstract: The present invention provides pharmaceutical compositions given once daily containing at least one therapeutically active ingredient selected from the group consisting of memantine and a pharmaceutically acceptable salt of memantine, and a pharmaceutically acceptable polymeric matrix carrier. The dosage forms of the invention sustain the release of the therapeutically active agent from about 4 to about 24 hours when said dosage form is exposed to aqueous solutions. following entry of said form into a use environment, wherein said dosage form has a dissolution rate of more than about 80% after passage of about 6 hours to about 12 hours following said entry into said use environment.
Inventor(s): Rastogi; Suneel K. (Island Park, NY), Rao; Niranjan (Belle Mead, NJ), Periclou; Antonia (Jersey City, NJ), Abramowitz; Wattanaporn (Hillsborough, NJ), Dedhiya; Mahendra G. (Pomona, NY), Mahashabde; Shashank (Kendall Park, NJ)
Assignee: Forest Laboratories Holdings Limited (BM)
Application Number:11/155,330
Patent Claims: 1. A method for treating Alzheimer's disease comprising once daily administration of a modified release solid oral dosage form comprising 28 mg .+-.5% of memantine or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable polymeric carrier substantially contributing to the modification of the release of the memantine or pharmaceutically acceptable salt thereof, said dosage form sustaining release of the memantine or pharmaceutically acceptable salt thereof from about 4 hours to about 24 hours following entry of said form into a use environment, wherein said dosage form has a single phase dissolution rate of less than about 80% after passage of about 6 hours following said entry into said use environment.

2. The method according to claim 1, wherein the dosage form comprises memantine hydrochloride.

3. The method according to claim 1, wherein the dissolution rate of more than about 80% is achieved after about 12 hours.

4. The method of claim 3, comprising the memantine or pharmaceutically acceptable salt thereof in an amount within the range of from about 1.0% w/w to about 20% w/w.

5. The method according to claim 1, wherein the dissolution rate of more than about 80% is achieved after about 6 hours.

6. The method of claim 5, wherein the memantine or a pharmaceutically acceptable salt thereof is present in amounts ranging from about 1.0% w/w to about 35% w/w.

7. The method of claim 1, wherein the polymeric carrier is a polymeric matrix.

8. The method of claim 7, wherein the polymeric matrix is a swellable matrix and comprises hydroxypropyl methylcellulose.

9. The method of claim 8, wherein the dissolution rate of more than about 80% is achieved after about 12 hours, and wherein the hydroxypropyl methylcellulose is present in amounts from about 50% w/w to about 80% w/w.

10. The method of claim 8, wherein the dissolution rate of more than about 80% is achieved after about 6 hours, and wherein the hydroxypropyl methylcellulose is present in amounts from about 20% w/w to about 70% w/w.

11. The method of claim 1, further comprising a filler.

12. The method of claim 11, wherein the filler is microcrystalline cellulose.

13. The method of claim 12, wherein the microcrystalline cellulose is present in an amount from about 5% w/w to about 80% w/w.

14. The method of claim 1, further comprising a lubricant.

15. The method of claim 14, wherein the lubricant is magnesium stearate.

16. The method of claim 15, wherein the dissolution rate of more than about 80% is achieved after about 12 hours, and wherein the magnesium stearate is present in an amount within the range from about 0.8% w/w to about 1.2% w/w.

17. The method of claim 15, wherein the dissolution rate of more than about 80% is achieved after about 6 hours, and wherein the magnesium stearate is present in an amount within the range from about 0.4% w/w to about 0.6% w/w.

18. The method of claim 1, further comprising one or more components selected from the group consisting of carriers, excipients, anti-adherants, fillers, stabilizing agents, binders, colorants, glidants, and lubricants.

19. The method of claim 1, wherein the dissolution rate exhibited by said modified release solid oral dosage form after about 1 hour is at least about 10% and up to about 35%.

20. The method of claim 1, wherein the dissolution rate exhibited by said modified release solid oral dosage form after about 2 to about 6 hours is at least about 30% and up to about 60%.

21. A method for treating Alzheimer's disease comprising once daily administration of a modified release solid oral dosage form comprising 28 mg .+-.5% of memantine or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable polymeric carrier substantially contributing to the modification of the release of the memantine or pharmaceutically acceptable salt thereof, the dosage form sustaining release of the memantine or pharmaceutically acceptable salt thereof following entry of the dosage form into a use environment, wherein the dosage form has a single phase dissolution rate of about 30% to about 60% after about 2 to about 6 hours following entry into the use environment.

22. A method for treating Alzheimer's disease comprising once daily administration of a modified release solid oral dosage form comprising 28 mg .+-.5% of memantine or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable polymeric carrier substantially contributing to the modification of the release of the memantine or pharmaceutically acceptable salt thereof, said dosage form sustaining release of the memantine or pharmaceutically acceptable salt thereof from about 4 hours to about 24 hours following entry of said form into a use environment, wherein said dosage form has a single phase dissolution rate and wherein the dosage form provides a Tmax of more than 10 hours.

23. The method of claim 21, wherein the dosage form provides a Tmax of more than 10 hours.
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