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Claims for Patent: 7,919,115

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Claims for Patent: 7,919,115

Title:Orally disintegrating tablet compositions of lamotrigine
Abstract: The compositions of the present invention composition comprise a therapeutically effective amount of particles comprising lamotrigine, in combination with granules comprising a disintegrant, and a sugar alcohol and/or a saccharide. These compositions are useful in treating epilepsy and bipolar disorder, particularly for patients with dysphagia, and to improve compliance with bipolar patients.
Inventor(s): Venkatesh; Gopi M. (Vandalia, OH), Vyas; Nehal H. (Huber Heights, OH), Gosselin; Michael (Loveland, OH), Lai; Jin-Wang (Springboro, OH)
Assignee: Eurand, Inc. (Valdalia, OH)
Application Number:12/166,757
Patent Claims: 1. An ODT consisting essentially of: lamotrigine microcapsules comprising 25 or 200 mg of lamotrigine crystals having an average particle size of about 1-50 .mu.m, coated with a taste-masking layer consisting of ethylcellulose, wherein the average coating weight of said microcapsules is about 15% of the total weight of the microcapsules; and rapidly dispersing granules comprising a granulate of crospovidone and mannitol in a ratio ranging from about 90/10 to about 99/1, wherein the rapidly dispersing granules are about 60% to 70% of the total weight of the ODT; and an additional disintegrant comprising crospovidone; wherein after a single oral administration said ODT provides; a C.sub.max in the range of 0.276 to 0.482 ng/mL of lamotrigine, an AUC.sub.0-24 in the range of 4.87 to 8.17 nghr/mL of lamotrigine, or both a C.sub.max in the range of 0.276 to 0.482 ng/mL of lamotrigine and an AUC.sub.0-24 in the range of 4.87 to 8.17 nghr/mL of lamotrigine, if the total amount of lamotrigine in the ODT is 25 mg, or a C.sub.max in the range of 2.21 to 3.95 ng/mL of lamotrigine, an AUC.sub.0-24 in the range of 36.0 to 63.6 nghr/mL of lamotrigine, or both a C.sub.max in the range of 2.21 to 3.95 ng/mL of lamotrigine and an AUC.sub.0-24 in the range of 36.0 to 63.6 nghr/mL of lamotrigine, if the total amount of lamotrigine in the ODT is 200 mg.

2. The ODT of claim 1, wherein the ethylcellulose has a viscosity of about 90-110 cps when tested in an Ubbelohde viscometer as a 5 weight % solution in 80:20 toluene/ethanol at 25.degree. C.

3. The ODT of claim 1, wherein the ODT substantially disintegrates within about 30 seconds after administration in the oral cavity of the patient.

4. The ODT of claim 1, wherein the ODT disintegrates within about 30 seconds when tested by the <USP 701> Disintegration Test.

5. The ODT of claim 1, wherein the ODT releases about 70% or more of the total dose of lamotrigine upon entering the stomach of the patient.

6. The ODT of claim 1, wherein the ODT releases about 70% or more of the lamotrigine in 30 min when tested for dissolution using United States Pharmacopoeia Apparatus 2 (paddles @ 75 rpm in 900 mL of 0.01N HCl buffer).

7. A method of treating a mood disorder, or treating or preventing seizures comprising administering to a patient in need thereof a therapeutically effective amount of the ODT of claim 1.

8. The ODT of claim 1 wherein said ODT provides a C.sub.max in the range of 0.276 to 0.482 ng/mL of lamotrigine, if the total amount of lamotrigine in the ODT is 25 mg.

9. The ODT of claim 1 wherein said ODT provides an AUC.sub.0-24 in the range of 4.87 to 8.17 nghr/mL of lamotrigine, if the total amount of lamotrigine in the ODT is 25 mg.

10. The ODT of claim 1 wherein said ODT provides a C.sub.max in the range of 0.276 to 0.482 ng/mL of lamotrigine and an AUC.sub.0-24 in the range of 4.87 to 8.17 nghr/mL of lamotrigine, if the total amount of lamotrigine in the ODT is 25 mg.

11. The ODT of claim 1 wherein said ODT provides a C.sub.max in the range of 2.21 to 3.95 ng/mL of lamotrigine, if the total amount of lamotrigine in the ODT is 200 mg.

12. The ODT of claim 1 wherein said ODT provides an AUC.sub.0-24 in the range of 36.0 to 63.6 nghr/mL of lamotrigine, if the total amount of lamotrigine in the ODT is 200 mg.

13. The ODT of claim 1 wherein said ODT provides a C.sub.max in the range of 2.21 to 3.95 ng/mL of lamotrigine and an AUC.sub.0-24 in the range of 36.0 to 63.6 nghr/mL of lamotrigine, if the total amount of lamotrigine in the ODT is 200 mg.
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