Claims for Patent: 8,318,788

Summary for Patent: 8,318,788

Title:	Layered pharmaceutical formulations
Abstract:	In one embodiment a layered pharmaceutical formulation includes two or more pharmaceutical layers and an intermediate layer disposed between at least two of the two or more pharmaceutical layers, the intermediate layer configured to dissolve in vivo to thereby leave the two or more pharmaceutical layers substantially intact. In one embodiment, an active pharmaceutical ingredient in at least one of the pharmaceutical layers is selected from bupropion, zonisamide, naltrexone, topiramate, phentermine, metformin, olanzapine and fluoxetine.
Inventor(s):	McKinney; Anthony (San Diego, CA), Tollefson; Gary (Indianapolis, IN), Weber; Eckard (San Diego, CA), Soltero; Rick (Holly Springs, NC)
Assignee:	Orexigen Therapeutics, Inc. (La Jolla, CA)
Application Number:	13/330,395
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,318,788
Patent Claims:	1. A method for affecting weight loss in a patient, comprising: identifying a patient in need of weight loss; administering to the patient a layered pharmaceutical formulation comprising a first pharmaceutical layer comprising naltrexone, a second pharmaceutical layer comprising bupropion, and an intermediate layer disposed between the first and the second pharmaceutical layers, wherein the intermediate layer is configured to rapidly dissolve in vivo, and thereby leave the first and the second pharmaceutical layers substantially intact but physically separated, and wherein the dissolution profile of naltrexone in the pharmaceutical formulation is substantially the same as a single compressed tablet of naltrexone having the same size and shape as the first pharmaceutical layer, and wherein the dissolution profile of bupropion in the layered pharmaceutical formulation is substantially the same as a single compressed tablet of the same pharmaceutical composition, size and shape as the second pharmaceutical layer. 2. The method of claim 1, wherein the intermediate layer comprises a monosaccharide, a disaccharide or a starch. 3. The method of claim 2, wherein the intermediate layer comprises lactose. 4. The method of claim 1, wherein the naltrexone comprises a sustained-release formulation. 5. The method of claim 1, wherein the bupropion comprises a sustained release formulation. 6. The method of claim 1, wherein the first pharmaceutical layer comprises between about 2 mg and about 35 mg of sustained-release naltrexone. 7. The method of claim 1, wherein the first pharmaceutical layer comprises between about 4 mg and about 10 mg of the sustained-release naltrexone. 8. The method of claim 1, wherein the second pharmaceutical layer comprises between about 50 mg and about 200 mg of sustained-release bupropion. 9. The method of claim 1, wherein the second pharmaceutical layer comprises between about 75 mg and about 150 mg of the sustained-release bupropion. 10. The method of claim 1, wherein the second pharmaceutical layer comprises between about 85 mg and about 100 mg of the sustained-release bupropion. 11. The method of claim 1, wherein the first and the second pharmaceutical layers separate in vivo in less than 1 minute. 12. A method for affecting weight loss in a patient, comprising: identifying a patient in need of weight loss; administering to the patient a layered pharmaceutical formulation comprising a first pharmaceutical layer comprising zonisamide, a second pharmaceutical layer comprising bupropion, and an intermediate layer disposed between the first and the second pharmaceutical layers, wherein the intermediate layer is configured to rapidly dissolve in vivo, and thereby leave the first and the second pharmaceutical layers substantially intact but physically separated, and wherein the dissolution profile of zonisamide in the pharmaceutical formulation is substantially the same as a single compressed tablet of zonisamide having the same size and shape as the first pharmaceutical layer, and wherein the dissolution profile of bupropion in the layered pharmaceutical formulation is substantially the same as a single compressed tablet of the same pharmaceutical composition, size and shape as the second pharmaceutical layer. 13. The method of claim 12, wherein the intermediate layer comprises a monosaccharide, a disaccharide or a starch. 14. The method of claim 13, wherein the intermediate layer comprises lactose. 15. The method of claim 12, wherein the zonisamide comprises a sustained-release formulation. 16. The method of claim 12, wherein the bupropion comprises a sustained release formulation. 17. The method of claim 12, wherein the second pharmaceutical layer comprises between about 50 mg and about 200 mg of sustained-release bupropion. 18. The method of claim 12, wherein the second pharmaceutical layer comprises between about 75 mg and about 150 mg of the sustained-release bupropion. 19. The method of claim 12, wherein the second pharmaceutical layer comprises between about 85 mg and about 100 mg of the sustained-release bupropion. 20. The method of claim 12, wherein the first and the second pharmaceutical layers separate in vivo in less than 1 minute.