Claims for Patent: 8,088,786

Summary for Patent: 8,088,786

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:	11/937,421
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,088,786
Patent Claims:	1. A layered pharmaceutical formulation for the administration of two or more active pharmaceutical ingredients comprising: a first pharmaceutical layer comprising between about 2 mg and about 35 mg of sustained-release naltrexone; a second pharmaceutical layer comprising between about 50 mg and about 200 mg of sustained-release bupropion; and an intermediate layer disposed between said first and said second pharmaceutical layers, wherein said intermediate layer comprising a monosaccharide sugar or a disaccharide sugar is configured to rapidly dissolve in vivo, and thereby leave said first and said 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 said 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 said second pharmaceutical layer. 2. The layered pharmaceutical formulation of claim 1, wherein said intermediate layer comprises lactose. 3. The layered pharmaceutical formulation of claim 1, wherein the first pharmaceutical layer comprises between about 4 mg and about 10 mg of said sustained-release naltrexone. 4. The layered pharmaceutical formulation of claim 1, wherein the second pharmaceutical layer comprises between about 75 mg and about 150 mg of said sustained-release bupropion. 5. The layered pharmaceutical formulation of claim 1, wherein the second pharmaceutical layer comprises between about 85 mg and about 100 mg of said sustained-release bupropion. 6. The layered pharmaceutical formulation of claim 1, wherein said first and said second pharmaceutical layers separate in vivo in less than 1 minute.