IP Library Granted Patent US 8,318,788
Granted Patent B2
US 8,318,788 · App. 13/330,395 · Granted Nov 27, 2012

Layered pharmaceutical formulations

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Quick Facts
Patent No.
US 8,318,788
App. No.
13/330,395
Granted
Nov 27, 2012
Kind
B2
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.

Claims (24)

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.

Assignments (7)
SECURITY INTEREST Recorded Dec 19, 2019
From: CURRAX PHARMACEUTICALS LLC; NALPROPION PHARMACEUTICALS LLC
To: WILMINGTON SAVINGS FUND SOCIETY, FSB
Reel/Frame 051377/0958 →
CHANGE OF NAME Recorded Oct 17, 2019
From: NALPROPION PHARMACEUTICALS, INC.
To: NALPROPION PHARMACEUTICALS LLC
Reel/Frame 050750/0497 →
RELEASE OF SECURITY INTEREST Recorded Sep 27, 2019
From: WILMINGTON SAVINGS FUND SOCIETY, FSB
To: NALPROPION PHARMACEUTICALS, INC.
Reel/Frame 050574/0106 →
SECURITY INTEREST Recorded Aug 6, 2018
From: NALPROPION PHARMACEUTICALS, INC.
To: WILMINGTON SAVINGS FUND SOCIETY, FSB, AS COLLATERAL AGENT
Reel/Frame 047288/0321 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 2, 2018
From: OREXIGEN THERAPEUTICS, INC.
To: NALPROPION PHARMACEUTICALS, INC.
Reel/Frame 046688/0661 →
SECURITY AGREEMENT Recorded Mar 21, 2016
From: OREXIGEN THERAPEUTICS, INC.
To: U.S. BANK NATIONAL ASSOCIATION, AS COLLATERAL AGENT
Reel/Frame 038180/0021 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 9, 2012
From: MCKINNEY, ANTHONY; TOLLEFSON, GARY; WEBER, ECKARD; SOLTERO, RICK
To: OREXIGEN THERAPEUTICS, INC.
Reel/Frame 029121/0736 →