US2023301922A1PendingUtilityA1

Layered Pharmaceutical Formulations

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Assignee: NALPROPION PHARMACEUTICALS LLCPriority: Nov 9, 2006Filed: May 4, 2023Published: Sep 28, 2023
Est. expiryNov 9, 2026(~0.3 yrs left)· nominal 20-yr term from priority
Inventors:Anthony A. MckinneyGary TollefsonEckard WeberRichard Soltero
A61K 9/209A61K 31/137A61K 31/138A61K 31/155A61K 31/35A61K 31/423A61K 31/485A61K 31/5513A61K 45/06A61K 9/0002A61K 31/42A61K 47/26A61K 9/2018A61K 9/2054A61K 31/357A61K 31/551A61P 25/04A61P 25/08A61P 25/24A61P 3/00A61P 3/04A61P 3/06A61P 43/00A61P 3/10A61K 9/0053A61K 9/2059A61K 2300/00
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Claims

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

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A layered pharmaceutical formulation for the administration of two or more active pharmaceutical ingredients comprising:
 a first pharmaceutical layer comprising a first active pharmaceutical ingredient;   a second pharmaceutical layer comprising a second active pharmaceutical ingredient; and   an intermediate layer disposed between said first and said second pharmaceutical layers,   wherein said intermediate layer is configured to rapidly dissolve in vivo, and thereby leave said first and said second pharmaceutical layers substantially intact but physically separated.   
     
     
         2 . The layered pharmaceutical formulation of  claim 1 , wherein each of said first and said second pharmaceutical layers comprises a dissolution profile substantially similar to a singularly compressed tablet of a similar composition. 
     
     
         3 . The layered pharmaceutical formulation of  claim 1 , wherein each of said first and said second pharmaceutical layers comprises a different pharmaceutical composition. 
     
     
         4 . The layered pharmaceutical formulation of  claim 1 , wherein at least one of said first and said second pharmaceutical layers comprises a controlled-release pharmaceutical composition. 
     
     
         5 . The layered pharmaceutical formulation of  claim 4 , wherein said controlled-release pharmaceutical composition comprises a sustained release pharmaceutical composition. 
     
     
         6 . The layered pharmaceutical formulation of  claim 1 , wherein at least one of said first and said second pharmaceutical layers comprises zonisamide. 
     
     
         7 . The layered pharmaceutical formulation of  claim 6 , wherein said zonisamide comprises a controlled-release zonisamide. 
     
     
         8 . The layered pharmaceutical formulation of  claim 7 , wherein said controlled-release zonisamide comprises a sustained-release zonisamide. 
     
     
         9 . The layered pharmaceutical formulation of  claim 6 , wherein said first layer comprises zonisamide, and said second layer comprises bupropion. 
     
     
         10 . The layered pharmaceutical formulation of  claim 1 , wherein at least one of said first and said second pharmaceutical layers comprises bupropion. 
     
     
         11 . The layered pharmaceutical formulation of  claim 9 , wherein said bupropion comprises a controlled-release bupropion. 
     
     
         12 . The layered pharmaceutical formulation of  claim 11 , wherein said controlled-release bupropion comprises a sustained-release bupropion. 
     
     
         13 . The layered pharmaceutical formulation of  claim 1 , wherein at least one of said first and said second pharmaceutical layers comprises naltrexone. 
     
     
         14 . The layered pharmaceutical formulation of  claim 13 , wherein said naltrexone comprises a controlled-release naltrexone. 
     
     
         15 . The layered pharmaceutical formulation of  claim 14 , wherein said controlled-release naltrexone comprises a sustained-release naltrexone. 
     
     
         16 . The layered pharmaceutical formulation of  claim 13 , wherein said first layer comprises naltrexone, and said second layer comprises bupropion. 
     
     
         17 . The layered pharmaceutical formulation of  claim 1 , wherein at least one of said first and said second pharmaceutical layers comprises fluoxetine. 
     
     
         18 . The layered pharmaceutical formulation of  claim 17 , wherein said first layer comprises fluoxetine and said second layer comprises naltrexone. 
     
     
         19 . The layered pharmaceutical formulation of  claim 1 , wherein at least one of said first and said second pharmaceutical layers comprises olanzapine. 
     
     
         20 . The layered pharmaceutical formulation of  claim 19 , wherein said first layer comprises olanzapine and said second layer comprises zonisamide. 
     
     
         21 . The layered pharmaceutical formulation of  claim 1 , wherein at least one of said first and said second pharmaceutical layers comprises an antidiabetic. 
     
     
         22 . The layered pharmaceutical formulation of  claim 21 , wherein said antidiabetic comprises metformin. 
     
     
         23 . The layered pharmaceutical formulation of  claim 22 , wherein said first layer comprises metformin, and said second layer comprises zonisamide. 
     
     
         24 . The layered pharmaceutical formulation of  claim 1 , wherein at least one of said first and said second pharmaceutical layers comprises topiramate. 
     
     
         25 . The layered pharmaceutical formulation of  claim 1 , wherein at least one of said first and said second pharmaceutical layers comprises phentermine. 
     
     
         26 . The layered pharmaceutical formulation of  claim 25 , wherein said first layer comprises phentermine, and said second layer comprises topiramate. 
     
     
         27 . The layered pharmaceutical formulation of  claim 1 , wherein said intermediate layer comprises at least one of a monosaccharide sugar, a disaccharide sugar, or a starch. 
     
     
         28 . The layered pharmaceutical formulation of  claim 27 , wherein said at least one intermediate layer comprises lactose. 
     
     
         29 . A method for affecting weight loss in a patient comprising:
 identifying a patient in need of weight loss;   providing a first dosage of the layered pharmaceutical formulation of  claim 1  to a patient in need thereof on a first day; and   providing a second dosage of the layered pharmaceutical formulation to the patient on a second day,   wherein said layered pharmaceutical formulation comprises a first layer comprising bupropion and a second layer comprising zonisamide or naltrexone.   
     
     
         30 . The method of  claim 29 , wherein said first dosage is greater than said second dosage. 
     
     
         31 . The method of  claim 29 , wherein said second dosage is greater than said first dosage. 
     
     
         32 . A method for treating an obesity related condition in a patient comprising:
 identifying a patient suffering from or at risk of an obesity related condition;   providing a first dosage of the layered pharmaceutical formulation of  claim 1  to the patient on a first day; and   providing a second dosage of the layered pharmaceutical formulation to the patient on a second day,   wherein said layered pharmaceutical formulation comprises a first layer comprising bupropion and a second layer comprising zonisamide or naltrexone.   
     
     
         33 . The method of  claim 32 , wherein said first dosage is different than said second dosage. 
     
     
         34 . The method of  claim 32 , wherein said second dosage is greater than said first dosage.

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