Combination tablet with chewable outer layer

Abstract

A pharmaceutical composition in the form of a combination tablet is described. The tablet has a rapidly absorbed component that enters the circulation by traversing the buccal mucosa, oral mucosa and combinations thereof, and a more slowly absorbed component that is swallowed. The therapeutic agent in the swallowed portion is absorbed across the gastric mucosa. The combination tablet may be modified, by varying the specific combinations of excipients, fillers, and the like to effect distinct release rates. In addition, the rapid and slow components may have identical or different therapeutic agents depending on the application to a specific medical condition. One embodiment of the combination tablet includes a prostaglandin inhibitor in the rapidly absorbed component in order to mitigate the side effects of immediate release niacin that is in the slow absorbing component. Such combination compositions will increase patient compliance with various dosing regimens due to the resultant decrease in the number of tablets that a patient would need to take on a daily basis.

1 .- 23 . (canceled) 
     
     
         24 . A pharmaceutical composition comprising:
 (a) a first portion comprising a non-steroidal anti-inflammatory drug; and   (b) a second portion comprising niacin,   wherein the first portion is formulated to dissolve in an oral cavity of a subject, wherein the second portion is formulated for dissolving in stomach, intestines, or further distal in the gastrointestinal tract of the subject, and wherein the ratio of niacin to the non-steroidal anti-inflammatory drug in the pharmaceutical composition is equal to or greater than 100/325.   
     
     
         25 . The pharmaceutical composition of  claim 24 , wherein the first portion further comprises a sweetening agent. 
     
     
         26 . The pharmaceutical composition of  claim 24 , wherein the first portion further comprises a water soluble sugar or sugar substitute. 
     
     
         27 . The pharmaceutical composition of  claim 24 , wherein the first portion is surrounded by a thin shell. 
     
     
         28 . The pharmaceutical composition of  claim 27 , wherein the first portion comprises liquid, gel or powder. 
     
     
         29 . The pharmaceutical composition of  claim 24 , wherein the pharmaceutical composition is a tablet. 
     
     
         30 . The pharmaceutical composition of  claim 29 , further comprising a third portion between the first and second portions. 
     
     
         31 . The pharmaceutical composition of  claim 30 , wherein the third portion comprises an enteric coating. 
     
     
         32 . The pharmaceutical composition of  claim 24 , wherein the non-steroidal anti-inflammatory drug is aspirin. 
     
     
         33 . The pharmaceutical composition of  claim 32 , wherein the ratio of niacin to aspirin is equal to or greater than 250/325. 
     
     
         34 . The pharmaceutical composition of  claim 32 , wherein the ratio of niacin to aspirin is equal to or greater than 500/325. 
     
     
         35 . The pharmaceutical composition of  claim 32 , wherein the first portion comprises at least 81 mg aspirin. 
     
     
         36 . The pharmaceutical composition of  claim 32 , wherein the first portion comprises at least 100 mg niacin. 
     
     
         37 . A method of administering niacin to a subject in need thereof, comprising administering to the subject the pharmaceutical composition of  claim 24 , wherein a flushing effect of niacin is reduced by the non-steroidal anti-inflammatory drug released into the subject's circulatory system across oral mucosa. 
     
     
         38 . A method of reducing the flushing effect of niacin in a subject in need thereof, comprising administering to the subject the pharmaceutical composition of  claim 24 , wherein a flushing effect of niacin is reduced by the non-steroidal anti-inflammatory drug released into the subject's circulatory system across oral mucosa.