Segmented pharmaceutical dosage forms

Abstract

A pharmaceutical tablet adapted for accurate division of a dose of a drug into two or more smaller doses, which tablet has two or more segments.

1 . A compressed, layered pharmaceutical dosage form having its height greater than its width and configured as
 a first segment comprising a composition containing an effective amount of one or more drugs, and   a second segment contacting said first segment, said second segment comprising an immediate release composition substantially free of drug and forming an inner inactive segment that is adjacent above said first segment and below   a third segment comprising a composition containing an effective amount of a drug or drugs, wherein   
       the compositions of said first and third segments and the drug or drugs contained in said compositions are physically and chemically compatible with one another, and wherein 
       the terms “height” and “width” and “above” and “below” refer to the position of said dosage form in a tablet die after tablet compression has been completed but before said tablet has been ejected from said die. 
     
     
         2 . A compressed, layered pharmaceutical dosage form having its height greater than its width and configured as
 a first segment comprising a composition containing an effective amount of one or more drugs, and   a second segment contacting said first segment, said second segment comprising an immediate release composition substantially free of drug and forming an inner inactive segment that is adjacent above said first segment and below   a third segment comprising a composition containing an effective amount of a drug or drugs, wherein said dosage form
 i) lacks a semi-permeable membrane coating, 
 ii) lacks an osmotically active component to alter the release of drug, or 
 iii) lacks a drug over-coating, 
   
       wherein the terms “height” and “width” and “above” and “below” refer to the position of said dosage form in a tablet die after tablet compression has been completed but before said tablet has been ejected from said die. 
     
     
         3 . A compressed, layered pharmaceutical dosage form having its height greater than its width and configured as
 a first segment comprising a composition containing an effective amount of one or more drugs (A),   a second segment contacting said first segment, said second segment comprising an immediate release composition substantially free of drug and forming an inner inactive segment that is adjacent above said first segment and below   a third segment comprising a composition containing an effective amount of a drug or drugs, wherein   
       dosage form comprises a tablet structure selected from the group consisting of A-I-A; A-I-B; A-I-A-I; A-I-B-I; A-I-B-I-A; A-I-B-I-B; A-I-B-I-C; and A-B-I-C wherein
 “A” represents an active segment comprising a first active drug or combination of more than one active drug; 
 “B” represents an active segment comprising a second active drug or combination of active drugs; 
 “C” represents an active segment comprising a third active drug or combination of drugs; and 
 “I” represents an inactive segment substantially free of active drug or combination of active drugs, and 
 
       wherein the terms “height” and “width” and “above” and “below” refer to the position of said dosage form in a tablet die after tablet compression has been completed but before said tablet has been ejected from said die. 
     
     
         4 . The dosage form of  claim 3 , wherein the compositions containing a drug or drugs, and the drug or drugs contained in said compositions are physically or chemically compatible with one another. 
     
     
         5 . The dosage form of  claim 3 , wherein said dosage form lacks a semi-permeable membrane coating. 
     
     
         6 . The dosage form of  claim 3 , wherein said dosage form lacks an osmotically active component to alter release of said drug or drugs. 
     
     
         7 . The dosage form of  claim 3 , wherein said dosage form lacks a drug over-coating. 
     
     
         8 . The dosage form of  claim 3  wherein said composition containing a drug or drugs is a controlled release composition selected from the group consisting of delayed release, modified release, sustained-release, and quick dissolve oral or buccal release. 
     
     
         9 . The dosage form of  claim 3 , wherein at least one of said drug or drugs in said first segment is different than at least one of said drug or drugs in said third segment. 
     
     
         10 . The dosage form of  claim 3  wherein the height of said inner segment is greater than a combined height of said first segment and said third segment. 
     
     
         11 . The dosage form of  claim 3  comprising a separation mark oriented substantially horizontally on or within the second, inner segment to guide tablet breaking through the inner segment without breaking through the first or third segment, said separation mark selected from the group consisting of a score, perforation, color, printed marking or indicia, and gelatin band. 
     
     
         12 . The pharmaceutical tablet of  claim 3  comprising in at least one segment a colorant for visually distinguishing said segment from another segment. 
     
     
         13 . The dosage form of  claim 3  wherein said inner segment has an effective height of at least 0.5 mm. 
     
     
         14 . The dosage form of  claim 13  wherein said inner segment has an effective height of about 1.5 mm to about 3 mm. 
     
     
         15 . The dosage form of  claim 3  wherein said tablet is further covered with an inert or pharmaceutically inactive composition. 
     
     
         16 . The dosage form of claim  78  wherein the inert or pharmaceutically inactive composition is a capsule.