USRE29076EExpiredUtility

Tablet formulation

Priority: Dec 4, 1974Filed: Mar 15, 1976Granted: Dec 14, 1976
Est. expiryDec 4, 1994(expired)· nominal 20-yr term from priority
A61K 9/2072A61J 3/10
4
PatentIndex Score
1
Cited by
15
References
9
Claims

Abstract

The disclosure is directed to formulations for tablets which are to be deeply grooved to facilitate breaking into predetermined portions by the user. A critical tablet weight for deeply grooved tablets is disclosed.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
       1. A chewable pharmaceutical tablet which is adequately imprinted with indicia or embossing and scored to form a groove which is 1/3 to 2/3 the depth of the total tablet thickness to facilitate separation into subdivisions containing substantially equal amounts of pharmaceutically active ingredient comprising a directly compressed formulation of:   ______________________________________                                    
A.    Active ingredient  5 to 10 milligrams                               
B.    Microcrystalline Cellulose                                          
                         20 to 25 percent                                 
                         by weight                                        
C.    Dextrose and corn syrup                                             
                         30 to 55 percent                                 
      solids granulation by weight                                        
D.    Mannitol           20 to 30 percent                                 
                         by weight                                        
E.    Magnesium stearate 0.9 to 1.0 percent -  by weight -F. The          
                         remainder being                                  
      pharmaceutically acceptable                                         
      fillers, extenders, flavoring                                       
      and the like.                                                       
______________________________________                                    
     
     
     
       2. A tablet as defined in claim 1 in which the ingredients are present in the following amounts:   ______________________________________                                    
A.    Microcrystalline cellulose                                          
                         20 percent by                                    
                         weight                                           
B.    Dextrose and corn syrup                                             
                         31.5 percent by                                  
      solids granulation weight                                           
C.    Mannitol           25 percent by                                    
                         weight                                           
D.    Magnesium stearate 1 percent by weight                              
______________________________________                                    
     
     
     
       3. A tablet as defined in claim 1 in which the total tablet weight is 150 to 175 milligrams. 
     
     
       4. A tablet as defined in claim 1 in which the total tablet weight is about 175 milligrams. 
     
     
       5. A tablet as defined in claim 1 in which the active ingredient is 10 milligrams of isosorbide dinitrate. 
     
     
       6. A chewable pharmaceutical tablet which is deeply adequately imprinted with indicia or embossing and scored to form a groove which is 1/3 to 2/3 the depth of the total tablet thickness to facilitate separation into subdivisions containing substantially equal amount of a pharmaceutically active ingredient comprising a directly compressed formulation of:   ______________________________________                                    
A.   Active ingredient   5 to 10 milligrams                               
B.   Microcrystalline Cellulose                                           
                         20 to 25 percent                                 
                         by weight                                        
C.   Dextrose and corn syrup solids                                       
                         50 to 55 percent                                 
     granulation         by weight                                        
D.   Magnesium stearate  0.35 to 0.4 per-                                 
                         cent by weight                                   
E.   Pharmaceutically acceptable                                          
                         remainder                                        
     fillers, extenders, flavoring                                        
     and the like.                                                        
______________________________________                                    
     
     
     
       7. A tablet as defined in claim 6 in which the total tablet weight is 150 to 175 milligrams. 
     
     
       8. A tablet as defined in claim 6 in which the total tablet weight is 175 milligrams. 
     
     
       9. A tablet as defined in claim 6 in which the active ingredient is 10 milligrams of isosorbide dinitrate. .Iadd. 10. A chewable pharmaceutical tablet which is adequately imprinted with indicia or embossing and scored to form a groove which is 1/3 to 2/3 the depth of the total tablet thickness to facilitate separation into subdivisions containing substantially equal amounts of pharmaceutically active ingredient comprising a directly compressed formulation of an effective amount of an active ingredient and:   ______________________________________                                    
.Iadd.A..Iaddend.                                                         
    .Iadd.Microcrystalline Cellulose.Iaddend.                             
                       .Iadd.20 to 25 percent by weight.Iaddend.          
.Iadd.B..Iaddend.                                                         
    .Iadd.Dextrose and corn syrup.Iaddend.                                
                       .Iadd.30 to 55 percent by weight.Iaddend.          
    .Iadd.solids granulation.Iaddend.                                     
.Iadd.C..Iaddend.                                                         
    .Iadd.Mannitol.Iaddend.                                               
                       .Iadd.20 to 30 percent by weight.Iaddend.          
.Iadd.D..Iaddend.                                                         
    .Iadd.Magnesium stearate.Iaddend.                                     
                       .Iadd.0.9 to 1.0 percent by.Iaddend.               
                       .Iadd.weight.Iaddend.                              
.Iadd.E..Iaddend.                                                         
    .Iadd.The remainder being.Iaddend.                                    
    .Iadd.pharmaceutically acceptable.Iaddend.                            
    .Iadd.fillers, extenders, flavoring.Iaddend.                          
    .Iadd.and the like..Iaddend.                                          
______________________________________                                    
 .Iadd. 11. A chewable pharmaceutical tablet which is deeply adequately
 imprinted with indicia or embossing and scored to form a groove which is
 1/3 to 2/3 the depth of the total tablet thickness to facilitate
 separation into subdivisions containing substantially equal amounts of a
 pharmaceutically active ingredient comprising a directly compressed
 formulation of an effective amount of an active ingredient and:
       ______________________________________                                    
.Iadd.A..Iaddend.                                                         
    .Iadd.Microcrystalline Cellulose.Iaddend.                             
                      .Iadd.20 to 25 percent by weight.Iaddend.           
.Iadd.B..Iaddend.                                                         
    .Iadd.Dextrose and corn syrup.Iaddend.                                
                      .Iadd.50 to 55 percent by weight.Iaddend.           
    .Iadd.solids granulation.Iaddend.                                     
.Iadd.C..Iaddend.                                                         
    .Iadd.Magnesium stearate.Iaddend.                                     
                      .Iadd.0.35 to 0.4 percent by weight.Iaddend.        
.Iadd.D..Iaddend.                                                         
    .Iadd.Pharmaceutically.Iaddend.                                       
                      .Iadd.remainder.Iaddend.                            
    .Iadd.acceptable fillers,.Iaddend.                                    
    .Iadd.extenders, flavoring.Iaddend.                                   
    .Iadd.and the like..Iaddend.                                          
______________________________________

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