Immediate release tablet

Abstract

An immediate release tablet is provided. The tablet comprises at least 60 weight % of an active ingredient and powdered wax having a melting point greater than about 90° C. The tablet may advantageously be produced by direct compression. Although the wax is hydrophobic, the tablet has excellent disintegration.

1 . (canceled)  
     
     
         2 .- 20 . (canceled)  
     
     
         21 . A swallowable immediate release tablet comprising at least 60 weight % of acetaminophen and a powdered wax having a melting point greater than about 90° C. and a particle size in the range of about 5 to about 100 microns, wherein the acetaminophen is released from the swallowable immediate release tablet by 30 minutes in pH 5.8 buffer.  
     
     
         22 . The tablet of  claim 21 , wherein the wax is selected from the group consisting of linear hydrocarbons, microcrystalline wax, and mixtures thereof.  
     
     
         23 . The tablet of  claim 21 , prepared by direct compression.  
     
     
         24 . The tablet of  claim 21 , which is substantially free of water-soluble, non-saccharide polymeric binders.  
     
     
         25 . The tablet of  claim 21 , which is substantially free of hydrated polymers.  
     
     
         26 . The tablet of  claim 21 , further comprising at least one outer coating.  
     
     
         27 . The tablet of  claim 26 , wherein the outer coating comprises a material selected from the group consisting of gelatin, isomalt, monosaccharides, disaccharides, polysaccharides starch, cellulose derivatives, shellacs, polyhedric alcohols, and polyalkylene glycols.  
     
     
         28 . The tablet of  claim 21 , wherein the tablet comprises up to about 20 weight percent wax.  
     
     
         29 . The tablet of  claim 21 , further comprising an excipient selected from the group consisting of disintegrants, flow aids, and lubricants.  
     
     
         30 . The tablet of  claim 21 , further comprising an insert disposed within the tablet.  
     
     
         31 . The tablet of  claim 30 , wherein the insert comprises at least one additional active ingredient.  
     
     
         32 . The tablet of  claim 31 , wherein the additional active ingredient has a different release profile from the active ingredient in the tablet.  
     
     
         33 . The tablet of  claim 31 , wherein the amount of additional active ingredient is from about 0.1 to about 30 mg.  
     
     
         34 . The tablet of  claim 31 , wherein the additional active ingredient is selected from the group consisting of loratadine, fexofenadine, cetirizine, chlorpheniramine, brompheniramine, diphenhydramine, pseudoephedrine, cyproheptadine, montelukast, loperamide, famotidine, dexamethasone, hydrocortisone, cyclobenzaprine, alendronate, hydrochlorthiazide, rofecoxib, indomethacin, ketoprofen, meloxicam, piroxicam, lovastatin, atorvastatin, pravastatin, simvastatin, finasteride, and pharmaceutically acceptable salts, esters, and mixtures thereof.  
     
     
         35 . A swallowable immediate release tablet comprising at least 60 weight percent of acetaminophen and a powdered wax having a particle size in the range of about 5 to about 100 microns that is selected from the group consisting of shellac wax, paraffin-type waxes, polyethylene glycol, and mixtures thereof, and wherein said swallowable immediate release tablet is prepared by direct compression, and the acetaminophen is released from the swallowable immediate release tablet by 30 minutes in pH 5.8 buffer.  
     
     
         36 . A swallowable immediate release tablet comprising at least 60 weight percent of acetaminophen and a powdered wax having a particle size in the range of about 5 to about 100 microns that is selected from the group consisting of shellac wax, paraffin-type waxes, polyethylene glycol, and mixtures thereof, and wherein said swallowable immediate release tablet is substantially free of water-soluble, non-saccharide polymeric binders, and the acetaminophen is released from the swallowable immediate release tablet by 30 minutes in pH 5.8 buffer.  
     
     
         37 . A swallowable immediate release tablet comprising at least 60 weight percent of acetaminophen and a powdered wax having a particle size in the range of about 5 to about 100 microns that is selected from the group consisting of shellac wax, paraffin-type waxes, polyethylene glycol, and mixtures thereof, and wherein said swallowable immediate release tablet is substantially free of hydrated polymers, and the acetaminophen is released from the swallowable immediate release tablet by 30 minutes in pH 5.8 buffer.