Tablet for pulsed delivery

Abstract

A pharmaceutical tablet comprising an immediate release portion containing an active ingredient and a delayed release portion, wherein the delayed release portion comprises an enteric-coated layer and within the enteric-coated layer there is at least one member selected from the group consisting of enteric-coated microparticle dosage forms containing an active ingredient and enteric-coated mini-tablet dosage forms containing an active ingredient, is disclosed.

1 . A pharmaceutical tablet, said tablet comprising an immediate release portion containing an active ingredient and a delayed release portion, wherein said delayed release portion comprises an enteric-coated layer and within said enteric-coated layer there is at least one member selected from the group consisting of enteric-coated microparticle dosage forms containing an active ingredient and enteric-coated minitablet dosage forms containing an active ingredient. 
     
     
         2 . The pharmaceutical tablet of  claim 1 , wherein said active ingredients consist of the same active ingredient. 
     
     
         3 . The pharmaceutical tablet of  claim 1 , wherein said active ingredients comprise at least two different active ingredients. 
     
     
         4 . The pharmaceutical tablet of  claim 1 , wherein said active ingredient is selected from the group consisting of antibiotics, antivirals, antifungals, and antineoplastics. 
     
     
         5 . The pharmaceutical tablet of  claim 4 , wherein said antibiotic is selected from the group consisting of beta-lactams, cephalosporins, and macrolides. 
     
     
         6 . The pharmaceutical tablet of  claim 3 , wherein said at least two different active ingredients comprise amoxicillin and clarithromycin. 
     
     
         7 . The pharmaceutical tablet of  claim 5 , wherein said beta-lactam antibiotic is amoxicillin. 
     
     
         8 . The pharmaceutical tablet of  claim 7 , wherein the compliment of amoxicillin released from each subsequently releasing dosage form expresses a maximum concentration in the serum that is equal to or exceeds the maximum concentration in the serum that is expressed by the compliment of amoxicillin released by the dosage form immediately preceding that subsequently-releasing dosage form. 
     
     
         9 . A method for preparing a pharmaceutical tablet having an immediate release portion and a delayed release portion for immediate and delayed release delivery of at least one active ingredient, said method comprising the steps of: (a) formulating a delayed release portion that comprises a core tablet and an enteric coating, such that said core tablet comprises at least one member selected from the group consisting of enteric-coated microparticle dosage forms containing an active ingredient and enteric-coated mini-tablet dosage forms containing an active ingredient; and such that said enteric coating covers said core tablet; and (b) applying an immediate release portion containing an active ingredient as an immediate release layer over said delayed release portion such that said immediate release layer at least partially covers said delayed release portion. 
     
     
         10 . A process for treating a bacterial infection in a host comprising: administering to a host the pharmaceutical tablet of  claim 1 , once or twice, daily. 
     
     
         11 . A process for treating a bacterial infection in a host comprising: administering to a host the pharmaceutical tablet of  claim 2 , once or twice, daily. 
     
     
         12 . A process for treating a bacterial infection in a host comprising: administering to a host the pharmaceutical tablet of  claim 3 , once or twice, daily. 
     
     
         13 . A process for treating a bacterial infection in a host comprising: administering to a host the pharmaceutical tablet of  claim 4 , once or twice, daily. 
     
     
         14 . A process for treating a bacterial infection in a host comprising: administering to a host the pharmaceutical tablet of  claim 5 , once or twice, daily. 
     
     
         15 . A process for treating a bacterial infection in a host comprising: administering to a host the pharmaceutical tablet of  claim 6 , once or twice, daily. 
     
     
         16 . A process for treating a bacterial infection in a host comprising: administering to a host the pharmaceutical tablet of  claim 7 , once or twice, daily. 
     
     
         17 . A process for treating a bacterial infection in a host comprising: administering to a host the pharmaceutical tablet of  claim 8 , once or twice, daily. 
     
     
         18 . A process for treating a bacterial infection in a host comprising: administering to a host the pharmaceutical tablet produced by the method of  claim 9 , once or twice, daily. 
     
     
         19 . The pharmaceutical tablet of  claim 1 , wherein said at least one member selected from the group consisting of enteric-coated microparticle dosage forms containing an active ingredient and enteric-coated minitablet dosage forms containing an active ingredient, is a pH-sensitive dosage form. 
     
     
         20 . The pharmaceutical tablet of  claim 1 , wherein said at least one member selected from the group consisting of enteric-coated microparticle dosage forms containing an active ingredient and enteric-coated minitablet dosage forms containing an active ingredient, is a pH-independent dosage form. 
     
     
         21 .- 22 . (canceled)