Bisacodyl dosage form with multiple enteric polymer coatings for colonic delivery

A compressed, bi-covex tablet for peroral administration in a human or other animal, having a gastrointestinal tract comprising a small intestine and a colon with a lumen therethrough having an inlet to the colon from the small intestine comprising:

• a. a safe and effective amount of rapidly dissolving bisacodyl and pharmaceutically acceptable excipients necessary to form a compressed, bi-convex tablet, with a maximum diameter of about 4 mm to about 10 mm;
• b. a non-pH dependent smoothing coat applied to the tablet to provide a smooth tablet surface free from edges and sharp curves;
• wherein the smoothing coat is selected from the group consisting of sucrose, Arabic gums hydroxypropyl cellulose, hydroxypropyl methylcellulose, polyethylene glycol, low viscosity hydroxypropyl cellulose, low viscosity hydroxypropyl methylcellulose, gelatin, sodium alginate, dextrin, psyllium husk powder, and mixtures thereof;
• and thereafter coating the tablet with:
• c. at least one inner enteric polymer coating layer selected from the group consisting of cellulose acetate phthalate;
• cellulose acetate trimelliate;
• hydroxypropyl methylcellulose phthalate;
• hydroxypropyl methylcellulose acetate succinate;
• polyvinyl acetate phthalate;
• poly(methacrylic acid, methyl methacrylate) 1:1;
• poly(methacrylic acid, ethyl acrylate) 1:1;
• and compatible mixtures thereof, and
• d. an outer enteric polymer coating layer wherein the outer coating layer is an enteric polymer that begins to dissolve in an aqueous media at a pH between about 6.8 to about 7.2 selected from the group consisting of poly(methacrylic acid, methyl methacrylate) 1:2, and a mixture of poly(methacrylic acid, methyl methacrylate) 1.1 and poly(methacrylic acid, methyl methacrylate) 1:2 in a ratio of about 1:10 to about 1:2;
• wherein the rapidly dissolving bisacodyl is released at a point near the inlet to, or within the colon;
• each of the inner coating layer(s) is an enteric polymer that begins to dissolve in an aqueous media at a pH between about 5 to about 6.3.