Stable Pharmaceutical Formulation of an Acid Labile Compound and Process for Preparing the Same

A tablet formulation of an acid labile benzimidazole derivative comprising:

• (a) a core of said acid labile benzimidazole derivative wherein said core comprises of, by weight:
• about 10 to 30% of said benzimidazole derivative,
• about 40 to 70% of a filler,
• about 2 to 10% of an alkaline agent, wherein the alkaline agent is sodium carbonate, and wherein the core is essentially free of disintegrant,
• (b) a seal or seal coating layer, and
• (c) an enteric coating layer.

A tablet formulation of pantoprazole in the form of a tablet comprising:

• (a) a core comprising pantoprazole, wherein said core comprises of, by weight:
• about 10 to 30% of said pantoprazole,
• about 40 to 70% of mannitol,
• about 2 to 10% of sodium carbonate and wherein the core is essentially free of disintegrant,
• (b) a seal or seal coating layer, and
• (c) an enteric coating layer.

A tablet formulation of an acid labile benzimidazole derivative in the form of a tablet comprising:

• (a) a core comprising said acid labile benzimidazole derivative wherein said core comprises of, by weight:
• about 10 to 30% of said benzimidazole derivative,
• about 40 to 70% of a filler,
• about 2 to 10% of an alkaline substance,
• about 0 to 1% of a binder,
• about 0.2 to 5% of a lubricant,
• about 0.5 to 10% of a glidant, and wherein the core is essentially free of disintegrant,
• (b) a seal or seal coating layer, and
• (c) an enteric coating layer.

An oral pharmaceutical formulation of pantoprazole in the form of a tablet comprising:

• (a) a core comprising pantoprazole wherein said core comprises of, by weight:
• about 10 to 30% of said pantoprazole,
• about 40 to 70% of mannitol,
• about 2 to 10% of sodium carbonate,
• about 0 to 1% of hydroxypropyl cellulose,
• about 0.2 to 5% of calcium stearate,
• about 0.2 to 5% of talc and wherein core is essentially free of disintegrant,
• (b) a seal or seal coating layer, and
• (c) an enteric coating layer.

A tablet formulation of lansoprazole in the form of a tablet comprising:

• (a) a core comprising lansoprazole wherein said core comprises of, by weight:
• about 10 to 30% of said lansoprazole,
• about 40 to 70% of mannitol,
• about 2 to 10% of sodium carbonate,
• about 0 to 1% of hydroxypropyl cellulose,
• about 0.2 to 5% of calcium stearate,
• about 0.2 to 5% of talc and wherein core is essentially free of disintegrant,
• (b) a seal or seal coating layer, and
• (c) an enteric coating layer.

A tablet formulation of rabeprazole in the form of a tablet comprising:

• (a) a core comprising rabeprazole wherein said core comprises of, by weight:
• about 10 to 30% of said rabeprazole,
• about 40 to 70% of mannitol,
• about 2 to 10% of sodium carbonate,
• about 0 to 1% of hydroxypropyl cellulose,
• about 0.2 to 5% of calcium stearate,
• about 0.2 to 5% of talc and wherein core is essentially free of disintegrant,
• (b) a seal or seal coating layer, and
• (c) an enteric coating layer.