Stable pharmaceutical composition comprising esomeprazole and sodium bicarbonate
The present invention relates to a stable pharmaceutical composition comprising omeprazole, its enantiomer, or its pharmaceutically acceptable salt, and sodium bicarbonate. Specifically, the present invention relates to a pharmaceutical composition with improved stability comprising a low dose of sodium bicarbonate, so that it has improved dissolution rate and bioavailability and also reduces side effects resulting from a high dose of sodium bicarbonate.
1. A tablet comprising:
20 mg or 40 mg of a magnesium salt of esomeprazole based on the weight of esomeprazole; and
800 mg of sodium bicarbonate;
wherein:
the magnesium salt of esomeprazole is in the form of a plurality of pellets or granules;
the pellets or granules do not comprise the sodium bicarbonate;
the pellets or granules are coated with a coating agent;
the sodium bicarbonate does not contact the magnesium salt of esomeprazole in the tablet; and
the tablet dissolves at pH 1.2.
2. The tablet according to claim 1 , wherein the magnesium salt of esomeprazole is esomeprazole magnesium trihydrate.
3. The tablet according to claim 1 , wherein the coating agent separates the sodium bicarbonate from the magnesium salt of esomeprazole.
4. The tablet according to claim 1 , wherein the coating agent does not comprise sodium bicarbonate.