Barium salt of benzimidazole derivative
The invention relates to crystalline barium salt of (S)-omeprazole, which is (S)- 5 -methoxy- 2 -[[( 4 -methoxy- 3,5 -dimethyl- 2 -pyridinyl)-methyl]sulfinyl]- 1 H-benzimidazole. The invention also relates to processes for preparing crystalline barium salt of (S)-omeprazole and pharmaceutical compositions that include the crystalline barium salt of (S)-omeprazole so prepared.
1. A process for the preparation of amorphous (S)-omeprazole barium comprising the step of contacting (S)-omeprazole freebase, its salt or derivatives, with a barium containing compound that is capable of forming the barium salt (S)-omeprazole in a suitable solvent comprising water, ketones, alcohols, esters, cyclic ethers, chlorinated hydrocarbons, nitriles, dipolar aprotic solvents, and mixtures thereof.
2. The process according to claim 1 , wherein the barium containing compound is the barium salt of an inorganic acid.
3. The process according to claim 2 , wherein the barium salt is selected from the group consisting of barium chloride, barium nitrate, barium phosphate, barium carbonate, and barium sulfate.
4. The process according to claim 1 , wherein the barium salt of an organic acid is used.
5. The process according to claim 4 , wherein the barium salt is selected from the group consisting of barium oxalate, barium acetate, barium lactate, barium succinate, barium citrate and barium tartrate.
6. The process according to claim 1 , wherein the barium containing compound is barium hydroxide.
7. The process according to claim 1 , wherein the solvent is selected from the group consisting of water, acetone, methanol and mixtures thereof.
8. The process according to claim 1 , which further comprises removing the solvent by vacuum distillation or spray drying.