TH49558A - Crystal form of omyprasol sodium salt - Google Patents

Abstract

DC60 (24/12/55) This invention involves a new form of sodium salt. 5-methoxy-2 - [[(4-methoxy-3,5-dimethyl-2-pyridinyl) methyl] sulfinyl] -1h - benzimidazole. (5-methoxy-2 - [[(4-methoxy-3,5- dimethyl-2-pyridinyl) methyl] sulfinyl] -1H-benzimidazole), commonly known under the common name omyprasol sodium ( omeprazole sodium salt). The invention also involved a process Also for the preparation of Omyprasol sodium B, which is a motion stable agent. Due to heat, as well as composition on drugs containing this substance And the use of this substance to maintain Stomach and intestinal disorders This invention involves a new type of sodium salt. 5-methoxy-2 - [[(4-methoxy-3,5-dimethyl-2-pyridinyl) methyl] sulfinyl] -1H-benzimidazole (5-mothoxy-2 - [[(4-methoxy-3,5- dimethyl-2-pyridinyl) methyl] sulfinyl] -1H-benzimidazole), known under the generic name omyprasol sodium ( omeprazole sodium salt). The invention also involved a process Also for the preparation of Omyprasol sodium B, which is a motion stable agent. Due to heat, as well as composition on drugs containing this substance And the use of this substance to maintain Gastrointestinal disorders, patent drug

Claims (9)

Disclaimers (all) that will not appear on the advertisement page: 1. Omeprazole sodium, type B, which has specific characteristics that Format in X-ray powder-doffraction Which shows good-value And the intensity follows significantly Value-D / Angstrom Relative intensity Value-D / Angstrom Relative intensity 9.8 Very strong 3.37 soft 7.8 very soft 3.25 very soft 6.7 strong 3.17 very soft 6.5 strong 3.14 soft 6.2 very soft 3.12 medium 5.9 medium 3.05 soft 5.8 very soft 2.99 soft 5.4 soft 2.98 medium 5.1 soft 2.91 medium 4.6 medium 2.89 medium 4.5 Medium 2.79 very soft 4.3 strong 2.62 very soft 4.1 medium 2.59 very soft 3.96 medium 2.50 very soft 3.92 medium 2.45 very soft 3.71 strong 2.40 very soft 3.60 soft 2.37 very soft 3.43 very soft 2.28 very soft 2. The omyprasol sodium HBB according to claim 1 is characterized by the presence of The unit is monoclinic. With parameter a = 15.09 angstroms b = 12.83 angstroms c = 9.82 angstroms beta = 94.4 degrees 3. A ladle for the preparation of omyprasol sodium carbonate, as defined in claim 1 or 2, including the steps of a) the addition of the aquifer Na base. In omyprasol in the solvent that contains Selected ethanol or isopropanol, Na means sodium and B means hydroxide or alcoxide; b) allow the solution to crystallize; c) For the obtained omyprasol sodium 4. Process according to claim 3, in which the alkaline Na-base is used by step a) is sodium hydroxide. 5. Process according to claim 3 or 4 in which alcohol is used in a) is isopropanol. 6. The process for the preparation of omyprasol sodium sodium, as defined in claim 1 or 2, includes the steps of a) dissolution of omyprasol sodium. Any or a mix of it In the solvent mixture containing alcohol and may be chosen to contain water, b) allow the solution to crystallize and c) the resulting omyprasol, sodium, and b). 7. Process for any of Clause 3 to 6. Which Omiprasol Sodium Babylon Will be used to induce crystallization 8. Pharmaceutical formulations Which consists of omyprasol sodium sodium, as defined As in claim 1 or 2, mixed with a pharmaceutical additive which is acceptable 9. Pharmaceutical formulation according to claim 8 in form for intravenous infusion (i.v.administration).