Omeprazole sodium salt

Details Omeprazole sodium salt Omeprazole sodium salt

1998-06-29

2001-03-27

Page, Thurman K. (Department: 1615)

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Tablets, lozenges, or pills

C424S451000, C424S452000, C424S465000, C424S468000, C424S469000

Reexamination Certificate

active

06207188

ABSTRACT:

FIELD OF THE INVENTION
This invention relates to a novel form of 5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1
H
-benzimidazole, known under the generic name omeprazole. More specifically, it relates to a novel form of the sodium salt of omeprazole, namely a well-defined omeprazole sodium monohydrate salt, hereinafter referred to as omeprazole sodium form B, and its use in the treatment of gastrointestinal disorders, pharmaceutical compositions containing it and preparation thereof.
BACKGROUND OF THE INVENTION AND PRIOR ART
The compound 5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1
H
-benzimidazole having the generic name omeprazole, as well as therapeutically acceptable salts thereof, are described in EP 5129. The specific alkaline salts of omeprazole, such as the sodium salt, are disclosed in EP 124 495. The omeprazole sodium salt produced according to examples 1 and 2 of EP 124 495 is a mixture of crystal forms and amorphous material. One of the crystal forms present in this mixture, hereinafter referred to as omeprazole sodium form A, is a hydrate with one to two water molecules, of which one water molecule is strongly bound in the crystal structure while the other is easily removed by drying. The resulting dried substance containing one strongly bound water molecule is very hygroscopic and absorbs water rapidly under normal conditions.
Omeprazole is a proton pump inhibitor, i.e. effective in inhibiting gastric acid secretion, and is useful as an antiulcer agent In a more general sense, omeprazole may be used for treatment of gastric-acid related diseases in mammals and especially in man.


REFERENCES:
patent: 4182889 (1980-01-01), Asai et al.
patent: 5948789 (1999-09-01), Larsson et al.
patent: 0005129 (1979-10-01), None
patent: 0124495 (1984-11-01), None
patent: 0247983 (1986-04-01), None
patent: 9601623 (1996-01-01), None
patent: 9900380 (1999-01-01), None

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