IP Library Granted Patent US 8,513,426
Granted Patent B2
US 8,513,426 · App. 12/914,032 · Granted Aug 20, 2013

Crystalline S-omeprazole strontium hydrate, method for preparing same, and pharmaceutical composition containing same

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Quick Facts
Patent No.
US 8,513,426
App. No.
12/914,032
Granted
Aug 20, 2013
Kind
B2
Abstract

Disclosed are a crystalline S-omeprazole strontium hydrate for the prevention or treatment of gastric acid-related diseases, which has high optical purity, theremostability, solubility and nonhygroscopicity, a method for preparing same, and a pharmaceutical composition containing same.

Claims (5)

1. A method for preparing a crystalline S-omeprazole strontium tetrahydrate of formula (I), which comprises the step of adding strontium hydroxide to a neutral solution containing S-omeprazole of formula (III) and stirring the resulting mixture:

2. The method of claim 1 , wherein the strontium hydroxide is used in an amount ranging 0.5 to 0.75 molar equivalents based on 1 molar equivalent of S-omeprazole.

3. The method of claim 1 , wherein the neutral solution containing S-omeprazole of formula (III) is prepared by dissolving or suspending S-omeprazole in an organic solvent selected from the group consisting of methanol, ethanol, 1-propanol, 2-propanol, acetonitrile, tetrahydrofuran, acetone and a mixture thereof, or in a mixture of one of the above-mentioned organic solvents and water.

4. The method of claim 3 , wherein the organic solvent is selected from methanol, acetone and a mixture thereof.

5. The method of claim 1 , wherein said S-omeprazole strontium tetrahydrate has X-ray powder diffraction spectrum showing major peaks having I/I o values of at least 3% at 2θ±0.2 of 5.6, 11.1, 13.5, 14.8, 16.2, 17.5, 18.0, 20.1, 20.4, 21.2, 22.2, 24.5, 25.2, 26.3, 27.5, 29.8, 31.1, 32.8 and 36.5.

Assignments (2)
CHANGE OF NAME Recorded Aug 3, 2012
From: HANMI HOLDINGS CO., LTD.
To: HANMI SCIENCE CO., LTD.
Reel/Frame 028722/0332 →
CHANGE OF NAME Recorded Feb 18, 2011
From: HANMI PHARM. CO., LTD.
To: HANMI HOLDINGS CO., LTD.
Reel/Frame 025835/0319 →