Method for preparing amorphous dexlansoprazole

A technology of dexlansoprazole and amorphous is applied in the field of preparation of amorphous dexlansoprazole, which can solve the problems that crystalline raw materials are not as good as amorphous raw materials, unfavorable scale-up production, complex operation, etc., so as to omit complicated process and can The effect of strong repeatability and simplified process flow

Inactive Publication Date: 2011-06-29
JIANGSU HANSOH PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] CN1150186C discloses a kind of crystallization of dexlansoprazole and the method for preparing this crystallization, this method relates to the method for obtaining amorphous dexlansoprazole by optical resolution, but this method needs to go through multiple inclusion resolution to obtain Finished products with higher optical purity are complicated to operate, which is not conducive to scale-up production; and in the preparation process of pharmaceutical compositions, crystalline raw materials are inferior to amorphous raw materials in many aspects, such as fluidity

Method used

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  • Method for preparing amorphous dexlansoprazole
  • Method for preparing amorphous dexlansoprazole
  • Method for preparing amorphous dexlansoprazole

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] The crude dexlansoprazole (235.6g) prepared in the following step 6 was dissolved in ammonia water (12.5%, 5040ml) at room temperature, filtered to remove a little black insoluble matter, and washed with dichloromethane (1000ml×3). The pH of the water layer was adjusted to about 9 with glacial acetic acid (1290 ml) at -10°C, and a white solid precipitated. Stir for 5 min, filter, wash the solid with ice water (1000 ml), and dry under vacuum at room temperature for 24 h to obtain dexlansoprazole (off-white solid, 150.0 g). By figure 1 It is confirmed that the product is amorphous dexlansoprazole.

Embodiment 2

[0033] As described in Example 1, the temperature is -5°C and the pH is 8.

[0034] Attached figure 2 It is confirmed that the product is amorphous dexlansoprazole.

Embodiment 3

[0036] As described in Example 1, the temperature is -25°C and the pH is 10.

[0037] Attached image 3 It is confirmed that the product is amorphous dexlansoprazole.

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Abstract

The invention relates to a method for preparing amorphous dexlansoprazole, which comprises the steps of dissolving dexlansoprazole or the crystal thereof in a single or mixed solvent, precipitating solids under alkaline conditions at a temperature of 5 DEG C below zero to 25 DEG C below zero, further filtering, washing and drying, and finally getting the amorphous dexlansoprazole.

Description

Technical field [0001] The invention relates to a method for preparing dexlansoprazole, in particular to a method for preparing amorphous dexlansoprazole. Background technique [0002] Dexlansoprazole is a new drug for gastroesophageal reflux disease that is superior to lansoprazole. Its structural formula is shown in the figure below. [0003] [0004] The FDA approved Takeda Pharmaceutical North America’s dexlansoprazole controlled-release capsules (dexlansoprazole, Kapidex) for the treatment of gastric burning sensation caused by non-erosive gastroesophageal reflux (GERD), erosive esophagitis (EE) and EE maintenance treatment is given once a day. This product is the first dual-release dual controlled release (DDR) proton pump inhibitor on the market. The preparation specification is 30 or 60 mg per capsule. [0005] Proton pump inhibitors reduce gastric acid production by inhibiting H' / K'-ATP. This product contains 2 types of enteric-coated granules. The time curve of the medi...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D401/12
Inventor 杨宝海潘必高徐世伟
Owner JIANGSU HANSOH PHARMA CO LTD
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