The Production Process of Lansoprazole

The production process of lansoprazole, a widely used proton pump inhibitor drug, involves several stages, including synthesis, purification, and formulation.
In this article, we will take a closer look at the production process of lansoprazole and the various techniques and equipment used in each stage.

1. Synthesis:

The synthesis of lansoprazole involves a multi-step reaction process that involves several chemical reactions.
The synthesis process typically begins with the synthesis of the intermediate compound 2-[[(4S)-4-(difluoromethyl)-2-oxo-1,3-oxazolidin-3-yl]-5,6-dihydroimidazo[1,2-d][1,4]benzoxazepin-9-yl]amide.

The synthesis of this intermediate compound involves several steps, including:

• The reaction of 2-chloromethyl-5,6-dihydroimidazo[1,2-d][1,4]benzoxazepine with 4-fluoromethylmorpholine to form N-((4S)-4-(difluoromethyl)-2-oxo-1,3-oxazolidin-3-yl)-N-(2-chloro-5,6-dihydroimidazo[1,2-d][1,4]benzoxazepin-9-yl)amide.
  
• The reduction of the intermediate compound with lithium aluminum hydride to form N-((4S)-4-(difluoromethyl)-2-oxo-1,3-oxazolidin-3-yl)-N-(2-chloro-5,6-dihydroimidazo[1,2-d][1,4]benzoxazepin-9-yl)amide.
  
• The hydrolysis of the intermediate compound with hydrochloric acid to form N-((4S)-4-(difluoromethyl)-2-oxo-1,3-oxazolidin-3-yl)-N-(2-chloro-5,6-dihydroimidazo[1,2-d][1,4]benzoxazepin-9-yl)amide.
  
• The N-dealkylation of the intermediate compound with sodium hydroxide to form N-((4S)-4-(difluoromethyl)-2-oxo-1,3-oxazolidin-3-yl)imidazo[1,2-d][1,4]benzoxazepin-9-ylamide.
  
• The final step involves the formation of lansoprazole through the reaction of N-((4S)-4-(difluoromethyl)-2-oxo-1,3-oxazolidin-3-yl)imidazo[1,2-d][1,4]benzoxazepin-9-ylamide with chloride ion to form the final product.
  

2. Purification:

After the synthesis of lansoprazole, the product is typically purified to remove any impurities that may have been introduced during the synthesis process.
Purification typically involves several techniques, including crystallization, chromatography, and filtration.

Crystallization is a common method used to purify lansoprazole.
The product is typically dissolved in a suitable solvent and allowed to crystallize.
The crystals are then collected and dried to remove any impurities.

Chromatography is another common technique used to purify lansoprazole.
The product is injected into a column packed with a suitable stationary phase, and a mobile phase is passed through the column to separate the impurities from the desired product.

Filtration is also used