New approaches to the synthesis of diclofenac choline

Abstract

The process described herein proceeds to obtaining diclofenac choline from choline bicarbonate and diclofenac acid in mild conditions, using non-toxic solvent, with the same impurity profile deriving from diclofenac particle as for diclofenac sodium EP. The substance is also substantially free from impurities deriving from choline and free from inorganic by-products, what means that the quality may be accepted for use as an active substance in medicine.

Keywords

• Diclofenac choline
• Anti-inflammatory agent
• Oromucosal solution
• Mouthwash solution