EN

API

Dexlansoprazole

KDMF APIs

Dexlansoprazole

Dexlansoprazole basic information

Korean name

덱스란소프라졸

Category

Digestive organs

CAS No.

138530-94-6

KDMF registration No.

20171024-209-J-174

Manufacturer

Mylan Laboratories Limited (Unit-7)

Specification

In-house

Product information

Dexlansoprazole product information

IUPAC Name

2-[(R)-[3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl]methanesulfinyl]-1H-1,3-benzodiazole

Synonyms

2-((R)-((3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl)methyl)sulfinyl)-1H-benzimidazol

Description

Dexlansoprazole is a new generation proton pump inhibitor (PPI) used for the management of symptoms associated with gastroesophageal reflux disease (GERD) and erosive esophagitis. Dexlansoprazole is the R-enantiomer of Lansoprazole, which is composed of a racemic mixture of the R- and S-enantiomers. Compared to the older generation of PPIs (which includes Pantoprazole, Omeprazole, and Lansoprazole), dexlansoprazole MR has a unique pharmacokinetic profile due to its delayed-release and dual-delivery release system. The active ingredient is released in two phases at different pH values and at different time points, resulting in two peak concentrations in the blood; 25% of the dose is released at pH 5.5 in the proximal duodenum, while the remaining 75% is released at pH 6.75 in the distal small intestine. As a result, dexlansoprazole has a peak concentration within 1-2 hours after dosing and another within 4-5 hours. Dexlansoprazole's unique pharmacokinetics addresses limitations of the older generation PPIs including short plasma half-life, break-through symptoms, and need for meal-associated dosing. These characteristics make dexlansoprazole a good option for people who struggle with adherence and strict dosage timing before meals.

Certificate of Analysis

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