Dexlansoprazole
덱스란소프라졸
KDMF APIs소화기관KDMF 등록
품목명 (영문)
Dexlansoprazole
품목명 (한글)
덱스란소프라졸
분류
소화기관
CAS No.
138530-94-6
KDMF 등록번호
20171024-209-J-174
제조원
Mylan Laboratories Limited (Unit-7)
규격
In-house
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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