Description:
Esomeprazole is also proton pump inhibitor and is one of the blockbuster molecule that is used in the treatment of ulcer. Esomeprazole is the chiral form of omeprazole. The product is also manufactured as enteric coated pellets. The API is manufactured under MKPPL's control and has a low impurity profile. MKPPL is currently developing a non-infringing process along with with a J.V. partners for API and pellets.
The quality of the pellets is based on the in-vitro dissolution test besides the assay and the impurity profile. The time dissolution values are direct measures of the coating efficiency and hence optimum therapeutic efficacy as it has a co-relation with in-vivo behaviors. |