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.