Bioequivalence and Bioavailability Forum

Dear All

I want to ask about KAPIDEX (dexlansoprazole) delayed release capsules, where innovator (Takeda) has used a dual release pattern. Kapidex DR Capsules contain two types of pellet

Part A – 25% of drug in granules with enteric coat which dissolves in the pH range not less than 5.0 and not more than 6.0 (Eudragit L 30D – 55)
Part B– 75% of drug in granules with a coat made of a mixture of two enteric polymers (Eudragit L and Eudragit S. releasing after pH 6.0)

And its in vivo profile is like this



My questions are

Q1. How this dual release pattern is helpful in case of Dexlansoprazole? Is it helpful in improving the BA or for increasing patient compliance or both and how?

Q2. Is this formulation possible without dual release pattern? Is there any otherway round?

Q3. Why is a significant dose of the drug (75%) released in the distal portion of small intestine or in large intestine where the pH is between 6-7.5?

Thanks a lot in advance...