Drug product formulation
development with
the protection
of intellectual property

Summary

The project included developing an oral delayed-release capsule (enteric). An innovative approach to formulation development allowed for bioequivalence with the reference product to be achieved and for the generation of intellectual property, which was confirmed by granting three patents.

In combination with an adequate registration strategy, an advantage over competitive manufacturers of generic drugs was obtained in the form of market priority, exclusivity, and patent protection for the applied technological solutions.