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Federica Giusti, PhD

Federica Giusti joined Janssen in 2018 as a Post-Doctoral Researcher in Dissolution Sciences. Since then, she has worked on the local GI delivery strategy and she also worked on dissolution method development and drug product characterization for different development projects.

Prior to joining Janssen, Federica graduated in chemistry and pharmaceutical technologies at the University of Camerino, Italy in 2015 and she obtained her PhD at the same University in chemical and pharmaceutical sciences and biotechnology with a main focus on food safety and quality in 2018.

Abstract

 

Dissolution test strategies for colon-targeting drug products: concept screening and QC considerations​

Novel formulations enabling colon targeting delivery through oral administration represent for many reasons an encouraging evolution for patients such as for health care providers.

Pursuing different objectives at every stage of the drug lifecycle, dissolution testing is currently challenged to support the development and the manufacturing of the product by evaluating its API delivery performance directly to the colon via different mechanisms and ensure its consistent (batch) quality within a defined set of specification criteria.

The in vitro implementation of mechanisms that can play a crucial role hampering and modifying the drug uptake of the GI microenvironment (e.g. local pH, presence of enzymes), can help to develop new and better fitting dissolution strategies for these specific products. Given the different physicochemical and release characteristics, more unconventional apparatus (e.g. USP3, USP4), procedures, and techniques should be employed on a case-by-case basis.

For in vitro evaluation of pH sensitive drug products, USP3 apparatus allows for a pH change throughout the dissolution test simulating the GI tract pH stages.

Since the increase in the bacteria population and in the associated enzymatic activities between the distal small intestine and the ascending colon, adding enzymes to compendial dissolution media can be potentially an effective and simpler tool to implement for the characterization of colon-targeting delivery formulation compared to commonly used approaches using fecal homogenate.

Nevertheless the X-ray tomography (Micro-CT), Raman imaging and IR spectroscopy, coupled with dissolution tests allow a better understanding or visualization of the intrinsic release mechanism from the drug product and clearly participate to a sound rational for the development of new formulations.