SEMINAIRE LMGP - 01.03.2022 - Dr Nawel KHALEF

“ Development and applications of thermal activity tracing in pharmaceutical R&D”

Associate Pr./ Dr, Nawel KHALEF
Université Grenoble Alpes- TIMC UMR 5525



Abstract

The presentation is an introduction to a novel methodology and instrumental approach developed in our laboratory consisting of thermal activity tracing of physical, chemical or biological processes under isothermal conditions. Isothermal calorimetry (IC) is used as measuring tool. As IC is non-specific, it has a broad range of applications and it is shown to be a valuable methodology to obtain both thermodynamics and kinetics information about numerous complex processes involved in various research areas.

Various application examples of frequently encountered problems in material and pharmaceutical development are shown: Stability and compatibility studies, shelf-life determination, Vapor- solid interaction, drug-(Bio)Polymers, drug-cyclodextrin Interactions, polymer hydration kinetics and sustained drug release dosage form optimization

Methods as well as designed instrumentation in our laboratory allowing to carry out studies of the effect of relative humidity (RH) upon ingredients physical stability, such as amorphous to crystalline phase transition and amorphous content assessment. Critical RHs of materials are determined. The method also allows solid surface characterizations such as sorption isotherms and surface energies “mapping” that take into account the surface heterogeneity and solubility of the material.

The method is shown to be rapid, accurate and can save valuable time in the early stage of development and can find applications as well in biological field such as cell growth and evaluation of growth inductors/inhibitors, biotechnology and optimization of bioreactors.