During drug manufacturing, active pharmaceutical ingredients (APIs) are exposed to variable environmental conditions and encounter multiple stresses, which may lead to phase transformations. Similarly, during storage, solid-state changes can occur and possibly involve a polymorphic transition, solvate formation or desolvation, or interconversion to an amorphous form (Morris, Griesser et al. 2001).
The consequences of these changes can affect the performance of an API, and as a result, the quality, stability, and therapeutic effects of the final product may differ from what was expected. It is therefore essential to discover possible phase changes during pharmaceutical development processes, and if possible, take precautions to control them.
Predicting the crystalline nature of an active pharmaceutical ingredient in its solid state remains a trying task for pharmaceutical manufacturers. The formation of hydrates and dehydration are mandatory data for development of APIs, and ex-situ spectroscopic studies are not satisfactory.
In this webinar, Prof. Gérard Coquerel, head of the Separative Sciences and Methods Laboratory at the University of Rouen Normandy, will illustrate how the precise identification of solid phases and their crystallinity are important for the design of drying, the storage conditions, and the repeatability of the solid transformations regarding APIs, as well as the identification of non-stoichiometric solids and the possible presence of polymorphs of hydrates and anhydrates.
Key learning objectives
· Explore the benefits of an in-line XRD InsituX technique
· Understand the hydration process in active pharmaceutical ingredients
· Learn the role and importance of solid phases and crystallinity
· Gain insights into the presence of various polymorphs of hydrates
Who should attend?
· API research and development scientists
· Formulation and R&D scientists
· QA/QC managers
· Analytical scientists
Speaker: Professor Gérard Coquerel, Head of the Separative Sciences and Methods Laboratory, University of Rouen Normandy
Prof. Gérard Coquerel is the founder and head of the Separative Sciences and Methods (SMS) Laboratory at the University of Rouen Normandy, France. The SMS laboratory is currently comprised of two teams: the crystallogenesis unit, headed by Prof. Samuel Petit since 2015 and the chromatography team, headed by Prof. Pascal Cardinael since 2011. The research activities of the crystallogenesis team are essentially focused on the study of crystallization of low molecular weight organic compounds, mostly pharmaceutical compounds, but also energetic materials or semiconducting materials. The research themes for the chromatography team focus on the elaboration of stationary phases for chromatography and the study of the mechanisms of chiral recognition supported by a double skill in organic chemistry and analytical chemistry.
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