Solid State Seminar
Regis Technologies invites you for a seminar on "The Importance of Solid Form Selection in Drug Development, and an Overview of the Crystallization Development Process" delivered by guest speaker Rolf Hilfiker, PhD, of Solvias AG. Read the abstract below for more details.
Join us for coffee and chemistry on Friday, September 12, from 8:30-10am.
The Importance of Solid Form Selection in Drug Development, and an Overview of the Crystallization Development Process
Rolf Hilfiker, PhD
Vice President and Head, Solid State Development, Solvias AG
Solid-state properties of active substances and excipients are of major practical and commercial importance all the way from research to manufacture of the final product. The search for, and more importantly the selection of the optimal solid form (salt, co-crystal, polymorph) is closely linked to the intended application of the final drug product.
The following issues will be addressed:
- How and when in the development cycle should solid state issues be dealt with?
- An integrated approach to solid-state development
- Discussion of efficient strategies for salt selection
- How to perform effective polymorphism screening, including HTS methods
- How to design a suitable crystallization process
Overview of Crystallization Development Process
In a salt and/or co-crystal screening and characterization the optimal salt or co-crystal has to be identified. This is followed by a polymorph and solvate screening of the corresponding substance wherein all relevant forms are identified and characterized. Typically, either the thermodynamically stable form at room temperature or a hydrate is selected. Knowledge of critical water activities for hydrate formation and kinetics of hydration and dehydration is therefore essential. After selecting the optimal form, a small scale crystallization process is developed to obtain the selected form with the desired particle size distribution and purity, while optimizing yield, speed, etc. Often a seeded crystallization process is required to achieve optimal control. This process is then scaled up in a kilo-lab, followed by production on a kg-scale in a GMP-facility.
Rolf Hifliker holds a PhD in physical chemistry from the University of Basel, Switzerland. He has been Post Doc at SUNY and Senior Research Fellow at the University of Basel. He also has more than 20 years of experience in industrial R&D from Ciba-Geigy, Novartis, and Solvias, where he currently leads a team of 20 in contract research and development in the solid-state area, working specifically with polymorphism studies, salt and co-crystal screening and selection, method development, crystallization optimization and more. Hifliker has also presented his work in more than 60 scientifc publications and several patents.