[WEBINAR] Industry bottlenecks in drug substance development: solubility, particle size and morphology
Computational methods play an increasingly important role in all stages of drug development and when used judiciously can help accelerate the timelines required to get over various process and manufacturing hurdles.
From a drug substance perspective, the solvent, or solvent mixture, from which your API is crystallized influences a plethora of factors including solubility, growth and nucleation kinetics, impurity rejection, polymorph control, solvation propensity and crystal morphology. Despite the importance of this choice, early phase development solvents are often chosen very quickly with only the impact of product yield considered. This can lead to purity, particle size and processability issues in later phases, just as the material is being delivered to the clinic or market.
Particle size and shape are also an important factor to consider and can cause issues, such as, poor processability, filter-ability, flow-ability, compressibility, and difficulty to form tablets. For example, particles that are too large can have poor or inconsistent dissolution rates and bioavailability.
Join our presenter, Dr. Jacek Zeglinski, a crystallisation expert who will take a deep dive into some of the many challenges which cause industry bottlenecks in drug substance development. In this talk he will show how computational tools allow us to screen many more solvents than would be possible using experimentation alone and thus help solve many of the above issues. He gives examples of real-life challenges being addressed with these tools and shows why they have become standard workhorses for us in our client projects - facilitating us to predict as many properties as possible, including shape/morphology of crystals of a particular API before conducting any wet lab experiments.