A variety of approaches exist for particle size control of active pharmaceutical ingredients during process development and scale up for the production of solid oral dose medicines, including reactive crystallization control, thermal and antisolvent crystallization control, and mechanical size reduction techniques such as milling. Pharmaceutical manufacturing and scale up challenges are well documented throughout literature and can be further exacerbated when materials exhibit poor crystallization behavior such as crystal agglomeration.
The case study presented by Dr. Naomi Briggs (Lead engineer II) from Alkermes at the Crystallization Workshop on October 3rd 2018 in Boston demonstrates the application of a seeded heat cycling approach to crystallization for de-agglomeration and particle size control, in addition to considerations for successful pilot plant scale-up.
The Crystalline instrument with through the vial analytical capabilities like turbidity, particle visualization, Raman helps you to optimize your crystallization process at an early stage with only small amount of material.
Curious to learn more?
Check out here how the Crystalline instrument was used at Alkermes to explore solubility in a fast and efficient way.