Innovative use of Spherical Agglomeration at scale to manufacture API with improved ‘flow’ property
Solving tough scientific challenges is our raison d’etre. This often leads us along under-explored paths that are both challenging and exciting.
One of the sophisticated particle design techniques that is used to improve an API particle’s ‘flow property’, among other physical properties, is Spherical Agglomeration. This technique is considered to be a complex one - and its transition from lab to manufacturing scale has not been achieved at a frequency that pharmaceutical industry would desire, given the value it brings.
Spherical agglomeration has been used in various bulk and fine chemical industries, with recent interest extending into pharmaceutical manufacturing & scalability. It is one of the particle design and engineering techniques that enlarges the size and shape of a particle by agglomeration to improve API developability in terms of flow and/or morphology, wettability and compressibility improving downstream API handling and formulation manufacturing. The technique requires an in-depth understanding of particle science & engineering, process design & engineering and manufacturing controls.
In a recent project involving an innovator pharma company looking to develop a high-dose drug, scientists at Sai Life Sciences leveraged rich cross-functional knowledge to convert an API that was fluffy and low density in nature into a dense agglomerate with a simultaneous increase in its flow properties. Our knowledge of particle sciences & engineering was applied successfully to alter the physical properties of the API particles by using a judicious mix of solvents, process parameters, equipment and engineering controls. Aided by rationale scientific experimentation and simulation software the team was able to scale up this product from a few grams at a lab scale to tens and hundreds of kilograms at a manufacturing scale. This improvement in the API flow properties helped our client to develop an improved and more efficient formulation process.
These are the kind of instances that bring a spring in our step and encourage us to ‘Make it better together’.
