Early Stage Development
Solid State Pharma is prepared to engineer and develop a robust process for your early phase API that ensures the correct polymorph is robustly isolated as a flowable solid. Our scientists are experienced in efficiently resolving crystallization challenges such as oiling out, gumming, filtration, drying, impurity purging, particle size and morphology control, minimizing residual solvent, maximizing yield, and many other parameters to meet our client’s specifications. This can range from developing a novel process to troubleshooting or building upon an existing process.
Solid State Pharma is also equipped to conduct Design of experiment (DOE) studies utilizing Design-Expert software and statistical analysis knowledge. Upon completion this service, you are provided with all data and knowledge generated for your API and a robust process to move forward with in your development.
Later Stage Development
Crystallization engineering is crucial in achieving consistent particle size distribution, morphology, filtration and drying. The crystallization engineering is usually performed on late phase APIs where deep understanding of process parameters on the quality is required. At this stage of development, there is already a wealth of knowledge available around the solid state and crystallization behaviour of the compound. In many cases, the solvent system is also locked.
With the crystallization engineering workflow, we primarily develop the understanding around the effect of supersaturation release, temperature, pH, mixing regime, mixing shear and dynamic on nucleation, growth, morphology, polymorphic form (if any), attrition, agglomeration etc. PAT tools such as FBRM will be used to monitor the particle size in real time. The outcome of this work is a scale independent robust process, which could be implemented at various scales.