Solid state research on an API forms the nexus between its chemical synthesis and subsequent formulation development. A fundamental part of crystal form research is to ensure reproducible and scalable production of the desired crystal form selected from solid-state studies. Our crystallization process development services help customers develop a scientific and rational crystallization process to generate the selected crystal form, as well as improve the overall quality of the product by optimizing yield, solvent residue, particle size and particle size distribution, and bulk density, among others.
We assist our customers to develop crystallization process for their preferred polymorphs. For metastable crystal forms, which may be desirable as they are outside the scope of third parties' polymorph patents, we develop processes featuring controlled supersaturation of solutions and separation of the resulting crystals from the solvent system. For stable crystal forms, we assist our customers to pinpoint the desirable process by balancing crystallization conditions to enhance the purity of crystal form and improve the crystallization yield.
We develop and optimize the crystallization process for our customers to improve the crystal habit and particle size. For example, we improve the conditions to avoid needle-shaped crystals that are fragile, because such crystals may break easily in the agitation and filtration process and produce a large number of secondary nucleation sites that negatively affect the final crystal size and form. We also systematically investigate the particle size distribution to reduce risks associated with uneven size distribution that could lead to dissolution issues and quality fluctuations of the crystal form.
Beyond individual computational or experimental services, we offer integrated solutions that combine our expertise in both computation and experimentation to cater to our customers' needs and address multiple aspects of their pharmaceutical solid-state R&D endeavors. We offer solutions that encompass solid-state property screening for lead molecules, solubility improvement studies, crystallization process development and crystal structure determination for challenging molecules, polymorph risk assessment, and polymorph patent breakthrough studies for generic drugs.