Solid-State Research

 In recent years, the solid-state characterization of small molecule drugs has become an important area of research in recent years in early-stage new drug R&D and preclinical drug discovery. A majority of marketed chemical drugs are administered in solid form, most commonly in the crystalline state. Different solid forms can affect the properties of a drug, such as solubility, bioavailability, stability, hygroscopicity, and powder flowability, leading to variable drug solvation and absorption rates in the human body. This impacts downstream DP dissolution and release, which determines the clinical efficacy and safety of the drug. Therefore, the primary goal of pharmaceutical solid-state research is to identify the most suitable solid form for a candidate drug molecule. Discovery and selection of favorable crystal/salt forms can significantly streamline the drug R&D process and help reduce R&D risks;

 Jiuzhou Pharma's solid-state research platform is staffed by experienced researchers who can assist customers with issues regarding crystal forms and crystallization processes that arise during CMC;

 We are equipped with state-of-the-art instruments and equipment to provide various services during new drug R&D, including: solid-state research (crystal/salt/cocrystal screening and systematic research, amorphous solid preparation and research); drug analysis and testing (pKa, Log P, Log D, crystal form analysis, thermal analysis, powder properties, particle size, qualitative and quantitative method development and validation for crystal forms in API or DPs); single crystal growth and structure elucidation; and crystallization process development;

 With an in-depth understanding of physicochemical properties and engineering principles, we develop crystallization processes for APIs and intermediates with crystal form and particle size requirements to facilitate material separation and enhance purity at workshops. During scale-up, we leverage process control of crystal forms and particle size to improve R&D success rate and accelerate time to market。