13 Mar 2024
en
Our solid form screening technology applies to polymorph screening, salt screening and cocrystal screening. Our screening technology is to design various crystallization conditions according to the physicochemical properties of the target compound and factors affecting drug crystallization, to screen and discover the most comprehensive solid form for subsequent evaluation and development. Our proprietary solid form screening technology has been applied to over 1,500 different drug molecules and proven to be efficient and effective in screening and identifying the most optimal solid form for development.
For new drug candidate compounds in the preclinical development stage, the main goal of our solid form screening service is to use a small number of screening experiments to find the most suitable drug crystal form quickly and efficiently for development. Usually, this crystal form is a thermodynamically most stable crystal form. According to the structural characteristics of the compound and its solubility in different solvent systems, Crystal Pharmatech designs experimental conditions that tend to produce thermodynamically stable crystal forms, generally a crystallization mode with slow release from supersaturation. If salt-forming or co-crystal forms are needed, Crystal Pharmatech predicts the salt-forming or co-crystal formation sites through compound structure analysis and physicochemical property testing and selects suitable counter-ions or cocrystal-formers for screening experiments. Crystal Pharmatech's precise experimental plan meets the development needs of innovative drug customers with a shorter time, fewer experiments, and less material consumption.
When an innovative drug enters the late clinical stage, in order to provide comprehensive patent protection for all available crystal forms that may be formed by its own new drug compound, innovative drug companies usually conduct a comprehensive and systematic evaluation of the new drug compound in clinical phase II or III. This type of solid form screening is usually called solid form IP screening. For this stage of screening, the primary goal is to find all crystal forms (usually metastable crystal forms) suitable for industrial development in addition to the thermodynamically most stable crystal forms and then seek patent protection for them. For this type of screening, Crystal Pharmatech has established different tiers of crystal form screening strategies and approaches. On the one hand, we will cover a wider range of crystallization methods and solvent systems and select many enabling crystallization methods; on the other hand, we will design experimental conditions that are prone to metastable crystal forms, which are mainly derived from the company's successful experience in supporting hundreds of solid form IP screening.
