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Salt Selection and Solid State screening Understanding the specific crystalline properties of each compound is the first step in screening. Based on initial insights into crystalline properties, we further design experimental protocols that include varying parameters such as solvents, temperature, humidity (water activity), etc. We systematically employ a high-variable screening approach to maximize the probability of identifying all solid-state forms. This approach aims to create greater value for our clients by ensuring comprehensive exploration of salt and crystal forms, followed by evaluation of pharmaceutical properties. Our complete set of screening equipment includes: ■ X 射线粉末衍射 (PXRD) ■ 差示扫描量热法(DSC) ■ 热重分析法 (TGA) ■ 动态蒸汽吸附法 (DVS) ■ 拉曼光谱(RM)
■ 高效液相色谱 (HPLC) ■ 偏光显微镜 (PLM) All of these technologies are utilized to select the optimal solid form of drugs for development purposes. ■ Screening all possible solid state of new chemical entities. ■ Determining the most suitable solid form for drug development. ■ Developing crystallization processes. ■ Implementing production schemes for stable crystal forms. Our screening services primarily include: The stages of solid state screening in pharmaceutical research are as follows: Early Stage: Thorough and reliable crystalline form screening during the early stages of preformulation is crucial. The goal of screening is to identify as many crystalline forms as possible and determine the most suitable and stable form for further study. However, despite comprehensive screening efforts, there remains an inevitable question: have we truly identified the most stable form? No researcher or expert can provide a 100% definitive answer, as metastable crystalline forms may maintain their structure over extended periods. Secondary Stage: During the secondary production of a drug, the active pharmaceutical ingredient (API) may undergo process-induced transformations, potentially leading to the discovery of new solid forms. Various conditions encountered during formulation processes can trigger polymorphic transformations in drug substances, ultimately affecting drug quality. Factors such as temperature (during drying stages), pressure (grinding, compression), or water and solvents (e.g., wet granulation) can influence crystalline form changes. Salt form screening, solid state screening, eutectic screening, amorphous screening, and amorphous solid dispersion screening. ■ Drying and Wet Grinding ■ Spray drying and freeze drying ■ Melt Crystallization: ■ Compression ■ Ultrasound: ■ Supercritical Anti-solvent (SAS) Method We can customize solid state research according to client needs, such as solid-state stability testing, drug product performance evaluation, and crystalline form dissolution studies In addition to common crystallization methods, we may selectively employ other screening methods based on the specific characteristics of the developed compound, such as: Stability testing Stability studies of solid state, under various conditions such as accelerated and long-term storage, light stability, exposure to pure water, alkaline and acidic conditions, oxidation, etc., provide scientific basis for selecting optimal drug crystalline forms, formulation development, process control in preparation, and storage conditions of pharmaceuticals. |