- The Importance of Solid Form ScreeningThe solid form screening of APIs is an important tool in the early process development of new drugs. The purpose is to find as many crystal forms as possible and determine the most suitable solid form for development, so that you can:Improve the Quality of DrugsThere are significant physical and chemical differences between different polymorphs of the same drug (hygroscopicity, physical/chemical/mechanical stability, purity and impurities). This could lead to differences in solubility, dissolution rate and bioavailability, which directly affect the quality of the final product.Optimize Intellectual PropertyAs a material structure patent, crystal form is an effective tool for prolonging the life cycle of new drugs. For generic drugs, it can break through the patent barriers of the original research and obtain the right to enter the market.Compliance with Registration RegulationsThe drug regulatory laws and regulations of China, US and other developed countries have set clear requirements for the content of crystal form research in new drug clinical trial applications, new drug marketing applications, and generic drug applications, and have formulated relevant guiding principles for crystal form research.The solid form screening platform of Medicilon Process Department strictly complies with the registration regulations and regulatory requirements of China’s NMPA, the US FDA and other regulatory agencies. It conducts research and control on the solid form of drug molecules in APIs and preparations, and can formulate the best effect based on the characteristics of the substance screening strategies, including but not limited to crystallization methods, solvent selection, and ion selection.
- Service Scope of Solid Form Screening PlatformDiscoveryVarious Salt Forms/Crystal Forms/Eutectic of APIEvaluationThe Druggability of Different Crystal Forms of API DevelopmentThe API crystallization production process to obtain the target crystal form, morphology and particle size

- PurposeImprove Drug PropertiesDiscover the Most Suitable Salt Type for DevelopmentEnsure Effective Patent ProtectionAvoid Prior Technology Patents
- TechnologyFree State Property CharacterizationSolubility in Different SolventsChoose the Right Counter IonVarious Salt-Forming TechnologiesCharacterization of Physical and Chemical PropertiesSolid and Solution Stability ResearchSalt Type Selection and RecommendationPatent Disclosure Materials
- Salt Type Screening ProcessThermal Analysis (TGA/DSC): Solvent (water) and Non-Solvate AnalysisNo Crystal TypeSolvent (water) Compound
Dynamic Moisture Sorption (DVS) Applications – Inspection of Sample Moisture Absorption

- PurposeImprove the Defects of the Free State PropertyDiscover the Most Suitable Eutectic Form for DevelopmentEnsure Effective Patent ProtectionAvoid Prior Technology Patents

- PurposeDiscover the Most Suitable Crystal Form for DevelopmentEnsure Effective Patent ProtectionAvoid Prior Technology Patents
- TechnologyAnalysis of Existing TechnologiesMultiple Crystallization TechniquesCharacterization of Physical and Chemical PropertiesSolid and Solution StabilityAnalysis of the Relative Stability of PolymorphsCrystal Type Selection and RecommendationPatent Disclosure Materials
- Polymorph Screening ProcessCharacterization→Scheme Design→Screening→Enlarge→Evaluation→Report Patent

- Raw Material Crystallinity or Impurity Crystal Type AnalysisQualitative and Quantitative Analysis of Crystal Forms of Raw Materials in PreparationsDevelopment and Verification of Particle Size Distribution Analysis MethodX-Ray Powder Diffraction Method (XRPD)Crystallinity CheckQualitative Analysis of Crystal Forms of Raw Materials in Preparations