Experimental Solid-State Formulation R&D
Our experimental services cover integrated solid-state research services from pre-clinical to NDA filing, including form screening, crystallization process development, amorphous solid dispersions development, analytical method development, and thorough solid-state characterization, etc.
Polymorph/salt/co-crystal screening and assessment
Assessment of form developability
IP protection for solid forms
Enhancement of drug bioavailability
Enhancement of key physicochemical properties
Crystallization process development
Crystallization process development can be used to improve the properties of API, such as particle-size distribution, crystal morphology, bulk properties, flowability, etc., thereby improving the processability and dissolution of drugs. For specific solid forms of drug substance, the crystallization process development would generate drugs with desired properties.
Enhancement of powder properties
Meta-stable form preparation
Kilogram-level crystallization process development for formulation study
Polymorph screening and selection
Solvent screening and selection
Critical process parameters
Residual solvent control
Amorphous solid dispersion formulation development
Technologies such as spray drying are used to disperse insoluble drugs in carrier polymer materials to improve their solubility. The carrier polymer materials are screened and selected to ensure that amorphous solid dispersion has qualified stability and dissolution performance at a gram scale.
BCS class II and IV drugs, crystalline drug with poor solubility, need a formulation with improved solubility
Analytical method development
Xtalpi’s solid-state team can provide analytical method development services such as, particle-size analysis, qualitative/quantitative form analysis, HPLC methods, etc. Xtalpi has an excellent team of experts constantly exploring and innovating in the field of analytical method development.
Particle-size analytical method development
HPLC method development
Qualitative solid form method development
Quantitative solid form method development
By various means of increasing drug solubility to improve bioavailability, such as salt formation, pH adjustment, addition of cosolvents, surfactants, cyclodextrin complexation, etc., We assist clients in developing suitable solution, suspension, and self-emulsifying formulations for toxicology and pharmacokinetic studies.
Solid-state characterization services
Xtalpi is equipped with top-tier testing facilities, providing comprehensive testing services for drug solid-state development to customers.
Solid State Characterization