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


    • Polymorph screening

    • Assessment of form developability

    • IP protection for solid forms

    • Salt/co-crystal screening

    • 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

  • Form control

  • Chiral separation

  • Residual solvent control

  • Particle-size optimization

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

Pre-formulation 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