Material Science Services
Determining the most suitable lead solid form of APIs is a critical step in pharmaceutical development. The physical form impacts the physicochemical properties and influences a range of important aspects of drug development, including developability of a drug candidate, stability, bioavailability and manufacturability for both the API and drug product.
Pharmaron’s material science team plays a critical role in bridging drug discovery, development and manufacturing. Our integrated material science teams deliver API solid form screening, characterization and pre-formulation services for selection of the most appropriate and stable solid form to advance a candidate into preclinical and clinical development. We ensure the key physical characteristics of the API and its solubility and stability are well studied to support the entire drug development process.
- Drug discovery support for initial compound profiling, crystallization and preclinical formulation development for candidate selection
- Material solid-state and physicochemical characterization
- Polymorph and salt/co-crystal screening for solid form selection
- Stable form developability assessment
- Preformulation for formulation development
- Development of fit-for-purpose formulations for preclinical safety and efficacy studies using various solubilization approaches
- API and intermediate crystallization process development for scale-up, control of polymorph, process efficiency and particle size/morphology
- Accelerated Stability Assessment Program (ASAP) and traditional stability studies
- Single crystal structure determination
- Comprehensive solid form screen for IP coverage