Material Science
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.
Capabilities
- 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
