Overcoming Formulation Hurdles
Early formulation development requires a strong foundational understanding of the properties of drug substance that will impact its behavior in a final dosage form. The knowledge of API properties of optimal solid form is gained through form screening and selection by J-STAR Crystallization R&D. The drug substance can be seamlessly progressed into preclinical formulation studies. We have extensive experience in screening and developing animal PK and Tox formulation, such as solution, suspension and enabling formulations. Our goal is first-time-right in preclinical formation selection based on comprehensive understanding of the physicochemical properties of a drug candidate.
We provide a full range of preformulation services:
- Polymorphism and crystallinity
- Melting point
- LogP/LogD and pKa
- Solubility in various solvents and pH’s
- Stability under different temperatures, humidity levels, and light exposure
- Excipient compatibility studies
- Tox and animal PK formulations
- Enabling formulation assessment for poorly soluble drugs
- Phase-appropriate analytical method development
