Pre-formulation
Building a strong foundation for drug product development through physicochemical characterization, solid-form evaluation, and early formulation assessment.
BioDuro’s preformulation scientists help sponsors understand how a compound’s physical and chemical properties may affect solubility, stability, bioavailability, and manufacturability. By identifying potential development challenges early, our teams can recommend a practical path forward and reduce the risk of delays later in the program.
Physicochemical Characterization
We evaluate the properties that may influence solubility, stability, absorption, and formulation selection.
- Equilibrium, intrinsic, and kinetic solubility
- pH-dependent aqueous solubility
- Solubility in biorelevant media, including SGF, FaSSIF, and FeSSIF
- Supersaturation assessment
- logP, logD, and pKa determination
- BCS classification support
- Intrinsic and media-based dissolution testing
- Solution stability and forced degradation studies
- Analytical method development for impurities
Solid Form Screening
Our scientists assess the physical form and material properties of a compound to identify potential stability and processing risks.
- Crystallinity assessment by XRPD
- Thermal characterization by DSC and TGA
- Hygroscopicity assessment by DVS
- Particle-size analysis
- Particle morphology evaluation
- Solid-state stability under light, heat, and humidity
Biopharmaceutical Evaluation
We help identify a chemically and physically stable form suitable for continued development and scale-up.
- Salt screening and selection
- Polymorph screening and characterization
- Co-crystal screening
- Crystallization process development
- Excipient compatibility studies
- Evaluation of solubility, stability, dissolution, and hygroscopicity
Early Preclinical Formulation Support
When conventional approaches are not sufficient, BioDuro can evaluate early formulation options to address solubility and exposure challenges and support preclinical studies.
- Solution and suspension formulations
- pH adjustment and cosolvent approaches
- Surfactants and cyclodextrins
- Micronization and nano-milling
- Lipid-based formulations
- Amorphous solid dispersion feasibility
- Formulation preparation for PK and toxicology studies
- Coordination with DMPK and in vivo evaluation
