Give your product the scientific basis for success
Our preformulation services team helps you start from a sound scientific basis, providing a thorough evaluation of your drug substance. Our efficient, balanced-approach returns benefits at every stage of the development process...facilitating FDA approvals and moving your drug into the clinic rapidly and through the development cycle more efficiently...ultimately saving you significant development time and money.
Select the most stable and bioavailable API form
Our API characterization studies determine the drug candidate with optimal physicochemical properties. We can help you avert situations that can result from failure to characterize and select the best polymorph and salt form for your API.
Physicochemical Properties:
- Salt synthesis and salt form selection
- Polymorphic screening and selection
- Solid and solution state stability
- pH, temperature degradation rate profile
- pKa, pH-distribution coefficient
- pH solubility
Shorten development time and costs
Our Formulation Development/Manufacturing Support studies are essential for the development of superior dosage forms with optimized manufacturing processes. We can help you converge more quickly to an optimized dosage form.
- API and excipient physical testing
- Intrinsic dissolution
- Excipient compatibility
- Micromeritics: flowability, density (true, bulk, tap), porosity, surface area
- Dynamic vapor sorption-desorption (hygroscopicity) profile
- Biopolymer analysis by GPC
Our first-class facilities, equipment assets, and expertise allow us to handle your most demanding preformulation challenges.
- State-of-the-art equipment:
- X-ray powder diffraction (vT, vRH)
- Thermal analysis: DSC, TGA, TMA
- VTI Dynamic Vapor sorption/desorption
- 500 mHz NMR
- LC-MS
- Optical microscope with image analysis (light, polarized, hot-stage)
- Intrinsic dissolution
- GPC with triple detection array (TDA)
- Particle size determination by laser light diffraction and light obscuration
- BET surface area determination
- FTIR
Our integrated project management strategy optimizes the effectiveness of allocated resources.
- Strategic regulatory planning
- Singe point of contact project management assigned to every project
- Facilitated contact with assigned scientific project leaders for all disciplines (formulation development, analytical development, clinical manufacturing)
For capabilities that meet your needs, and outcomes that exceed your expectations, partner with Catalent today. For more information fill out our Contact us form or call a member of our sales staff toll-free at 866.720.3148.