Formulations for PK/Efficacy/Tox Studies

This is an integrated approach to finding the right form and formulation at every step of the development cycle using decision trees and guidance documents built from our over 80 years of innovative pharmaceutical experience. Using our preclinical formulation development services—delivered through our SMART biopharmaceutical solutions—will lead to the shortest possible development timelines with limited resource utilization.

Our formulation approaches to deliver molecules to support PK/Efficacy/Tox studies include tox formulation development, solution and suspension formulation selection through vehicle screening, and solubilization through pH adjustment, co-solvents, surfactants, cyclodextrin, and in-situ salt formation. In addition, we also apply special drug delivery technologies for insoluble compounds.

•  Conventional - Solution/Suspension Formulations

　　- pH Adjustment

　　- Co-solvents

　　- Surfactants

　　- Cyclodextrin

　　- In-situ Salt

• Enabling - Enhance Solubility & Bioavailability

         - Amorphous Solid Dispersion 

            ■ Spray drying or Lyophilization

         - Size Reduction

            ■ Nano-milling: Nano-suspension

            ■ Micronization by Jet-milling

         - Lipid-based Formulation

         - Self-emulsifying Drug Delivery Systems (SEDDS)

Micronization 1~10 μm	Nano-milling <1000 nm	Spray Drying ASD	Freeze Drying Lyophilization	Extruder Liposome