Pre-formulation

Vanton researches all critical pre-formulation parameters to better and more efficiently guide the product development processes and patent strategy for clients. Pre-formulation studies are on an as-needed basis to be cost-effective for clients.

• Drug substance ‘s (DS) Solubility, Sensitivity, and Process-ability

-pH  –solvents  –heat  –shear forces  –UV Light  –Moisture

• Interactions between DS and excipient candidates

-Chemical Stability  -Physical Adsorption  –Complexation

• Surface Activity as needed
• Crystallinity (mostly for transdermal patch)

Drug Substance Stability

• 40 oC/75%RH accelerated stability study
• 25 oC/60%RH stability study or other zone configurations
• Stress studies