Pre-formulation

Vanton evaluates the critical pre-formulation parameters that guide product development to set the patent strategy for clients. Pre-formulation studies are on an as-needed basis

• Drug substance (DS) Solubility, Sensitivity, and Process-ability
  – pH
  – Shear forces
  – Solvents
  – UV Light
  – Heat
  – Moisture

• Interactions between DS and excipient candidates
  – Chemical Stability
  – Physical Adsorption
  – Complexation
• Surface Activity( as needed)
• Crystallinity (mostly for transdermal patch formulations)

Drug Substance Stability

• 40℃ / 75%RH accelerated stability
• 25℃ / 60%RH stability and other zone configurations
• Stress studies

Novel Formulations

We work closely with clients to

• Run a FEASIBILITY study in order to rapidly and cost-effectively determine the commercial viability of a product
• Design and test formulation prototypes
• Convert the feasibility program to a full product development program once promising prototype formulations are identified
• Efficiently exit the program should the feasibility formulations fail to meet the client requirement(s)

NOTE – The FEASIBILITY PROGRAM includes evaluation of:

1. Novelty/process-ability
2. Manufacturability with existing equipment
3. Patentability

Vanton has an excellent track record for assisting clients earn patents through its novel platform technologies and/or processes.

Novel Delivery Systems

To assist clients in establishing intellectual property protection for their products, Vanton has the expertise and capability of designing novel product forms and/or processes.

In the past, Vanton has built several novel delivery systems for:

• Tablet/Capsule (IR, CR, ER, and other special pharmacokinetic forms)
• Oral disintegration tablet (ODT)
• Injectable (liquid, suspension, liposome, gel, cream, emulsion, microemulsion)
• Transdermal patch (matrix, reservoir, etc.)