Novel Formulations

We work closely with clients to

• First run a FEASIBILITY PROGRAM upon client’s request to ensure that
  An effective and commercially viable delivery system is feasible

• Design a series of cost effective formulation prototypes
• Terminate the feasibility program as soon as possible by
  Moving into the full development program if the prototype formulations are promising
• Exiting program if the developed prototype formulations do not meet the requirement following joint-assessment with the clients

NOTE: In the FEASIBILITY PROGRAM each formulation takes into account:

1. novelty
2. process-ability
3. manufacturability
4. no new equipment design needed, and
5. patentability

Vanton often incorporates know-how processes to further protect client’s patentability. As such, there have been many patents and know-hows established between Vanton and its clients in the past.

Beyond the Feasibility program, Vanton runs a full drug development program until at least phase I with its client unless there is no IND granted by FDA.

Novel Delivery Systems

At time clients may look for totally new delivery systems. In such cases, Vanton sets up an agreement with clients on how the delivery systems are to be designed to maximize patentability and to protect both our client’s and Vanton’s rights. Milestones and expectations are set forth for the project progress

In the past, Vanton had built several new delivery systems on

• Tablet/Capsule (IR, CR, ER, and other special pharmacokinetic forms)
  Oral disintegration tablet (ODT)
• Injectables (liquids, suspensions, liposome, gels, creams, emulsions, microemulaions)
• Transdermal patches (matrix, reservoir)

Product Development

Following successful feasibility study, the prototype formulations selected are further developed into product form:

• Establishing commercial dosage form [e.g., Tablet, Capsule, injectable liquid, cream, transdermal patch, gel, emulsion, microparticle, etc.)
• Developing analytical methods

For constructing commercial products, Vanton develops cost-effective manufacturing processes that is scalable with batch-to-batch variation that meets the industrial standard.

In this phase, it requires developing test methods, validating processes, and selecting the right equipment, and Vanton is equipped to assist its clients for a full drug development program.

More specifically, Vanton is capable of developing both 505B1, 505B2 and ANDA drug for its clients. Vanton is capable of

• Establishing and validating testing methods according to USP/ICH guidelines
• Identifying critical attributes and setting the drug product specifications
• Preparing PRE-IND CMC package and manufacturing GLP pre-clinical batches
• Preparing IND CMC documentation and manufacturing clinical materials

NOTE: Vanton is also capable of developing non-conventional R&D testing methods for speeding up development process as needed.

Patent Strategy

Protecting client’s intellectual properties (IP) is an area Vanton focues. Maximizing IP protection for the clients using formulation or delivery system technologies has been Vanton’s goal.

Vanton help clients in:

• Establishing an IP
• Strengthening an existing IP
• Enhancing the embodiments of claims