Aveva - Transdermal Drug Delivery Systems

The ideal partner to bring your product to commercial success, offering a breadth of transdermal innovation from a depth of experience.

Aveva Drug Delivery Systems is a Nitto Denko company, which is one of the world's largest manufacturers of and a pioneer in transdermal drug delivery systems with revenues exceeding $7 billion. Nitto Denko has a 40-year history of providing pharmaceutical partners with fully integrated, controlled-release transdermal products that fulfill unmet market needs or are high-quality, low-cost brand equivalents.

Leveraging this experience, Aveva offers a full range of research, development and manufacturing capabilities using a number of sophisticated technologies to produce proprietary and generic transdermal drug delivery systems that fortify R&D pipelines and enhance compounds by:

• Enhancing bioavailability via bypassing first pass metabolism
• Minimizing pharmaco-kinetic peaks and troughs
• Improving tolerability and dosing
• Increasing patient compliance
• Continous delivery

Commercial successes can be found in the following therapeutic categories:

• Smoking cessation
• Asthma
• Pain management
• Cardiovascular disease
• Dermatologicals
• Women's health
• Nutraceuticals
• Central nervous system

Approved products:

• Fentanyl Transdermal Patch (pain) - approved in the US and Canada in 2008
• Lidocaine Transdermal Patch (pain) - approved in Japan (sales revenue $15 million in 2008)
• Clonidine Transdermal Patch (hypertension) - approved in the US August 2009
• Clearback Nicotine Transdermal Patch (smoking cessation) - approved in the US and Canada
• ISDN (Isosorbide Dinitrate) Transdermal Patch (cardiovascular) - approved in Japan
• Tulobuterol Transdermal Patch (asthma, bronchitis, emphysema) - approved in Japan, Korea and China

Customized transdermal drug delivery systems

Our deal configurations are designed for maximum flexibility in accordance with the needs of our partners, and are as unique to each client as our customized transdermal drug delivery systems:

• Challenge our scientists to perform feasibility studies for transdermal administration of your product using innovative techniques in computer modeling and cadaver skin permeation testing
• Collaborate with us on R&D for new chemical entities (NCE) and accretive lifecycle management (LCM) of portfolio compounds
• Capitalize on global opportunities for commercialization of approved products from Aveva Drug Delivery Systems

Overcoming formulation challenges with creative solutions

At Aveva Drug Delivery Systems, we don't employ just one process in the development of transdermal drug delivery systems. We create individualized systems that are specifically designed for the chemical entity, rapidly and cost-effectively generating unique products to meet specialized needs.

We have a long history in overcoming significant challenges with our technologies:

• Drug-in-adhesive technology for volatile drugs
• Exclusive polymer combinations for solubility of crystalline drugs
• Unique multilayer designs for controlled delivery profiles
• Specialized formulations and processing for labile molecules
• Liquid systems for poorly soluble drugs and to maximum delivery rates
• Permeation-enhancer technology
• I:I manufacturing to packaging ratio for maximum productivity

We clearly recognize and understand the need for leading-edge capabilities and innovative technologies in order to open up a growing pool of new pharmaceutical compounds for transdermal drug delivery.

Proprietary gel matrix adhesive

At the forefront of innovation, Aveva and Nitto Denko produced the first and only marketed transdermal patch using a revolutionary gel matrix adhesive system for an unequaled balance of adhesion reliability and gentleness. Because the gel matrix adhesive doesn't cause a disruption of the stratum corneum (skin) during removal, these patches can be removed and reapplied with minimal skin irritation and a desirable patient experience is achieved.

Crystal reservoir technology

One of the most successful advancements in transdermal drug delivery systems, our crystal reservoir technology has resulted in smaller patches with a more controlled and sustained drug release. This efficient drug delivery technology may minimize the amount of active pharmaceutical ingredients required.

This efficient way of releasing a drug is based on the oversaturation of an adhesive polymer with medication, thus forcing a partial crystallization of the drug. The presence of both molecular solute and solid crystal forms allow for a considerably higher concentration and consistent supply of drug in each patch. As the skin absorbs the molecular solute, crystals re-dissolve to maintain maximum thermodynamic activity at the site of contact.

This technology is employed in the commercial production of the world's only Asthma Patch, which is sold in Japan and is one of the most successful patches in the world.