Successful Product Commercialization

By Robert Becker

“With increasing challenges facing drug discovery, we see the lifecycle management strategy for product portfolios becoming more important for all of our pharmaceutical partners”
-Robert Becker, Eurand

The breadth and depth of Eurand's oral technology platforms enables us to combine and adapt the technologies to the drug substance, turning difficult drug candidates into easy-to-administer products for patients. Our expertise lies not only in our proven oral pharmaceutical technologies, but also in our capabilities ranging from formulation development and analytical testing, to small batch GMP-manufacturing and full scale commercialization. These key attributes, paired with scientific professionalism and patent protection on our technologies and formulations, attract our partners and allow us to extend and maximize the market potential of our partners' therapies, whether prescription or over-the-counter.

With increasing challenges facing drug discovery, we see the lifecycle management strategy for product portfolios becoming more important for all of our pharmaceutical partners. Generating products with key differentiating benefits, gaining clinical and regulatory approvals and enabling patient convenience are all important considerations that must be achieved when developing new formulations of existing drugs.

At Eurand, we address these issues by assessing a variety of existing drug features such as API properties, physical characteristics of the desired dosage form and in vivo requirements, to name a few. Our R&D team then determines and tests the most appropriate technology or combination of technologies to apply that will produce an optimal formulation with enhancements such as increased bioavailability, custom release profiles and patient-friendly organoleptic properties.

When working with pharmaceutical partners, our aim is to convene as a single project team, aligning on the goals and objectives of the project. Key to this approach is a communication pathway promoting teamwork. Strong management support, the use of metrics and continuous improvements are implemented effectively to provide an environment that fosters success.

Whatever the size of our partner, the approach is similar. We work with our partners to completely understand the market requirements and the desired product profile. We then create a comprehensive development plan that combines our scientific resources with clinical and regulatory expertise, which includes a program designed to achieve the product timing and budgetary targets required by our partners. Our partners value the ability to be a part of the process every step of the way – for example, the development deliverables are jointly reviewed at key milestones in order to allow the partner to track the program appropriately and make timely adjustments, if necessary.

Developing Lamictal ODT

Some of the most common reasons for poor patient compliance with drug therapy are poor taste and difficulty in administering the drug. Our goal was to work with GlaxoSmithKline to provide an effective formulation of the product that is pleasant tasting, easy-to-swallow and convenient. The development of Lamictal ODT came as a result of our collaborative process.

We used our AdvaTab ODT technology, which makes use of our proprietary granulation and tableting processes that allow the tablet to disintegrate rapidly in the mouth without chewing or the need for liquid. We combined this with our Microcaps taste-masking technology, which provides a coating that encapsulates drug particles, forming an inert barrier between the medication and the taste buds while still allowing the drug to dissolve in the stomach.  The Microcaps coating technology employs a distinctive coacervation process and can also incorporate spray coating, creating polymeric membranes of differing porosity and thickness to encapsulate drug particles. Because the coated particles have a very small size, the formulation can be created to have a smooth and pleasant 'mouthfeel' for patients.

Through successful partnerships such as this, Eurand adds value to pharmaceutical brand portfolios while continuing its commitment to develop and commercialize products that better address patient needs. Eurand develops, manufactures and commercializes enhanced pharmaceutical and biopharmaceutical products based on proprietary technologies, and has developed successful alliances with leading pharmaceutical and healthcare companies. We recently co-developed a new formulation of Lamictal (lamotrigine) with pharmaceutical partner GlaxoSmithKline. Approved by the United States Food and Drug Administration (FDA) in May 2009, Lamictal (lamotrigine) ODT (oral disintegrating tablets) represents Eurand's fifth FDA-approved drug since 2001.

For more info please vitist www.eurand.com.

Robert Becker, Ph.D., is Chief Research Officer of Eurand and oversees all research and formulation development activities worldwide. His background includes senior management positions at Biogen Idec GmbH, Lilly Research Laboratories and Boehringer Ingelheim. Dr. Becker holds a degree in Chemistry and a Ph.D. in Physical Chemistry from the Technical University of Munich, Germany.