20-11-2009 Making A Patch
Making A Patch
Noven's most significant distinguishing characteristic is our
intellectual property. Noven's patch process is proprietary; we hold
over 30 U.S. and 100 international patents that protect it. And while
Noven will develop patches for license to others (Novartis AG and
Aventis for example), we prefer to seek out higher margin projects
that we can market ourselves before we consider development
projects for third parties.
Noven's formulation scientists and capabilities distinguish us as
well. All of Noven's patches use an advanced drug-in-adhesive
matrix, meaning that the drug is mixed with the adhesive that holds
the patch on the skin. Each completed patch is an ultra-thin, three-
layer laminate comprised of the patch backing, the drug/adhesive
mix and the release liner (the part peeled away and disposed of
upon application) (Fig. 1).
The design and development of the ideal combination of drug, adhesive and backing is where our technical know-
how and proprietary technology first come into play. Proper formulation ensures that the product will deliver a safe
and effective dose and adhere for the intended wear period. Our research and development group includes
chemical engineers who are formulation experts. In fact, both Noven's founder and its Chief Technical Officer are
chemical engineers by training.
The greatest technological challenge at this stage is preventing drug crystallization, skin irritation and failed
adhesion as the patch approaches the small size and high efficiency of Vivelle-Dot ®. Our DOT Matrix ® technology
is the solution to this challenge and is subject to several patents that do not expire until 2014.
Manufacturing presents its own challenges. We believe we have one of the most advanced patch manufacturing
facilities in the world. Located on our 10-acre corporate headquarters in Miami, Florida, Noven's facility occupies
about 80,000 square feet and has the capacity to produce 400 million patches per year. Quality control and
quality assurance systems check and double-check every step in the process.
Our facility is approved by the U.S. Food and Drug Administration and the Medicines
Control Agency of the United Kingdom, and is certified by the U.S. Drug Enforcement
Administration for the production of patches that contain controlled substances. Our
facility is busy and efficient, currently producing Vivelle®, Vivelle-Dot®, CombiPatch®,
Estradot ®, Menorest®, Estalis ®, Femiest ® and DentiPatch® for commercial sale
around the world.
We enjoy excellent production flexibility and are not reliant on third parties for
Figure 2 machinery engineering. Our in-house engineers can design, build and maintain most
production equipment, including special purpose and replacement parts. They can
also support R&D by rapidly fabricating or modifying equipment essential to that
function's specialized needs.