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08.21.12 – Scaling Up the Manufacture of Microneedle Arrays

August 21, 2012
Breakthrough in Drug Delivery

Scaling Up the Manufacture of Microneedle Arrays

Whether you’ve received a flu vaccine or an injection of pain-killer, you’ve experienced a long needle puncturing some part of your body. What if you could receive the same drug by application of a tiny patch on your arm? Imagine the benefit to those people who require frequent shots to simply receive a small self-applied patch instead. Imagine elderly patients not having to remember which pills to take. Imagine the potential for more efficient and less costly vaccinations worldwide, particularly for those in need of aid. Microneedle transdermal patches may enable all these possibilities.

10x Technology was recently invited to deliver a presentation at the 2nd Annual Microneedle Drug Delivery Conference held in Cork, Ireland from May 12-15, 2012. It was a fascinating and well-organized event attended by leaders in the field of drug delivery from around the world. The Conference explored the use of Microneedles, typically in the form of a transdermal patch, for the effective delivery of a wide range of drugs. The potential advantages of this delivery technique over conventional methods include the following:
  • avoids pain associated with parenteral injections;
  • provides a convenient and easy-to-use format (including extended dosing periods);
  • has a form factor that is more efficient to distribute, use and dispose (avoiding reuse issues);
  • may avoid side effects associated with oral administration;
  • and potentially can be manufactured for less cost relative to conventional needles.
Microneedles in the form of a transdermal patch open up a wide range of possibilities from the simple and convenient delivery of a single drug to what are seemingly “science fiction” possibilities. Imagine a patch on your arm that could read what is going on inside your body and deliver the precise amount of drug you need without any intervention on your part – an invaluable device for a diabetic who regularly pricks for glucose levels and must administer insulin shots.

In the event you are asking why conventional transdermal patches without Microneedles can’t be used to deliver these drugs the answer is quite simple. Our skin functions to keeping foreign molecules out. The molecule size of a significant number of drugs we humans (and animals too) need is too large to effectively transfer through the skin with conventional patches. A patch with tiny Microneedles penetrates the skin just enough to enable the drug to enter the bloodstream, but not so far as to create the pain and inconvenience associated with hypodermic needles.

So, what’s keeping this science fiction from becoming reality? A significant amount of testing has already been done. A number of early-drug candidates have been identified and are at various stages of pre-clinical and clinical trials. Of course, like any drug delivery device, the testing is extensive and requires considerable time and investment. A key outstanding issue remaining is scalability. Most of the microneedle arrays used in testing have been produced at labscale in small quantities out of expensive materials. What is needed is a manufacturing process technology that can ensure consistent and precision replication of large quantities of Microneedles and it must do so at an acceptable economic value proposition.

This is the subject matter that 10x was asked to present at the Microneedle Conference in Cork. At 10x, we have used our microreplication technology to design, master, tool andmanufacture Microneedles in a range of commercially -available polymers that could be used in transdermal drug delivery patches. We have supplied prototype samples to several companies for testing and we stand ready to support their needs to scale up production when needed under our contract manufacturing platform. The 10x process is capable of producing precision Microneedles (see table for tolerances) in large volumes at a low cost – this would be hundreds of millions of Microneedle patches today with potential to scale up as the industry requires. We join many of others in the life sciences community who are anxious to see this promising technology commercialized.
For additional information on 10x Microneedle technology, please contact Laurence Hayward at lhayward@10xtechnology.com or at (312) 508-3174. A copy of the presentation delivered in Cork is also available as are sample Microneedle arrays.