Microneedles - A Novel Alternative in Selected Drug Delivery Areas

Microneedles are a novel drug delivery technology that can offer promising advantages as an alternative to classical needle injections and other routes of administration. Therefore Vetter, global provider of aseptic prefilled drug delivery systems and Microdermics, a medical device company developing a novel hollow, metal microneedle drug and vaccine delivery system, have entered into a strategic cooperation.

The market in alternatives to traditional needle injections is forecasted to grow rapidly, reaching in excess of 480 million units by 2030 according to a Roots Analysis report. Driving this growth is the market need to provide delivery systems with increased patient convenience and thus, compliance. Microneedle technology may offer one such solution.

A Novel Approach That Presents New Opportunities for Drug Delivery Procedures

Microneedles are a novel technology that can offer advantages as an alternative to classical needle injections and other routes of administration. The key to this promising technology in the field of vaccination, and currently in testing for biologics, is reducing the injectable dose needed to trigger an immune response, as well as accelerating drug absorption by the body. Additionally, because traditional syringes deliver drugs with a hypodermic needle directly into the muscle or subcutaneous space, they can cause pain and bleeding, depending on the individual pain perception and body characteristics.

Several forms of microneedle technology are available today including hollow needles in which the drug runs through the needle, solid needles where the drug is placed directly on the needle itself, and dissolving microneedles that deliver encapsulated drugs in a minimally invasive manner. Such microneedle delivery systems have, so far, had limited success due to the materials used (silicon and plastic), which significantly limit their commercial scalability and robustness. Furthermore, there are roadblocks to commercialization of this technology mainly due to limited investment in scalable aseptic manufacture at the later phases of development.

A Cooperation to Investigate & Develop Microneedle Technology for Selected Drug Delivery

To overcome these hurdles Vetter and Microdermics have joined forces to lever the expertise of both firms and enable process development and device manufacture on a commercial scale. Microdermics has developed a novel, metallic microneedle drug delivery platform. With Microdermics’ microneedles there is only upper dermal penetration as the drug delivery system has hollow, metallic microneedles that are less than 1mm long. Thus, blood vessels and nerve tissue are avoided, resulting in enhanced patient convenience and increased patient compliance.

An economic benefit of Microdermics’ hollow, metallic microneedle delivery system is its efficacy. Biologics currently delivered with a traditional hypodermic needle often go into either the muscle or the subcutaneous space, yet the same medications delivered to the upper dermis with a microneedle may provide well-documented dose sparing effects. Microdermics’ hollow metallic microneedle technology is commercially scalable and capable of pain-free injections into the pharmacokinetically beneficial intradermal space, providing improved comfort and treatment to patients. The company has successfully demonstrated the initial safety of its microneedle system, and is planning Phase 1 human clinical trials for vaccine and therapeutic delivery, to be initiated in 2017.

As global operating contract development and manufacturing organization (CDMO), Vetter supports its customers with the combined portfolio of device development and associated drug product manufacturing and packaging services. The company tries to integrate its customers in technological advancements as early as possible. Microdermics‘ injection systems will be jointly tested and performance validated in order to enter into dialogue with (bio-)pharmaceutical companies on this innovative technology.

For more information about Vetter and Microdermics, as well as their corresponding individual service portfolios, please visit: www.vetter-pharma.com or www.microdermics.com.