Microneedle tech to boost intradermal drug delivery

The microneedle technology has been licensed from the Georgia Tech Research Corporation (GTRC), and consists of hollow microneedles made by microelectrical mechanical system technology (MEMS) designed to painlessly increase permeability of the skin and allow fluid delivery with less risk of clogging. The GTRC has made sharp-tipped, solid polymer microneedles as a core structure, which are then coated with metal to add strength. Following the agreement announced yesterday, Apogee now has exclusive rights to a US patent application and know-how related to the design and manufacturing of microneedle-based drug delivery systems from GTRC. With the GTRC's technology offering low fabrication costs among other benefits, Apogee believes that once fully developed, the technology will support efficient manufacturing of its own intradermal drug delivery system PyraDerm, as well as helping to boost the product in the marketplace. "We believe that when the technology is incorporated, we will be able to increase the drug dose our PyraDerm system can deliver and thereby expand the potential market applications,"​ said Apogee's chief operating officer David Meyers. "In addition, we believe the technology will facilitate the development of the effective manufacturing process consistent with the stringent requirements of the pharmaceutical industry." ​ Apogee has high hopes for it PyraDerm delivery system, and is pursuing a dedicated development plan for the product. The device itself consists of an array of silicon micro-pyramids approximately ¹​/50 inch long, covered in a proprietary solid state drug formulation and supplied in a patch applicator. The company believes the drug delivery system has an edge over other products as it is able to encapsulate a range of therapeutic compounds that are highly insoluble or have very low bioavailability, as well as the ability to precisely release the drug either instantaneously or over a set period of time. The firm is aiming to apply PyraDerm for the delivery of large molecules based drugs such as proteins, peptides and antibody-based medicines. "We believe the benefits of our PyraDerm solution will make it attractive for the delivery of vaccines, high potency protein-based drugs, as well as for the delivery of certain other active ingredients,"​ Alexander Andrianov, vice president of R&D at the company, said last week. "PyraDerm may also be suitable to the delivery of large molecule protein and polypeptide drugs, which are among the most effective treatments available today for certain diseases. These drugs cannot be delivered with traditional passive transdermal patches and are a challenge to deliver orally because the can be deactivated during digestion." ​​The length and design of the microneedles can be manufactured to ensure optimal delivery of specific drugs into the skin, and the company believes the solid state drug formulation used could improve the stability of biologically active compounds compared to liquid formulations - which could also enhance shelf-life and ease transport and storage issues. PyraDerm has been designed as a potentially low cost, painless delivery system that could provide pharmaceutical companies a potential means of extending patent protection for current drug formulations. Apogee intends to incorporate GTRC's technology into its delivery system during the first half of 2007, and begin in vivo​ evaluation of the product over the next few months. During the past year the company has also initiated steps to establish pharmaceutical industry compliant manufacturing methods and regulatory strategies, efforts which will be expanded during 2007.