Buckeye Pharmaceuticals

Although there are many drugs available to treat dermatological diseases, delivery of optimal doses for a number of disorders remains a challenge. Systemic administration of these drugs, through either oral ingestion or injection, requires extremely large doses, often accompanied by undesired toxicities or side effects. The obvious solution is to deliver the drug topically directly to the target tissue. Unfortunately, the barrier function of the skin restricts the quantity of drug delivered by conventional formulations. The small quantities of drug delivered limit the clinical efficacy of available topical formulations, resulting in frequent applications and long courses of treatment to provide only small, if any, clinical benefit.

Many approaches have been used to resolve these barriers to drug delivery. These include:

Transdermal diffusion
Iontophoresis
Electroporation
Microneedles & thermal poration

Iontophoresis, an electrochemical technology under development for nearly 20 years, has shown the most promise, utilizing a low-voltage electric current to induce fluid and particle movement. However, it is limited to a small class of drugs which are polarized and small enough to permeated the skin.

Buckeye's lead technology, MACROESIS^TM (patent pending) shows great clinical promise to overcome earlier limitations and open the door to a broad range of active compounds. It is ideal for delivering efficacious dosages in a non-invasive and safe manner. MACROESIS^TM goes significantly beyond the promise of iontophoresis by utilizing both AC and DC electrochemistry delivered through disposable electrodes and targeted drug delivery to actively push drugs to where they are needed.

MACROESIS^TM drug delivery utilizes electokinesis, a low-voltage electric current to induce fluid and particle movement. It involves the application of an electromotive force to transport ions and neutral molecules through a solid or liquid medium, in this case the protective stratum corneum, and into the epidermis. Ionized drugs (charged molecules) are transported actively by the force of the applied electrical field (electrorepulsion). In iontophoresis, like charges repel, so positively charged ions are driven into the skin at the anode (positive electrode), while negatively charged ions are driven into the skin at the cathode (negative electrode). Neutral, water soluble drug molecules are transported by electroosmosis, the bulk fluid flow associated with cation (positively charged molecules) transport by an electric field. Two electrodes are used in conjunction with the patient’s skin to form a closed circuit, which allows the flow of current.

MACROESIS^TM applies proprietary technology to polarize molecules, allowing a much wider classes of drugs to be take advantage of this process.

Our initial focus is onchomycosis ($1.6 billion market in US alone) in which antifungal drugs can be driven right through the nail cuticle to the actual location of the fungus growth. Initial prototypic tests show great promise for onchomychosis as well as numerous other therapeutic markets including herpes labialis and catheter infections.

Our EUTIFORM^TM technology uses a proprietary oral drug reformulation technology and has been shown to significantly improve solubility of active pharmaceutical ingredients by transforming physical structure without impacting chemical activity, thus maintaining their therapeutic effect. We have reformulated existing pharmaceuticals that have side effect challenges by creating a lower dose proprietary formulation. This would lower dosage required for immuno-suppressed individuals and offer new possibilities for viability of many existing drugs to new markets as well as new drugs under development. The initial reformulations will be licensed out to big Pharma and to generic drug companies.