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Nanotechnology of Microemulsions. NanoMedex Pharmaceuticals, Inc. has developed a formulation strategy to allow drugs that are only soluble in oil to be soluble in water. To administer a drug intravenously the drug must first be dissolved in water. The NanoMedex nanotechnology formulation strategy utilizes components that encapsulate the active pharmaceutical ingredient (API)  into spheres (5-30 nm) so small they allow the drug to become randomly dispersed in water and act as if the drug has dissolved in the water.

Broad Based Technology Application

The human body is composed of over 70% water. Intravenous drugs are given to man in an aqueous solution. To administer a drug intravenously the active pharmaceutical ingredient (API) must first be dissolved in water. The NanoMedex (NMDX) nanotechnology formulation strategy utilizes components that encapsulate the APIs into spheres. These spheres are sufficiently small to allow the API to become randomly dispersed in water as a nanoemulsion, and act as if the API has dissolved in the water.

Delivery of poorly water-soluble active pharmaceutical ingredients is therefore a major industry-wide challenge facing pharmaceutical companies. A number of approaches utilizing solubilizing agents with various degrees of biological activity has been the industry standard. Eliminating these components by developing novel microemulsion formulations, which replace problematic excipients or, combinations of excipients will increase the safety and efficacy of the drug thereby decreasing the rate and severity of side effects. Any drug that has poor solubility in water is an ideal candidate for the NMDX formulation strategy. Virtually all-new chemical entity (NCEs) drugs have an oil or solid form, which makes it a potential product for formulation by microemulsion technology. NMDX’s patent rights extend across well over 100 drugs and drug classes. The NMDX formulation strategy is being applied to a wide range of drug classes including chemotherapeutics, anesthetics, anti-infectives, anti-inflammatories, immunosuppressants, anti-arrythmics and vitamins.

First Drug Application- Propofol

NMDX has selected Microfol™ as its lead candidate in development of its nanoemulsion technology. Microfol™ is NMDX’s reformulation of Astra Zeneca’s Diprivan®, an approved anesthetic drug formulation containing propofol in a lipid based formulation. This product is now available as a generic product. Existing lipid-based formulations are associated with a number of complications directly attributable to the macroemulsion’s formulation components (i.e. bacterial growth, egg allergy) in prolonged ICU use (i.e. hyperlipidiema) and since the current formulations have high levels of biologically active excipients these have been implicated in promoting bacterial growth and have contributed to systemic infections in patients.

The NMDX nanoemulsion formulation potentially resolves these clinical limitations and complications associated with use. This safety risk and the need for anesthesiologist’s monitoring has limited propofol’s use outside of the hospital settings. Microfol™ is anticipated to increase options for use in ambulatory surgical centers (ASC) as well as hospital settings. This is due to Microfol™ containing surfactant excipients generally regarded as safe (GRAS, IIG) and previously approved by the FDA. Additionally, these formulation components are not expected to present the same risks as the lipid based components

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