A project to produce a number of pharmaceuticals— anti-inflammatory drugs, diuretics, and statins in phospholipid capsules with extremely small particles (less than 30 nm) recently won approval from the Supervisory Council of RUSNANO. The total budget for the project is $27.5 million (831 million rubles). RUSNANO will invest $11.3 (341 million rubles).
As a result of implementing the project, in 2010–2015 a Russian company will establish original commercial production of medications that are without parallel in the entire world. The unique technology for fusing the most dissimilar drug substances in phospholipid nanoparticles was developed in the Russian Federation. It will enable the project company to enter the market with innovative and highly effective forms of medications in only one to two years, with minimal risk, and with a minimal budget.
The capsules of drug nanoparticles (micelles) are composed of phospholipids—natural fat molecules that form in cell membranes. Phospholipid nanoparticles easily penetrate the cells and free the active drug ingredients precisely where they are needed. Phagocytes and other cells of the human defense system that imbibe objects foreign to the organism are unable to distinguish the 15-nm to 25-nm drug nanoparticles. Therefore, the nanoparticles circulate in the blood stream longer and leave it largely in those places where the vessel walls are most penetrable. Those most penetrable places—for example, the locus of inflammation or tumor—often require therapeutic intervention.
The scientific investigator, the body responsible for conducting experimental work and medical trials for the project, will be the V.N. Orekhovich Institute of Biomedical Chemistry of the Russian Academy of Medical Sciences. Its chief, Academician Alexander Archakov, is one of the world’s leading specialists in medical nanobiotechnology. Project company EkhoBiPharmDubna, located in the special economic zone in Dubna, Moscow Oblast, will produce the nanomedications.
“Drug production and supplies to the drug delivery system is an innovative area of the pharmaceutical industry worldwide,” noted Academician Archakov. “The scientific group in this project has already made particularly valuable contribution to phospholipid-carrying nanosystems, making it possible to imbed in phospholipid micelles non-soluble substances—nearly 75 percent of all medications.”
The first series of drugs are expected to enter production and sale in 2011–2012. These will be nanoforms of indometacin (a non-steroid anti-inflammatory drug), prednisolone (a steroid anti-inflammatory drug), and chlorine-E6 (an active ingredient in photosensitizers—medications used to treat a long list of illnesses in oncology, otolaryngology, dermatology, dentistry, and surgery with an innovative method of photodynamic therapy.) In the second series of medication, 2012–2015, the project company plans to issue nanoforms of verospiron (a potassium-sparing diuretic) and the innovative statin nanophospholip (a drug that decreases the level of cholesterol in the blood and helps fight cardiovascular diseases).
RUSNANO Managing Director Olga Shpichko commented: “Drugs produced with this technology are going to be highly competitive in the marketplace because of the originality and universality of the know-how. The modest price of nanomedications and their considerably greater effectiveness than traditional counterparts will make the new drugs available to a huge portion of the populace. Therefore, this project has tremendous social importance.” The project was announced on January 18th, 2010.
