Why are most of the advertised medicines not always effective?
What is the cause of complications when taking medicines?
How can you explain that the development and production of new drugs are so expensive?
When we are talking about pharmaceutical industry, both doctors and patients have a lot of questions and reproaches in relation to manufacturers of drugs. However, most of them are easy to explain.
Last century pharmacology was limited to relatively simple molecules with a “coarse” effect on one or another function according to the principle of its intensification or inhibition. These drugs had high bioavailability, but, as a rule, non-physiological effect.
Modern pharmacology, based on the molecular biology principles, studies and develops drugs based on complex macromolecules. However, the accurate recipe, high-quality ingredients, high purification rate of medicines, created according to the last century traditional technologies, does not guarantee their effectiveness and safety. The main obstacle that drugs on the basis of macromolecules can not overcome – is low bioavailability and, accordingly, low efficiency. By oral administration, most of the healing components are being destroyed, getting into the gastrointestinal tract’s aggressive environment. Injection administration of drugs causes many side effects due to high antigenicity (foreignness) of active substances. The solution was found occasionally in the Institute of Cytology and Genetics of the Siberian Branch of Russian Academy of Sciences (SB RAS).
АХIS-technology – innovative technology for creating pharmaceuticals
It all started with the search of an enzymatic drug for the infected wounds treatment. Direct use of enzymes (proteases) began in the 50’s of the last century. It has been proven that enzymatic systems provide wounds to cleanse, and their deficiency leads to the spread of purulent infection to healthy tissues. However, by the 1970s it was clear that these high efficiency enzymes also led to severe side effects: proteases destroyed healthy tissues.
By the suggestion of Professor R.I. Salganik active enzyme macromolecules were attached to artificial polymers in the Institute of Cytology and Genetics of the SB RAS. The new composition gave amazing results: the wounds quickly cleansed and healed. Then, already being an academician, R.I. Salganik proposed the idea of “sewing” proteases together using electron-beam synthesis. Consequently, after many years of joint work with scientists of the Institute of Nuclear Physics named after G.I. Budker of the SB RAS, his student A.V. Troitsky realized the “sewing” technology.
Numerous animal tests have shown that the drug “Imosimaza”, which was produced for external use, is well absorbed when ingested and has anti-inflammatory and antithrombotic effects.
It was decided to develop a technology for obtaining enzymatic drugs for intravenous and oral administration. Finally, АХIS-technology was developed – the technology of biological substances immobilization.
Illustration of AXIS-technology
АХIS-technology in action
- Neutral carrier selection. The technology uses polyethylene oxide (PEG-1500) polymer, which is allowed to be used in the pharmaceutical industry. This polymer is an inert substance, i.e. does not interact with the body and is eliminated naturally. The properties of the polymer make it possible to preserve the biological effectiveness of complex macromolecules that will be connected to it.
- Electron beam time and energy selection. The scientists faced the task to calculate the optimal electron beam impact time and energy at which the resulting bonds would be strong enough that the molecules would not “fall apart”, but also not rigid, otherwise the new molecular construction would not be able to act in the body. The solution search took several years. To achieve the desired effect, the polymer is activated by a stream of accelerated electrons at energies of several megaelectronvolts (MeV).
- Macromolecules biological activity preservation. The combination of biologically active molecules with neutral polyethylene oxide molecules does not affect normally the initial biological activity. With the help of АХIS-technology, even traditional ingredients, such as aspen bark, sea-buckthorn berries, etc., retain high efficiency.
- New positive properties acquisition. The body perceives biologically active macromolecules as potentially dangerous foreign substances that need to be destroyed with the help of the immune system (allergy, inflammation, and anaphylaxis). Neutral to the body, the polymer “masks” the macromolecules, preventing dangerous and unnecessary defensive reactions from the body. At the same time, the positive properties of macromolecules are preserved.
Properties of the new drug that is produced with the help of АХIS-technology:
- curative effectiveness significant increase;
- substances acquire the ability to penetrate into the blood through the walls of the stomach and intestine when ingested, thereby bioavailability increases;
- sterility – the electron-beam synthesis process destroys bacteria and viruses;
- apyrogenic (absence of substances that cause an undesirable immune response (eg, fever));
- high storage stability.
Application of АХIS-technology in practice
АХIS™ technology has been successfully used in production for more than 10 years, playing a key role in creating new unique products – biologically active additives (BAA), pharmaceutical and veterinary drugs:
- dnaclub® – a line of highly effective supplements for the prevention and correction of a wide range of diseases;
- Trombovazim – the first thrombolytic peroral drug for the thrombosis prevention and thrombi destruction in vessels. It is used for heart attacks, strokes, chronic venous insufficiency prophylaxis and complex therapy.
- Imosimaza – a highly effective drug for the pyo-inflammatory diseases treatment. It is widely used in surgery, dentistry, pulmonology and veterinary medicine.