Scientific approach

The company's product range is based on a technology that refines upon the inhaled formulation for delivery of active pharmaceutical ingredients (APIs).

The scope of the technology covers the treatment of systemic and infectious diseases (tuberculosis, oncology, pulmonology, cardiovascular diseases etc.).
Problems and challenges in the market of treatment of systemic and infectious diseases
An enormous number of patients in Russia and worldwide are treated with highly toxic medications. Such therapy regimens are necessary, for example, for tuberculosis, oncological and other systemic and infectious diseases. Systemic intake of highly toxic medications (in the form of tablets for oral administration) is complicated by severe side effects.

The main programs of chemotherapy presuppose simultaneous intake of various medications. In this case, the concentration of active substance in each medication must be at a high level to achieve the desired therapeutic effect.

The practice of chemotherapy for tuberculosis and oncology shows that in the face of severe side effects, patients avoid, feign or refuse treatment. This causes the formation of multiple drug resistance and the need to use combinations of even more expensive and toxic medications to continue therapy.

It is impossible to calculate the accurate dose of the substance that got directly into the blood, and, therefore, the accurate therapy cannot be prescribed because of the individual characteristics of each person (low bioavailability in case of oral administration).

There is an alternative method for delivery of active substance - inhalation. Using this method, it is possible to significantly increase bioavailability and to avoid the harmful effects of chemicals on human organs and systems by delivering the active substance directly to the pulmonary circulation through the air vesicles (lower lungs).

Currently, the inhalation method is used to treat respiratory diseases. This is due to the fact that existing ultrasonic nebulizers are able to deliver particles of matter only to the upper lungs. Attempts to create an inhaler capable of delivering the active substance to the air vesicles were unsuccessful. Either the particles are too large and do not reach the alveolar region, or their concentration is so low that, in order to achieve the desired therapeutic effect, inhalation should last dozens of hours.
Solution
Within the framework of integration projects of the institutes of the Siberian Branch of the Russian Academy of Sciences, a technology has been developed to create stable aerosol forms from solid forms of APIs. The active substance in such aerosol reaches directly the alveolar region of the lungs with the subsequent highly effective transition to the pulmonary circulation.

The obtained aerosol has a high (up to 10⁹ 1/cm³) and stable concentration of API particles during the entire inhalation period. The technology allows the use of stable forms of aerosol of various medications to treat a wide range of diseases.

This approach allows:
1. To significantly reduce medication dose to achieve a similar therapeutic effect using an aerosol form (an alternative to the oral method of API administration).
2. To improve the quality of life of patients due to a multiple reduction in toxicity of treatment and a reduction in side effects compared to oral administration of APIs.
3. To increase the adherence of patients to treatment, which will lead to a reduction in the number of patients infected with multidrug-resistant strains.

Achievements
The Scientific Project Team has been conducting research and development of a technology for improvement of the inhaled formulation for delivery of active pharmaceutical ingredients since 2006. To date, the results have been obtained, allowing to create market solutions and to implement the product in medical practice.
1. The mechanisms of formation and control of stable forms of medicinal aerosols have been studied;
2. The mechanisms of delivery of particulate aerosols to the systemic circulatory system and their sedimentation in the lungs have been studied using the example of known medications;
3. A method for generation of a stable aerosol has been developed and patented;
4. A prototype of a universal aerosol inhaler has been developed;
5. The composition of materials for manufacture of an API container has been determined, allowing to operate in a heating mode over 200 degrees Celsius
6. The models of study of the biological effect of medicinal aerosols on laboratory animals have been developed;
7. The pharmacokinetic and pharmacodynamic properties of aerosol of various APIs have been studied on laboratory animals;
8. An extended laboratory study of isoniazid was undertaken, including on infected laboratory mice, which confirmed the presence of a similar therapeutic effect when the dose of the active substance is reduced by 5 times.
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