The review presents the geographical distribution, botanical description, chemical composition, information about the use in medicine and the study of the pharmacological activity of the representatives of the genus Genista L. It is shown that the plants of the genus are widely distributed on the territory of the Russian Federation, however, it is rather difficult to systematize the plants of the genus of interest on the basis of morphological characters, since they have an extensive habitat and, accordingly, the morphological characteristics of one species vary greatly within the range. Plants of the genus have a rich composition of biologically active substances. At the same time, an analysis of literature data on products of the secondary metabolism of species of the genus Genista revealed an uneven degree of their knowledge. Infusions and decoctions from the grass of Genista are used in folk medicine as a diuretic, choleretic and laxative, and an analysis of literary sources showed that plants of the genus are promising in various pathologies. The authors of the review showed the need for a complex morphological, anatomical, phytochemical, and molecular genetic study of plants of the genus Genista to clarify the taxonomy and introduction into medical practice.

Alkaline hydrolysis of amide carboxyethylalginic acid, obtained by alkylation of alginic acid with acrylamide was carried out. The synthesis of carboxyethylalginic acid, which was not described before in the literature, was carried out. Conditions for obtaining polyacid were studied. The reaction of its esterification was investigated. The effect of acid concentration, reaction time and degree of carboxyethylation of the polysaccharide on the degree of esterification and the yield of the target product were shown.

The article presents information on the structure, classification and functions of NO-synthases. The main inhibitors of the enzyme, as well as their mechanisms of action, are considered. Among the substances activating the activity of the enzyme, special attention was paid to substances of nucleotide-peptide nature, using the example of a substance isolated from Saccharomyces cerevisiae race 14, it was found that the nucleotide preparation based on a substance isolated from Saccharomyces cerevisiae race 14. has a more pronounced activating action in comparison with T-activin, and helps to restore the functions of the enzyme in diseases such as diabetes.

The paper presents an overview of the structure and functions of caspase group enzymes. The main stages and ways of development of programmed cell death - apoptosis were demonstrated. The mechanisms of inhibition and activation of caspasesand their role in cell apoptosis are demonstrated. The different stages of caspase activation in the body are still insufficiently studied. At present, the structure, properties, key points of the functioning and regulation of caspases in the body have been studied in detail, but at the molecular and cellular levels it is not enough to directly regulate their activity. Modern studies of the effect of artificially created substances of different nature on these enzymes, in turn, open up prospects for further search for methods of their regulation, which in turn would allow using the knowledge gained in the treatment of oncological, autoimmune and neurodegenerative diseases.

The present study is devoted to the creation and study of transdermal dosage forms with mexidol and experimental substantiation of their therapeutic efficacy. The original technological scheme of production of one of the most popular structures transdermal - transdermal patches with mexidol. Selected efficient packaging, a shelf life of dosage forms. Developed, justified, biopharmaceutical research confirmed the optimal composition cohesive mass. Conducted optimal standardization of patches according to the most characteristic and important indicators. Studied local irritating effect and hipersensitivity proposed dosage form. Investigated and confirmed the ability of transdermal forms of mexidol to percutaneous transport.

The aim of the study is the development and standardization of granules in hard gelatin capsules based on the composition of dry extracts of Bidens tripartita L., Solidago canadensis L. and Agrimonia eupatoria L. herbs, possessing nephroprotective activity and antifibrotics in toxic nephropathies. Developed the structure and defined the quality indicators of the pellets with dry extracts of Bidens tripartita L., Solidago canadensis L. and Agrimonia eupatoria L. herbs. The quality specification for the drug - granules of the composition of dry extracts in solid gelatin capsules is developed.

The risks for the functional characteristics of Salbutamol pressurized metered dose inhaler (pMDI), such as the uniformity of delivered dose, the distribution of salbutamol particles at the stages of the Andersen impactor (apparatus D), and the respirable fraction, were studied and identified. It is shown that these risks can be associated with the solubility of salbutamol sulfate (SS), the formulation of pMDI, the water content in the SS and ethanol, as well as the particle size distribution of SS. A relationship is shown between the particle size distribution of the SS, the rate of their sedimentation and the performance characteristics of the preparation. The properties of SS crystals are investigated and the possibility of enantiomers presence is shown. The risks associated with the production process, the materials of the primary packaging and the correctness of the quality control procedures are discussed. It is shown that the use of containers made of aluminum alloy EN AW-5052-0 without internal coating does not pose the risk of the release of elemental impurities into the preparation. Unjustified replacement of actuators may pose a risk to the performance characteristics of Salbutamol pMDI and in vitro equivalence as compared with the reference medicinal product.

The characteristic of disintegrants used in technology of solid dosage forms is reviewed. The effect on release of substances of different classes from the tablets according to the biopharmaceutical classification system is presented. The characteristic of disintegrants used in technology of solid dosage forms is reviewed. The mechanisms of their action and methods of compounding into tablets, as well as factors that must be considered when choosing the optimal disintegrant, are given. The results of studies on the effectiveness of various disintegrants (crospovidone, croscarmellose sodium, sodium starch glycollate, etc.) on the release of active substances of different classes according to the biopharmaceutical classification system from tablets are discussed. A promising use of co-disintegrating agents in the technology of tablets of substances of class II BCS is highlighted. Examples of disintegrants of natural origin (mucus) used in tablets dispersed in the oral cavity are given.

The work is devoted to the development of nasal spray containing naltrexone hydrochloride. Naltrexone in doses of 3-5 mg/day acts on the opioid growth factor receptor (OGFr) and toll-like receptor 4 that makes it promising for use in the complex therapy of autoimmune diseases and conditions caused by impaired immunity. To prevent leakage of the drug from the nasal cavity, the thermosensitive poloxamer (Kolliphor® P 407) was introduced into its composition. The dynamic viscosity was studied of model samples in the temperature range of 7-37 °C. The rate of dialysis and the degree of release was investigated of naltrexone. Selected the optimal composition to create a comfortable to use drug «Naltrexone hydrochloride, nasal spray», 25 mg/ml.

Experimental study of the hypoglycemic properties of composition, prepared from medicinal plants has showed in terms of glucose tolerance test. There increases in animals by loading of glucose the tolerance to carbohydrates. The conclusion about the prospects of further pharmacological study of the original composition prepared from medicinal plants is positive with the aim of developing the antidiabetic agents.

Rosaceae plants are widely used in medical practice. Many species of this family, including representatives of the genus Meadowsweet, are used in folk medicine. Little-known representatives of the genus are the Meadowsweet kamtschatica - Filipendula kamtschatica (Pall.) Maxim. and the Meadowsweet palmata - Filipendula palmata (Pall.) Maxim. Filipendula kamtschatica has a Pacific type of range, is endemic to the Russian Far East. Filipendula palmata is widely distributed in Eastern Siberia and the Far East. Both species are easily cultivated. In the aerial parts of plants contain various groups of biologically active substances: compounds of polyphenolic nature (tannins, flavonoids, phenolic acids); essential oils, triterpene compounds, vitamins, amino acids, polysaccharides. Filipendula palmata use in folk medicine as an anti-inflammatory, diaphoretic, diuretic, anthelmintic, astringent and restorative means, in the treatment of rheumatism, arterial hypertension, nervous disorders, upper respiratory tract and epilepsy. Filipendula kamtschatica has hemostatic, anti-inflammatory, analgetic, astringent, diuretic and antiscorbutic effects. Data on the morphological and anatomical study of the leaves of these species of the meadowsweet are absent in the literature. The purpose of this work is to develop criteria for the authenticity of the leaves of the Meadowsweet palmate and Meadowsweet kamchatika such as morphological and anatomical signs. The objects of the study were dried leaves of Filipendula kamchatika harvested in St. Petersburg and Leningrad region from cultivated plants in 2011-2012, and leaves of a Filipendula palmata collected in 2014 in the Republic of Buryatia. The appearance of the leaves was studied using a binocular magnifier; their anatomical structure was determined by preparing temporary preparations using a microscope «Micromed-1 VAR 1-20». The main macroscopic signs of the leaves of the two species of the Filipendula have been determined. In surface preparations, the epidermis of the upper side of the leaves of the Meadowsweet kamchatika and the Meadowsweet palmate morphologically differs from the epidermis of the lower side. The upper epidermis consists of polygonal cells with straight walls, in the Filipendula kamchatika places with a clear-shaped thickening. The epidermis of the lower side consists of cells with winding side walls. Stomata anamazing type. The general anatomical signs of the leaves are simple, thick-walled unicellular hairs with an expanded base and druses of calcium oxalate crystals in the mesophyll. For the leaves of Filipendula camtschatica are characterized by thin-walled capitate hairs, with 1-2-cell oval head on 2-3-(6)-cell stem. In the leaves of Filipendula palmata there are thin-walled unicellular hairs of different lengths, secretory cells, idioblasts with yellow-brown content were found in the mesophyll of the leaf.

The article contains materials, methods and results of preclinical experimental test of acute toxicity of drugs «Ibuprofen», suspension for oral administration [for children], LP 001651 from 13.04.2012 and referent «Nurofen for children», suspension for oral administration, P N014745/01 from 22.08.2008. Ibuprofen preparations compared were found equivalent in acute toxicity studies. The work will be continued in order to prove the bioequivalence of the claimed preparations.

The aim of this work was to study the distribution of the labeled ¹²³I peptide-protein drug Cellex in organs and tissues of rats after single intravenous injection and accumulation. After a single intravenous injection of radiolabeled [¹²³I]Cellex it was found that the drug is characterized by rapid distribution into tissues and organs. The highest content of the drug in all organs and tissues was observed in 15 minutes after its administration. It was established that the drug penetrates the blood-brain barrier and about 6% of the drug accumulates in the brain, which is 10% of the total amount of the drug found in all organs in 15 minutes after administration.

Center of Pharmaceutical Analytics purchased and installed LabWare LIMS laboratory information system, LabWare ELN electronic laboratory journals from LabWare company. At the moment, the system is integrating into the work of the laboratory, templates for research work are created and employees are trained. The article opens a series of articles of the integration of the LIMS system into the work of the analytical center. LabWare has received universal recognition, is a leader in the global market of global Laboratory information systems (LIMS) and has a wide range of loyal users.

Background: Non-clinical and clinical overviews are an obligatory part of the Common Technical Document, that is the new format of the registration dossier in the Russian Federation and Eurasian Economic Union. Development of the overview demands on specific skills of the literature search and critical appraisal and also of systematization of scientific data. Goal of the paper consists of the description of the latest legislative rules about the development of the reviews for generic drug application by Russian national and EAEU rules and also practical experience of SMA LitReview. Conclusions: The review is one of the key elements of the generic drug dossier now in the Russian Federation and EAEU. In some cases, the review can replace the results of own trials of the Sponsor. Review process demands skills of the use of the international bibliographic databases, critical appraisal, good academic writing skills and also knowledge of modern Russian and EAEU law.