As part of the development of the composition and technology of the lyophilized dosage form with the pharmaceutical substance (FS) GK-2, which possesses neuroprotective activity, model compositions and technological properties are studied with different temperature regimes of production. In connection with the peptide structure and low stability of the FS, the use of excipients stabilizing dosage form during the lyophilization cycle (cryoprotectants and lyoprotectors) was suggested. In this study, we selected the ratios of cryo- and lyoprotectors when using mannitol or sorbitol as a cryoprotectant, and as a lyоprotector for sucrose. Model compositions with different exipients ratios were studied by optical microscopy in polarized light to demonstrate the physical state of mannitol at different ratios of explosives. Using the Harrington generalized desirability function, the most optimal composition is chosen, which meets the requirements of SF XIII and has the most acceptable technological characteristics and optimal technological process.

The paper discusses the process selection of excipients to obtain tablets containing as active ingredients Ginkgo biloba extract and vinpocetine. We used the method of experiment planning and evaluation of the results using the desirability function. Shown the ability to use indirect indicators of quality tablets at the stage of preliminary selection of excipient composition. The result of experiment planning and evaluation of it for desirability function was able to select the optimal composition of ingredients to create the drug in the form of tablets containing a combination of vinpocetine and Ginkgo biloba extract.

Radiopharmaceutical with rhenium-188 and lypiodol is synthesized in medical organizations from a kit of reagents and eluate from the ¹⁸⁸W/¹⁸⁸Re generator. The kit of reagents consists of three vials: lyophilized reagent N 1 containing tin dichloride, lyophilized reagent N 2 - sodium dithiobenzoate, and reagent N 3 - lipiodol. A domestic technology was developed for obtaining a lyophilized reagent containing tin dichloride. Quality control of the sodium perrhenate, ¹⁸⁸Re solution obtained from the generator (eluate) should be carried out before each synthesis of the radiopharmaceutical. The results of quality control of radiopharmaceuticals synthesized from lyophilized reagent N 1 of domestic and imported production, showed their identity by index «radiochemical purity».

The article presents the results of rheological properties study of vaginal gels, registered in the Russian Federation. Was justified the optimal rheological characteristics, which can be recommended for use to the pharmaceutical development of vaginal gels. It is advisable to use the rheological optimum to select the type of packaging and method of dosing of vaginal gels according to their rheological characteristics.

There are presented a method for measuring the amount of pneumatic transported bulk material in particulate production. The method is based on the Pockels’ effect. The block diagram of the automated system for measuring the flow of bulk dielectric materials with an electro-optic Pockels cell is developed by the authors. The measuring system has a sufficiently high accuracy and speed, which is relevant for continuous flow monitoring in the technological process and quality assurance of pharmaceutical products.

Some biologically active additives based on synthetic organic germanium were analyzed. The contents of germanium element and microelements in the germa-nium-containing minerals and some herbal plants were studied. The necessity of the deepened investigation of the germanium content in domestic herbal plants and the development of a modern atlas of plants indicating all microelements determined by the newest high-precision methods is substantiated.

The article shows the approaches to the educational process in preparation for the specialty "Pharmacy" in Russia and The United Kingdom, using the example of the University of Bath. Described features of the teaching of pharmacy, characteristic for the construction of training courses in the UK.

Solubility is the most important quality indicator, reflecting the physicochemical properties of active pharmaceutical ingredients (APIs). Prior to the release of API, solubility is one of the key factors affecting the efficacy and safety of drugs. Therefore, the directed development of new drugs with predetermined properties (drug design) should be basedon solubility of candidate substances and be taken into account when evaluating the bioequivalence of generic drugs branded, including in vitro - in vivo correlation. Given that the pharmacopeia regulation of the test for the solubility of API is reduced to a visual estimate and approximate solubility, we developed a kinetic dissolution evaluation method by laser diffraction and performed statistical analysis of the results obtained under repeatability conditions.

A procedure for quantitative determination of 5-methyl-6-nitro-7-oxo-1,2,4-triazolo[1,5-a]pirimidinide l -argininy was developed using the HPLC method with UV detection. To achieve the best chromatographic characteristics, it is proposed to use a column with a grafted octadecylsilyl phase 5-100-c18 (EKA, Sweden). The possibility of applying the developed procedure for the technological control of the third stage of the drug «Triazid» preparation was proved by the validation.

The pilot studies on derivative synthesis based on pyrrolo-pyridine and pyrrolo-pyrrole groups possessing pharmacological activity have been conducted. Domino reactions principle has been used during the studies. The possibility of physico-chemical methods appliance has been studied in order to standardize the obtained chemical compounds. Synthesized benzyl ether 5-tert-butyl-1-benzyl-2,4-dioxohexahydro-1H-pyrrolo[3,2]pyridine-3a,5-(6H)-dicarboxylate and benzyl ether 5-tert-butyl-2,4-dioxo-1-phenethylhexahydro-1H-pyrrolo[3,2c]-3a,5(6H)-dicarboxylate were isolated by column chromatography (adsorbent - silica gel). The purity of products were monitored by TLC (thin layer chromatography) during the purification steps, eluent cyclohexane:acetone=3:2, sorbent on Silufol silica gel plates.

The reaction of hydrazide of corboxyethyl alginic acid with aromatic aldehydes was studied. The effect of the time limit, the reagent ratio and the structure of the carbonyl compound to delivery end of the product were determined. It has been established that electron-withdrawing substituting groups in the benzene ring of aldehyde accelerate the reaction of formation of hydrazones, and electron-donating-inhibit.

The investigation of the antifungal activity of promising new compound of some pyrazole-3-carboxamides containing the ion of silver, against clinical isolates of Candida spp. by means micromethod two-fold serial dilution in liquid medium was the aim of the study. The results of an in-depth study of these compound for clinical strains of Candida albicans, a typical pathogen that causes surface and invasive candidiasis, as well as for less frequent non-albicans species of Candida spp., showing resistance to the most commonly used antimycotics, are presented. The studied compound showed a high antifungal activity, including against to multiresistant clinical isolates (MIC of 0.03 to 4.6 mg/l).

The method of obtaining new heterocyclic compounds - chlorides 2-[(Z)-1-(3,5-diaryl-1,3,4-thiadiazol-2(3H)-iliden)methyl]-3,5-diaryl-1,3,4-thiadiazol-3 was developed. The structure and individuality of the obtained compounds are proved by the physico-chemical methods for the identification of organic compounds: ¹Н and ¹³С NMR, IR spectrometry, mass spectrometry. Antibacterial activity was defined against Escherihia coli, Staphylococcus aureus, Bacillus cereus. It was shown that these compounds have a pronounced antibacterial activity against gram-positive bacteria. The most active compound has been identified, which can potentially be used in medicine as an antimicrobial agent.

The problem was considered to determine bacterial endotoxins in human albumin drugs. To improve the safety of medicines the option of dual control was recommended, which includes the rabbit pyrogen test and determining bacterial endotoxins by the LAL-test. The causes described justify the need for dual control of albumin drugs on the content of the pyrogens/bacterial endotoxins, the main of which is the special nature of the albumin molecule reversibly binding a large number of compounds, including endotoxins. There were given known causes of false-positive and false-negative reactions of the LAL-test, and sample preparation variant including dilution, temperature treatment and the use of special dispersing agents.

Employees of the department of pharmaceutical chemistry and phar-maceutical technology received modified forms of terpene-indole alkaloids (TIA) - vincristine (VCR) and vinblastine (VBL) known in the therapy of oncological diseases by incorporating them into erythrocyte carriers (EN). This method of modification allows solving simultaneously the problems of directional transport of effective antitumor drugs and reducing the frequency and strength of side effects, and, consequently, increasing the patient's compliance to the prescribed treatment. In this paper, stability and shelf life studies of encapsulated TIAs in EN have been carried out. It was found that keeping TIA encapsulated erythrocyte form at +4 °С for 7 days is the optimal condition for storage of TIA preparations without significant reduction of the therapeutic dose (not less than 95% of the encapsulated amount).

The results of the study of the chemical composition of alcohol extract of tansy balsamic are given in this article. The component composition of samples of alcohol extraction samples was studied by gas chromatography-mass spectrometry. Qualitative analysis was carried out on the NIST-05 complete mass spectra library and corresponding to the values of chromatographic linear indices. Forty two compounds were identified indicated by the method of chromatography-mass spectrometry in alcohol extraction, obtained from balsamic tansy. Markers are the thujone, the carvone, the cineole, the limonene. The combination of compounds identified by the methods of chromatography-mass spectrometry makes it possible to identify this type of raw material.

The interrelation between accumulation of serious metals and water-soluble polysaccharides in roots of a Taraxacum officinale, collected in the territory of the Voronezh region in the natural biogeocenoses which are influenced various anthropogenic influence is studied. Results of a research of the selected samples of roots of a dandelion medicinal show, in general, ecologically safe condition of the studied medicinal vegetable raw materials. On the content of arsenic only two samples which are brought together close combined heat and power plants of «VOGRES» and the chemical company LLC «Bormash» are recognized as unsatisfactory. On accumulation of water-soluble polysaccharides of roots of a Taraxacum officinale serious metals don't exert the expressed impact.

Dissolution profiles of four extended release valproic acid tablets from different manufacturers and granules Depakine® Chronosphere 500 mg were studied in three dissolution media: pH 1.2; 4.5, 6.8 (quality control medium). Dissolution profiles similarity for tablets was approved and more rapid dissolution of Depakine® Chronosphere 500 mg was demonstrated in media pH 4.5, 6.8. API did slightly released in buffer pH 1.2 because of low solubility of valproate in acid form therefore these data were not taken into account.

Rabbits' model of local radiation burn has been imaged clearly in 48 h past injection of ¹¹¹In-labeled mesenchimal stem cells using three methods of injection (intravenously, locally, intracardially). SPECT Imaging of rabbits with model of skin radiation burn has confirmed possibility to use ¹¹¹In-labeled mesenchimal stem cells for imaging and studying of its migration and accumulation in pathologic foci.

The antiarrhythmic activity of 19 derivatives 1,4-dicarboxylic acids in experiments on white mice on the model of chlorocalcium arrhythmia and acute toxicity of 6 compounds. As a standard, the drug «Lidocaine» was used. Two compounds showed an antiarrhythmic effect exceeding the standard effect by 6 times [ED₅₀=7.3 mg/kg (5.3÷10.0)] and 3 times [ED₅₀=6.9 mg/kg (5.0÷9.5)]. 4-Aminobenzoylhydrazide itaconic acid has antiarrhythmic activity, the same derivatives of succinic, maleic, citraconic and dimethylmaleic acids are not active. Isonicotinoylhydrazide phthalic acid exceeds the antiarrhythmic activity of the standard, the same hydrazides of maleic, dimethylmaleic and tetrachlorophthalic acids do not possess an antiarrhythmic effect.

 

Аs a result of a set of scientific and experimental studies, gel and drug films have been developed that provide intensive mineralization of dentin. Previously conducted preclinical studies have studied the specific remineralizing activity and antimicrobial effect, as well as acute toxicity of dosage forms. To determine the anti-inflammatory activity, a model of acute inflammatory edema was used to evaluate the increase in the volume of the inflamed foot of rats, by introducing a phlogogenic agent. Based on the results obtained, it is established that the gel and the drug films have a sufficiently pronounced anti-inflammatory effect.

Studying the susceptibility of dermatophyte strains to naftifine revealed that the range of inhibitory concentrations (MIC) is 0,1-0,2 μg/ml. The naftifine spectrum is very wide and includes almost all mycotic pathogens. Testing the strains of Trichophyton rubrum, Trichophyton mentagrophytes, Microsporum canis and Epidermophyton floccosum in comparison with clotrimazole and 4-imidazole antimycotics has shown that naftifine is the most active drug affecting dermatophytes. In concentrations of no more than 1,0 μg/ml, naftifine inhibited 98,75% of dermatophyte strains. Naftifine hydrochloride can find a worthy use in the treatment of skin diseases against the background of infectious and inflammatory processes associated with mycoses.

The matter presents the analysis of results for GMP inspections of foreign manufacturing sites in 2017 and gives the comparison of them with the results from 2016. Statistical evaluation of the results obtained is also given. In comparison with the corresponding results from 2016, there is a significant increase in the total number of inspections conducted. The changes also reflected in the percentage of discovered GMP non-conformities both in terms of criticality and in the categories of good manufacturing practices. The article also presents some examples of discovered GMP non-conformities.

The key areas of focus of the WНO on the question of immunization and vaccines including anti-influenza vaccines are generalized. Domestic market of anti-influenza vaccines are analyzed. It is established, that Russian Federation is active participant of mainstreaming developing world in the area of immunobiotechnology.

Medicinal plant raw materials is a promising source for the development of drugs used for the prevention and treatment of thyroid dysfunction. It is interesting the study of the domestic pharmaceutical market in order to determine the proportion of drugs of plant origin, the above-mentioned pharmacological group. The results of this study indicate that among the drugs used for the prevention and treatment of diseases of the thyroid gland, drugs of plant origin do not exist; the largest proportion of the substances represented by the Russian manufacturers. At the same time, among the ready-to-use dosage forms, the form has an advantage, as a country of origin is Germany, which indicates the patient's dependence on supplies from abroad. The study also showed a lack of diversity of dosage forms of the studied group of drugs, which affects the adherence of patients to the treatment.

The article presents information about the organization of pharmacovigilance system in a pharmaceutical company. The main tasks and methods of pharmacovigilance achievement are described. The system of notification of adverse reactions of pharmacotherapy is described.