In this article we analyse key amendments that came into force as of October 2015 in the sphere of the price regulation for medicines included into the list of essential and vitally important products.

It was developed combined dosage form - tablets, each containing 0,25 g of acetylsalicylic acid and 0,1 g of cycvalon that meet the requirements of the State Pharmacopeia XII and State Pharmacopeia XIII. Addition of cycvalon allows to prepare tablets at a low pressure, which will reduce labor, energy costs of manufacture of tablets and to increase the service life of the press tool.

During steps of drug development area determination the decision area was framed providing isolation observed work activities from operating activities in order to set task achievement in specified time. Represented in the present paper approach to process analysis and implementation (including product development and lifecycle) characterized high level of concerned person involvement and high efficiency.

The article summarizes the modern technologies for producing solid dosage forms (SDF). Was presented an overview of technological equipment for laboratory development and pilot batches production of SDF. In particular, this material accumulates answers to industrial engineers requirements for the design of processing equipment developed for solving following tasks: solids milling, powder and damp substances mixing, granulating, tabletization, coating and packaging of finished solid dosage form.

The article discusses the development process of a combined medicinal product Phosphaladin^® intended for the treatment of HIV infection, based on phosphazide and lamivudine. A brief review of epidemiological situation on HIV infection taking into account the import substitution policy in the pharmaceutical industry, as well as the problem of providing HIV-infected patients require therapy. Considers the issues of pharmaceutical development combined drug and preparation of preclinical and clinical units of the registration dossier.

An extraction of birch buds was made using two types of extractants - with water and mixture of isopropyl alcohol: water with variable ratio. An ultrasound was used to intensify the extraction process. The effect of ultrasound on the quality of the extracts was evaluated on the various stages of the process. Experimentally the optimal mode of obtaining extracts of birch buds with high output of extractive substance was selected.

Currently nanotechnologies have a significant impact on the development of medicine. Silver nanoparticles is one of the most widely studied objects nanotechnology. The methods of preparation of silver nanoparticles. Examples of the use of silver nanoparticles in medicine and pharmacy.

Represented are the results of model experiments in the construction of chemical plague-vaccine transdermal variant prototype. Objective of the study is to demonstrate the possibility in principle to design natural biopolymer-based composite and feasibility of its application as depot antigens of chemical vaccines by the example of plague microbe capsular antigen.

Biopharmaceuticals intended for gene therapy are mostly presented by supercoiled plasmid DNA obtained with bacteria cell lines. The properties of their formulations, including stability under different storage conditions, are barely studied. This article describes the typical pharmaceutical development of freeze-dried gene therapeutics. By means of process analytical technological methods the preparations formulated were controlled during storage. Furthermore, the composition of the formulations was optimized for prolonged storage.

Therapeutics produced by eukaryotic cell lines could possible be contaminated with bioburden; the most dangerous for human is viral contamination. The article describes the problem of viral safety of biopharmaceuticals. The strategy of downstream process steps for the viral safety guarantee is discussed. The methods of viral inactivation, filtration, purification are given in the paper.

Two licensed vaccines Gardasil and Cervarix, containing main capsid protein L1 virus-like particles antigen, are used for prevention of diseases associated with human papilloma virus. L1 cannot provide protection against all pathogenic strains of HPV, shows low efficacy in middle and old age vaccinated patients, and are not therapeutically effective. The next generation of vaccines that contain minor protein L2 conserved epitopes as well as oncoproteins E6 and E7 promise to provide broad protection against all HPV, and prevent the emergence and spread of skin lesions.

Validation of UV-spectrometry assay method for dissolution profile test for levofloxacine tablets was carried out. The evaluated validation characteristics were: specificity, linearity, accuracy, precision, analytical range. It was shown than main validation characteristics meet the Russian State Pharmacopoeia requirements.

The article presents the results of a qualitative analysis of organic acids in the mixture of the multivitamin raw material № 2. Thin layer chromatography method was confirmed to contain apple, citric and ascorbic acids. Quantitative analysis of the amount of organic acids and ascorbic acid was conducted by potentiometric titration method developed by the authors. The results were compared with the datas of the indicator titration and coulometry. The advantage of using a potentiometer to more accurately establish the endpoint was showed.

The article presents data on the development of methods of quantitative determination of total flavonoids in the motherwort (Leonurus, L.) herb, infusion and tincture spectrophotometric method. The features and applications of differential photometry "through" standardization of medicinal plants and drugs based on it. It is proved, that adding acid leads to the formation of complexes of flavonoids with aluminum chloride in a ratio of 1:1.

Spectral characteristics of leaves and oil extract of a nettle by a two-blast furnace in various solvents are investigated. The characteristic strips of ab-sorption caused by presence carotenoids and chlorophylls are revealed. The method of spectrophotometry certain a content of studied pigments in leaves of a nettle by a two-blast furnace and an oil extract. The method bidimentional TLC leads division of pigments of investigated objects. The general characteristic zones detected as on the chromatograms of raw material, and an oil extract are revealed. Chromatographic profiles of pigments of each type of raw material and the oil extract received on its basis, has a unequal appearance that it is possible to use with a view of their standardization, using a method of «prints of fingers» biologically active substances on the chromatograms. Content of studied biologically active substances in an oil extract on two orders below in comparison with leaves that is maybe connected with features of allocation the given pigments fat vegetable oils. The choice of the best type of plates for division of pigments of leaves and an oil extract of a nettle by a two-blast furnace in a thin layer is lead.

Advanced products containing the biologically active components of chaga mushroom (Inonotus obliquus) have been reviewed. A great interest in chaga as a promising natural crude drug has been found. Conventional and innovative medicinal products containing chaga in any forms and amounts have been considered.

The article presents information on the distribution, on the use in traditional medicine, the chemical composition of plant material, pharmacological study of lady's mantle (Alchemilla vulgaris L.), as well as the results of a study in culture Vero cell toxicity and antiviral properties of aqueous solutions of dry ethanol extract of the aerial parts and the ethyl acetate extract of the roots of lady's mantle, growing in Western Siberia, in respect of the herpes simplex virus. It is shown that the extracts derived from both aerial parts and roots of plants have on the Vero cell culture antiviral activity against herpes simplex virus of 1 and 2-type.

Merits and demerits of six ways of an assessment of an intermediate precision (IP) for validation of analytical methods are considered. It is established that only four of them can be recommended for IP assessment, and three - with restrictions Recommendations about use of the considered ways of an assessment of IP are made. It is shown that use of the most widely applied way of an assessment of intermediate precision - on a relative standard deviation of set of results of chemists, can lead to receiving a wrong conclusion about an IP of a method. It is offered the new (most universal) way of an assessment of an intermediate precision, that has perspective of application in pharmacy.

The article describes the dissolution test results for the Betaserc (betahistine) IR tablets using the equipment with manual sampling and automatic sampling. The results were compared using F-test and Student's t-test and considered to be comparable for manual and automatic dissolution equipment.

Modern approaches of dissolution profile test were reviewed in terms of documents, research design, principles of choice of test conditions, selection and validation of assay methods, results evaluation and technique of the carrying out of experiment directly. The article reflects both Russian and foreign perspectives on dissolution profile test.

The purpose of the real research was studying of antidiabetic activity of new products of organic synthesis - guanidinium salt 2-aminophenylacetate. It was detected a pronounced hypoglycemic effect of the compounds when administered in intact animals and animals with alloxan diabetes model, and shows that the studied compound exhibits antiadrenergic effect and potentiates the effect of exogenous insulin.

A procedure for simultaneous quantitative determination of meldonium, L-carnitine, and γ-butyrobetaine in blood plasma by high-performance liquid chromatography with mass-selective detection and the isotopically labeled d9L-carnitine as internal standard is proposed. An algorithm for constructing calibration plots for the quantitation of biogenic plasma components (L-carnitine, and γ-butyrobetaine) is developed. The procedure is validated for the concentration range from 0,05 to 20 µg/cm³ and applied in a pharmacometabolomic study of blood plasma on protracted administration of meldonium as a monopreparation and as a complex with L-carnitine.

The review of current «cocktail» phenotyping methods for biotransformation activity determination enabling simultaneous characterization of main cytochrome P450 isoforms activity was made. Furthermore, the possibility of their application in clinical practice in order to correct administered drugs dosage for the purpose of minimizing drug adverse reactions appearance risk was assessed.

A sensitive method for quantification of pinoline and its metabolite in human plasma using solid phase extraction and high performance liquid chromatography with mass-spectrometry was developed. Analytical range was 250-1500 pg/ml both for pinoline and for 6-hydroxy-1,2,3,4-tetrahydro-β-carboline. The developed method may be used to determine the current status of CYP2D6 activity.

The article describes some approaches to choice of the most potent non-narcotic analgesics among agents investigated in various R&D stages. Preparations non-narcotic analgesics for relief of severe and moderate pain are relatively new area of pharmaceuticals. Their application is very important as an alternative to opiates. However, the actual number of drug candidates is very limited. As a result of the authors analysis one of the most potent non-narcotic analgesics (PNS neurons sodium channel blocker) - Tetrodotoxin (TTX) was recognized as the most promising. Currently FSUE «GosZMP» conducting preclinical studies of injectable preparation of TTX.

The article treats and summarizes the knowledge on the regulatory framework and the government procurements practice of medicinal products. The authors established that there are inconsistencies of the implementation of the regulatory requirements for the organization of government procurements. The necessity of distinctive features of medicinal products as the objectives of government procurement preferences for local manufacturers of medicinal products has been established. It is proposed to exercise a right of the Government of the Russian Federation in the setting of distinctive features of the specific objectives of government procurements (Part 5 of Article 33 of the Federal Law «On the contract system»).

A review of GMP-inspections results and the main found deficiencies was carried out. It was established that in the field of inspection of pharmaceutical companies the unresolved problems with the interpretation of the revealed deficiencies are still, i.e. with the objective (a unified, standardized) assigned to these inconsistencies to a criticality levels, which, in turn, affect the regulatory decisions. These problems are current not only to GMP inspections for Commonwealth of Independent States, but also to other inspections (included and not included to PIC/S). The unified procedure of assigning levels of severity with the subsequent completion of the document and its approbation on an international scale was proposed. For processing, ranking and summarize the results of the inspections we used the Pareto analysis for the first time. The results of this analysis allow place right priorities in planning and conducting of GMP-inspections, and for the enterprises - for rational use of the resources to address the causes, to get rid of the dominant issues (critical deficiencies). It was shown that the methodology for ranking of the identified deficiencies with the primary breakdown to the certain categories and followed by their grouping into separate blocks is perspective but needs to be developed and improved in future.

The article describes acute problem - absence of reference standards (Federal Reference Standards) of controlled ingredients of some potent pharmaceuticals (especially narcotic and psychotropic substances) in Russia. Authors present an algorithm for solving this task. According to regulatory documents providing traceability and technical regulation in Russian Federation requires use of the Federal Reference Standards for any official quantitative studies of narcotic and psychotropic substances. Lack of the reference standards does not allow provide: legally meaningful assessment of quality of medical products; to ensure industrial safety of work with substances belonging to list of dangerous goods; to conduct quantitative forensic analysis using instrumental methods, etc. Development of the Federal Reference Standards should be organized in the framework of technological cooperation of organizations (laboratories) which has necessary licenses. Production of the highest quality standards should be organized on a specialized facility where Federal S&T Center "Inversiya" has already made Federal Reference Standards of toxic chemicals. Creation and introduction in practices Federal Reference Standards of the controlled substances will provide scientific, technical and methodological foundations in development and implementation technologies for production of potent pharmaceutical ingredients in Russian Federation and solutions in the field of criminology and chemical safety and security.

The paper demonstrates application of the newly developed procedure for pre-selection of suppliers of active pharmaceutical ingredient to manufacture of drugs using the tools of risk analysis. The procedure allows to organize the process of selecting suppliers, to reduce the risk of acquiring the substance non-pharmacopoeia quality, to minimize the consumption of cost, time and manpower resources for qualifying manufacturers, to form a reasonable list of manufacturers to audit their production sites.

The paper presents the pages of life and some character traits of the Roman physician Galen. The source of information is the materials published in domestic and foreign literature.