The article provides a brief overview of the use of solid dispersions of NSAIDs with polymeric carriers. Solid dispersions are entered in various dosage forms for different purposes. The data are provided on the use of different dispersions to optimize biopharmaceutical properties. Various aspects are disclosed of producing, research and the medical uses of drugs on the basis of solid dispersions.

The article describes the comparison results of the compression mass technological characteristics and quality profile of dosage forms produced with the use of modern combined additive agents. Technological parameters such as the flowability and bulk density of the compositions were analyzed. Orodispersible tablets were produced by direct compression. The quality of the tablet compositions was investigated in terms of appearance, average tablet weight, friability, hardness and disintegration.

There are several methods for solving the problem of an adequate dosage form for the hydrophobic and poorly soluble pharmaceutical substances which comprise a structure modification, preparation of solid dispersion systems, a change in pH, the use of cosolvents and solubilizers introduction of substances in the formulation of lipid nature and complexation. In this review, special attention is paid to the preparation of nanostructured dosage form for these classes of drugs. Are examples of drugs used successfully in clinical practice the development of which applied these methods.

The article gives an overview of the modern aspects in the production of suppositories. The nomenclature and brief description of excipients that used in the composition of suppositories were described. There were also reviewed the typical equipment for production of mentioned dosage form (DF), pharmacopoeial principles for regulation of quality and various instruments for its evaluation.

The quality of Paracetamol suppositories produced by domestic manufacturers has been investigated and their compliance with pharmacopoeial requirements has been established. Dissolution profile test of paracetamol suppositories of different producers has been carried out and nonequivalence of profiles due to the properties of the suppository basis has been shown. The importance of hydroxyl value and melting point of fat suppository bases used as pharmaceutical factors has been highlighted.

The article is concerned to control temperature setting sterilization in the manufacture of infusion solution. The description of the experiment in the analysis of uniformity of temperature distribution at three levels of camera steam sterilizer GEC 91425АR-2, designed and constructed statistical Shewhart charts, for determining the stability and controllability of the process sterilization temperature, calculated capability index of process.

The article discusses the development of a production technique for recombinant follicle-stimulating hormone used in the treatment of infertility, in the culture of Chinese hamster ovary cells. As part of the creation of the technological platform receiving hormone the bioprocess in wave-induced motion bioreactor has been optimized. A number of parameters that influence on the bioprocess was studied, as follows: optimal cell density, concentration of metabolites, temperature shift and its duration.

Today technologies stimulating growth and stabilization of new blood vessel, regulating trajectory of vascular growth are promising for the treatment of ischemia. These technologies represent a therapeutic angiogenesis. Its are essential in the rapidly developing regenerative medicine. In the present work we describe the development and validation methods for determining the specific impurities (purity) gene therapeutic drug using the electrophoresis method in agarose gel followed by densitometry of electrophoretogram. This drug is designed for the treatment of lower limb ischemia. This drug is a combination preparation containing a mixture of DNA plasmid encoding the gene of hepatocyte growth factor and gene of Angiopoietin-1.

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, and analytical range. It was shown than main validation characteristics meet the Russian State Pharmacopoeia XIII requirements.

Developed method for the quantitative determination of 5-[2-(3-tret-butylamino-2-hydroxypropoxy) phenoxymethyl]-3-methyl-1,2,4-oxadiazole hydrochloride in polymer drug films by UV-spectrometry. The method was validated by indicators such as accuracy, specificity, analytical area, the linearity and convergence. The method can be used for the quantitative determination of 5-[2-(3-tret-butylamino-2-hydroxypropoxy)phenoxymethyl]-3-methyl-1,2,4-oxadiazole hydrochloride in polymer drug films.

The State Pharmacopoeia XIII sets out the main principles of quality of pharmaceutical substances listed parametrs that should be included in the regulatory documents, given the characteristics of these indicators and recommendations for their regulation. Input quality control performance and valuation limits must comply with the appointment of the pharmaceutical substance. This paper presents the key indicators that can be used to standardize the inclusion complex of disulfiram with hydroxypropyl-β-cyclodextrin for later use as a pharmaceutical substance.

Today studies related with development of particular pharmacopoeia monograph for the Homeopathic Pharmacopoeia of the Russian Federation are especially relevant. Particular pharmacopoeia monographs regulate the requirements for homeopathic crude herbal drugs and homoeopathic mother tinctures. In the article the history of snowdrops use in classical medicine and homeopathy is presented. Modern standardization problems of homeopathic crude herbal drugs and homoeopathic mother tinctures produced from Voronov’s snowdrop (Galanthus woronowii Losinsk.) and common snowdrop (Galanthus nivalis L.) are considered.

Fatty vegetable oils are natural mixtures of triacylglycerols. The composition of fatty oils may include various biologically active substances, which cause corresponding pharmacological action fatty oil. For a long time (from 1968 to 2015) in our country, fatty oils regulated quality control requirements sheathe pharmacopoeial article (SPA) of the State Pharmacopoeia (SP) of the Soviet Union X Vol. In this regard, the first time for the national pharmacopoeia developed harmonized with the European pharmacopeia draft SPA «vegetable fatty oils», which includes the modern requirements for quality and safety of fatty oils. Oil extracts of pharmaceutical grade currently widely available in the pharmaceutical market as a beauty and massage oils. To determine whether the oil extracts is recommended to use the standards of sanitary rules and norms 2.3.2.1078-01 for dietary supplements based on plant oils, state standards and technical conditions. At the same time, it should be noted that many of the concepts which characterize the quality of vegetable oils are treated differently in the relevant government standards and SP XIII. There was a need to update and improve the pharmacopoeial article and other normative documents on certain types of oils used in pharmacy, harmonized with the SPA SP XIII ed. The paper analyzes the current state of, and prospects for the development of approaches to improve the standardization and evaluation of the quality of vegetable oils and oil extracts of pharmaceutical grade.

Biopharmaceutical solubility was experimentally determined for innovation anti-retroviral API phosphazide (Nikavir®) which was classified as BCS Class 3 drug. Dissolution profile test for Nikavir® 200 mg and 400 mg in three media pH 1.2, 4.5, 6.8 was conducted, and equivalence for both dosages was shown. Also dissolution profile test for phosphazide and lamivudine fixed combination 150 mg + 400 mg (Phosphaladine®) was performed in three media pH 1.2, 4.5, 6.8 against two reference drug products Nikavir® 400 mg and Epivir® (lamivudine) 150 mg. Dissolution profiles for lamivudine were equivalent in all three media, and phosphazide profiles were equivalent in pH 1.2. Studied batch of phosphazide and lamivudine fixed combination was recommended to be a clinical biobatch for further BE studies.

In this study the effect of magnitomicells based on carbon incapsulated iron nanoparticles on the ultrastructure of rat’s liver and lungs after intravenous injection of their aqueous suspensions was investigated. Deducing of animal from the experiment was conducted in 1st and 40th days after intravenous injection of suspensions of nanoparticles. Ultrastructural examination of the liver and lung of rats was performed with a transmission electron microscope. Ultrastructural signs of damage of hepatocytes, pneumocytes and mononuclear phagocytes are not detected.

The article presents the results of studying of specific activity of the combined drug «Geoscape» on the model of experimental formalin arthritis of the knee joint in rats. The aim of the study was the comparative analysis of the benefits of the combined composition on monocomponents (meloxicam, dexamethasone, Echinacea dry extract). Was installed high efficiency antipyretic and anti-inflammatory action «Geoscape» compared to the individual drug components. Macroscopic and histological analysis revealed a beneficial effect of the investigated tools to components of the joint.

Recommendations presented in the article are based on current regulations and guidelines of regulatory authorities on clinical trials of bioequivalence and professional experience of authors and will be useful for medical writers to plan clinical trial lege artis. Article gives information about choice of inclusion / exclusion criteria, reference, dosages evaluated, study design, bioanalytical method validation, outcome measures and acceptance criteria for resulting protocol.

Due to increasing needs in new domestic medical drugs and devices, it's becoming very topical to train complex design specialists of clinical trials and medical devices tests. Because of it in this research we surveyed main skills and required competence for such specialists by questioning potential companies-employers. All data we obtained allowed us to make a list of professional activity tasks and/or job functions for «medical writers» that correlates with the needs of companies-employers.

During the analysis of international requirements for designing of clinical trials we found that principal documents are provided by ICH. The main standard in Russian Federation is the National State Standard “Good Clinical Practice”, that is similar to ICH GCP. Thorough industrial standards are issued by global regulators: FDA and EMA. Currently there is absence of local regulatory documents on designing clinical trials in Russia, thus there might be a distinct need in development of national regulatory documents and its harmonization with international standards for pharmaceutical industry.

A method for quantification of capecitabine and 5-fluorouracil in human plasma was developed. The sample preparation was carried out by protein precipitation with methanol. The quantitative determination was performed by HPLC with a triple quadrupole mass-detector. The method was validated in terms of selectivity, calibration curve, accuracy, precision, lower limit of quantification, and stability. The analytical range was 10.0-20000.0 ng/mL for capecitabine and 10.0-400.0 ng/ml for 5-fluorouracil. The developed method may be used for bioequivalence studies of capecitabine drug products.

Budget impact analysis and cost-utility analysis for the therapy of end-stage renal failure by methods of peritoneal dialysis and hemodialysis were performed by means of a developed analytical model of decision making. Effect of impact on the budget of extension of the peritoneal dialysis program was defined. Budget impact analysis has shown that the use of peritoneal dialysis as first-line therapy for patients with end-stage renal failure is accompanied by savings of the federal budget. It has also been found that peritoneal dialysis as compared to hemodialysis is characterized as a dominant point of view of the analysis «cost-utility», having a smaller value of the coefficient «cost-utility».

The main requirements for a quality system of GMP-inspectorate in terms of inspectors’ appropriate training were described and analyzed. The existing international recommendations in this area were summarized. It was shown that the training of inspectors should be organized and carried out on such principles as systemacy, consistency, professionalism and performance of the international recommendations on training. The additional professional retraining program for GMP inspectors/auditors was developed, tested, and approved. The developed program can be used successfully for training of GMP-inspectors from regulatory authorities of the states that are members of Eurasian Economic Union. The program can be used successfully for training of GMP-inspectors from regulatory authorities of the states that are members of BRICS after some adaptation also.

According to comparative analysis of medical consumption of potent analgesics in economically developed countries was justified the need to increase production of active ingredients of potent analgesics in Russia by more than ten times. Also a list of the most relevant analgesics for production for chronic patients and for use in emergency situations was provided. It was shown that the production of substances of potent analgesics in Russia by 2020 should be increased up to 5-6 tons in morphine equivalent. This amount takes into account the need to expand diversity of dosage forms suitable for patient, including transdermal, transmucosal, intranasal, and others. The proportion of natural and semi-synthetic opioid analgesics should be at least 50% of the total production in morphine equivalent. Use of genetically modified varieties of opium poppy allows to obtain the raw material with a predetermined content of target alkaloids. It is proposed to organize production of active analgesics ingredients at one of repurposed military facilities, as well as recreate biotechnological production of raw materials on the basis of genetically modified varieties of poppy. This approach allows to produce active analgesics ingredients for all pharmaceutical manufacturers of Russian Federation. It is proposed to organize production of certified reference materials of significant pharmaceutical drugs and psychotropic substances for all Russian consumers - more than 250 licensed organizations in industry, health care, law enforcement, chemical safety and security.

The article describes the procedure of patent term extension to be granted on inventions relating to drugs and of granting a supplementary patent in view of recent amendments introduced in the Civil Code of the Russian Federation. Some advices are given on drafting patent applications on such inventions.

Hygienic standardization of harmful substances in the air of the working area, aimed at maintaining the health of workers is an essential attribute of any chemical production, including pharmaceutical producing. In most cases, new for domestic producers drugs do not have the required national hygienic standards. In this paper we consider the possibility of using international standards in Russian companies. To achieve this goal, a comparison of the Russian hygienic parameter of a harmful substance concentration threshold limit value in the air of the working area with similar European and North American index was performed. Theoretical foundations of establishment methods and index numerical values were compared.

The article provides an overview of the first medical manuscript sources that regulate drugs production in Russia XVI and XVII centuries: vineyard, lechebnik, pharmacopoeias. Here are the details about the first pharmacies - Here are the details about the first pharmacies - green benches, an Pharmaceutical decree, which functions include control the drug production.