Article shows the results of development and technological issues of darunavir ethanolate in capsule form. Soluplus was used to increase the biopharmaceutical characteristics of current drug formulation. Results of dissolution profile studies shows that intensity and release rate of API from the capsules are proportional to concentration of solubilizer and close to comparator agent. Results of the studies have shown necessity to research the physical and chemical characteristics of darunavir ethanolate substances and it could be used in the development of an innovative dosage form.

The work is dedicated to the development of technology for obtaining a freeze-dried dosage form LHS-1208 and the establishment of methods of quality control of the drug. The authors have shown spectrophotometric analysis techniques and flash chromatography.

Medicines used for the treatment of drug addiction nowadays are ineffective. In the last decade, various schools around the world are developing a new approach: the therapeutic vaccine for the treatment of drug addiction. The vaccine injection raises the production of specific antibodies that bind to the drug when it is used and substantially reduces its concentration in the brain. The review describes the main approaches to the design of anti-drug vaccines, their composition, the problems faced by researchers in their development.

Theoretically substantiated and experimentally determined viscosity and adhesive properties of the experimental compositions of the liquid formulation with plant extracts of Eucalyptus (evkalimin) and Echinacea purpurea (estifan). It proved that are designed mucoadhesive pharmaceutical compositions that might provide a sustained action on the surface of the oral mucosa.

Natural polyphenols are valuable compounds possessing scavenging properties towards radical oxygen species, and complexing properties towards proteins. Therefore, phenolic compounds have attracted increasing attention as potential agents for preventing and treating many oxidative stress-related diseases, such as cardiovascular diseases, cancer, ageing, diabetes mellitus and neurodegenerative diseases. Polyphenolic compounds are characterized by a very high sensitivity to several environmental factors including physical, chemical and biological conditions and can be oxidized very quickly with a considerable loss in activity. Development of new approaches to stabilisation and protection of these compounds from degradation and therefore to improve their biological activity is of interest. The literature describes many encapsulation methods, many of which have been successfully used for plant polyphenols. This review provides some plant polyphenols and their basic chemical and biological properties as well as methods of encapsulating polyphenols, which are divided into physical, physico-chemical, chemical methods and other methods of stabilization.

In this material were reviewed biopharmaceutical aspects of suppositories – described the relation between rectal route of administration, bioaccessibility and principles of dosage forms formulation. Also, in the article were shown the physical and chemical characteristics of API, matrix and excipients (surface-active agents, prolongation agents, cyclodextrines, etc.). Was presented information about mucoadhesive suppositories, suppositories with different types of release methods (immediate intensive or prolonged) and poloxamer-based thermo-reversible liquid suppositories (characteristics, pharmaceutical, technological and biopharmaceutical parameters of quality).

The article presents the results of the studying rheological characteristics of nimesulide oral gel experimental samples on the basis of the combined matrix. We have investigated influence of rheological properties of the nimesulide release from oral gels. We have established a gel with optimal rheological and biopharmaceutical characteristics.

The article presents data on the development of an assay method of silver in pharmaceutical substance «Argamid» based on silver salt sulfadimidine. The method is based on the rhodanometric titration with potentiometric indication of the final point. The results of the validation assessment of the method are shown.

The experimental tests for quality control of magnetic medical ointments, magnetic suppositories (with procaine, diclofenac), iron-carbon composite (active ingredient of heat conductivity systems for the magnetic control heat transference in the cryosurgery) have been developed.

In order to ensure reliable and accurate results, the authors carried out the validation procedure developed technique for spectrophotometric quantification of the active substance for the lyophilized liposomal formulation of national hydrophobic antitumor compounds from the group of indolocarbazole - LHS-1208. As a result of the establishment of the specificity, linearity, range of use, accuracy and precision of a validated method may be used in the range of 80-120% concentration LHS-1208 in the dosage form.

The aim of the study was to develop and validate a new method of quantitative determination of residual organic solvents in a substance A using GLC. Studies were carried out with gas chromatography with a flame ionization detector and sampling from the vapor phase. The effect of the polarity of the stationary phase for the chromatographic separation of the organic solvents peaks: Chloroform, Ethanol, Methylene Chloride, Cyclohexane, Ethyl Acetate, Methanol, N, N-dimethylformamide, 2-propanol was investigated. Chromatographic separation of Ethanol, Methanol, 2-propanol, Ethyl Acetate, Methylene Chloride and Cyclohexane was performed with quartz capillary column DB-624, 30 m × 0.20 mm, 1.8 micron; Chloroform and N, N-dimethylformamide – DB-WAX, 30 m × 0.50 mm, 0.25 mm. System suitability criteria and the validity of method were determined. Method has high specificity, precision, linearity, sensitivity and reliability.

Five dosage forms from various manufacturers containing acetyl salicylic acid was investigated with the DSC method. It was found that the amount of acetylsalicylic acid in these preparations is equal to 80-85 wt.%, which corresponds to the regulatory framework of the SP XIII.

On the territory of the European part of Russia along with creeping thyme grows about 20 closely related species, which do not differ loggers in nature and are used along with creeping thyme. Analysis of the scientific literature reveals that until recently the study of the chemical composition of herb thyme various kinds main attention was paid to the definition of a very limited set of biochemical parameters characterizing mainly quantitative content of essential oils and their composition, whereas the other biologically active substances. We studied enough. Available information on the composition of biologically active substances is fragmented and, as a rule, reflects the results of short term observation relates to the different geographical areas and received at different times by different methods of analysis, which complicates the comparison of quantitative content of certain compounds. The analysis generally showed sig-nificant similarity in composition of the biologically active substances of various kinds of herb thyme. This allows you to use other types of medicine that grow in different areas, as well as solve the problem of rational use of natural resources and the need to move away from the culture creeping thyme in a limited geography in Russia. A number of studies have shown that informal types of thyme also have a pronounced anti-inflammatory activity. At the same time, essential oil of different kinds of herb thyme composition characterized by individual components, which, along with microscopic features can be used for identification purposes.

Drug release studies (or in vitro release) of valsartan in three dissolution media simulating the main sections of the gastrointestinal tract were conducted. The concentrations were determined using UV/Vis spectrophotometer (Varian Cary 50) at 254 nm. The study was conducted using dissolution apparatus with the paddle assemble; 5-mL sample aliquots were withdrawn at 5, 10, 15, and 30 min. Estimation f2 parameter confirmed the equivalence of valsartan dissolution kinetics: f2=67 in hydrochloric acid solution, pH 1,2; f2=57 in phosphate buffer, pH 4,5, and in phosphate buffer, pH 6,8 - dissolution amount is greater than 85% at 15 min, so the two products are deemed equivalent, and a profile comparison is not necessary.

The article describes the main historical stages in the development of the science of drug dissolution and the dissolution profile test from the theoretical foundations of dissolution, developed in the first half of the 20th century, and the development of a relationship between dissolution and bioavailability in the 1950s, going to the introduction of biowaiver based on the BCS.

Development of method for determining the melting enthalpy of monotropic transitions and the activation energy of substances decomposition using highly thermally conductive inert material by differential scanning calorimetry and its practical use for determining the weight content of the active substance in solid medicinal substance.

A new GCMS-based method for quantitative determination of active substance of new contrast drug based on sulfur hexafluoride (SH) in the rat blood plasma is produced. A ratio plot of peak area of sulfur hexafluoride to peak area of internal standard toluene [y, S(SH)/S(toluene)] versus concentration of sulfur hexafluoride (x, µL/mL) was linear over 0.003-0.500 µL/mL. The calibration graph can be described by the equation y=0.9526x+0.0037 (r²=0.9990). Limit of quantitation (LOQ) (signal-to-noise 10,12) was 0.003 µL/mL. Inter- and intra-serial accuracy related to nominal concentrations were 100.40-101.20% and 86.67-110.0%, respectively. The RSD values for inter- and intra-serial accuracy were 3.68-4.15% and 1.23-10.68%, respectively. The samples of the same series with SH concentrations 0.01 µL/mL and 0.50 µL/mL were analyzed in order to determine the stability. Samples were stored for 24 hours to determine the short-term stability. To determine the long-term stability Samples were stored for 25 days. Short-term stability at room temperature were 0.52% and 1.86% and long-term stability at -20 °C were -90.43% and -81.81% for SH concentrations 0.01 µL/mL and 0.50 µl/ml, respectively. Accuracy during freezing and thawing of samples were 102.30% and 100.10% and RSD values were 5.40% and 1.50%, respectively.

This article presents the data on the effect of protargolum solutions in different concentrations on human dermal fibroblasts. For evaluation of the metabolic activity of the cells MTT-test was used. This test is based on the ability of NAD-H-adjective oxydoreductases to represent the amount of viable cells. It was determined, that the critical concentration of protargolum solution, responsible for inhibitory effect on fibroblasts proliferation is on the range 2 · 10^-2 - 5 · 10^-1 mg/ml.

The express method for simultaneous determination of enalapril and enalaprilat in human serum using HPLC-MS/MS is proposed. A simple sample preparation procedure, short analysis time, and a wide analytical range for both analytes (5.00 to 250.00 ng/mL) characterize this method. This technique is useful for carrying out routine research, such as therapeutic drug monitoring, bioequivalence studies and evaluation of the interchangeability of enalapril drug products.

Development, validation and application of in vitro (dosage forms) and in vivo (blood plasma) anti-Xa and anti-IIa enoxaparine sodium assay by UV-spectrophotometer. Assay methods were applied for enoxaparine sodium dosage forms and rabbit plasma samples. It was shown that assay methods are suitable for these analytical purposes including standardization of enoxaparine sodium preparations.

Simultaneous quantification method of assaying main CYP isoforms substrates-markers and their metabolites in urine using HPLC-MS/MS was developed to determine activity of following isoforms: caffeine/paraxanthine for CYP1A2, losartane/E-3174 for CYP2C9, cortisole/6-β-hydroxycortisole for CYP3A4 and pinoline/6-hydroxy-1,2,3,4-tetrahydro-β-carboline for CYP2D6. Carbamazepine was used as internal standart. Urine was used as biological object, samples were prepared by extraction with ethyl acetate : hexane : diethyl ether (50:35:15) mixture continued with pH correction of urine sample using borate buffer (pH=9,4) and following extraction with ethyl acetate : hexane mixture (50:50). Method was successfully validated and can be put in clinical practice for CYP isoforms activity determination.

Method of quantitative determination of darbepoetin alfa in rabbit blood plasma was developed. Quantitative determination was performed by ELISA using commercially available ELISA kits for assay «Erythropoietin ELISA-Best». The method was validated on the following parameters: specificity, linearity, precision, accuracy, and the stability samples. Linear range of methods for determining darbepoetin alfa in the blood plasma of rabbits was 67-2000 pg/mL, the limit of detection - 31 pg/ml. The method can be used for bioequivalence and toxicokinetics studies of drugs of darbepoetin alfa.

Complex clinical and biological study of 115 schizophrenic patients with long-term antipsychotic treatment was carried out. Concentrations of brain-derived neurotrophic factor (BDNF) and prolactin levels in blood serum in schizophrenic patients and healthy subjects were determined to multiplex analyzer MAGPIX (Luminex, USA) using the kits MILLIPLEX® MAP (Merck, Germany). BDNF concentration was significantly correlated with the severity of positive symptoms in schizophrenic patients. Antipsychotics induced hyperprolactinemia is the need to monitor the level of prolactin to develop personalized approaches to treatment and improve the quality of life of patients.

Certificate of compliance to GOST 33044-2014 "Principles of Good Laboratory Practice" issued by an internationally recognized, competent and independent certification body serves, is one of the criteria for the selection of the contractor and the guarantee of the quality of services provided to many customers, as one of the mandatory conditions and exit organization development at the global, national or sectoral markets. This paper describes the first experience of GLP-certification for Russian bioanalytical laboratory.

This article is intended for specialists on drug registration and specialists in clinical trials. There are analyzed the main projects of foreign documents regulating the amount of the registration program and the program of clinical trials required to bring to market the combined drugs. Article clarifies the principal possibility for development of certain combination types and gives comprehensive information about different clinical development strategy types of fixed combination medicinal products supported with evaluation of their applicability according to intended claim of the combination. Some practical recommendations for study design selection are also given.

The article gives an overview of the Russian pharmaceutical legislation in XVIII-XIX centuries and describes the first Russian departmental and government pharmacopoeia (1756, 1778, 1798). There is analyses the first Apothecary statue (1789) and the second Apothecary statue (1857). It is got experts from Apothecary Statues that reflecting the requirements of the time to the qualification, morals, responsibility of the pharmacist to the manufacturing and dispensing drugs.