Determination of the content of insoluble pharmaceutical substances in dosage forms is an urgent task, since their dosage is very important for the optimal ratio between the therapeutic effect and ensuring the necessary bioavailability. The use of micellar media as a matrix allows increasing solubility. This report presents the results of the influence of the micellar system consist from cetyltrimethylammonium bromide, CTAB, dimethyl sulfoxide, DMSO and water on the determination of the content of 5-aminosalicylic acid (5-ASA) in pharmaceutical substances and in dosage forms. 5-ASA is widely used for the treatment of inflammatory bowel diseases, ulcerative colitis and Crohn's disease. To obtain the optimal matrix, the methodology of the response surface (MRS) and three-level Box-Benken plans (BBP) were used. The intensity of the absorption band of 5-ASA (A(330)), which reflects the acid content, was used as the target function. The independent factors were: the concentration of CTAB (pC(CTAB), mol/l); the acidity of medium (pH); the proportion of DMSO in the binary solvent (alpha DMSO). The BBP consisting of fifteen compositions were compiled and response surfaces constructed. Optimal conditions for the determination of 5-ASA by the absorption band A(330) are: pC(CTAB) = 1.1, pH = 7.6, alpha(DMSO) = 0.3. In this matrix, the content of 5-ASA in the pharmaceutical substance was established and good metrological performance was achieved. The use of MRS and BBP contributes to the development of effective methods for quality control of 5-ASA dosage forms from different manufacturers.

The response surface methodology using three-level Box-Behnken plans was applied in order to optimize the yield of the cone and chair conformers in the synthesis of calix[4]resorcinol functionalized with 4-dimethylammoniophenyl group along the lower rim. We used data from one-factor experiments in which the temperature, reaction time, and molar ratio of HCl to the reactants of the reaction mixture were varied to plot the response surfaces. The ratio of conformers was calculated based on the analysis of 1H NMR spectra of the products isolated from the reaction mixture. The adequacy of the proposed mathematical models for determining the yields of chair and cone conformations is confirmed by a high correlation coefficient ( R 0.99979). Optimal conditions were found for the maximum yield of the chair conformation (50°C, 2 h, molar ratio of HCl to reagents in the reaction mixture is 1-1.5, yield 100%). The optimal conditions for obtaining the cone conformation are: temperature 68.6°С, stirring time in the range of 2.24-6.44 h and the molar ratio of HCl to reagents in the reaction mixture is 2. Carrying out the synthesis under these conditions leads to the yield of the cone conformation in the range of 57.70-58.07%.

It was shown by the conductometric study that the formation of micelles in the cetyltrimethylam¬monium bromide (CTAB) – dimethylsulfoxide (DMSO) – water system occurs at higher critical micelle concentrations (CMC) than in the CTAB – water system. The solubilization of nitroxoline in this system upon reaching the CMC was determined by the spectrophotometric method. The Box–Behnken design was used to obtain systems with the highest light absorption of nitroxoline, depending on the CTAB concentration, the acidity of the pH medium, and the proportion of DMSO when searching for the optimal matrix. A sensitive and selective technique suitable for micellar media and spectrophotometric analysis was developed using the response surface methodology for the determination of nitroxoline in medicines.

The results of using the “response surface” methodology and the Box–Behnken design in the spectrophotometric determination of medicinal substances in a micellar matrix are presented on examples of dapsone and procaine. 5,7-Dichloro-4,6-dinitrobenzofuroxan is used as a reagent. The design of the neonol–water (80%)–dimethyl sulfoxide (20%) composition matrix is varied using the following factors: reagent concentration, pH, and neonol concentration. Optimization is performed using a three-level Box–Behnken plan. A significant increase in the intensity of the absorption band of the reaction products in the micellar pseudophase is shown. The optimal conditions under which medicinal substances can be determined by spectrophotometry in liquid and solid medicinal forms are found.

4-Aminophenol (APh) is a toxic chemical that may be present as an impurity in drugs based on pa-racetamol, one of the main antipyretic analgesics. Thus, its content must be controlled to curb potential negative effects. Here, we explored the use of the response surface method and the three-level Box- Behnken designs to obtain an optimal premicellar matrix for the spectrophotometric determination of the APh impurities in drugs. For this purpose, the spectrochemical reaction of APh with 5,7-dichloro-4,6-dinitrobenzofuroxan (DCDNBF) was carried out, and the UV spectrum of the reaction product in the premicellar matrix composed of ethoxylated nonylphenol (neonol, APh 9-10) + dimethyl sulfoxide (DMSO) (20%) + H2O (80%) before and after the formation of micelles was analyzed. The response surfaces constructed with the help of the Statistica 10 software package turned out to be of prognostic value and were used to calculate the composition of the optimal matrix. An increase in the intensity of the absorption band in the premicellar region and a linear dependence in the concentration range of 5.10-7-2.10-4 mol/L APh were shown. The express and environmentally safe spectrophotometric meth-od developed and tested in this study makes it possible to determine the APh content in dosage forms at the level of 0.0027%, which exceeds the maximum allowable one in paracetamol (no more than 0.01%).

In today's economic environment, businesses are forced to operate in a highly competitive, complex and volatile environment. A distinctive feature of the current conditions is also the fact that in addition to the increasing demand for goods and services of high quality among consumers, the demand for innovative products is increasing. Against the background of the continuous development of technologies in various fields, enterprises began to actively introduce them to create innovative products. At the same time, enterprises striving to strengthen their positions in the market faced the problem of constantly reducing the development and production of innovative products while maintaining a high level of quality. It is currently impossible to solve this problem without digitalization of enterprises, which means the introduction of digital technologies not only in production and technology, but also in financial and organizational and managerial areas. From these positions, it seems relevant to develop organizational and management methods aimed at improving the innovative development of the enterprise. The authors of the article presented a model of an innovative QMS, built on the basis of the integration of a quality management system and an innovation management system using a digital platform as a basis for the creation and effective functioning of a modern enterprise. Within the framework of this model, the possibility of applying the process approach to the construction of an innovative QMS was considered, measures for its creation were developed, and an assessment of the planned economic effect from the introduction of an innovative QMS was given.

The process of micelle formation in a mixture of nonionic surfactant (cetyl ether of polyoxyethylene (10), Brij56) and anionic surfactant (sodium dodecyl sulfate, SDS) in the presence of NaCl electrolyte in dimethyl sulfoxide - water binary solvent by the tensiometric method was studied. The influence of content of dimethyl sulfoxide, NaCl, Brij 56 and SDS was studied. A multifactorial experiment was performed to optimize the selecting process of a system based on the mixture of surfactants in the binary solvent with the lowest values of the critical micelle concentration (CMC). For this, the methodology for determining the response surfaces and the three-level Box - Behnken plans were applied. Using the ''Statistica 10'' software package, the most significant factors were identified, the interaction effects between them were evaluated, the response surfaces were constructed and the optimal conditions for obtaining mixed systems with minimal CMC values were determined. The minimum value of CMC in the SDS broken vertical bar Brij 56 broken vertical bar NaCl broken vertical bar DMSO broken vertical bar H2O system was achieved under the following composition: alpha(Brij56) = 0,680; C-NaCl = 0,140 mol/l;omega(DMSO) = 0,024 (2,4 %). The minimum CMC of this mixture equals to 3,137.10(-5) mol/l. The experimental data are consistent with the calculated values of CMC (3,05 +/- 0.091).10(-5) mol/l.

Micellar systems of surfactants can be used for solubilization improvement of poorly water-soluble organic compounds, including medicinal substances and their precursors. Results of the solubilization study of the medicinal substance precursor 5,7-dichloro-4,6-dinitrobenzofuroksan are given. Spe.trophotometric and tenziometric methods were used for the analysis of the micellar systems of nonionic surfactants such as 4-(1,1,3,3-tetrametylbutylphenoxypolyethoxyethanol) (Tr X-100), polyoxyethylene (10) cetyl ether (Brij 56), cationic surfactant - cetyltrimethylammonium bromide (CTAB), anionic surfactant - sodium dodecylsulphate (SDS). Solubilization ability of surfactant was considered in the terms of molar solubilization ratio (R-m,R-s), the micelle-water partition coefficient (K-M) and the free energy of solubilization (Delta G(s)(0)). Solubilization effectiveness of

Brij 56 ≤ Tr X -100 Nonionic surfactants SUR can be used for increase solubility and bioavalability poor dissolved biologically active material. In this work we have used spectrophotometrical method and studied the solubilyzation of biologically active substance, having antibacterial and fungicide activity, 5,7-dichloro-4,6-dinitrobenzofuroxan in water system of nonionic SUR/ It is shown different type of solubility dependencies from surfactant’s concentrations for different SUR. Solubility was characterized by terms of molar solubilyzation ratio, micellar-water partitution coefficient. We have shown the following order of solubilyzation efficiency: Brij 56

The conditions for spectrophotometric determination of mesalazine in urine using 7-chloro-4,6-dinitrobenzofuroxane as an analytical reagent have been established. The optimum analytical results are achieved at a wavelength of 500 nm for a solution with pH 6 – 8. The detection limit for mesalazine is 0.31 μg/mL. The possibility of using the proposed method for assessing mesalazine acetylation in metabolic processes by individual human phenotypes has been shown.

A method for the quantitative determination of ascorbic acid, thiamine, riboflavin, nicotinamide and pyridoxine in hexavit multivitamin preparation and the like medicinal mixtures has been developed based on high performance liquid chromatography (HPLC). Conditions of chromatographic separations of a mixture of vitamins in a regime of gradient eluation in an acidic medium on reverse-phase Discovery RP Amide C16 are established. The proposed technique was verified by the analysis of commercial vitamin preparations.

A method for the assay of ascorbic acid, thiamine, riboflavin, nicotinamide, and pyridoxine in Hexavit was developed using HPLC. The conditions for chromatographic separation of vitamin mixtures with gradient elution in acidic medium on a reverse phase Discovery RP Amide C16 column were established. This method was verified by analysis of industrial vitamin formulations.

Установлены условия спектрофотометрического определения месалазина в моче при использовании 7-хлор-4,6-динитробензофуроксана как аналитического реагента. Оптимальные результаты определений достигаются при длине волны 500 нм и pH 6 - 8. Предел обнаружения месалазина составляет 0,31 мкг/мл. Показана возможность использования разработанной методики для оценки индивидуальных фенотипов метаболизма процессов ацетилирования месалазина у человека.