Drug Development and Registration最新文献

{"title":"The Use of Ultrasound in the Extraction of Biologically Active Compounds from Plant Raw Materials, Used or promising for Use in Medicine (Review)","authors":"A. A. Elapov, N. Kuznetsov, A. Marakhova","doi":"10.33380/2305-2066-2021-10-4-96-116","DOIUrl":"https://doi.org/10.33380/2305-2066-2021-10-4-96-116","url":null,"abstract":"Introduction. This review examines the current state of technology for ultrasonic isolation of biologically active components from medicinal vegetal raw materials. The main emphasis is placed on \"green\" technologies that intensify the processes of isolation of components such as flavonoids.Text. Modern technologies imply the use of combined methods, including, in addition to ultrasound, significant grinding of raw materials before the extraction process, the use of supercritical solvents (liquefied gases) under excessive pressure. The effect of ultrasound power and temperature on the output of the extracted components was also considered.Conclusion. 1. To increase the yield of biologically active compounds from plant raw materials among various physical methods of extraction intensification, the use of ultrasound dominates. 2. Ultrasonic extraction can be divided into several main types: extraction in an ultrasonic bath, the use of submersible ultrasonic emitters, as well as the combination of ultrasonic extraction with additional types of influence. 3. In the literature, examples of the use of ultrasonic extraction for the isolation of phenolic compounds are most fully presented, it being noted that the parameters need to be selected individually for each individual plant. 4. The power of ultrasound and the nature of the extractant can affect the course of oxidative processes in the extract, and such phenomena are characteristic not only for too high capacities, but also for low ones. 5. Ultrasound can significantly increase the yield of biologically active compounds even in aqueous extraction of fresh raw materials. 6. The spectrum of extractants selection for ultrasonic extraction of plant raw materials is quite large. Both organic solvents (ethanol, methanol, ethyl acetate, acetone) and water can be used, as well as mixtures of various extractants.","PeriodicalId":36465,"journal":{"name":"Drug Development and Registration","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-11-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41644646","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Retrospective Analysis of Experimental and Clinical Studies of Flakozid in Viral Hepatitis","authors":"V. V. Karabaeva, L. Krepkova, A. N. Babenko, V. Bortnikova, T. V. Fateeva, P. G. Mizina, N. S. Mikheeva, O. Karabaeva","doi":"10.33380/2305-2066-2021-10-4-169-176","DOIUrl":"https://doi.org/10.33380/2305-2066-2021-10-4-169-176","url":null,"abstract":"Introduction. Viral hepatitis (HV) by its socio-economic significance occupies one of the leading places in human infectious pathology, therefore, the development of fundamentally new methods of prevention, diagnosis and treatment, as well as the creation of new antiviral drugs remain relevant. An antiviral herbal drug \"Flakozid\" has been created in VILAR, which is presented in a dosage form – 0,1 g tablets for oral administration.Аim. To analyze the experimental and clinical efficacy and safety of flakozid therapy in viral hepatitis.Materials and methods. Experimental study of the effect of flakozid on viral hepatitis A (HAV). The AGMK cell culture (BS-C-1 line) and the hepatitis A virus strain HM 175 adapted to it were used in the work. The studies were conducted in two series of experiments using different concentrations of the drug, which was introduced into cultures simultaneously with the infection of HAV. Experimental study of the effect of flakozid on viral hepatitis C (HCV). In the present experiments, a virus-containing culture fluid collected from infected cultures of chicken embryo fibroblasts containing 7,0 lg TCD50/ml of infectious HCV (genotype 1b) was used. The cytotoxic, viricidal and antiviral activity of flakozid was studied using transplanted cultures of pig embryo kidney cells (SPEV) obtained from the collection of cell lines of the D. I. Ivanovsky Research institute of virology of the Ministry of Health of the Russian Federation. In the experiments, a one-day monolayer of cells grown in 96-well plastic culture panels was used. ID50 – the concentration of the drug \"Flacozid\", which inhibits the development of the virus in the monolayer by 50 %, and CD50 – its minimum concentration, which causes cytotoxic destruction of 50 % of the cells of the monolayer, as well as the CTI – chemotherapeutic index, calculated as the ratio of CD50 to ID50, were determined. A well – known domestic antiviral agent, \"Ribavirin\", was used as a comparison drug. Clinical studies of flakozid in viral hepatitis A. The results of clinical studies of the antiviral drug \"Flakozid\" (0,1 g tablets) were analyzed in 258 patients with viral hepatitis A. \"Flakozid\" was prescribed to patients with a moderate course of the disease, 0,1 g 3 times a day for 20 days against the background of basic therapy: diet, alkaline drinking, Enterodes®. The therapeutic effect was assessed by clinical (weakness, decreased appetite, nausea, vomiting) and biochemical parameters (the level of direct bilirubin, transaminase activity), as well as by the severity of hepatolienal syndrome. Clinical studies of flakozid in viral hepatitis В. The results of clinical studies of the antiviral drug \"Flakozid\"(0,1 g tablets) were analyzed in 410 patients with acute viral hepatitis B, which was regarded as moderate. \"Flakozid\" was prescribed against the background of basic therapy: diet and detoxification therapy: 5 % glucose solution, 5 % ascorbic acid solution, \"Hemodesi\", at a daily dose","PeriodicalId":36465,"journal":{"name":"Drug Development and Registration","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-11-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41893415","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Investigation of Colloidal Structure and Biopharmaceutical Properties of New Antibacterial Composition of Gramicidin S","authors":"A. Drannikov, I. S. Vatlin, M. Trusova, A. Di Martino, S. Krivoshchekov, А. M. Guriev, M. Belousov","doi":"10.33380/2305-2066-2021-10-4-129-137","DOIUrl":"https://doi.org/10.33380/2305-2066-2021-10-4-129-137","url":null,"abstract":"Introduction. Gramicidin S has been conventionally manufactured as buccal tablets. However, in the past decade, the interest in the development of spray formulations has been growing. Those formulations contain excipients that enhance the solubility of the antibiotic in water solutions. However, the real structure of gramicidin S containing sprays remains unrevealed.Aim. Investigation of colloidal structure and biopharmaceutical properties of new gramicidin S antibacterial composition.Materials and methods. The composition sample was obtained using gramicidin S dihydrochloride, propylene glycol, polysorbate-80, ethanol and purified water. Raman spectroscopy has been performed to determine the composition of the phases. Dynamic light scattering analysis was performed to characterize the composition particles. Release of gramicidin S was performed by dialysis method and the concentration was determined by HPLC. The antimicrobial properties were investigated in accordance with the requirements of the XIV edition of the Russian pharmacopoeia.Results and discussion. Dynamic light scattering analysis results show gramicidin S formulation particles having an average size in solution 5–50 nm and ζ-potential (–1.1: +7.9 mV). Based on the obtained data on the composition properties and formulation parameters it was classified as colloidal solution. The kinetic stability evaluation was performed. We compared the solubility in water and release parameters of the active pharmaceutical ingredient in the native state and in the micelles. The enhancement of the antimicrobial activity of the peptide in the colloidal solution was confirmed and ascribed to the synergic effect gramicidin S – surfactant.Conclusion. We reported the colloidal type of the composition, that aggregate gramicidin S at a concentration of 8 mg/mL. We found that gramicidin S inclusion into the colloidal solution led to significant efficiency increase, which reveals the potential to reduce the drug dose and side effects level.","PeriodicalId":36465,"journal":{"name":"Drug Development and Registration","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-11-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49609999","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Simultaneous Determination of Candesartan and Hydrochlorothiazide in Human Plasma by HPLC-MS/MS","authors":"P. K. Karnakova, T. N. Komarov, O. A. Archakova, D. S. Shchelgacheva, A. V. Aleshina, N. S. Bagaeva, P. A. Karpova, I. Shohin","doi":"10.33380/2305-2066-2021-10-4-177-189","DOIUrl":"https://doi.org/10.33380/2305-2066-2021-10-4-177-189","url":null,"abstract":"Introduction. Combined drugs have the greatest efficacy and safety in arterial hypertension treatment. The combination of candesartan and hydrochlorothiazide (AT1-receptor antagonist and a thiazide diuretic, respectively) provides high efficiency of antihypertensive combination therapy, therefore it is widely used in medical practice. Developing a method for simultaneous determination of candesartan and hydrochlorithiazide in human blood plasma is necessary for performing the analytical part of pharmacokinetic studies and bioequivalence studies of multicomponent drugs.Aim. The aim of this study is to develop a method for quantitative determination of candesartan and hydrochlorothiazide in human plasma by high-performance liquid chromatography – tandem mass spectrometry (HPLC-MS/MS) for further bioequivalence studies.Materials and methods. Determination of candesartan and hydrochlorothiazide in human plasma by HPLC-MS/MS. The samples were processed by acetonitrile protein precipitation. Internal standard: mixed solution of valsartan and indapamide. Mobile phase: 0.1 % formic acid solution in water (eluent A), 0.1 % formic acid in acetonitrile (eluent B). Column: Phenomenex Luna Phenyl-Hexyl, 50x4.6 mm, 5 μm. Analytical range: 2.00– 300.00 ng/mL for candesartan, 2.00–200.00 ng/mL for hydrochlorothiazide in human plasma. Ionization source: electrospray ionization. Detection conditions: 441.10 → 192.00 m/z, 441.10 → 263.15 m/z (candesartan), 295.85 → 269.00 m/z (hydrochlorothiazide), 436.00 → 207.05 m/z (valsartan), 363.85 → 132.10, 363.85 → 189.00 m/z (indapamide).Results and discussion. This method was validated by selectivity, matrix effect, calibration curve, accuracy, precision, spike recovery, the lower limit of quantification, carry-over effect and stability. The developed method meets the requirements for conducting bioequivalence studies of medicinal products within the framework of the Eurasian Economic Union.Conclusion. The analytical range was 2.00–300.00 ng/mL for candesartan, 2.00–200.00 ng/mL for hydrochlorothiazide in human plasma. The method was applied in BE study of the combination of candesartan and hydrochlorothiazide.","PeriodicalId":36465,"journal":{"name":"Drug Development and Registration","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-11-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49288931","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Procedure for Reviewing Pharmaceutical Inspections in the Eurasian Economic Union (Review)","authors":"A. P. Meshkovskiy, V. Beregovykh, V. N. Shestakov, N. Pyatigorskaya, Z. Aladysheva, N. Nikolenko, A. M. Pyatigorskiy, E. I. Nesterkina","doi":"10.33380/2305-2066-2021-10-3-138-146","DOIUrl":"https://doi.org/10.33380/2305-2066-2021-10-3-138-146","url":null,"abstract":"Introduction. The article discusses significant changes in the procedure for pharmaceutical inspection of drug manufacturers for compliance with the requirements of the rules of good manufacturing practice (GMP) of the Eurasian Economic Union (EAEU), related to restrictions due to the COVID-19 pandemic.Text. The article presents the main international guidelines describing the remote conduct of pharmaceutical inspections, which is the basis for further updating the relevant procedures in the law of the EAEU. An overview of the foreign practice of pharmaceutical inspection during the pandemic is given. In addition, the changes in the Russian regulatory approaches to control and supervision in the Russian legislation are presented.Conclusion. These data give an idea that, with considering the above, there is a need for further convergence of the requirements, the practice of conducting pharmaceutical inspections for compliance with the requirements of GMP Rules in order to harmonize the norms between Russian regulatory documents, the norms of the EAEU law and international standards. This requires the development of a dialogue with the participation of stakeholders.","PeriodicalId":36465,"journal":{"name":"Drug Development and Registration","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-08-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42778482","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Biomedical Applications of Silver Nanoparticles (Review)","authors":"Довлет Таганович Реджепов, А А Водяшкин, Антонина Витальевна Сергородцева, Ярослав Михайлович Станишевский","doi":"10.33380/2305-2066-2021-10-3-176-187","DOIUrl":"https://doi.org/10.33380/2305-2066-2021-10-3-176-187","url":null,"abstract":"Introduction. Silver nanoparticles have unique physicochemical properties and can be used for the diagnosis and treatment of various kinds of infections, oncological diseases, as well as drug delivery. The review presents an analysis of scientific literature on the use of silver nanoparticles for biomedical purposes.Text. The review discusses the perspectives of the silver nanoparticles use in the treatment of oncological diseases as a carrier of drugs, as well as the direct manifestation of their cytotoxic effect on cancer cells. Also, there is considered the use of silver nanoparticles for imparting or enhancing the antibacterial effects of dressings and dental materials. The mechanism of action of silver nanoparticles against viruses is considered. This research presents the use of composite materials containing silver nanoparticles for biomedical purposes.Conclusion. On the basis of the literature data analysis, carried out by the authors, there are shown possibilities of the nanotechnology achievements for the application in medicine.","PeriodicalId":36465,"journal":{"name":"Drug Development and Registration","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-08-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41899407","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Labeling of Immunobiological Drugs, Produced by the Russian Research An-ti-Plague Institution \"Microbe\" of the Rospotrebnadzor (Review)","authors":"A. Komissarov, O. A. Lobovikova, I. V. Shul’gina, V. S. Kostyuchenko, E. G. Abramova, O. A. Volokh, N. V. Sinitsyna, V. A. Demchenko, A. S. Fes'kova, A. K. Nikiforov","doi":"10.33380/2305-2066-2021-10-3-115-130","DOIUrl":"https://doi.org/10.33380/2305-2066-2021-10-3-115-130","url":null,"abstract":"Introduction. This publication describes the design and implementation sequence of technological procedures for labeling immunobiological medicinal products produced by the FGHI RusRAPI \"Microbe\" of the Rospotrebnadzor. In light of meeting the requirements of the Federal Act \"On the Circulation of Pharmaceutical Products\", the materials of this study are undoubtedly relevant.Text. The paper presents a step-by-step sequence of introducing technological procedures for labeling and interaction with the system for monitoring the movement of pharmaceutical products (MMPP) into the production process of medicines. At the preparatory stage, the following main issues were addressed: verification of the identity of information about medicinal products in the State Register of Medicines and in the automatic identification system \"UNISCAN/GS1 RUS\"; determination of the method and possibility of applying the identification means onto the secondary packaging; amendments to the pharma-copoeial monographs of the enterprise for each type of drug. Stage 2 [development of requirements for the system of labeling, serialization, verification and aggregation (LSVAS)] included the following activities: development of a functional model of the labeling process in the FGHI RusRAPI \"Microbe\" and determination of the responsible for the implementation of this scheme units; determination of the method of secondary packaging (manual or automatic), as well as the required degree of aggregation and the required automation of the process, based on the analysis of the functional model and the technological process of labeling; analysis of the experience of introducing drug labeling systems; analysis of the existing IT-structure of the FGHI RusRAPI \"Microbe\"; monitoring of the market of hardware and software manufacturers; development of technical requirements for the created system of marking, serialization, verification and aggregation. Stage 3 (implementation of the labeling, serialization, verification and aggregation system at the production sites) included the following activities: equipment supply and commissioning; equipment qualification (IQ/OQ); training of the personnel; amendments to regulatory documents. In the materials devoted to the implementation of the final stage, the issues of validation of technological procedures for drug labeling and interaction with the system of labeling, serialization, verification and aggregation are considered.Conclusion. The works performed made it possible to produce medicines in accordance with the requirements of the Federal Act \"On the Circulation of Pharmaceutical Products\" and the Decree of the Government of the Russian Federation dated December 14, 2018 № 1556 \"On Approval of the Regulation on the System for Monitoring the Movement of Drugs for Medical Use\". The material presented may be of interest to manufacturers who produce medicines in small amounts.","PeriodicalId":36465,"journal":{"name":"Drug Development and Registration","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-08-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"69657551","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Standardization of the Pharmaceutical Substance of the Drug LCS-1208","authors":"В. Игнатьева, В. Ярцева, Зоя Сергеевна Шпрах, А. П. Будько, Л. В. Эктова, Д. А. Козин, Ю. Решетняк, О. В. Нестерова, Е. А. Панкратова, Elena V. Ignateva, I. V. Yartseva, Z. Shprakh, A. P. Bud’ko, Lydya V. Ektova, D. A. Kozin, V. Y. Reshetnyak, Olga V. Nesterova, Elizaveta A. Pankratova","doi":"10.33380/2305-2066-2021-10-3-88-94","DOIUrl":"https://doi.org/10.33380/2305-2066-2021-10-3-88-94","url":null,"abstract":"Introduction. Indolocarbazole derivatives are of increasing scientific interest for practical oncology. A number of N-glycosides, indolo[2,3-a] carbazole under the laboratory code LCS, were synthesized in the laboratory of chemical synthesis of the National Medical Center of Oncology named after N.N. Blokhin. Currently, one of the most promising compounds in this class is LCS-1208, a representative of the arabinoside class of indolo [2,3-a]pyrrolo[3,4-c]carbazole-5,7-dione. According to the mechanism of biological action, LCS-1208 is a protein kinase C inhibitor and is of great interest for the treatment of malignant neoplasms.Aim. chemical and pharmaceutical standardization of the pharmaceutical substance LCS-1208.Materials and methods. Laboratory samples of pharmaceutical substance LCS-1208. Methods of investigation: gravimetry, spectrophotometry, polarimetry, high-performance liquid chromatography (HPLC), high-resolution nuclear magnetic resonance (NMR) spectroscopy and infrared (IR) spectroscopy.Results and discussion. The quality assessment of LCS-1208 was carried out according to the indicators adopted in the XIV edition of the State Pharmacopoeia of the Russian Federation for quality control of pharmaceutical substances. LCS-1208 - orange amorphous powder, odorless; soluble in dimethylsulfoxide (DMSO) and dimethylformamide (DMF); very slightly soluble in 95 % ethyl alcohol and practically insoluble in water. The authenticity of the substance is confirmed by NMR and IR spectra, as well as electronic absorption spectra. The values of the specific optical rotation of LCS-1208 (1 % solution in DMF) are placed in the range from +58° to +61°. All the studied samples of the substance were free of inorganic impurities, sulphate ash, heavy metals and contained no more than 1.0 % water, determined by the K. Fischer titration method. The content of possible related impurities in the substance LCS-1208 and the content of the main active substance were determined by HPLC. The studied laboratory series of the pharmaceutical substance LCS-1208 contained no more than 1.0 % of any single and no more than 3 % of the total unidentified impurities. The content of the main active substance was more than 97 %.Conclusion. As a result of the work carried out, quality criteria and parameters were selected and methods for their determination were developed, which allow to adequately assess the quality and standardness of the pharmaceutical substance LCS-1208.","PeriodicalId":36465,"journal":{"name":"Drug Development and Registration","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-08-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48007316","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Получение таблеток динитрата 2-фенил-9-диэтиламиноэтилимидазо[1,2-α]бензимидазола и разработка методик контроля их качества","authors":"Ангелина Михайловна Доманина, Максим Валентинович Черников, Ирина Петровна Ремезова, Элеонора Федоровна Степанова, Александр Михайлович Шевченко, Артем Владимирович Морозов","doi":"10.33380/2305-2066-2021-10-2-62-67","DOIUrl":"https://doi.org/10.33380/2305-2066-2021-10-2-62-67","url":null,"abstract":"Introduction. Currently, for the treatment of gastric ulcer, drugs with a combined effect are used. To eliminate possible side effects of the drugs used, the search for new molecules to create more effective and safe histamine H 2 receptors continues. As a possible solution to these problems, we investigated the substance dinitrate of 2-phenyl-9-diethylaminoethylimidazo[1,2-α]benzimidazole (DFDB). Aim. The aim of this study was to obtain 2-phenyl-9-diethylaminoethylimidazo[1,2-α]benzimidazole dinitrate tablets and develop methods for quality control. Materials and methods. The object of study was tablets based on the substance DF DB. The physicochemical and technological properties of the tablet dosage form were studied. Pharmaco-technological and physico-chemical indicators were determined according to the methods of the State Pharmacopoeia of the XIV edition. Identification and quantitative determination of DFDB in tablets was performed by HPLC. Results and discussion. Based on the physico-chemical properties and determination of the main technological indicators of DFDB, an optimal tableting technology has been developed. The optimal composition of tablets has been developed. Identification of tablets is proposed to be carried out using HPLC in comparison with the standard sample of DFDB. Related impurities, according to the data obtained, do not exceed 0.1 %. We found that the tablets do not have an antimicrobial effect. The analyzed tablets correspond to category 3A. The content of DFDB should be from 95 to 105 % of the declared amount in one tablet. During the analysis, we conducted biopharmaceutical and technological studies of the finished dosage form during storage under the conditions of long-term stability testing in polymer cans with screw-on lids. It is shown that the selected composition of excipients and the production technology ensure the stability of the finished dosage form for two years of storage under the observed conditions. To select the tableting technology, the main technological properties of the DFDB substance are analyzed. The choice of excipients and the composition of the film coating was carried out. Conclusion. The technology is developed and standardization of tablets based on the substance DFDB is proposed.","PeriodicalId":36465,"journal":{"name":"Drug Development and Registration","volume":"10 1","pages":"62-67"},"PeriodicalIF":0.0,"publicationDate":"2021-05-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"69657951","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"HPLC-UV Method Development and Validation for Vitamin D3 (Cholecalciferol) Quantitation in Drugs and Dietary Supplements","authors":"I. Shohin, E. A. Malashenko, Yu. V. Medvedev, M. Bogachuk, S. A. Kulakov, M. A. Paleeva","doi":"10.33380/2305-2066-2021-10-2-87-99","DOIUrl":"https://doi.org/10.33380/2305-2066-2021-10-2-87-99","url":null,"abstract":"Introduction. An inadequate diet and living in the northern regions can lead to a lack of vitamin D3 and the development of diseases, including a decrease in immunity. To compensate for the lack of vitamin D, vitamin drugs are used that contain vitamin D in one of its active forms (usually in the form of cholecalciferol, vitamin D3).Aim. To develop and validate HPLC-UV method for the determination of vitamin D3 in vitamin drugs and to evaluate the content of cholecalciferol in selected drugs anddietary supplements presented in the Russian Federation.Materials and methods. Determination of vitamin D3 was carried out by HPLC with UV detection at a wavelength 266 nm. Sample preparation of vitamin drugs was carried out by extraction with methanol (for liquid dosage forms based on aqueous or triglyceride solutions) and extraction with an aqueous-methanol solution (for solid dosage forms based on water-soluble substances with vitamin D3) in a ratio of 2 to 8 (water-methanol).Results and discussions. The analysis methodology for the parameter \"Vitamin D3 (cholecalciferol) content\" in vitamin dosage forms by HPLC was validated according to the following validation parameters: specificity; accuracy; precision; linearity; range.Conclusion. The analysis methodology for the parameter \"Vitamin D3 (cholecalciferol) content\" in vitamin dosage forms by HPLC was developed. The method was validated according to the following validation parameters: specificity; accuracy; precision; linearity; range. The range of the method was 9,5–38 μg/ml. The method was used to determine vitamin D3 in vitamin drugs based on water-soluble forms of vitamin D3, in the form of aqueous solutions and form of fatty acids triglyceridessolutions.","PeriodicalId":36465,"journal":{"name":"Drug Development and Registration","volume":"10 1","pages":"87-99"},"PeriodicalIF":0.0,"publicationDate":"2021-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"69657503","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}