{"title":"Modelling of the composition of emulsion medicines and cosmetics stabilized by a biocomplex of surfactant substances based on rhamnolipids Pseudomonas sp. PS-17","authors":"Iryna Pelekh-Bondaruk, I. Revyatskyy, S. Bilous","doi":"10.15587/2519-4852.2023.282367","DOIUrl":"https://doi.org/10.15587/2519-4852.2023.282367","url":null,"abstract":"The aim. To study the biocomplex of surfactants based on rhamnolipids Pseudomonas sp. PS-17 (biocomplex PS) as an emulsifier and co-emulsifier by using the method of modelling the composition of emulsions for use in dermatology. \u0000Materials and methods. The biocomplex PS is a biogenic surface-active complex synthesized by bacteria of the genus Pseudomonas, which is a viscous mass that includes rhamnolipids, which make up to 80 % of the biocomplex, as well as alginate and water. The methods of computer simulation of semi-automated selection of the composition of the oil phase and emulsifiers of medicinal or cosmetic emulsions developed in the MO Excel program were used. In modelling processes, the biocomplex PS was studied as an independent emulsifier in o/w type emulsions, as well as a co-emulsifier of this type of emulsions in combination with type II emulsifiers. \u0000Results. The substantiation of the concentration of emulsifiers in the composition of emulsion medicinal and cosmetic products is mainly carried out based on experimental studies; therefore, it requires a long time and is expensive. To reduce the number of technological experiments in the development of emulsion products stabilized by a biocomplex of surfactants based on biocomplex PS, a method of computer simulation of the composition of emulsions in the MO Excel program was developed and used. A method based on the application of the hydrophilic-lipophilic balance system. Two examples of solving specific problems of choosing a complex emulsifier and the composition of the oil phase components of the emulsion product are given. \u0000Conclusions: The use of a semi-automated modelling system provides a reasoned choice of the composition of the oil phase of the emulsion when using the PS biocomplex as an independent emulsifier or the choice of the ratio between the PS biocomplex and the type II emulsifier when using a complex emulsifier and allows rational experimental study","PeriodicalId":21674,"journal":{"name":"ScienceRise: Pharmaceutical Science","volume":"63 6","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73267977","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}
O. Tkachova, L. Iakovlieva, O. Gerasymova, Ya. O. Butko, Liliia Kovalenko
{"title":"Comparative analysis of the consumption of antidepressants in Ukraine, Estonia and Norway","authors":"O. Tkachova, L. Iakovlieva, O. Gerasymova, Ya. O. Butko, Liliia Kovalenko","doi":"10.15587/2519-4852.2023.281833","DOIUrl":"https://doi.org/10.15587/2519-4852.2023.281833","url":null,"abstract":"Due to modern living conditions, the number of patients suffering from chronic depression is increasing every year. Antidepressants (AD) are one of the most popular drugs. In recent years, the demand for AD has increased in many countries of the world. The analysis of trends in the level and structure of AD consumption in Ukraine compared to other countries is relevant. \u0000The aim. The purpose of the study was to study the assortment of AD in Ukraine for 2020-2021, as well as to analyze the volume and structure of AD consumption compared to similar data for Estonia and Norway. \u0000Materials and methods. Marketing analysis of the range of drugs on the market and ATC/DDD-methodology were used to study the volume of drug consumption. The analysis of the assortment and consumption volumes of AD was carried out according to the data of the State Register of Medicinal Products of Ukraine and the analytical company \"Proxima Research\"/\"Morion\". Calculations of consumption volumes were made according to the ATC/DDD methodology in terms of DDDs per 1000 inhabitants per day (DID). The obtained results of the level and structure of AD consumption were compared with similar data on the official resources of the State representatives of medicinal products of Estonia and Norway. \u0000Results. The obtained results showed that ADs in Ukraine during 2020-2021 were represented by 19 INNs, mostly drugs of foreign manufacturers. The pharmaceutical market was dominated by selective serotonin reuptake inhibitors (SSRIs). It was established that the consumption of AD among the population of Estonia exceeded the indicators in Ukraine by 12.2-13.6 times, and in Norway by 18.2-21.6 times. The leader in terms of consumption in the three studied countries was a representative of the SSRI group escitalopram, but its consumption in Estonia and Norway was higher than in Ukraine, respectively, by 7.7-9.4 times and by 16.8-21.3 times. \u0000Conclusions. A significant difference in AD consumption may indicate that in Estonia and Norway, a greater number of patients with chronic depression seek medical help and receive pharmacotherapy than in Ukraine","PeriodicalId":21674,"journal":{"name":"ScienceRise: Pharmaceutical Science","volume":"19 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84806835","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}
E. Bezuglaya, A. Liapunova, I. Zinchenko, N. Lyapunov
{"title":"Study of factors affecting the in vitro release of dexpanthenol from solutions and topical semi-solid preparations","authors":"E. Bezuglaya, A. Liapunova, I. Zinchenko, N. Lyapunov","doi":"10.15587/2519-4852.2023.279283","DOIUrl":"https://doi.org/10.15587/2519-4852.2023.279283","url":null,"abstract":"The aim. To identify the factors influencing the in vitro release of dexpanthenol (DP) from solutions and semi-solid preparations. \u0000Materials and methods. Dispersed systems containing 5.0 % DP were studied: solutions that were Newtonian liquids and semi-solid preparations (creams, gels and ointment) with non-Newtonian flow behaviour. Rheological studies were performed by rotational viscometry. In vitro release tests were performed using vertical diffusion cells. The content of DP in the receptor medium was determined by liquid chromatography. \u0000Results. It has been shown that the greatest values of release parameters of DP were characteristic of its aqueous solution; they decreased when propylene glycol (PG), macrogol 400 (M400), and poloxamer 338 (P338) were added but remained at a high enough level. The inclusion of cationic surfactant and cetostearyl alcohol (CSA) (0.5 : 4.5 % m/m) into the Newtonian liquid led to the formation of disperse system with a plastic flow behaviour and to significant decrease in the DP release. In the case of a cream containing a non-ionic surfactant and CSA, the release parameters of DP were also at a low level. The release of DP from the w/o emulsion-based ointment was minimal. Compared to DP aqueous solution, the rate of DP release from a carbomer-based gel decreased by 2.8 times; when 20 % of a mixture of PG and M400 (10 : 10 % m/m) was added to such a gel, the rate of drug release decreased by another 1.5 times. The fastest and most complete release of DP was observed in the case of the P338-based disperse system, which transformed from a Newtonian liquid into a gel at 32 °C. \u0000Conclusions. In vitro release of DP depended on the type of base; rapid and complete release of DP was characteristic of its aqueous solution, and minimal release was observed in the case of hydrophobic ointment. The use of CSA in combination with a surfactant or carbomer to create bases for semi-solid preparations with plastic flow behaviour was a considerable factor that significantly slowed down the release of DP from them. The greatest values of the release parameters of DP were observed in the case of a gel based on P338","PeriodicalId":21674,"journal":{"name":"ScienceRise: Pharmaceutical Science","volume":"24 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86675321","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":"Assessment of the availability of medicines for patients with mental and behavioral disorders according to the results of a survey of physicians and pharmacists in Ukraine","authors":"A. Nemchenko, A. Lyadenko, O. Nemchenko, S. Lebed","doi":"10.15587/2519-4852.2023.281222","DOIUrl":"https://doi.org/10.15587/2519-4852.2023.281222","url":null,"abstract":"The aim: to analyze the results of a questionnaire survey of secondary care physicians and pharmacy pharmacists, participants of the government program \"Affordable Medicines\" (hereinafter the Program) regarding the assessment of the availability of medicines for patients with mental and behavioural disorders. \u0000Materials and methods: in the research process, legal acts, protocols for the treatment of patients with mental and behavioural disorders, the results of a questionnaire survey of doctors and pharmacists - participants of the Program, scientific publications related to questionnaires of doctors and pharmacists on the topics of generic drug replacement and co-payment were used patients. The research was conducted using the methods of questionnaire survey, systematization and generalization of data. \u0000Research results: 134 doctors and 336 pharmacists from 22 regions of Ukraine took part in the questionnaire survey. According to the results of the survey, it was established that doctors of 11 specialties prescribe medicinal products (pharmaceuticals) for the treatment of patients with mental and behavioural disorders with depressive disorders. Most patients with this disease turn to a secondary care physician without visiting a primary care physician, which negatively affects the availability of medicines for patients, as well as the reliability of statistical indicators of the prevalence and incidence of patients with depressive disorders. \u0000The main problem affecting the availability of drugs for patients with depressive disorders is the lack of drugs in the Program in the presence of the corresponding INN in the Unified Clinical Protocol of primary, secondary (specialized) and tertiary (highly specialized) medical care \"Depression\", which forces patients to buy drugs on their own cost, and as a result, it leads to a decrease in the availability of medicines for vulnerable sections of the population under the conditions of the war in Ukraine. \u0000As for the issue of generic replacement of drugs according to the results of the questionnaire: 72.4 % of doctors believe that such replacement can only be carried out by a specialist doctor, while 67.9 % of pharmacists confirmed that they carry out generic replacement of prescribed drugs in case of their absence in pharmacies 76.1 % of doctors and 80.6 % of pharmacists support the need for regulatory and legal settlement of the issue of generic drug replacement in order to increase their access and availability for patients. 74.4 % of the surveyed pharmacists confirmed the desire of patients to receive medicines free of charge due to the Program. \u0000Conclusions: The results of the conducted questionnaire survey of doctors and pharmacists showed the importance of the regulatory settlement of issues regarding drug prescriptions under INN, generic substitution of drugs and patient co-payment, as all the listed mechanisms have an impact on increasing the availability of drugs for patients with mental and beha","PeriodicalId":21674,"journal":{"name":"ScienceRise: Pharmaceutical Science","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90292510","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":"Analysis of pharmaceutical supply of breast cancer patients","authors":"Yaroslava Rafalska, K. Kosyachenko","doi":"10.15587/2519-4852.2023.283490","DOIUrl":"https://doi.org/10.15587/2519-4852.2023.283490","url":null,"abstract":"The aim: to conduct a clinical and economic analysis of the state of pharmaceutical support for patients with breast cancer in women.\u0000Materials and methods. During the research, data from the National List of Essential Medicines, the 14th State Formulary of Medicines, the Ukrainian clinical protocol, the clinical protocols of Great Britain and the United States of America for the treatment of breast cancer, and a depersonalized database of drug prescriptions were used. The research used such methods as clinical-economic, organizational-economic, mathematical-statistical, graphic, grouping and generalization.\u0000Research results. It was established that 46 schemes of schemes for the treatment of breast cancer are presented in Ukrainian and international clinical protocols (Great Britain, USA). In all three protocols, there were 5 regimens for the treatment of breast cancer, such as CMF (Cyclophosphamide, Methotrexat, Fluorouracil), AC (Doxorubicin, Cyclophosphamide), DC (Docetaxel, Cyclophosphamide), TC (Trastuzumab, Capecitabin), EC (Epirubicin, Cyclophosphamide).\u0000Analysis of the pharmaceutical component in the protocols for individual drugs showed that they included 23 drugs according to the INN, which belong to the group of antineoplastic drugs. The Ukrainian clinical protocol includes 17 drugs, the British protocol – 14 drugs, and the American one – 15 drugs. The frequency analysis of antineoplastic drugs included in the Ukrainian clinical protocol revealed the TOP-3 in terms of drug prescription frequency: L01A A01 Cyclophosphamide (Ki=0.037), L01C D02 Docetaxel (Ki=0.029), L01D B01 Doxorubicin (Ki=0.026). The largest number of prescribed drugs are vital drugs – 61.96 %, the smallest share – essential drugs – 2.17 %, and the share of non-essential drugs is 35.87 %. The ABC analysis made it possible to determine the group of the most expensive drugs in the treatment of breast cancer - these are antineoplastic and immunomodulating agents. The total expenses for this group amounted to UAH 772,459.96, which according to the US dollar exchange rate of the National Bank of Ukraine at the end of August 2022 was USD 21,122.77. According to the analysis of the matrix of the integrated ABC-VEN-frequency analysis, it was established that the largest number of prescriptions belonged to the group of less expensive and vital drugs (B/V) – 7 drugs (48.73 % of the total amount. At the same time, the largest amount of expenses is observed in for the A/V group – UAH 772,459.96 (52.83 % of all costs directed to the pharmaceutical support of patients). The results of the structural analysis of the group of the most expensive drugs showed that the highest costs were characteristic of L01CD02 Docetaxel (UAH 1166,531.31; 39.81 % of the total cost in the group), and the lowest – for L01DB01 Doxorubicin – UAH 63,694.14 (5.46 %, respectively).\u0000Conclusions. According to the results of the conducted research, it was established that the largest costs fall on the group of e","PeriodicalId":21674,"journal":{"name":"ScienceRise: Pharmaceutical Science","volume":"25 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81194980","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":"The study of the natural substances obtained from the poplar buds and their use for protection against the action of ionizing radiation","authors":"A. Mechshanova, V. Polyakov, T. Radoykova","doi":"10.15587/2519-4852.2023.271837","DOIUrl":"https://doi.org/10.15587/2519-4852.2023.271837","url":null,"abstract":"Currently, natural plant extracts, which include biologically active substances, are increasingly used to produce medicines and cosmetics.\u0000In connection with the dangers of a radioecological crisis, special attention is paid to finding ways to protect against the effects of chronic exposure to low-intensity ionizing radiation in natural conditions. Currently, there is no ideal and safe radioprotective agent available, and we are seeing a great effort to find these agents from natural sources.\u0000Poplar extract is possible for use as a radioprotective shield from γ-radiation. Samples of protective screens were made from poplar extract on paper and showed a significant radioprotective effect. Phenolic compounds and flavonoids are widely present in plants as a second metabolite and are considered for research depending on their benefits for human health, healing and preventing many disorders. The main biologically active properties of flavonoids include antioxidant, anti-inflammatory, antitumor, rejuvenating, antibacterial and viral, neuroprotective and radioprotective action.\u0000The aim of this work was – the study of Flavonoids in an extract obtained from poplar buds and the possibility of their use for protection against radiation.\u0000Materials and methods. The object of research is the vegetative organs of poplar (buds). In the process of work, experimental studies were carried out on the extraction and separation of natural compounds, identification of flavonoids, and study of the chemical composition of biologically active complexes of poplar and preparations based on them.\u0000Research results. Data from these studies provide the identification of flavonoids by spectroscopy and quantification of flavonoids in poplar bud extract and can contribute to the optimization of radioprotection procedures. The main components found in the poplar buds dry extract are 2',6'-dihydroxy-4'-methoxychalcone – are 2',6'-dihydroxy-4'-methoxychalcone – 2,67 %, 3,4-dihydro-2',6'-dihydroxy-4'-methoxychalcone – 2,33 %, pinobaxin -1,91 %, chrysin – 0,76 %, pinostrobin – 0,04 %, pinocembrin – 0,61 %, tectochrysin- 0,54 % and galangin – 0,18 % of dry material. The results showed that the power of the penetrating radiation decreases with increasing the thickness of the protective screen. The power of penetrating radiation decreased from 78 % at the layer of 0.5 mm to 10 % at 3 mm layer thickness. Further increasing the thickness of the protective screen (> 3 mm), doesn’t affect the dose rate.\u0000Conclusions. The composition of the poplar buds' ethanol extract was investigated. Samples of protective screens made on the basis of poplar extract on paper showed a significant radioprotective effect on low-intensity ionizing radiation","PeriodicalId":21674,"journal":{"name":"ScienceRise: Pharmaceutical Science","volume":"57 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90630843","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}
Y. Boiko, Yevhen Тantsura, I. Boiko, Liudmyla Tantsura
{"title":"Peculiarities of the effect of antiepileptic drugs on seizures in mice with corneal kindling against the background of low-dose premedication with carbamazepine and sulthiame","authors":"Y. Boiko, Yevhen Тantsura, I. Boiko, Liudmyla Tantsura","doi":"10.15587/2519-4852.2023.265308","DOIUrl":"https://doi.org/10.15587/2519-4852.2023.265308","url":null,"abstract":"The aim. The aim of the study was to evaluate the effectiveness of antiepileptic drugs (AED) with a different mechanism of action against the background of prior use of low doses of carbamazepine and sultiam in the model of corneal kindling in mice.\u0000Materials and methods. The corneal kindling model in mice was used. The convulsive model was reproduced under the parallel preliminary administration of carbamazepine and sulthiame 30 minutes before electrostimulation. The anticonvulsant activity of AED (sulthiame, levetiracetam, carbamazepine, valproate, lamotrigine and retigabine) was studied under conditions after the formation of a stable syndrome of the generalised convulsive activity.\u0000Results and discussion. The administration of carbamazepine and sulthiame drugs modulates the activity of the cytochrome P450 enzyme system. Thus, carbamazepine in the dose of 7 and 12 mg/kg showed no significant anticonvulsant activity (the convulsive intensity – 4.42±0.25 points; 4.44±0.32 points) after its preliminary chronic administration, the same doses of carbamazepine showed a noticeable anticonvulsant effect in the control group of animals (3.52±0.26 points; 3.2±0.6 points, respectively). The anticonvulsant activity of lamotrigine changed both in the case of the preliminary chronic administration of an inducer (carbamazepine), and an inhibitor (sulthiame) of the cytochrome P450 system.\u0000Conclusion. Changes in the pharmacological effects of AED observed against the background of chronic administration of carbamazepine and sulthiame, in our opinion, may be due to both the modulation of the cytochrome P450 system and other groups of enzymes involved in the AED metabolism","PeriodicalId":21674,"journal":{"name":"ScienceRise: Pharmaceutical Science","volume":"159 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75195921","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":"Development of a method for the quantitative determination of the solubility limits of poorly soluble in water substances on the example of quercetin","authors":"N. Khanina, V. Georgiyants, V. Khanin","doi":"10.15587/2519-4852.2023.283293","DOIUrl":"https://doi.org/10.15587/2519-4852.2023.283293","url":null,"abstract":"Aim. To consider the importance of this physicochemical characteristic as a determining factor in the study of bioequivalence and bioavailability, there is a need to develop a method to quantitatively determine the solubility limit of quercetin.\u0000Materials and methods. The quercetin concentration was determined in the obtained samples using chromatographic and external standard methods. The pharmacopeial standard – PS of the SPU was used as a standard. For measurements, an Agilent 1290 liquid chromatograph with an Agilent 6530 TOF mass spectrometric detector was used, using a 50×4.6 mm column filled with a sorbent with a grafted phase of octyl silica gel, particle size – 1.7 μm.\u0000Results. The exact limit of the solubility of quercetin, as a poorly soluble substance, has been established. Based on the data obtained, the kinetics of the dissolution of quercetin was studied. In tandem with the QTOF mass spectrometric detector, the HPLC method was utilized in the identification and quantification process. To accurately determine the point that will correspond to the solubility limit of quercetin in water, the obtained experimental dependence was approximated by a polynomial dependence, for which, by solving a system of equations in the Microsoft Excel program, concentration values were found corresponding to the inflection points of the studied dependences.\u0000Conclusions. When studying their bioavailability, a new approach has been developed to quantitatively determine the solubility limit of difficult or practically insoluble substances in aqueous media with a neutral pH value. The exact value of the solubility limit for the test sample of quercetin was established, which was 3.02 mcg/ml. The kinetics of the release of quercetin in aqueous solutions was studied","PeriodicalId":21674,"journal":{"name":"ScienceRise: Pharmaceutical Science","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87723523","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":"Development and validation of a new spectrophotometric method for the determination of gabapentin in capsules","authors":"K. Miedviedieva, S. Vasyuk, Olena Portna","doi":"10.15587/2519-4852.2023.283270","DOIUrl":"https://doi.org/10.15587/2519-4852.2023.283270","url":null,"abstract":"In Ukraine, there are about 100 thousand people with epilepsy. Gabapentin is an effective antiepileptic agent for oral use, presented in capsules of different dosages from different manufacturers. Therefore, the urgent task of pharmaceutical analysis today is the development of highly accurate, reliable, affordable and fast methods of quantitative determination.\u0000The aim of the work is to develop a spectrophotometric technique for the quantitative determination of gabapentin in capsules based on the reaction with diazole red 2J in compliance with the SPhU.\u0000Material and methods. As reagent and solvent, diazole red 2J of AR grade, acetone of AR grade and purified water was used. Analytical equipment: Specord 200 and Specord 250 Plus spectrophotometers, ABT-120-5DM and Radwag XA 210.4Y electronic scales, Elmasonic E 60H and Sonorex Digitec DT100H ultrasonic baths, measuring glassware of A class.\u0000Results. A simple, accurate and eco-friendly colourimetric method was developed for the quantification of gabapentin in capsules. The method was based on the reaction of gabapentin with diazole red 2J to give a coloured product having analytical maxima at 390 nm. Factors affecting colour development and stability were optimized and incorporated into the procedure. Regression analysis of Beer's plot showed a good correlation (not less than 0.999) in a concentration range of 2.10 – 3.64 mg/100 ml. The detection and quantification limits were 2.25 % and 6.19 %, respectively. The intra- and inter-laboratory precision demonstrates and reflects no interference by the capsule additives and confirms the reproducibility of the method in the selected concentration range. The prediction of the total uncertainty of the results of the developed method is calculated and displayed to assess the correctness of the reproduction of the method.\u0000Conclusions. It has been proven that the developed method meets the requirements of the State Pharmacopoeia of Ukraine and allows to perform the correct quality control of medicinal products.","PeriodicalId":21674,"journal":{"name":"ScienceRise: Pharmaceutical Science","volume":"126 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83723204","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}
L. Bodnar, Nataliia Polovko, N. Bevz, V. Hrudko, O.P. Perepelytsia
{"title":"Biopharmaceutical justification of the creation of self-emulsifying drug delivery systems with simvastatin","authors":"L. Bodnar, Nataliia Polovko, N. Bevz, V. Hrudko, O.P. Perepelytsia","doi":"10.15587/2519-4852.2023.277351","DOIUrl":"https://doi.org/10.15587/2519-4852.2023.277351","url":null,"abstract":"The aim of the research – to conduct biopharmaceutical tests of capsules with a self-emulsifying delivery system of simvastatin to confirm the effectiveness and feasibility of introducing into the composition of self-emulsifying drug delivery systems active pharmaceutical ingredients that are difficult to dissolve in the gastric juice environment. \u0000Material and methods. Substances, excipients, reagents and materials used during research were simvastatin (India, p. DK40-2005021, 99.09 %), castor oil (Ukraine), polyethylene glycol 40 hydrogenated castor oil (India), Tween 80 (Ukraine), glycerol monostearate (Gustav Heess GmbH, Germany), polyethylene glycol 100 stearate (ERCA, Italy), hard gelatin capsules No. 3 white (China), 0.1 M hydrochloric acid solution (made from concentrated hydrochloric acid), ethanol 96 % (Ukraine), filter paper 90 mm white tape (Ukraine). The reference drug is \"Simvastatin-Sandoz\" (Salyutas Pharma, Germany, series LX5161). \u0000An Evolution 60S spectrophotometer (USA) was used to carry out studies by absorption spectrophotometry. \u0000Results. Preliminary study of the absorption spectra of absorption of the substance, bases, gelatin capsules, developed self-emulsifying systems and the reference drug made it possible to predict and optimize the conduct of biopharmaceutical research. The study of the release of simvastatin from the developed delivery systems and the reference drug, which was carried out at a temperature of 37 ℃ in an environment of 0.1M hydrochloric acid, showed that the introduction of simvastatin into the composition of the investigated self-emulsifying compositions allows to increase its solubility in this solvent by five times, compared to the reference drug. \u0000Conclusions. The obtained results indicate the effectiveness of the introduction of simvastatin into the composition of self-emulsifying drug delivery systems and the feasibility of using such systems to improve the solubility and accelerate the release of a poorly water-soluble active pharmaceutical ingredient into the gastric juice environment","PeriodicalId":21674,"journal":{"name":"ScienceRise: Pharmaceutical Science","volume":"28 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79313989","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}