Olena Anatoliivna Ruban
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Olena Anatoliivna Ruban has a total of 144 co-authors. Here are the top co-authors by number of shared publications:
- Inna Kovalevska
National University of Pharmacy
15 shared publications - Yuliia Maslii
Department of Drug Technology and Social Pharmacy, Lithuanian University of Health Sciences, LT-50161 Kaunas, Lithuania
14 shared publications - Tetiana Kolisnyk
School of Pharmacy, Queen's University Belfast, 97 Lisburn Road, Belfast BT9 7BL, Northern Ireland, United Kingdom
8 shared publications - I. V. Zupanets
National University of Pharmacy
6 shared publications - Nataliya Gerbina
Department of Drug Technology and Social Pharmacy, Lithuanian University of Health Sciences, LT-50161 Kaunas, Lithuania
6 shared publications - O. I. Ivaniuk
National University of Pharmacy
4 shared publications
Latest Publications
- Open Access
- 30 June 2026
- Published by Private Company Technology Center in ScienceRise: Pharmaceutical Science
- No. 3 (61),p. 28-38
Experimental substantiation of the efficacy of combined administration of loratadine and dry extract of hare's ear (Bupleurum aureum Fisch.) in an ovalbumin-induced allergic rhinitis model in immature rats
The present study comprehensively investigated the clinical manifestations, hematological, immunological, and biochemical parameters in immature rats with ovalbumin-induced allergic rhinitis following loratadine monotherapy and its combined administration with a standardized dry extract of Bupleurum aureum. The aim − to experimentally evaluate the effects of the combined administration of loratadine and a standardized Bupleurum aureum extract on the course of ovalbumin-induced allergic rhinitis in immature rats by assessing clinical manifestations, immune-inflammatory response, and oxidative stress parameters. Materials and methods. Experimental modeling of ovalbumin-induced allergic rhinitis in rats enables the reproduction of the main pathogenetic mechanisms of this disease and allows for a comprehensive assessment of both clinical manifestations and changes in the immune, hematological, and pro-/antioxidant systems. Such a model is informative for studying the efficacy of potential antiallergic agents and their effects on various components of the pathological process. Results. According to the results of experimental studies, ovalbumin-induced allergic rhinitis in immature rats weighing 70–100 g is accompanied by the development of a systemic IgE-mediated immune response, an inflammatory reaction, and oxidative stress, as evidenced by changes in clinical, hematological, biochemical, and immunological parameters, Loratadine monotherapy provides partial correction of allergic rhinitis manifestations, effectively reducing the severity of clinical symptoms and the level of pro-inflammatory mediators; however, it does not fully normalize systemic immunological and pro-/antioxidant disturbances, The use of a pharmaceutical syrup formulation containing loratadine and dry extract of Bupleurum aureum (DEBA) at a dose of 0.15 mg/kg in terms of loratadine and 0.15 mg/kg of DEBA demonstrates a more pronounced and balanced therapeutic effect, manifested by normalization of clinical signs, hematological parameters, markers of systemic inflammation, IgE-mediated immune response, and indicators of oxidative–antioxidative balance, The advantages of the combination therapy are likely due to the synergistic interaction of the components with different mechanisms of action, enabling effects on key pathogenetic links of allergic rhinitis—from the immediate histamine-mediated reaction to systemic inflammation and oxidative damage. Conclusion. Allergic rhinitis is one of the most common forms of IgE-mediated allergic diseases, characterized by both local manifestations in the nasal mucosa and systemic immunoinflammatory and metabolic disturbances. Its pathogenesis is primarily driven by activation of the Th2 immune response, increased IgE levels, histamine release and other inflammatory mediators, as well as eosinophil involvement and the development of oxidative stress, which contribute to the persistence and chronicity of the inflammatory process. Particular interest lies in the evaluation of the efficacy of loratadine monotherapy as a representative of H1-histamine receptor blockers, as well as its combined use with biologically active plant-derived components that may potentially influence the inflammatory and oxidative components of the allergic process. The combination of such approaches expands the understanding of possibilities for pathogenetic correction of allergic inflammation and helps to determine the advantages of multi-component therapy
- 30 June 2026
- Published by Private Company Technology Center in ScienceRise: Pharmaceutical Science
- No. 3 (61),p. 28-38
Open AccessExperimental substantiation of the efficacy of combined administration of loratadine and dry extract of hare's ear (Bupleurum aureum Fisch.) in an ovalbumin-induced allergic rhinitis model in immature rats
The present study comprehensively investigated the clinical manifestations, hematological, immunological, and biochemical parameters in immature rats with ovalbumin-induced allergic rhinitis following loratadine monotherapy and its combined administration with a standardized dry extract of Bupleurum aureum. The aim − to experimentally evaluate the effects of the combined administration of loratadine and a standardized Bupleurum aureum extract on the course of ovalbumin-induced allergic rhinitis in immature rats by assessing clinical manifestations, immune-inflammatory response, and oxidative stress parameters. Materials and methods. Experimental modeling of ovalbumin-induced allergic rhinitis in rats enables the reproduction of the main pathogenetic mechanisms of this disease and allows for a comprehensive assessment of both clinical manifestations and changes in the immune, hematological, and pro-/antioxidant systems. Such a model is informative for studying the efficacy of potential antiallergic agents and their effects on various components of the pathological process. Results. According to the results of experimental studies, ovalbumin-induced allergic rhinitis in immature rats weighing 70–100 g is accompanied by the development of a systemic IgE-mediated immune response, an inflammatory reaction, and oxidative stress, as evidenced by changes in clinical, hematological, biochemical, and immunological parameters, Loratadine monotherapy provides partial correction of allergic rhinitis manifestations, effectively reducing the severity of clinical symptoms and the level of pro-inflammatory mediators; however, it does not fully normalize systemic immunological and pro-/antioxidant disturbances, The use of a pharmaceutical syrup formulation containing loratadine and dry extract of Bupleurum aureum (DEBA) at a dose of 0.15 mg/kg in terms of loratadine and 0.15 mg/kg of DEBA demonstrates a more pronounced and balanced therapeutic effect, manifested by normalization of clinical signs, hematological parameters, markers of systemic inflammation, IgE-mediated immune response, and indicators of oxidative–antioxidative balance, The advantages of the combination therapy are likely due to the synergistic interaction of the components with different mechanisms of action, enabling effects on key pathogenetic links of allergic rhinitis—from the immediate histamine-mediated reaction to systemic inflammation and oxidative damage. Conclusion. Allergic rhinitis is one of the most common forms of IgE-mediated allergic diseases, characterized by both local manifestations in the nasal mucosa and systemic immunoinflammatory and metabolic disturbances. Its pathogenesis is primarily driven by activation of the Th2 immune response, increased IgE levels, histamine release and other inflammatory mediators, as well as eosinophil involvement and the development of oxidative stress, which contribute to the persistence and chronicity of the inflammatory process. Particular interest lies in the evaluation of the efficacy of loratadine monotherapy as a representative of H1-histamine receptor blockers, as well as its combined use with biologically active plant-derived components that may potentially influence the inflammatory and oxidative components of the allergic process. The combination of such approaches expands the understanding of possibilities for pathogenetic correction of allergic inflammation and helps to determine the advantages of multi-component therapy
- Open Access
- 30 March 2026
- Published by Kharkiv National University of Radioelectronics in Innovative technologies and scientific solutions for industries
- No. 1(35),p. 154-167
Investigation of the damping properties of 3D-printed liners with controlled perforation
This study focuses on thermoplastic polyurethane (TPU) liners with controlled internal perforation intended for use in the “residual limb–liner–socket” system of lower-limb prostheses. The influence of material stiffness, hole geometry, and degree of perforation on vibration damping efficiency under impact–dynamic loading is investigated. The aim of the work is the experimental determination and optimization of the damping characteristics of TPU liners by varying material stiffness, hole shape, and perforation percentage using the free-decay vibration method. Tasks: to analyze the functional role of the liner as a damping element in the prosthetic system; to fabricate a series of 3D-printed TPU specimens with different stiffness levels, hole geometries, and perforation degrees; to implement an impact-based method for measuring free damped vibrations for each specimen; to determine the damping ratio and vibration attenuation percentage; to process experimental data in order to identify optimal combinations of material and geometric parameters; and to establish the relationships between material stiffness, perforation level, hole pattern, and the damping properties of liners. Results: a method for evaluating the damping characteristics of 3D-printed TPU liners with controlled internal structures was implemented and experimentally validated. A nonlinear dependence of vibration damping efficiency on the degree of perforation was identified, along with a systematic decrease in damping as TPU stiffness increased. It was shown that hexagonal hole geometry provides a more uniform deformation distribution and slightly higher damping efficiency compared to rhombic and triangular patterns. The obtained relationships enable targeted design of damping liners with an optimal balance between stiffness and vibration attenuation capacity. These findings support the solution of the following practical challenges: reduction of impact loads by decreasing peak dynamic forces transmitted from the prosthetic socket to the soft tissues of the residual limb; pressure redistribution through the formation of more uniform contact stresses at the skin–liner interface; improved user comfort by reducing vibration, pain, and skin irritation during walking; individual optimization through personalized selection of liner geometry and material based on body parameters, activity level, and tissue condition; and engineering design of structurally optimized components for biomedical applications. Conclusions: the study experimentally confirms the feasibility of controlling the damping properties of TPU liners by adjusting material stiffness, degree of perforation, and hole geometry. An optimal perforation range was identified for each TPU stiffness level, as well as the advantages of hexagonal perforation in terms of deformation uniformity and vibration damping efficiency.
- 30 March 2026
- Published by Kharkiv National University of Radioelectronics in Innovative technologies and scientific solutions for industries
- No. 1(35),p. 154-167
Open AccessInvestigation of the damping properties of 3D-printed liners with controlled perforation
This study focuses on thermoplastic polyurethane (TPU) liners with controlled internal perforation intended for use in the “residual limb–liner–socket” system of lower-limb prostheses. The influence of material stiffness, hole geometry, and degree of perforation on vibration damping efficiency under impact–dynamic loading is investigated. The aim of the work is the experimental determination and optimization of the damping characteristics of TPU liners by varying material stiffness, hole shape, and perforation percentage using the free-decay vibration method. Tasks: to analyze the functional role of the liner as a damping element in the prosthetic system; to fabricate a series of 3D-printed TPU specimens with different stiffness levels, hole geometries, and perforation degrees; to implement an impact-based method for measuring free damped vibrations for each specimen; to determine the damping ratio and vibration attenuation percentage; to process experimental data in order to identify optimal combinations of material and geometric parameters; and to establish the relationships between material stiffness, perforation level, hole pattern, and the damping properties of liners. Results: a method for evaluating the damping characteristics of 3D-printed TPU liners with controlled internal structures was implemented and experimentally validated. A nonlinear dependence of vibration damping efficiency on the degree of perforation was identified, along with a systematic decrease in damping as TPU stiffness increased. It was shown that hexagonal hole geometry provides a more uniform deformation distribution and slightly higher damping efficiency compared to rhombic and triangular patterns. The obtained relationships enable targeted design of damping liners with an optimal balance between stiffness and vibration attenuation capacity. These findings support the solution of the following practical challenges: reduction of impact loads by decreasing peak dynamic forces transmitted from the prosthetic socket to the soft tissues of the residual limb; pressure redistribution through the formation of more uniform contact stresses at the skin–liner interface; improved user comfort by reducing vibration, pain, and skin irritation during walking; individual optimization through personalized selection of liner geometry and material based on body parameters, activity level, and tissue condition; and engineering design of structurally optimized components for biomedical applications. Conclusions: the study experimentally confirms the feasibility of controlling the damping properties of TPU liners by adjusting material stiffness, degree of perforation, and hole geometry. An optimal perforation range was identified for each TPU stiffness level, as well as the advantages of hexagonal perforation in terms of deformation uniformity and vibration damping efficiency.
- Open Access
- 26 March 2026
- Published by Ukrainian Military Medical Academy in Ukrainian Journal of Military Medicine
- Vol. 7 (1) , 160-169
Соціально-економічне та біофармацевтичне обґрунтування розробки лікувально-профілактичних засобів для догляду за куксою
Вступ. Воєнні дії на території Україні призвели до різкого зростання кількості осіб з ампутаціями кінцівок, що за оцінками Національної служби здоров’я України та Міністерства охорони здоров’я України (МОЗ) сягає понад 90 тисяч осіб у 2025 році. Така ситуація актуалізує потребу у комплексній медико-соціальній реабілітації та забезпеченні пацієнтів засобами для догляду за залишковою кінцівкою (куксою). Стан шкіри кукси є визначальним для успішного використання протезів, адже ураження шкіри, мацерація, рубцювання чи інфікування часто призводять до відмови від протезування та зниження якості життя. Зростання попиту на спеціалізовані лікарські форми при дефіциті доступних препаратів на внутрішньому ринку зумовлює потребу у створенні вітчизняних засобів із доведеною ефективністю. Мета. обґрунтувати соціально-економічну та біофармацевтичну доцільність розробки, промислового виробництва та впровадження на ринок спеціалізованих МЛЗ для догляду за куксою. Матеріали і методи. Матеріалами дослідження стали дані спеціалізованої літератури, Національної служби здоров’я України, МОЗ України, Державного експертного центру МОЗ України, офіційні сайти виробників лікувально-профілактичних засобів, дані сайтів міжнародних і регіональних організацій, які надають допомогу особам із ампутаціями. Використано історичний, порівняльний, логічний, математико-статистичний, маркетинговий та контент-аналіз. Результати. Ринок засобів для догляду за куксою в Україні представлений переважно імпортними найменуваннями компаній США та ЄС. Із 28 проаналізованих найменувань реально доступними в аптеках і на локальних маркетплейсах є лише 15. Значна частина засобів має комбінований склад, однак їх висока вартість обмежує регулярне використання пацієнтами з низьким доходом. Біофармацевтичний аналіз підтвердив ключову роль допоміжних речовин у складі м’яких лікарських засобів, зокрема призначених для догляду за куксою: гідрофільні гелі та емульсії типу «олія у воді» забезпечують швидке проникнення АФІ та їх біодоступність, тоді як гідрофобні основи створюють захисну плівку і пролонгують дію. Висновки. Асортимент засобів для догляду за куксою в Україні є обмеженим та залежним від імпорту. Висока ціна зазначених засобів суттєво знижує соціально-економічну доступність для пацієнтів. Відсутність вітчизняних розробок підкреслює актуальність створення спеціалізованих м’яких лікарських засобів на основі вітчизняної сировини. Перспективним є виробництво гідрофільних гелів і силіконових кремів із комбінованою дією (антибактеріальною, протизапальною, репаративною), що відповідатиме біофармацевтичним вимогам та соціально-економічним потребам українських пацієнтів.
- 26 March 2026
- Published by Ukrainian Military Medical Academy in Ukrainian Journal of Military Medicine
- Vol. 7 (1) , 160-169
Open AccessСоціально-економічне та біофармацевтичне обґрунтування розробки лікувально-профілактичних засобів для догляду за куксою
Вступ. Воєнні дії на території Україні призвели до різкого зростання кількості осіб з ампутаціями кінцівок, що за оцінками Національної служби здоров’я України та Міністерства охорони здоров’я України (МОЗ) сягає понад 90 тисяч осіб у 2025 році. Така ситуація актуалізує потребу у комплексній медико-соціальній реабілітації та забезпеченні пацієнтів засобами для догляду за залишковою кінцівкою (куксою). Стан шкіри кукси є визначальним для успішного використання протезів, адже ураження шкіри, мацерація, рубцювання чи інфікування часто призводять до відмови від протезування та зниження якості життя. Зростання попиту на спеціалізовані лікарські форми при дефіциті доступних препаратів на внутрішньому ринку зумовлює потребу у створенні вітчизняних засобів із доведеною ефективністю. Мета. обґрунтувати соціально-економічну та біофармацевтичну доцільність розробки, промислового виробництва та впровадження на ринок спеціалізованих МЛЗ для догляду за куксою. Матеріали і методи. Матеріалами дослідження стали дані спеціалізованої літератури, Національної служби здоров’я України, МОЗ України, Державного експертного центру МОЗ України, офіційні сайти виробників лікувально-профілактичних засобів, дані сайтів міжнародних і регіональних організацій, які надають допомогу особам із ампутаціями. Використано історичний, порівняльний, логічний, математико-статистичний, маркетинговий та контент-аналіз. Результати. Ринок засобів для догляду за куксою в Україні представлений переважно імпортними найменуваннями компаній США та ЄС. Із 28 проаналізованих найменувань реально доступними в аптеках і на локальних маркетплейсах є лише 15. Значна частина засобів має комбінований склад, однак їх висока вартість обмежує регулярне використання пацієнтами з низьким доходом. Біофармацевтичний аналіз підтвердив ключову роль допоміжних речовин у складі м’яких лікарських засобів, зокрема призначених для догляду за куксою: гідрофільні гелі та емульсії типу «олія у воді» забезпечують швидке проникнення АФІ та їх біодоступність, тоді як гідрофобні основи створюють захисну плівку і пролонгують дію. Висновки. Асортимент засобів для догляду за куксою в Україні є обмеженим та залежним від імпорту. Висока ціна зазначених засобів суттєво знижує соціально-економічну доступність для пацієнтів. Відсутність вітчизняних розробок підкреслює актуальність створення спеціалізованих м’яких лікарських засобів на основі вітчизняної сировини. Перспективним є виробництво гідрофільних гелів і силіконових кремів із комбінованою дією (антибактеріальною, протизапальною, репаративною), що відповідатиме біофармацевтичним вимогам та соціально-економічним потребам українських пацієнтів.
- Open Access
- 30 December 2025
- Published by Dnipro State Medical University
- Vol. 30 (4) , 184-198
Physicochemical and wound tensile-strength studies in the development of a cream formulation for application during the acute and post-acute rehabilitation phases following limb amputation
The full-scale war in Ukraine has led to a humanitarian crisis and has placed a significant burden on the healthcare system, particularly in the fields of traumatology, rehabilitation, and medical support for disabled people. From 2022 to 2024, more than 90,000 amputations were documented in Ukraine, most amputations are of the lower limbs, which created an increased demand for modern healthcare and rehabilitation products. Particularly important became ensuring proper stump care – a key component of the amputation recovery process, which is often underestimated. The aim of this study was the scientific substantiation, development, and testing of the composition of a semisolid medicinal formulation based on modern excipients and active pharmaceutical ingredients (glucosamine hydrochloride, miramistin, dexpanthenol, vitamin D) for stump care after amputation. To achieve this goal, a comprehensive study of the physico-chemical and structure-mechanical properties of the developed samples was carried out, as well as an evaluation of their pharmacological (reparative) effectiveness using scar tensile strength as a parameter in a linear incision wound model. It was established that the emulsifier content significantly affects the structure-mechanical and adhesive properties of creams intended for stump care. The best ratio of parameters was observed in the sample containing 5% emulsifier. The bioadhesion of creams decreases under the influence of electrolytes. The most pharmacologically effective were prototype formulations with glucosamine hydrochloride alone and in combination with miramistin, which outperformed the comparison drug (gel Pantestin-Darnitsa) in a model of a linear cut wound in rats. These formulations produced a statistically significant increase in scar tensile strength, while gel Pantestin-Darnitsa was at the trend level. It was shown that variations in the content of emulsifier, glycerin, and silicone components significantly influence the structural-mechanical, microstructural, and bioadhesive properties of the formulation. Samples with the optimal ratio of these components demonstrated high stability, uniform microstructure, and a sufficient level of skin adhesion, for instance, under conditions that simulate skin perspiration. Thus, a promising formulation has been obtained, which can be further used in preclinical and clinical studies and implemented into stump care practice for patients after lower limb amputations.
- 30 December 2025
- Published by Dnipro State Medical University
- Vol. 30 (4) , 184-198
Open AccessPhysicochemical and wound tensile-strength studies in the development of a cream formulation for application during the acute and post-acute rehabilitation phases following limb amputation
The full-scale war in Ukraine has led to a humanitarian crisis and has placed a significant burden on the healthcare system, particularly in the fields of traumatology, rehabilitation, and medical support for disabled people. From 2022 to 2024, more than 90,000 amputations were documented in Ukraine, most amputations are of the lower limbs, which created an increased demand for modern healthcare and rehabilitation products. Particularly important became ensuring proper stump care – a key component of the amputation recovery process, which is often underestimated. The aim of this study was the scientific substantiation, development, and testing of the composition of a semisolid medicinal formulation based on modern excipients and active pharmaceutical ingredients (glucosamine hydrochloride, miramistin, dexpanthenol, vitamin D) for stump care after amputation. To achieve this goal, a comprehensive study of the physico-chemical and structure-mechanical properties of the developed samples was carried out, as well as an evaluation of their pharmacological (reparative) effectiveness using scar tensile strength as a parameter in a linear incision wound model. It was established that the emulsifier content significantly affects the structure-mechanical and adhesive properties of creams intended for stump care. The best ratio of parameters was observed in the sample containing 5% emulsifier. The bioadhesion of creams decreases under the influence of electrolytes. The most pharmacologically effective were prototype formulations with glucosamine hydrochloride alone and in combination with miramistin, which outperformed the comparison drug (gel Pantestin-Darnitsa) in a model of a linear cut wound in rats. These formulations produced a statistically significant increase in scar tensile strength, while gel Pantestin-Darnitsa was at the trend level. It was shown that variations in the content of emulsifier, glycerin, and silicone components significantly influence the structural-mechanical, microstructural, and bioadhesive properties of the formulation. Samples with the optimal ratio of these components demonstrated high stability, uniform microstructure, and a sufficient level of skin adhesion, for instance, under conditions that simulate skin perspiration. Thus, a promising formulation has been obtained, which can be further used in preclinical and clinical studies and implemented into stump care practice for patients after lower limb amputations.
- 29 December 2025
- Published by Publishing House Helvetica (Publications) in Fitoterapia
- No. 4,p. 165-179
The effect of cream with glucosamine hydrochloride and miramistin on the healing of full-thickness flat wounds in rats
- 29 December 2025
- Published by Publishing House Helvetica (Publications) in Fitoterapia
- No. 4,p. 165-179
The effect of cream with glucosamine hydrochloride and miramistin on the healing of full-thickness flat wounds in rats
- Open Access
- 18 December 2025
- Published by Private Company Technology Center in ScienceRise: Pharmaceutical Science
- No. 6 (58),p. 52-58
Development and validation of an HPLC method for the determination of glucosamine hydrochloride in a medicinal product in the form of a cream
The development of medicinal products requires the use of selective and reproducible analytical methods that ensure reliable determination of active ingredients. The analysis of glucosamine hydrochloride as a medicinal product in the form of a cream has specific challenges due to its high polarity and lack of a chromophore; therefore, its determination within the dosage form requires a specially adapted analytical approach. The aim. To develop and validate a liquid chromatographic method for the determination of glucosamine hydrochloride in a medicinal product in the form of a cream in accordance with the requirements of ICH Q2(R2), the State Pharmacopoeia of Ukraine (SPhU), and the European Pharmacopoeia (EP). Materials and methods. The object of the study was an experimental batch of a cream containing glucosamine hydrochloride (1%). The analysis was performed using a KNAUER Smartline chromatograph equipped with a UV detector and a Zorbax SB-C8 column (150 × 4.6 mm, 5 μm). Phenyl isothiocyanate was used for derivatization, resulting in the formation of a UV-active glucosamine derivative. Validation was carried out with respect to specificity, linearity, accuracy, precision, system suitability, and robustness. Results. Optimal chromatographic conditions were established (mobile phase: acetonitrile–water, 40:60, acidified with phosphoric acid to pH 3.0; detection wavelength 230 nm; flow rate 1.0 mL/min; column thermostat temperature 25°C), ensuring complete separation of the glucosamine derivative (retention time 2.21 min) from sodium benzoate (retention time 3.55 min) and other excipients in the cream formulation. The minimum required concentration of the derivatization reagent was determined to be 0.008–0.01 g/mL. Evaluation of validation parameters confirmed the specificity of the method, its linearity within the 80–120% range (r = 0.9991), precision (ΔZ = 0.61%), accuracy (δ = 0.31%), repeatability (≤ 2%), and robustness (analytical solutions stable for 1 hour). Metrological assessment (n = 6) demonstrated that the systematic error was statistically insignificant, while the relative uncertainty of a single determination was 7.88% at a confidence level of P = 0.95. The detection limit of glucosamine hydrochloride is 0.23 μg/ml. Conclusions. An HPLC method for the determination of glucosamine hydrochloride in a cream formulation after derivatization with phenyl isothiocyanate has been proposed and experimentally substantiated. The method complies with the requirements of international guidelines and can be applied in quality control for the identification and quantitative determination of the active pharmaceutical ingredient in the investigated medicinal product
- 18 December 2025
- Published by Private Company Technology Center in ScienceRise: Pharmaceutical Science
- No. 6 (58),p. 52-58
Open AccessDevelopment and validation of an HPLC method for the determination of glucosamine hydrochloride in a medicinal product in the form of a cream
The development of medicinal products requires the use of selective and reproducible analytical methods that ensure reliable determination of active ingredients. The analysis of glucosamine hydrochloride as a medicinal product in the form of a cream has specific challenges due to its high polarity and lack of a chromophore; therefore, its determination within the dosage form requires a specially adapted analytical approach. The aim. To develop and validate a liquid chromatographic method for the determination of glucosamine hydrochloride in a medicinal product in the form of a cream in accordance with the requirements of ICH Q2(R2), the State Pharmacopoeia of Ukraine (SPhU), and the European Pharmacopoeia (EP). Materials and methods. The object of the study was an experimental batch of a cream containing glucosamine hydrochloride (1%). The analysis was performed using a KNAUER Smartline chromatograph equipped with a UV detector and a Zorbax SB-C8 column (150 × 4.6 mm, 5 μm). Phenyl isothiocyanate was used for derivatization, resulting in the formation of a UV-active glucosamine derivative. Validation was carried out with respect to specificity, linearity, accuracy, precision, system suitability, and robustness. Results. Optimal chromatographic conditions were established (mobile phase: acetonitrile–water, 40:60, acidified with phosphoric acid to pH 3.0; detection wavelength 230 nm; flow rate 1.0 mL/min; column thermostat temperature 25°C), ensuring complete separation of the glucosamine derivative (retention time 2.21 min) from sodium benzoate (retention time 3.55 min) and other excipients in the cream formulation. The minimum required concentration of the derivatization reagent was determined to be 0.008–0.01 g/mL. Evaluation of validation parameters confirmed the specificity of the method, its linearity within the 80–120% range (r = 0.9991), precision (ΔZ = 0.61%), accuracy (δ = 0.31%), repeatability (≤ 2%), and robustness (analytical solutions stable for 1 hour). Metrological assessment (n = 6) demonstrated that the systematic error was statistically insignificant, while the relative uncertainty of a single determination was 7.88% at a confidence level of P = 0.95. The detection limit of glucosamine hydrochloride is 0.23 μg/ml. Conclusions. An HPLC method for the determination of glucosamine hydrochloride in a cream formulation after derivatization with phenyl isothiocyanate has been proposed and experimentally substantiated. The method complies with the requirements of international guidelines and can be applied in quality control for the identification and quantitative determination of the active pharmaceutical ingredient in the investigated medicinal product
- Open Access
- 28 February 2025
- Published by Private Company Technology Center in ScienceRise: Pharmaceutical Science
- No. 1 (53),p. 93-105
Research on the development of the composition of complex action dental films with calcium hydroxyapatite
The aim. Development of the composition of dental films for remineralization, treatment and prevention of dental hyperesthesia, prevention of the formation of microbial biofilms, elimination of pathogenic microflora. Methods. Determination of crystallographic characteristics, uniformity of particle distribution and their ability to aggregation was carried out by microscopy, viscosity – by rotational viscometer, pH-potentiometrically. The tensile strength of the films, the ability to stretch and lengthen, the strength of the bioadhesive bond were investigated by a texture analyzer, the thickness of the films – by calipers. Antimicrobial activity was determined by the disk-diffusion method and by the effectiveness of antimicrobial preservatives. Results. The choice of CHA concentration (10 %) was based on the analysis of literature sources. Structural-mechanical and organoleptic studies established the feasibility of using a combined system with the inclusion of purified water, glycerin and macrogol 400. The study of sedimentation and aggregation stability of the samples showed a uniform distribution of particles in samples from PVA, HEC, HPC. Films from Sodium Alginate, PVP, Na-CMC and HPMC were excluded from the work due to unsatisfactory properties. Structural-mechanical and physico-chemical properties allowed us to choose 5 % PVA as the film former, and 4 % glycerin as the plasticizer. The concentrations of API (metronidazole and chlorhexidine) were selected based on antimicrobial activity and preservative effect. Conclusions. As APIs, CHA – a remineralizing, anti-caries agent, metronidazole and chlorhexidine – antimicrobial components were selected. The introduction of CHA is rational in a complex dispersion medium, metronidazole as a suspension with glycerin, chlorhexidine as a 20 % solution. The composition of the film base was substantiated. The concentrations of metronidazole and chlorhexidine bigluconate were determined. The developed drug met the specifications of the MQC
- 28 February 2025
- Published by Private Company Technology Center in ScienceRise: Pharmaceutical Science
- No. 1 (53),p. 93-105
Open AccessResearch on the development of the composition of complex action dental films with calcium hydroxyapatite
The aim. Development of the composition of dental films for remineralization, treatment and prevention of dental hyperesthesia, prevention of the formation of microbial biofilms, elimination of pathogenic microflora. Methods. Determination of crystallographic characteristics, uniformity of particle distribution and their ability to aggregation was carried out by microscopy, viscosity – by rotational viscometer, pH-potentiometrically. The tensile strength of the films, the ability to stretch and lengthen, the strength of the bioadhesive bond were investigated by a texture analyzer, the thickness of the films – by calipers. Antimicrobial activity was determined by the disk-diffusion method and by the effectiveness of antimicrobial preservatives. Results. The choice of CHA concentration (10 %) was based on the analysis of literature sources. Structural-mechanical and organoleptic studies established the feasibility of using a combined system with the inclusion of purified water, glycerin and macrogol 400. The study of sedimentation and aggregation stability of the samples showed a uniform distribution of particles in samples from PVA, HEC, HPC. Films from Sodium Alginate, PVP, Na-CMC and HPMC were excluded from the work due to unsatisfactory properties. Structural-mechanical and physico-chemical properties allowed us to choose 5 % PVA as the film former, and 4 % glycerin as the plasticizer. The concentrations of API (metronidazole and chlorhexidine) were selected based on antimicrobial activity and preservative effect. Conclusions. As APIs, CHA – a remineralizing, anti-caries agent, metronidazole and chlorhexidine – antimicrobial components were selected. The introduction of CHA is rational in a complex dispersion medium, metronidazole as a suspension with glycerin, chlorhexidine as a 20 % solution. The composition of the film base was substantiated. The concentrations of metronidazole and chlorhexidine bigluconate were determined. The developed drug met the specifications of the MQC
- Open Access
Phenolic Compounds and Pharmacological Potential of Lavandula angustifolia Extracts for the Treatment of Neurodegenerative Diseases
The search for neuroprotective compounds in lavender is driven by its traditional use for brain health, with antioxidant activity serving as a key mechanism in reducing oxidative stress and supporting cognitive function. Lavender’s potential to protect neurons is based on its calming, anti-stress properties, which increase the brain’s resistance to neurodegeneration. Although lavender is not a traditional medicinal plant in Ukraine, it is increasingly recognised for its medicinal properties and is widely cultivated in the country. Lavender use in Ukraine is influenced by both global herbal practices and local medical traditions. The aim of this study was to optimise the preparation of lavender herb extracts, perform chemical profiling and evaluate their antioxidant and neuroprotective activities. The study focused on Lavandula angustifolia cultivated in Lviv, Ukraine. Modern analytical methods were used, including HPLC, spectrophotometry, molecular docking, lyophilisation and pharmacological testing. The selection of the optimal conditions for obtaining lavender herb extracts was determined on the basis of the results of the total yield of phenolic compounds in each extract, where it was found that the raw material–solvent ratio (1:10) in water and 50% ethanol gave the highest yield of substances; the preferred extraction time was 20 min, and the temperature was 60–70 °C, especially for water extraction. Further HPLC analysis identified marker compounds including rosmarinic acid (28.31 mg/g), chlorogenic acid (1.64 mg/g) and luteolin (0.23 mg/g) in the lyophilised ethanol extract, which were previously recognised as neuroprotective markers by molecular docking. The water extract showed higher antioxidant (total 50.85 mg/g) and neuroprotective activity, probably due to synergistic interactions among the components. Behavioural tests further demonstrated the neuroprotective potential of lavender herb. These results demonstrate the potential neuroprotective activity of lavender herb and open new possibilities for its use in the treatment of various neurodegenerative diseases.
Open AccessPhenolic Compounds and Pharmacological Potential of Lavandula angustifolia Extracts for the Treatment of Neurodegenerative Diseases
The search for neuroprotective compounds in lavender is driven by its traditional use for brain health, with antioxidant activity serving as a key mechanism in reducing oxidative stress and supporting cognitive function. Lavender’s potential to protect neurons is based on its calming, anti-stress properties, which increase the brain’s resistance to neurodegeneration. Although lavender is not a traditional medicinal plant in Ukraine, it is increasingly recognised for its medicinal properties and is widely cultivated in the country. Lavender use in Ukraine is influenced by both global herbal practices and local medical traditions. The aim of this study was to optimise the preparation of lavender herb extracts, perform chemical profiling and evaluate their antioxidant and neuroprotective activities. The study focused on Lavandula angustifolia cultivated in Lviv, Ukraine. Modern analytical methods were used, including HPLC, spectrophotometry, molecular docking, lyophilisation and pharmacological testing. The selection of the optimal conditions for obtaining lavender herb extracts was determined on the basis of the results of the total yield of phenolic compounds in each extract, where it was found that the raw material–solvent ratio (1:10) in water and 50% ethanol gave the highest yield of substances; the preferred extraction time was 20 min, and the temperature was 60–70 °C, especially for water extraction. Further HPLC analysis identified marker compounds including rosmarinic acid (28.31 mg/g), chlorogenic acid (1.64 mg/g) and luteolin (0.23 mg/g) in the lyophilised ethanol extract, which were previously recognised as neuroprotective markers by molecular docking. The water extract showed higher antioxidant (total 50.85 mg/g) and neuroprotective activity, probably due to synergistic interactions among the components. Behavioural tests further demonstrated the neuroprotective potential of lavender herb. These results demonstrate the potential neuroprotective activity of lavender herb and open new possibilities for its use in the treatment of various neurodegenerative diseases.
- Open Access
- 18 December 2024
- Published by Private Company Technology Center in ScienceRise: Pharmaceutical Science
- No. 6(52),p. 27-36
Rat transtibial hindlimb amputation model: characteristic of the central nervous system functional state, physical endurance and body mass in dynamic
Limb loss is a relevant medical and social problem. In a full-scale war environment, amputation became a frequent occasion, which requires adequate rehabilitation measures in preparation for prosthetic procedures. The post-traumatic period's peculiarities, specifically the central nervous system (CNS) functional characteristics and physical endurance, must be known. Experimental studies on animal models play an important role; however, there is no information available about such studies. The aim. To determine the influence of hindlimb loss on the state of the central nervous system in terms of behavioural responses, physical endurance, and body mass dynamics of rats in the early and late post-amputation period. To characterise the indicated amputation model for further use in experimental studies. Materials and methods. The experiment was conducted on white male rats. Transtibial amputation at the level of the lower third of the hind limb was performed in aseptic conditions in 6 animals under thiopental-sodium anaesthesia (40 mg/kg intraperitoneally). The state of CNS and physical endurance was determined during the early (3-4 days after amputation) and long-term (2 months after surgery) periods. Locomotor and exploratory activity, emotional responses and vegetative support were determined in the Open field test, and anxiety was determined in the Light-dark box test. The coordination of animal movement was measured in the rotarod test, and the depression level was measured in the Porsolt swim test. The physical endurance of the rats was studied using the forced swimming test with a load (5 % of the body mass at the base of the tail) as a control were used rats with comparable body mass. STATISTICA 12.0 was used to process the results. Results. In the early post-amputation period, exploratory behaviour and emotional results of rats in the Open field test were significantly suppressed, while in the long-term period of significance, only the reduction of emotional responses. In the Light-dark box test, the latency to enter the darkened compartment of the chamber increases reliably in both periods of observation (especially in the early period). Collectively, these results indicate changes in the reaction of animals with amputation of the hindlimb to stressful experimental conditions, in particular, an anxiety reduction, which requires further research. In the rotarod test, a significant deterioration of movement coordination of rats with amputation was found in both observation periods. After amputation, the manifestations of depressive behaviour in the Porsolt swimming test progressed, and the physical endurance in the forced swimming test with a load was significantly reduced. The body mass of rats with hindlimb amputation was significantly increased after 2 months (22 % average increase vs 4 % average increase in control, p<0.01). Results are important for experimental-based optimal rehabilitation programs after lower limb amputation. Conclusion. An easy-to-perform model of transtibial amputation at the level of the lower third of the hindlimb in rats is proposed. It is concluded that after amputation, exploratory behaviour and emotional responses were suppressed, which indicates changes in the responses of animals with amputation of the hindlimb to stressful experimental conditions, in particular, an anxiety reduction, which differentiates this animal amputation model from human amputation. After amputation, the depressed behaviour of rats progresses, movement coordination steadily worsens, and physical endurance is significantly reduced. The body mass of rats with hindlimb amputation increases considerably
- 18 December 2024
- Published by Private Company Technology Center in ScienceRise: Pharmaceutical Science
- No. 6(52),p. 27-36
Open AccessRat transtibial hindlimb amputation model: characteristic of the central nervous system functional state, physical endurance and body mass in dynamic
Limb loss is a relevant medical and social problem. In a full-scale war environment, amputation became a frequent occasion, which requires adequate rehabilitation measures in preparation for prosthetic procedures. The post-traumatic period's peculiarities, specifically the central nervous system (CNS) functional characteristics and physical endurance, must be known. Experimental studies on animal models play an important role; however, there is no information available about such studies. The aim. To determine the influence of hindlimb loss on the state of the central nervous system in terms of behavioural responses, physical endurance, and body mass dynamics of rats in the early and late post-amputation period. To characterise the indicated amputation model for further use in experimental studies. Materials and methods. The experiment was conducted on white male rats. Transtibial amputation at the level of the lower third of the hind limb was performed in aseptic conditions in 6 animals under thiopental-sodium anaesthesia (40 mg/kg intraperitoneally). The state of CNS and physical endurance was determined during the early (3-4 days after amputation) and long-term (2 months after surgery) periods. Locomotor and exploratory activity, emotional responses and vegetative support were determined in the Open field test, and anxiety was determined in the Light-dark box test. The coordination of animal movement was measured in the rotarod test, and the depression level was measured in the Porsolt swim test. The physical endurance of the rats was studied using the forced swimming test with a load (5 % of the body mass at the base of the tail) as a control were used rats with comparable body mass. STATISTICA 12.0 was used to process the results. Results. In the early post-amputation period, exploratory behaviour and emotional results of rats in the Open field test were significantly suppressed, while in the long-term period of significance, only the reduction of emotional responses. In the Light-dark box test, the latency to enter the darkened compartment of the chamber increases reliably in both periods of observation (especially in the early period). Collectively, these results indicate changes in the reaction of animals with amputation of the hindlimb to stressful experimental conditions, in particular, an anxiety reduction, which requires further research. In the rotarod test, a significant deterioration of movement coordination of rats with amputation was found in both observation periods. After amputation, the manifestations of depressive behaviour in the Porsolt swimming test progressed, and the physical endurance in the forced swimming test with a load was significantly reduced. The body mass of rats with hindlimb amputation was significantly increased after 2 months (22 % average increase vs 4 % average increase in control, p<0.01). Results are important for experimental-based optimal rehabilitation programs after lower limb amputation. Conclusion. An easy-to-perform model of transtibial amputation at the level of the lower third of the hindlimb in rats is proposed. It is concluded that after amputation, exploratory behaviour and emotional responses were suppressed, which indicates changes in the responses of animals with amputation of the hindlimb to stressful experimental conditions, in particular, an anxiety reduction, which differentiates this animal amputation model from human amputation. After amputation, the depressed behaviour of rats progresses, movement coordination steadily worsens, and physical endurance is significantly reduced. The body mass of rats with hindlimb amputation increases considerably
- Open Access
- 27 November 2024
- Published by National University of Pharmacy in News of Pharmacy
- Vol. 108 (2) , 37-42
Substantiation of the composition of sublingual tablets for the treatment of CNS disorders
Aim. To develop the composition of sublingual tablets with L-tryptophan, glycine and a dry peony extract. Materials and methods. L-tryptophan, glycine and a dry peony extract were used as active pharmaceutical ingredients; Lactose GranuLac 200, MCC 102, HPMC methocel K4M CR Premium, HPMC methocel E4M CR Premium, aspartame, maltodextrin, sorbitol, sucralose, Mint cloroph FLV PDR, Strawberry FLV PDR, Apple FLV PDR, Plasdone K-25, crospovidone XL-10, nonessylin and calcium stearate were used as excipients. The pharmacotechnological studies were conducted in accordance with the methods of the State Pharmacopoeia of Ukraine. Results and discussion. The studies of the pharmacotechnological properties of APIs showed unsatisfactory results (poor fluidity, poor cohesive properties; high hygroscopicity of the peony extract), so it was decided to improve the technological properties of the active substances by wet granulation. Plasdone K-25 (15% aqueous solution) was chosen as a binder. The next step was to select a flour adhesive to improve the bioavailability of the active ingredients. According to the literature, HPMC was included in the composition of the test samples: HPMC methocel E4M CR Premium and HPMC methocel K4M CR Premium. According to the research results, HPMC methocel K4M CR Premium was included in the composition. The tablets developed had a bitter taste due to the presence of tryptophan and the peony extract. To correct the taste and odor, aspartame and Mint cloroph FLV PDR were used. Their optimal content in the formulation was experimentally determined. Conclusions. As a result of the studies conducted, the following substances have been selected: the binder for granulating the tablet mixture – Plasdone K-25; the flour adhesive to improve bioavailability – HPMC methocel K4M CR Premium; flavors for taste and odor to mask the bitter taste of sublingual tablets – aspartame and Mint cloroph FLV PDR.
- 27 November 2024
- Published by National University of Pharmacy in News of Pharmacy
- Vol. 108 (2) , 37-42
Open AccessSubstantiation of the composition of sublingual tablets for the treatment of CNS disorders
Aim. To develop the composition of sublingual tablets with L-tryptophan, glycine and a dry peony extract. Materials and methods. L-tryptophan, glycine and a dry peony extract were used as active pharmaceutical ingredients; Lactose GranuLac 200, MCC 102, HPMC methocel K4M CR Premium, HPMC methocel E4M CR Premium, aspartame, maltodextrin, sorbitol, sucralose, Mint cloroph FLV PDR, Strawberry FLV PDR, Apple FLV PDR, Plasdone K-25, crospovidone XL-10, nonessylin and calcium stearate were used as excipients. The pharmacotechnological studies were conducted in accordance with the methods of the State Pharmacopoeia of Ukraine. Results and discussion. The studies of the pharmacotechnological properties of APIs showed unsatisfactory results (poor fluidity, poor cohesive properties; high hygroscopicity of the peony extract), so it was decided to improve the technological properties of the active substances by wet granulation. Plasdone K-25 (15% aqueous solution) was chosen as a binder. The next step was to select a flour adhesive to improve the bioavailability of the active ingredients. According to the literature, HPMC was included in the composition of the test samples: HPMC methocel E4M CR Premium and HPMC methocel K4M CR Premium. According to the research results, HPMC methocel K4M CR Premium was included in the composition. The tablets developed had a bitter taste due to the presence of tryptophan and the peony extract. To correct the taste and odor, aspartame and Mint cloroph FLV PDR were used. Their optimal content in the formulation was experimentally determined. Conclusions. As a result of the studies conducted, the following substances have been selected: the binder for granulating the tablet mixture – Plasdone K-25; the flour adhesive to improve bioavailability – HPMC methocel K4M CR Premium; flavors for taste and odor to mask the bitter taste of sublingual tablets – aspartame and Mint cloroph FLV PDR.