Introduction. Customer feedback evaluation and satisfaction monitoring for products and services are an essential component of any quality management system. The mechanisms for collecting and processing feedback are well established and widely applied across various areas of industry and business. Unfortunately, there are few practical examples of implementing feedback assessment and satisfaction analysis systems specifically within the context of scientific R&D laboratory services. Currently, the organization of a feedback assessment system remains the responsibility of individual managers or units, which limits opportunities for discussion and methodology refinement. However, improving feedback analysis is essential for enhancing the quality, effectiveness, and accessibility of services. It also constitutes a fundamental component of the ongoing development of the structure and management systems of R&D laboratories and academic research centers. Aim. To develop and propose a methodology for customer satisfaction feedback collection and processing as part of a comprehensive assessment of research and development (R&D) services for commercial, scientific, educational and research organizations, and to test the proposed approach using the service model of the Laboratory Complex at Sirius University. Materials and methods. Feedback was collected and processed for the Laboratory Complex units: internal scientific services, general laboratory services, including equipment maintenance, external commercial scientific services, and commercial educational programs. To evaluate satisfaction, the Customer Satisfaction Index (CSI) was chosen. It measures not only overall satisfaction with services but also evaluates each service component according to its importance for each respondent. The surveys were built using LimeSurvey, an open-source survey design application. Data processing was performed using a system based on the FastAPI framework, with Jinja2 for server-side HTML template generation and PostgreSQL as the database management system. Results and discussion. As a result of the study, a comprehensive methodology for collecting and processing feedback was tested, allowing assessment of trends in internal and external customer satisfaction. In addition, the influence of complementary factors on CSI was evaluated. The CSI analysis became part of the input data for the management review of unit performance and served as a key component in defining the strategy for improving the R&D service delivery model. Conclusion. Measuring customer satisfaction in offered services is one of the key factors determining the success of R&D commercialization. The proposed methodology for implementing a feedback collection and processing system can be used as a universal approach to implementing a customer satisfaction assessment protocol for R&D services in commercial, scientific, educational and research organizations.
Introduction. Non-alcoholic (metabolic dysfunction-associated) fatty liver disease (NAFLD) encompasses a spectrum of common pathological conditions associated with systemic metabolic dysfunction. The development of new effective and safe pharmacological therapies for NAFLD and its comorbid conditions remains an ongoing challenge. The malonic acid derivative maloben (sodium 4,4’-(propanediamido)dibenzoate) is currently undergoing phase II clinical trials for NAFLD; however, its molecular mechanism of action requires further investigation and clarification. Aim. The aim of this study was to investigate the potential mechanisms of action of maloben using molecular docking. Materials and methods. Molecular docking of maloben structures protonated at physiological pH was performed using the Schrödinger Suite with the Glide XP scoring function. The target molecules included proteins with established roles in the pathogenesis of NAFLD, including Kelch-like ECH-associated protein 1 (KEAP-1), the glucagon-like peptide 1 receptor (GLP-1R), the farnesoid X receptor (FXR), peroxisome proliferator-activated receptor γ (PPAR-γ), and thyroid hormone receptors (THR) β and α. Docking results were evaluated and interpreted based on the calculated binding energy values for the selected targets. Results and discussion. Molecular docking generated binding maps of maloben structures with the selected targets and identified the lowest binding energy values for two of them: PPAR-γ (−8.425 kcal/mol) and FXR (−8.369 kcal/mol). Accordingly, the selective PPAR-γ agonist pioglitazone, the PPAR-α/γ/δ agonist bezafibrate, and the FXR agonist cilofexor were chosen as comparator ligands for further analysis. Based on the docking results, these compounds exhibited lower binding energies (−11.177 kcal/mol, −10.907 kcal/mol, and −15.870 kcal/mol, respectively) than maloben; however, the latter may have an advantage with respect to several physicochemical predictors of pharmacokinetics. Maloben has a molecular weight of 340.29 Da and octanol/water partition coefficient (logD) and apparent aqueous solubility (logS) values of 1.763 and 4.58, respectively, which are favorable for intestinal absorption and membrane permeability. Conclusion. The results indicate that the hepatotropic and metabolic effects of maloben may be mediated by its interaction with PPAR-γ and/or FXR. Several physicochemical predictors suggest that maloben may exhibit a favorable pharmacokinetic profile following oral administration.
Introduction. Lipid complexes (LCs) from Barents Sea brown algae are a valuable source of biologically active compounds for the pharmaceutical industry. Despite the successful use of LCs from Laminaria algae in medicinal preparations, the potential of bladderwrack ( Fucus vesiculosus ) remains underexplored. Comparative characterization of their detailed fatty acid profiles together with biological indices is important for justifying their interchangeability and assessing the therapeutic advantages of these substances. Aim. Based on lipid profiling and biological indices, to evaluate the equivalence of LCs from Saccharina latissima and Fucus vesiculosus from the Barents Sea for drug development. Materials and methods. LCs from S. latissima and F. vesiculosus were obtained in the course of cascade seaweed processing. Fatty acid methyl esters (FAMEs) were analyzed by gas chromatography (GC). The atherogenicity index (AI), thrombogenicity index (TI), and hypo-/hypercholesterolemic fatty acid ratio (hH) were calculated, along with specific fatty acid ratios. Statistical data processing was performed using GraphPad Prism 9.0. Results and discussion. Detailed GC profiling enabled comparison of LC compositions based on 42 identified fatty acids for the first time. Overall, both LCs were comparable in terms of fatty acid profile and AI and hH indices. The LC from F. vesiculosus contained a higher amount of polyunsaturated fatty acids (PUFAs) and was characterized by a predominance of eicosapentaenoic acid (EPA) (26,425 ± 1,199 μg/g). A statistically significant difference in the thrombogenicity index was found: TI was 0.53 ± 0.02 for the fucus LC versus 0.60 ± 0.02 for S. latissima ( p < 0.05). The ω-6/ω-3 PUFA ratio in the fucus LC was 0.73 ± 0.03, and the EPA/ARA ratio was 1.86 ± 0.10. The presence of odd-chain (C15:0, C17:0) and long-chain (up to C24:0) fatty acids may expand the application possibilities of the F. vesiculosus LC. Conclusion. The lipid complex from F. vesiculosus can be considered a promising alternative to S. latissima and is of interest for further study as a pharmaceutical substance for the development of new medicinal products.
Introduction. One of the most widely used drugs by the domestic health care is the first direct and highly specific inhibitor of activated blood coagulation factor X, Xarelto (INN: rivaroxaban) in tablet form of four strengths of 5 mg, 10 mg, 15 mg and 20 mg. The drug is used to prevent and treat thrombosis in various patients for a wide range of indications, both arterial and venous. Xarelto has been studied in detail in international randomized clinical trials, where its high efficacy in different patient categories has been demonstrated. The market launch of a domestic generic drug, which is no less effective therapeutically than the original drug, is still relevant and in demand. Aim. The aim of the study is to justify the criteria for the drug substance selection, excipients and drug technology using cause and effect analysis with the Ishikawa diagram at the preformulation stage, taking into account the requirements of the modern international paradigm of pharmaceutical development – QbD. Materials and methods. Objects of study: rivaroxaban substances of Zhejiang Liaoyuan Pharmaceutical Co., Ltd. (China), Virdev Intermediates Pvt. Ltd. (India) and Dr. Reddy's Laboratories Ltd. (India), excipients: microcrystalline cellulose, hypromellose, lactose monohydrate, sodium lauryl sulfate, croscarmellose sodium, magnesium stearate. Research methods: content analysis, comparative information and analytical methods, cause and effect risk analysis based on the Ishikawa diagram. Results and discussion. In order to develop a generic drug in the context of international pharmaceutical development practicе at the preformulation stage, a risk analysis of the use of rivaroxaban substance (API) from 3 manufacturers was carried out with the establishment of critical quality attributes (CQAs) that directly affect the rivaroxaban tablets quality, and the manufacturer was selected. Critical material attributes (CMAs) were reviewed taking into account their biopharmaceutical classification, their impact on the dosage form quality and, mainly, on the bioavailability of rivaroxaban was assessed. Given the large number of types and brands of excipients used in rivaroxaban tablets, their multifunctionality and variability of properties, the rational composition and technology of tablet cores using fluid-bed granulation with an aqueous suspension of the substance as a wetting agent are theoretically justified. The planned target product profile (QTPP) is based on the quality parameters of the innovative medicinal product – "Xarelto® 2.5 mg, 10 mg, 15 mg, 20 mg film-coated tablets", marketing authorization holder (MA) – Bayer Pharma AG, Germany. Conclusion. Based on the analytical studies performed using a risk-based approach, the choice of rivaroxaban substance and excipients was made taking into account their critical quality attributes. Wet granulation technology is proposed, potential critical parameters of the technology affecting the tablet quality are identified. The results obtained make it possible to proceed to the experimental development of the rivaroxaban tablets quantitative composition using the technology of fluid bed granulation with the critical process parameters determination and design space.
Introduction. Advancing the standardization framework for medicinal plant raw materials requires greater harmonization of pharmacopoeial specifications and more consistent approaches to quality assessment. Across national pharmacopoeias, quality requirements for raw materials derived from Linum L. species vary with respect to identification criteria, purity parameters, pharmacopoeial quality parameters of the herbal raw material (total ash, acid-insoluble ash, loss on drying, and extractable matter), and the assessment of biologically active constituents. These differences highlight the need to systematize and critically compare the requirements currently in place. Neither Linum pallescens Bunge nor Linum heterosepalum Regel is covered by the pharmacopoeias examined, underscoring the need to establish appropriate quality criteria for these species. The quality parameters and their acceptance criteria for the herbal medicinal raw materials of Linum pallescens Bunge and Linum heterosepalum Regel comply with pharmacopoeial requirements. These species are of particular interest due to the availability of a functioning domestic raw material base, the use of renewable sources of plant material, and the study of their chemical composition for the production of domestic herbal medicinal products. Aim. To conduct a comparative assessment of the pharmacopoeial quality indicators of medicinal plant materials belonging to the genus Linum L. by evaluating pharmacopoeial monographs from different countries and establishing quality specifications for the seeds of Linum pallescens Bunge and Linum heterosepalum Regel. Materials and methods. Pharmacopoeial requirements for the quality assessment of medicinal plant materials belonging to the genus Linum L. were evaluated through a comparative analysis of 13 pharmacopoeias from different countries. Results and discussion. Review of 13 pharmacopoeial monographs revealed the principal quality requirements for medicinal plant materials of the genus Linum L., together with differences in the approaches used for their identification and standardization. A comprehensive quality specification was developed for the seeds of Linum pallescens Bunge and Linum heterosepalum Regel, aimed at expanding the range of pharmacopoeial plant materials and facilitating their use by pharmaceutical manufacturers as plant material for the production of medicinal products. Conclusion. For raw materials derived from plants of the genus Linum L., a comparative assessment of pharmacopoeial quality requirements was conducted; on this basis, a quality specification was developed for Linum pallescens and Linum heterosepalum .
