Nanoparticles (NPs) represent a unique class of structures in the modern world. In comparison to macro- and microparticles, NPs exhibit advantages due to their physicochemical properties. This has resulted in their extensive application not only in technical and engineering sciences, but also in pharmacy and medicine. A recent analysis of the scientific literature revealed that the number of articles related to the search term “nanoparticle drugs” has exceeded 65,000 in the last decade alone, according to PubMed. The growth of scientific publications on NPs and nanomaterials (NMs) in pharmacy demonstrates the rapidly developing interest of scientists in exploring alternative ways to deliver drugs, thereby improving their pharmacokinetic and pharmacodynamic properties, and the increased biocompatibility of many nanopharmaceuticals is a unique key to two mandatory pharmaceutical requirements—drug efficacy and safety. A comprehensive review of the literature indicates that the modern pharmaceutical industry is increasingly employing nanostructures. The exploration of their physicochemical properties with a subsequent modern approach to quality control remains the main task of modern pharmaceutical chemistry. The primary objective of this review is to provide a comprehensive overview of data on NPs, their physicochemical properties, and modern approaches to their synthesis, modification of their surface, and application in pharmacy.

According to the WHO, the prevalence of type I and type II diabetes in the world exceeds 800 million people (14% of the adult population). Insulin pharmaceuticals are therapeutically applied in various configurations with different pharmacokinetic characteristics. There exist highly effective, validated methods for their quality control. However, each method exhibits a number of disadvantages, including long-term sample preparation, significant expense, and the inability to analyze the sample without opening the primary packaging. Objective: The aim of current work is to develop a new approach to control the qualitative and quantitative characteristics of a drugs based on insulin glulisine without opening the primary packaging. Materials and methods: Insulin glulisine; TES-92 for estimating the intensity of the flux density of its intrinsic radiothermal emission; Zetasizer Nano ZSP for determining the dimensional characteristics of the samples. Results: The heating of the samples to 370С effectively activates the emission activity (9.5 ± 0.5 µW/m2). The proposed method enables the differentiation of drugs that possess divergent qualitative characteristics. The effect of stress factors on the emission activity of insulin glulisine has been studied: heating, freezing and UV irradiation reduce the values of the flux density (1.2 ± 0.1; 1.7 ± 0.2; 3.2 ± 0.7 µW/m2). The feasibility of employing the proposed method for the quantitative determination of insulin samples is demonstrated. Conclusion: Based on the results obtained, the radiothermal emission detection method can be applied to control the qualitative and quantitative characteristics of biologically active drugs without opening the primary packaging. Keywords: insulin, quality control, quantity control, non-invasive method, intrinsic radiothermal emission, diabetes

Introduction. Virus-Like Particles (VLPs) are nanoscale entities characterized by surface shape heterogeneity and enhanced emission activity in the millimeter wavelength range (30-300 GHz), which is influenced by external physical factors such as heating or electromagnetic radiation. This phenomenon presents opportunities for the noninvasive determination of accurate concentrations of the protein component in commercially prepared VLP vaccines. Objective. To propose a modern and rapid approach for the quantitative determination of native proteins in VLP-containing vaccines, which enables research to be conducted without opening the primary packaging. Materials and methods. Vaccines imitating rotavirus (Gam-VLP-Rota) and SARS-CoV2 virus (Gam-VLP-multivac) were studied. The density of the radiothermal emission flux at extremely high frequency (EHF) wavelengths was measured using a TES-92 device. The reference values for protein concentration in vaccines, prior to the addition of the adjuvant, were measured using the commercial "Micro BCA™ Protein Assay Kit". The dimensional characteristics of the VLP vaccine were analyzed using dynamic laser light scattering (Zetasizer Nano ZSP). Results. A strong linear correlation (r = 0.99) was established between the flux density of radiothermal emission and the protein content in vaccines, allowing for analysis without opening the packaging. The validation procedure for this technique assessed linearity, accuracy, and intra-laboratory precision for Gam-VLP-multivac. Conclusion. The values of the intrinsic radiothermal emission flux density enabled the determination of the native concentration of complex-shaped virus-like nanoparticles in vaccines without the need to open the primary packaging, irrespective of the presence of an adjuvant. Keywords: VLP, Virus-Like Particles, quality control, protein concentration determination, radiothermal emission.

Oligopeptides, i.e. biopolymers containing up to fifty amino acids, are being recognized as first-line treatments for a growing number of disorders. The review encompasses various aspects of the application of these active pharmaceutical ingredients, ranging from methods for obtaining a peptide molecule and formulating a dosage form, including excipients and their key properties, to various information on the pharmacokinetics and pharmacodynamics of peptide drugs supported by scientific experimental data, as well as modern quality control methods. The review considers that the application of peptide therapeutics covers a wide range of diseases. They include cancers of various genesis; bacterial infections; type 2 diabetes, neurological diseases, and eye diseases. The review notes that this is just a small fraction of the nosologies in which peptide bioregulators have demonstrated effective clinical activity. The review considers the role of excipients. A distinctive feature of the review is the consideration of innovative methods for quality control of peptide therapeutics. The methods include: high-performance liquid chromatography with tandem mass spectrometry, ultracentrifugation with flow-through rotors, dynamic laser light scattering, small-angle laser light scattering. The review specifically highlights the analysis of dispersion in turbid and opaque media – two-dimensional dynamic laser light scattering based on the kinetics of diffuse reflection with data analysis using a mathematical topological model. A non-invasive method for detecting intrinsic radiothermal emission of biologically active nanoparticles, which can be easily used for peptide molecules, is also described. The review presents a hypothesis according to which the background level of peptides forms a specific electromagnetic field of cells and tissues. Keywords: peptide drugs, modern drugs, safe drugs, peptide drugs review, peptide synthesis, peptide pharmacokinetics, peptide pharmacodynamics, drug excipients.

Virus-like particle (VLP) - based vaccines exhibit outstanding clinical, epidemiological, and immunological efficacy and specificity. The novel technology used for producing their active component without incorporating live viruses enables both injectable and non-injectable (e.g., intranasal) administration, emphasizing the need for a comprehensive safety assessment. This study is part of a preclinical toxicological evaluation program aimed at assessing the safety profile of the “Gam-VLP-rota” vaccine candidate targeting human rotavirus infection. The goal of this extended toxicology study was to confirm the safety of a single intramuscular administration of the vaccine in Sprague-Dawley rats. The study focused on identifying possible adverse effects both acutely (within 24 hours post-administration) and after a 14-day recovery period, aiming to detect delayed toxicological signs. Toxicological endpoints included evaluation of target organs, coagulation parameters, hematology, clinical biochemistry, necropsy findings, and histopathological analysis. This article presents a segment of the results, including changes in serum biochemical parameters after a single immunization and histological examination of internal organs and the injection site in rats. Keywords: VLP; vaccines; preclinical studies; vaccine safety; toxicological chemistry.

Background. Rotavirus infection remains a major cause of severe gastroenteritis in children worldwide. Virus-like particle (VLP)-based vaccines are considered a promising non-replicating alternative to live vaccines due to their favorable safety profile. Objective. To evaluate the acute toxicity of the VLP-based vaccine “Gam-VLP-rota” following single intramuscular administration in Sprague–Dawley (SD) rats. Materials and Methods. Male and female SD rats were allocated into four experimental groups (vehicle control; 30, 120, and 600 µg antigen per animal; n = 14 per sex per group). The vaccine was administered once into the quadriceps femoris muscle (0.2 mL per animal). Animals were euthanized either 24 h after administration (Day 2) or after a 14-day recovery period (Day 15). Clinical condition, body weight, and food consumption were monitored. Hemostasis parameters, hematology, serum biochemistry, bone marrow cellular composition, organ weights, necropsy findings, histopathology, and local tolerability were evaluated. Results. No mortality or severe clinical manifestations were observed. On Day 2, transient intergroup differences in body weight gain and moderate reduction in food intake were detected in animals receiving the highest antigen dose (600 µg). These parameters normalized by Days 7–15. Reversible changes in hemostasis were recorded, including prolonged prothrombin time and elevated fibrinogen levels. Hematological analysis on Day 2 demonstrated dose-dependent neutrophilia accompanied by relative lymphopenia with absolute lymphocytosis; hematological and myelogram parameters returned to baseline by Day 15. In serum biochemistry, animals receiving 600 µg antigen showed increased total protein and globulin levels in both sexes, along with decreased ALT and alkaline phosphatase activity in males; these differences resolved by Day 15. No pathological alterations were detected macroscopically or microscopically in examined organs. Reactive enlargement of inguinal lymph nodes without signs of inflammation was observed. No local irritative effects were identified. Conclusion. Single intramuscular administration of the VLP-based vaccine “Gam-VLP-rota” at a dose of 600 µg antigen per animal (approximately 20× the anticipated clinical dose) demonstrated a favorable safety profile in an acute toxicity model. Keywords: rotavirus; virus-like particles; preclinical toxicology; hematology; serum biochemistry; histopathology; Sprague–Dawley rats; vaccine safety.