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

Hyaluronidase and its modified analogs are clinically significant enzyme-based pharmaceuticals used to treat fibrosis, increase tissue permeability, and improve drug diffusion. While pharmacopeial quality control methods are well defined, scientific literature provides limited information about the physicochemical evaluation of such enzyme pharmaceuticals, necessitating a more holistic analytical approach. Commercial pharmaceuticals of hyaluronidase and its modified analog were analyzed using a combination of dynamic light scattering, infrared spectroscopy, and detection of intrinsic radiothermal emission (RTE). Dimensional characteristics were studied using a Zetasizer Nano ZSP (ZetasizerNano ZSP, Malvern Instruments, Malvern, UK) confirmed theoretical diameters of 5–8 nm, consistent with experimental values (6–8 nm). Fourier-Transform infrared spectroscopy (FTIR) (Agilent Cary 630, Agilent Technologies, Santa Clara, CA, USA) revealed characteristic transmission bands for the modified enzyme at 1464, 1448, 1326, 1158, and 1010 cm⁻¹, confirming structural modification. RTE measurements using a TES-92 detector (TES Electrical Electronic Corp., Taipei, Taiwan) demonstrated a correlation between emission intensity and shelf life: 12.8 ± 0.8 µW/m² for proper shelf-life samples, 8.3 ± 0.8 µW/m² for six-month-expired, and 5.1 ± 1.0 µW/m² for one-year-expired pharmaceuticals. The study offers a promising supplementary tool for pharmaceutical quality control of hyaluronidase-based drugs.