New Method of Quality and Quantity Control of the Insulin Glulisine Pharmaceuticals Based on Intrinsic Radiothermal Emission
Abstract
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
Keywords:
insulin, quality control, quantity control, non-invasive method, intrinsic radiothermal emission, diabetesDOI
https://doi.org/10.22270/jddt.v15i6.7189References
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