Biomedical Chemistry: Research and Methods, 2018, 1(4), e00081

Methods of Accelerated Prediction of The Shelf Life of Medical Polysaccharide-Based Hydrogels

T.S. Byrkina1*, K.P. Loveckij2, N.D.Oltarzhevskaya1

1LLC «Coletex» , 4-6 non-residential premises, 21 Pavlovskaya str., Moscow,115093 Russia; *e-mail:
2Peoples' Friendship University of Russia, 3 Ordzhonikidze str., Moscow, 115419 Russia

Keywords:hydrogel materials; medical products; sodium alginate; accelerated aging; shelf life


The whole version of this paper is available in Russian.

The paper describes an accelerated technique for determining the warranty period for the hydrogel-based polymer materials used for medical purposes. It deals with the technological production stages of hydrogel therapeutic materials «Kolegel» based on a polysaccharide of sodium alginate. On these stages deterioration of the material properties might lead to reduction of the shelf life of products (using natural raw materials, sterilization). The article introduces the ways to reduce this negative effect and subsequently increase the warranty period of the medical product by adding stabilizing additives into its composition. The method for determining the shelf life of sodium alginate hydrogel material depends on the added stabilizing additives (potassium sorbate and preservative based on 2-phenoxyethanol) in the «accelerated aging» mode; based on a mathematical description of two parallel processes occurring in hydrogels which are stored at elevated temperatures, namely: a change in the microbial contamination of hydrogels to the stage of final sterilization (using the Barany-Roberts model), a change in the dynamic viscosity after the conclusion of radiation sterilization of hydrogels (using a model based on the Arrhenius equation).

Figure 1. The growth curves of microorganisms in the sample of hydrogel based on the SA 7.00%, obtained according to the traditional Baranya-Roberts model (a) and the adjusted Baranya-Roberts model (b).
Figure 2. The growth curves of microorganisms in hydrogels during storage at 25°C.
Figure 3. Viscosity change of a sterile hydrogel with PS with time.
Figure 4. Viscosity change of a sterile hydrogel with PE with time.

Table 1. Terms of experimental storage depending on temperature.


Supplementary materials are available at


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