Determination of the shelf-life and storage conditions of the gel for treatment of wounds in the ii phase of the wound process

Abstract

With the purpose of complex research of soft medicinal product – gel for treatment of wounds in the II phase of the wound process the assessment of the indicators, which are specified in the corresponding normative documents and allow to control comprehensively the quality of the product developed during its shelf-life, has been carried out. During the experiment the methods regulated by such normative documents as the SPhU and SUC 24.5-37-103:2004 “Cosmetic Gels” have been used. The gel developed was stable according to the experimental indicators within 2 years under the modes studied: the pH value was stable for all the series of the gel samples and was within the range of 5.0-7.5; the quantitative content of the substances was within the QCM project; the mass of a gel tube did not changed. After centrifugation the gel breaking was not observed, the temperature change did not also affect the stability of the product developed during the study. The data obtained allowed to recommend the shelf-life of 2 years at the room temperature in aluminium tubes. Based on the study of the structural-mechanical properties of the gel samples during storage the complete flow rheograms have been built, according to their data it can be seen that during the period under research the gel samples have not practically changed their rheological characteristics. It indicates the strength of the gel structure and the right choice of active substances and excipients, their concentrations, and the rational technology. The mechanical stability values of the product developed during the whole storage period have not practically changed, and it indicates the drug stability in the process of storage, as well as the absence of interaction between the active substances. According to the research data both after preparation and during the long storage of the gel the indicators obtained characterize it as a structured system with positive consumer and structural mechanical properties.