Choice of the preservative in the composition of vaginal gel with resveratrol and hyaluronic acid for treatment of urogenital symptoms in the climaх period

Анотація

Aim. Microbial contamination of a product is possible in the process of production, storage and use, which can shorten the shelf life and adversely affect the safety profile of the drug. Therefore, an important criterion for evaluating the quality of a medicinal product is microbiological purity. The aim of the study was to determine and compare the antimicrobial effectiveness of preservatives in the composition of the vaginal gel with resveratrol and hyaluronic acid. Materials and methods. The objects of the study were samples of vaginal gel with various antimicrobial preservatives, which have no irritant effect on the mucous membranes, and are safe for the human body. Preservative selection studies have been conducted using the antimicrobial preservative efficacy evaluation technique described in SPU 2.0 (Vol. 1, Sec.5.1.3, p. 773). The principle of the method is that to the samples of the finished dosage form with various preservatives, which are in the primary packaging, introduce a certain number of test microorganisms and store these samples at a certain temperature (from 20 to 25 ºC) in a dark place. Immediately after inoculation and at specified intervals (2, 7, 14 and 28 days), samples (usually 1.0 g) are taken from the inoculated samples and the number of viable microorganisms is determined. All studies were performed in aseptic conditions, using a laminar box (Biological Safety Cabinet AC2-4E1 " Esco", Indonesia). Staphylococcus aureus ATCC 6538, Pseudomonas aeruginosa ATCC 9027, Candida albicans ATCC 885-653, Aspergillus brasiliensis ATCC 16404 were used as test microorganisms for inoculation of gel samples. Results. The research on the choice of antimicrobial preservative in the composition of vaginal gel for the treatment of urogenital symptoms, has been conducted, according to which it can be concluded that samples of gels with preservatives Cosgard 0.5%, Leucidal 2.0% and EuxylPE 9010 0.7% meet the criterion "A » According to the requirements of SPU for non-sterile medicines and are promising for further research on the development of composition and optimal technology of semisolid dosage form of vaginal gel. According to the research, the antimicrobial effectiveness of 0.5% Cosgard preservative gel was higher than the 2.0% Leucidal preservative gel samples and 0.7% Euxyl PE 9010, which will contribute to the quality of the developed gel during its storage. On the basis of the conducted researches the expediency of preservative Cosgard at a concentration of 0.5% introduction into the composition of vaginal gel with resveratrol and hyaluronic acid has been established. Conclusions. It has been established that the optimal antimicrobial preservative in the composition of vaginal gel is the preservatives Cosgard in concentration 0,5%.  The conducted studies are promising for further research on the development of composition and optimal technology of semisolid dosage forms.