Study of the efficacy of antimicrobial preservatives in justifying the composition of a dermatological gel with a phytocomplex

Abstract

The microbiological stability of medicinal products always requires close attention during the pharmaceutical development phase, as microbial contamination can pose a threat to both the health of the patient and the stability of the medicinal product. The level of microbial contamination can be controlled by monitoring the quality of raw materials, compliance with appropriate sanitation of production facilities and equipment, the use of scientifically justified preservatives in the drug.

The aim of the work is to substantiate the use of a preservative and its concentration in the composition of the developed gel with phytocomplex.

Materials and methods. The objects of the study were gel samples with the addition of a preservative: Euxyl 9010K (90 % phenoxyethanol, 10 % ethylhexylglycerol), methyl parahydroxybenzoate (E218), sorbic acid, potassium sorbate, benzoic acid. Concentrations of antimicrobial substances used corresponded to their average value from the range of used concentrations. The research has used the method of evaluating the effectiveness of antimicrobial preservatives, given in SPU 2.0.

Results. Experimental studies using preservatives Euxyl 9010K 0.60 %, methyl parahydroxybenzoate 0.25 %, sorbic acid 0.10 %, potassium sorbate 0.25 %, benzoic acid 0.15 % in the samples of the developed gel with phytocomplex had shown that the obtained results for all samples fully meet the requirements of SPU in terms of “antimicrobial efficacy of preservatives” for topical drugs. According to the results of the first stage of research, it had been found that the greatest antimicrobial efficacy was shown by a sample with the preservative Euxyl 9010K. The subject of the second stage of research was the substantiation of the concentration of Euxyl 9010K (0.45 %, 0.60 %, and 0.75 %) based on the results of which it had been established that the gel samples with concentrations of Euxyl 9010K 0.60 % and 0.75 % met the requirements of SPU on the indicator of “antimicrobial efficacy of preservatives” for topical medicinal products. The sample with a concentration of Euxyl 9010K 0.45 % also met these requirements, but the logarithm of the reduction in the number of viable cells of Pseudomonas aeruginosa bacteria after 2 days of storage is 2.00, which was the limit value according to the requirements of SPU.

Conclusions. The expediency of using Euxyl 9010K (90 % phenoxyethanol, 10 % ethylhexylglycerol) at a concentration of 0.60 % as a preservative had been experimentally substantiated.