Research on the selection of emulgel preservative with thick extract of feverfew

Abstract

Introduction. The composition of the emulsifier with a thick extract of feverfew obtained at the Department of Botany of NUPh, was developed and experimentally substantiated for the prevention and treatment of inflammatory diseases of joints and connective tissues at the Department of Factory Technology of Drugs of the National University of Pharmacy. The drug contains API of plant origin and purified water - both components affect the stability of the product during storage and use due to the risk of biological contamination of the finished dosage form. The presence of microorganisms in non-sterile drugs can cause a reduction or even inactivation of their therapeutic effect, so at the stage of pharmaceutical development should be considered to ensure microbiological purity. Materials and methods. Tests on the effectiveness of antimicrobial preservatives were performed according to the method of SPhU (State Pharmacopoeia of Ukraine) 2.3, paragraph 5.1.3. Soybean-Casein agar and Sabouraud dextrose agar were used as nutrient media, and buffer solution with sodium chloride and peptone pH = 7.0, containing 50 g / lpolysorbate-80, 5 g / l lecithin, 1 g / l histidine hydrochloride were used as a solvent. Staphylococcus aureus ATCC 6538, Pseudomonas aeruginosa ATCC 9027, Candida albicans ATCC 10231, Aspergillus brasiliensis ATCC 16404 were used as test cultures of microorganisms. Results and discussion. The obtained data indicate that the sample of emulsifier without preservative does not meet the requirements of SPhU, because the logarithm of the reduction of viable bacterial microorganisms (S. aureus and P. aeruginosa) is less than 2.0 and 3.0 in 2 days and 7 days respectively. For cells of C. albicans and A. brasiliensis, on the 14th day lg, the reduction in the number of viable cells in samples required by the SPhU should be at least 2.0, and in samples without preservatives - 1.76 for C. albicans and 1.65 for A. brasiliensis, which also do not meet the requirements. Thus, the obtained results prove the need to add to the composition of the developed emulsion antimicrobial preservatives. According to the research, it is possible to note compliance of the received data with the requirements of SPhU to preparations for dermal application in terms of emulgel with selected preservatives (sodium benzoate, phenoxyethanol, phenylethyl alcohol and the combination of nipagin + nipazol). Conclusion. Given the requirements of safety and economy, physicochemical properties and the possibility of using as a flavoring, the most acceptable preservative in this development is phenylethyl alcohol, as the most acceptable concentration of the preservative was 1.0%. Samples of emulgel with preservative in the selected concentration were laid on the preservation and determination of quality indicators during the offered storage time.

Key words: emulgel, antimicrobial preservatives, antimicrobial activity, phenylethyl alcohol.

DOI: 10.5281/zenodo.6634854