Study of technological and therapeutic quality indicators of an antimicrobial oral spray for the treatment of infectious inflammatory diseases of the oral cavity

Introduction. The use of antibiotics in the treatment of infectious diseases has led to significant achievements in medicine, but the problem of microbial resistance to antibiotics and the need to develop new antibacterial drugs remain extremely relevant today. One of the promising areas in combating this problem is the search for antimicrobial substances among plant raw materials. This study focused on the substance sangviritrin, which has pronounced antimicrobial properties.

Aim. The aim of the study was to investigate the technological and therapeutic characteristics of an oral dosed spray of sangviritrin for the treatment of infectious and inflammatory diseases of the oral cavity.

Materials and methods. The object of the study was an oral metered spray of sangviritrin, packaged in 30 ml light-protective glass bottles (LLC "TС "BELAND", Russia) 30 ml polyethylene bottles (LLC "SRP Group", Russia), and LF plastic nozzles (Shenzhen Bona Pharma Technology Co., Ltd., China). The minimum filling volume of the bottle, requirements for primary and secondary pumping, and requirements for nozzle cleaning were determined. The substances extracted from the packaging were studied using high-performance liquid chromatography with tandem mass spectrometry (HPLC-MS), gas chromatography-mass spectrometry (GC-MS), and inductively coupled plasma mass spectrometry (ICP-MS). The stability of the spray was determined in long-term and accelerated tests. The antimicrobial activity of the sangviritrin spray was determined for 21 strains of microorganisms.

Results and discussion. The minimum filling volume of the vial was 31 ml. It was shown that there are no requirements for priming the spray dispenser, cleaning the dispenser after use, or shaking. Extractable substances from Russian-made polyethylene bottles were studied using HPLC-MS, GC-MS, and IS-MS methods. The experiment demonstrated that these substances are present in concentrations below the threshold value and cannot adversely affect the safety of the drug. Long-term studies have demonstrated the stability of the developed dosage form for 12 months, and accelerated testing has determined the shelf life of the spray to be 2 years. An in vitro study of the antimicrobial activity of sangviritrin spray using a spot test showed its effectiveness against 18 strains of bacteria and three strains of Candida fungi.

Conclusion. The developed dosage form is stable during storage, methods for controlling its quality have been determined, the choice of packaging is justified, and this drug is promising for use in the treatment of inflammatory diseases of the oral cavity.

1. Shallcross L. J., Davies S. C. The World Health Assembly resolution on antimicrobial resistance. Journal of Antimicrobial Chemotherapy. 2014;69(11):2883–2885. DOI: 10.1093/jac/dku346.

2. Baker R. E., Mahmud A. S., Miller I. F., Rajeev M., Rasambainarivo F., Rice B. L., Takahashi S., Tatem A. J., Wagner C. E., Wang L.-F., Wesolowski A., Metcalf C. J. E. Infectious disease in an era of global change. Nature Reviews Microbiology. 2022;20(4):193–205. DOI: 10.1038/s41579-021-00639-z.

3. Onishchenko G. G. On the incidence of nosocomial infectious diseases. Sterilization and hospital infections. 2006;1:5–7. (In Russ.)

4. Pokrovsky V. I., Semina N. A., Kovaleva E. P. Epidemiology and prevention of nosocomial infections in the Russian Federation. Sterilization and hospital infections. 2006;1:8–11. (In Russ.)

5. Scheffler R. J., Colmer S., Tynan H., Demain A. L., Gullo V. P. Antimicrobials, drug discovery, and genome mining. Applied Microbiology and Biotechnology. 2013;97(3):969–978. DOI: 10.1007/s00253-012-4609-8.

6. Baran A., Kwiatkowska A., Potocki L. Antibiotics and Bacterial Resistance—A Short Story of an Endless Arms Race. International Journal of Molecular Sciences. 2023;24(6):5777. DOI: 10.3390/ijms24065777.

7. Abrosimova O. N., Pivovarova N. S., Burakova M. A., Shebitchenko T. S. Development of Technology and Composition of the Medicinal Product for Oral Cavity Based on Phytosubstances. Drug development & registration. 2021;10(4):37–45. (In Russ.) DOI: 10.33380/2305-2066-2021-10-4(1)-37-45.

8. Anurova M. N., Dorokhina Ya. A., Gulenkov A. S., Demina N. B., Korol L. A., Mizina P. G. Pharmaceutical development of sangviritrin spray for the treatment of inflammatory diseases of the oral cavity. Drug development & registration. 2025;14(1):160–170. (In Russ.) DOI: 10.33380/2305-2066-2025-14-1-1851.

9. Kozak M., Pawlik A. The Role of the Oral Microbiome in the Development of Diseases. International Journal of Molecular Sciences. 2023;24(6):5231. DOI: 10.3390/ijms24065231.

10. Kabanova A. A., Pokhodenko-Chudakova I. O., Plotnikov F. V. Present-day conceptions on etiology of infectious and inflammatory processes in the maxillofacial region. Analytical review of the literature. Bulletin of Problems of Biology and Medicine. 2015;1(4):21–26. (In Russ.)

11. Bhattacharya S., Sae-Tia S., Fries B. C. Candidiasis and Mechanisms of Antifungal Resistance. Antibiotics. 2020;9(6):312. DOI: 10.3390/antibiotics9060312.