Abstract
Diseases of the digestive organs are one of the most frequent causes of loss of working capacity and development of disability. Worldwide, according to the World Journal of Gastroenterology, more than 5 million people suffer from inflammatory bowel diseases. The economic damage from these diseases is twice as high as that from cardiovascular diseases. The choice of drugs with pronounced pharmacological activity, a minimal number of side effects and the possibility of long-term use in the case of various diseases, including chronic and long-term ones, is especially important considering the public's growing concern for natural and biological treatment methods.
Microbiological and statistical research methods were used during the research.
The effectiveness of sodium benzoate and potassium sorbate preservatives was studied in concentrations of 0.2, 0.3, 0.4, and 0.5%. The research results of experimental microemulsion samples showed their compliance with SPhU requirements for the indicator «antimicrobial effectiveness of preservatives» for oral medicines with sodium benzoate and potassium sorbate preservatives in concentrations of 0.4 and 0.5%.
The microemulsion production technology, developed based on a set of previously conducted physicochemical, technological, rheological, and microbiological studies, consists of the following stages: weighing components, obtaining an oil solution, obtaining an aqueous solution, obtaining a microemulsion, packing and labelling the microemulsion, packaging the microemulsion. Critical parameters have been established that must be monitored during the preparation of the drug.
It has been experimentally proven that the developed microemulsion meets SPhU requirements regarding «microbiological purity».
As a result of conducting microbiological studies, the preservative and its concentration in the composition of the microemulsion – potassium sorbite in the amount of 0.4% were chosen. The microemulsion production technology is outlined and the critical parameters that must be monitored during the drug’s production are established. According to the «microbiological purity» indicator, the developed microemulsion meets the SPhU requirements.
Publisher
The State Expert Center of the Ministry of Health of Ukraine
Reference12 articles.
1. Hiulmamedov F. I., Tomashevskyi M. I., Yarosh A. M. Perspektyvy suchasnoi fizychnoi reabilitatsii khvorykh na nespetsyfichnyi vyrazkovyi kolit / Pedahohika, psykholohiia ta medyko-biolohichni problemy fizychnoho vykhovannia i sportu: naukova monohrafiia / Za red. prof. Yermakova S. S. – Kharkiv: KHDADM (KHKHPI), 2008 (6). – S. 229–242.
2. Fylypiuk O., Shmalko О., Vyshnevska L. Aqua foeniculi: different approaches to the compounded technology // Pharmacology Online. – 2021. – V. 3. – P. 1256‒1264. ISSN: 1827-8620
3. Tomasik М. P., Warzyszak Р., Małek R. et al. Ulcerative colitis – recent and potential methods of treatment – review. Ulcerative colitis – recent and potential methods of treatment – review // J. Education, Health and Sport. – 2023. – N 13. – P. 65–73. https://doi.org/10.12775/JEHS.2023.13.03.009
4. Kryvoviaz O. V., Holod A. S. Obgruntuvannia skladu i ratsionalnoi tekhnolohii dytiachykh emulsii // Farmats. zhurn. – 2011. – № 3. – S. 38–42. – URL: http://nbuv.gov.ua/UJRN/pharmazh_2011_3_9
5. Sonawane A., Deshmukh A., Sonawane S. A Review on Self Micro Emulsifying Drug Delivery System (SMEDDS) // Ijsrm. Human. – 2021. – V. 19, N 1. ‒ Р. 25–33.