Ivaniuk O. Development of the composition and technology of vaginal gel with resveratrol and hyaluronic acid.

The dissertation work (PhD thesis) is devoted to the development of a new drug in the form of a vaginal gel with a substance of natural origin – resveratrol and moisturizing agent – hyaluronic acid, the action of which is aimed at preventing and treating the effects of hypoestrogenic conditions of various etiologies. The structure and development trends of the pharmaceutical market of Ukraine for the prevention and treatment of hypoestrogenic conditions in women are studied. Based on the results of the analysis, the necessity and expediency of developing a domestic drug in this field of action was determined. On the basis of physicochemical, structural-mechanical, biopharmaceutical researches the original structure of vaginal gel under the conditional name "Vagitrol" is developed in the dissertation work. Were studied physicochemical properties of resveratrol and hyaluronic acid, the results of which determined the optimal method of their introduction into the dosage form. Rheological studies substantiate the introduction of Aristoflex as a gelling agent and OraRez as a mucoadhesive. Was defined the influence of propylene glycol on the biopharmaceutical properties of the gel and its optimal content in the composition of the preparation was determined. Were conducted researches on the choice of antimicrobial preservative. The organoleptic and physicochemical parameters of the gel were studied, which allow controlling the quality of the drug during production and storage, as well as the terms and conditions of storage of "Vagitrol" gel – 2 years, 3 months at a temperature of 8–25 ˚С. Pharmacological studies have confirmed the specific activity of the developed drug. It was established that the developed gel restores vaginal secretion to a physiological state, increases the functional activity of epithelial cells, helps to normalize the content of estradiol and progesterone, and improves the functional state of the central nervous system. Projects of Quality Control Methods (QCM) and technological industrial regulations for the production of "Vagitrol" gel have been developed, and the technology of its industrial production has been tested in the conditions of PJSC "CHERVONA ZIRKA "CHEMICAL & PHARMACEUTICAL PLANT" (Kharkiv) (approbation act dated 05.02.2020). The originality of the composition and technology of production of the developed drug is protected by the patent of Ukraine for a utility model № u 201905153 dated 26.12.2019, and the results of research work are reflected in the information letter № 255-2019 "Development of vaginal gel technology with resveratrol and hyaluronic acid".