The dissertation is a pharmacological study of a new vaginal gel of combined composition with resveratrol and hyaluronic acid, intended for the treatment of hypoestrogenic disorders, in particular, genitourinary disorders, which occur in women due to physiological (menopausal) or pathological (post-castration) levels. The dissertation presents a theoretical and experimental substantiation of the feasibility of developing a drug of local (topical) action, which included such active pharmaceutical ingredients as polyphenol resveratrol and hyaluronic acid. Phytoestrogen Resveratrol is analog of natural sex hormones, estrogen receptor agonist. Hyaluronic acid is exogenic glucosamine glycan analog. It is part of vaginal mucus, physiological moisturizer, lubricant, and an important component of the protective barrier of the genital tract. Together with excipients (lactic acid, etc.), they form an original composition that still has no analogs in the Ukrainian pharmaceutical market.
With the onset of menopause in women, there are genetically programmed age-related changes associated with a gradual decline in ovarian function. Premature "exclusion" of the ovaries, which occurs after surgical or pharmacological castration, due to ovarian depletion syndrome after assisted reproductive technologies, leads to abrupt changes in the hormonal background in younger women. Different etiologies of menopausal disorders develop against the background of estrogen deficiency and can cause pathological symptoms - menopausal syndrome, which reduces the quality of life of women. Menopause is the cause of osteoporosis, cardiovascular complications, cognitive impairment, metabolic and metabolic disorders in women.
Hormone replacement therapy (menopausal hormone therapy, MHT) is currently the most effective treatment for menopausal syndrome. Nevertheless, there are still women who are contraindicated or stop taking hormonal drugs due to side effects. A significant proportion of women in Ukraine do not seek medical attention for MHT due to hormonal phobia or ignorance of MHT. The effectiveness and safety of MHT depend on the timely start of therapy when the "therapeutic window" is still open [2]. Therefore, most women should have alternative treatments for menopausal symptoms, including systemic and topical phytoestrogen therapy. There is a significant number of drugs and dietary supplements containing phytoestrogens in the oral dosage forms in Ukraine. On the other hand, there is a lack of topical drugs that complement systemic effects or eliminate mainly genitourinary manifestations (dryness, itching, irritation of the vaginal mucosa, dyspareunia, urinary incontinence, etc..) To sum up, significant demand for topical drugs is not offset by a limited range of drugs.
A promising way to solve the current scientific problem of modern pharmacology is the development of vaginal drugs with multimodal action with phytoestrogens, obtained using modern pharmaceutical technologies and show high pharmacological activity in hypoestrogenic conditions that can effectively and safely correct pathological manifestations, including genitourinary symptoms. There are almost no Ukrainian drugs of this action, and most of the available range is represented by foreign drugs.
Vaginal gels with resveratrol and hyaluronic acid were developed under the guidance of Doctor of Pharmacy, Professor Ruban O.A. at the Department of Industrial Technology of the National University of Pharmacy (Kharkov). The gels contain resveratrol (R), which is a polyphenol, a phytoestrogen that does not require prior metabolism to detect pharmacological action (unlike soy isoflavones), hyaluronic acid (HA), and excipients, including lactic acid (LA). Resveratrol substance containing 50% trans-resveratrol of plant origin, obtained from Polygonum Cuspidatum. Two drugs were selected for comparison. The first drug was Ginodek gel, used in screening studies, has two common components (hyaluronan, lactic acid) with the studied gels and the same indications for use. The second comparison drug, Colpotrophin cream, was used in the in-depth pharmacological studies of the sample leader and is used for hormone replacement therapy, contains promestrin, a synthetic estrogen.
