Innovative product development as an adjuvant in the female sexual dysfunction treatment using jambu (Spilanthes acmella var oleracea) extract

• Grant number: 19/16427-0
• Support Opportunities: Research Grants - Innovative Research in Small Business - PIPE
• Start date: September 01, 2020
• End date: June 30, 2021
• Field of knowledge: Health Sciences - Pharmacy - Pharmaceutical Technology
• Principal Investigator: Valeria dos Santos Cozzolino Yugue
• Grantee: Valeria dos Santos Cozzolino Yugue
• Company: Yugue Assessores S/S Ltda
• CNAE: Atividades profissionais, científicas e técnicas não especificadas anteriormente
• City: Cotia
• Associated researchers: Ricardo Toshio Yugue ; Sabrina Sayori Okada Matino

Abstract

The jambu (Spilanthes acmella var oleracea) is native to Brazil and belongs to the Asteraceae family. This species is particularly rich in alkylamides and N-isobutylamides, and spilanthol is considered responsible for the biological activities of the species. This plant is widely used in northern Brazilian cuisine and is also traditionally used in some regions of Brazil as a powerful aphrodisiac in cases of low sexual desire. Scientific studies have shown that jambu has vasorelaxative activity and was able to inhibit nitric oxide (NO) production. These activities may be useful in the treatment of sexual dysfunction, which is characterized by the alteration from instinctive manifestation to no stimulation response and changes in the phases of desire, arousal and orgasm. Among the dysfunctions, hypoactive sexual desire disorder (HSDD) is the most prevalent female sexual health problem, affecting up to one third of adult women. During sex, jambu would contribute to arousal, the phase of parasympathetic increased blood flow to the genitals, which in women leads to clitoral erection and assists in the vaginal lubricating film formation. This is due to the nitric oxide (NO) involvement, leading to smooth muscles relaxation, facilitating the entry of blood in the genital region. The jambu action was studied in female rats and its influence on the estrous cycle of rats was verified without altering folliculogenesis. In humans in a double-blind, placebo-controlled, randomized, crossover clinical trial confirmed increased desire and sexual satisfaction in men and increased desire and sexual arousal in women with the use of an intimate cream containing jambu during intercourse. Low toxicity to jambu is reported and no neurotoxicity was observed in memory, motor coordination and locomotion tests, but an anxiogenic effect on locomotion test in rats and mice was observed (da Silva, 2013). Jambu is also considered safe (GRAS # 3783) by FEMA and EFSA as a food additive. The route of application of the product will be topical, with low mucosal permeation (0.32% of the initial dose), thus, the safety of the product will be even greater compared to its oral use. This project aims to develop an innovative product that contains a standardized jambu extract as an adjunct in the treatment of hypoactive sexual desire disorder (HSDD). To achieve this goal, the proposing firm describes its strategies and resources that will enable project execution, and details the processes, methods, and techniques that will be employed to deliver the planned results. (AU)