Nanostructured emulsion based on brassica oleracea, polyacrylic acid gel, emollients, petrolatum and lanolin, for gynaecological applications

Abstract

The present patent application relates to a composition based on an ethanolic extract of the leaves of Brassica oleracea var. capitata, stabilised with polyacrylic acid and containing emollients, petrolatum and lanolin, for gynaecological applications, with a particular focus on genitourinary syndrome. The present technology is based on a semi-solid emulsion of moderate consistency, containing 5% to 20% of a glycolic / ethanolic extract of Brassica oleracea var. capitata, 15% to 40% polyacrylic acid gel, emulsifiers, petrolatum, lanolin and preservatives; it is capable of self-emulsifying in the presence of excess water, functioning as a controlled-release system for its constituents. It acts as a lubricating agent, reducing symptoms of vaginal atrophy such as itching, dryness, pain and burning sensation; it improves sexual relations for patients undergoing menopause, and, furthermore, it has no side effects as it is non-toxic, does not adversely affect patients' liver or kidney function, and does not impair patients' quality of life whilst in use. Furthermore, the present technology has been shown to promote hydration, lubrication, healing and strengthening of the vaginal mucosa through collagen formation and angiogenesis, thereby increasing endothelial thickness.

Description

Nanostructured emulsion based on Brassica oleracea, polyacrylic acid gel, emollients, petrolatum and lanolin, for gynecological applications. Field of application

[0001] This technology relates to a nanostructured emulsion, based on Brassica olearacea var. capitata leaves, polyacrylic acid gel, and the emollients petrolatum and lanolin, intended for the treatment of vaginal pathological disorders, especially in the treatment of Genitourinary Syndrome. The formulation is stabilized by hydrophilic polyacrylic acid (PAA), which overcomes the presence of the hydrophobic components of the Brassica extract. Together with lanolin and petrolatum, it provides greater rigidity and mechanical and colloidal stability to the formulation. The formulation does not present side effects or toxicity in patients, does not affect their renal and hepatic functions, and does not impair their quality of life.The invention, for internal or external use, is capable of improving the vaginal health index (VHI), particularly the "secretion" parameter; reducing symptoms of vaginal atrophy (VAS), especially itching, burning, dryness, and pain; reducing pain during sexual intercourse in menopausal women; and promoting hydration, reptelization, healing, lubrication, mucosal strengthening, and acting as an anti-hemorrhagic. State of the art

[0002] Vaginal diseases are a global health problem affecting millions of women of all ages, with significant impacts on quality of life, sexual health, and emotional well-being. It is estimated that around 75% of women of reproductive age will experience at least one episode of vulvovaginitis in their lifetime, with fungal and bacterial infections being the most common (https: / / doi.org / 10.36557 / 2674-8169.2024v6n4p1947-1952).

[0003] However, this situation tends to worsen during menopause, when there is a progressive reduction in the secretion of ovarian hormones, such as estrogen and progesterone, which occurs when the finite stock of ovarian follicles is depleted. Menopause, which generally occurs between the ages of 45 and 55, marks the end of menstruation. Petition 870250020852, dated 03 / 17 / 2025, page 6 / 43, is accompanied by a series of physiological changes. This indicates that at least one-third of women's lives will be spent in the post-menopausal period.

[0004] Estrogen is responsible for maintaining an acidic vaginal pH, essential for preventing vaginal infections, and also for keeping the vaginal epithelium thicker, with a rougher surface, increasing vascularization and lubrication. The reduction in its levels during menopause directly affects vaginal health, reducing epithelial thickness, blood flow, and mucus production, with a loss of rugosity; this can lead to the development of chronic conditions such as Genitourinary Syndrome of Menopause (GSM).

[0005] GMO induces increased vulnerability to vaginal atrophy in at least 50% of women, considerably affecting quality of life in post-menopause, manifesting in local symptoms such as vaginal dryness, dyspareunia, itching, and irritation, usually resulting from hypoestrogenism, in addition to various symptoms throughout the body, such as night sweats, sleep disturbances, and mood swings. Despite the availability of hormonal and non-hormonal options, the search for effective and safe alternatives remains essential for women who have contraindications to the use of topical or intravaginal hormonal therapies (doi: 10.7759 / cureus.54802).

[0006] Studies have revealed that postmenopausal women have a higher risk of developing vaginal infections compared to women of reproductive age. The prevalence of infections such as candidiasis and bacterial vaginosis may increase during menopause due to changes in pH and local microbiota (https: / / doi.Org / 10.1097 / QAD.0000000000000432).

[0007] Furthermore, several scientific studies indicate that 40% to 60% of postmenopausal women report symptoms such as pain during sexual intercourse, as well as itching and burning, which are directly related to these changes. This condition, if not treated properly, can lead to more serious complications, such as generalized urinary tract infections and negative impacts on mental health, such as anxiety and depression (doi: 10.2147 / IJWH.S44579).

[0008] Despite advances in awareness and treatment of vaginal diseases, many women still face barriers to seeking help, including social stigma, lack of information, and limited access to health services. Overall, in low-risk countries... Petition 870250020852, dated 03 / 17 / 2025, page 7 / 43 and average income, only 20% of menopausal women receive adequate treatment for vaginal symptoms, so that GMS generates and will continue to generate a great impact on women's health, with significant loss of quality of life, decreased sexual health and psychological well-being.

[0009] Considering that MGS (Genetic Metabolic Syndrome) is a problem of global relevance, several technologies in the form of antibiotics, pastes, ointments, creams, gels and related products for the treatment of vaginal diseases, especially those resulting from menopausal processes, are described in the state of the art. As examples, patents using non-hormonal synthetic compounds, such as antibiotics and antivirals, stand out: BR112019021404A2 (2019) refers to the use of furazide for bacterial treatment of the vaginal tract, in particular against Gardnerella vaginalis and / or Atopobium vaginae bacteria. BRPI0711525A2 (2012) deals with a pharmaceutical composition based on triphenylethylene derivatives and tamoxifen to treat symptoms of atrophic vaginitis. WO2016020861 A2 (2015) relates to a composition for films or sponges for the prevention and treatment of urogenital or vaginal infections, containing a pasteurizer, a mucoadhesive polymer, a probiotic and / or prebiotic, and an antibiotic.Brazilian patent BR1020170049280A2 reports a gel containing a drug combination based on fluconazole and amiodarone, for the treatment of vaginal candidiasis caused by fluconazole-sensitive and fluconazole-resistant strains. Brazilian patent BR1120230076544A2 (2021) cites a pharmaceutical composition containing aniline derivatives as active ingredients, for the prevention and / or treatment of vaginal viral diseases. Brazilian patent BR1120220258615A2 describes a gel based on metronidazole, terconazole, and a thickening agent for the treatment of bacterial vaginosis and vulvovaginal candidiasis. Patent PI05079276A2 (2005) mentions the use of pyrimidine ethers and compositions for the treatment of pain in the vaginal region. Patent BR1120240165582A2 (2023) refers to compositions based on polyglutamic acid for treating, preventing or reducing the symptoms of vaginal dryness and symptoms associated with menopause.Technology BR1020190262168A2 (2019) refers to a pharmaceutical product based on micelles dispersed in a hybrid hydrogel for the treatment of vaginal diseases. Technology PT1509215E (2003) refers to a formulation for the treatment or prophylaxis of urogenital atrophy and its symptoms in women based on toremifene derivatives. WO / 2023 / 147289 (2023) describes compounds and compositions based on flavonoids and their derivatives for the local treatment of GMS. Petition 870250020852, dated 03 / 17 / 2025, page 8 / 43

[0010] Unlike other technologies based on cosmetic-pharmaceutical formulations, there are physical methods focused on electromagnetic or photoluminescent stimulation therapies capable of producing positive effects against GMS. As examples, JP2020529298A (2018) provides a vaginal phototherapy device based on LEDs for multiple bacterial and fungal infections. US20220133401 A1 (2022) describes a device that generates electrical pulses to stimulate the vaginal tract.

[0011] Regarding the use of hormone replacement therapies, these have been in the public domain for years, with topical vaginal estrogen administration currently considered the gold standard of treatment and offering long-term improvement with continued use. For example, relatively old technologies such as ATE269706T1 (2000) describe topical formulations for hormone therapy capable of interfering with EP2 or EP4 prostanoid receptor agonists, favoring the reduction of GM symptoms; while US6165491A (2000) describes a pharmaceutical composition based on estrogen and progesterone for the treatment of GM.

[0012] Topical use of estrogen allows for little systemic absorption and significant clinical improvement of symptoms. However, some women do not want or do not adapt to repeated applications of vaginal creams or suppositories, and others have contraindications. The average adherence to medication is quite variable, from 52% in users of vaginal creams to 74% in users of vaginal suppositories. Among the most common adverse effects are vaginal discharge, vulvovaginal candidiasis, vaginal bleeding, and breast pain (10.1097 / GME.0000000000001609). In any case, relatively recent technologies based on hormonal therapies are still in the state of the art, some of which, such as US20210069102A1 (2020), use vasodilating hormones, such as angiotensin receptor blockers, angiotensin-converting enzyme inhibitors, or calcium channel blockers, whose action occurs through contact with the epithelium.RU2833138C1 (2024) describes a combined hormonal therapy, based on estrogen and progestin suppositories, combined with immunomodulatory peptides for the treatment of GSM.

[0013] Considering the fact that many hormone therapies are expensive, as well as the fact that hormones, antibiotics, and other chemicals often cause side effects, the development of formulations based on natural products, often incorporated into matrices with [specific ingredients], has become increasingly common. Petition 870250020852, dated 03 / 17 / 2025, page 9 / 43, concerns lubricating, emollient, and antimicrobial adjuvants aimed at the multifunctional treatment of GMS. It is important to emphasize that extracts of natural products, especially plants, due to their many chemical constituents, can act synergistically, reducing and even eliminating the various symptoms of GMS. This fact can be proven by the technologies described in the prior art, which in turn cite complex formulations containing at least one natural product as an active ingredient. Examples of patents containing natural products can be highlighted below.

[0014] Brazilian patent BR102021004842A2 (2021) describes a vaginal moisturizing gel containing Lactobacillus Paracasei (VGA), sodium hyaluronate, propylene glycol, carbopol, sodium lactate, sodium benzoate, lactic acid, and polycarbophil. Brazilian patent BR1020220267600 (2022) cites and claims a process for obtaining a vaginal gel based on carbopol with Annona muricata / ., with anticandidiasis activity. Brazilian patent BR1120230178142A2 (2022) cites and claims a pharmaceutical composition for use in the treatment of inflammation in the genitourinary tract based on lactobacilli. Brazilian patent BR102019004426A2 (2019) refers to a vaginal gel of typified propolis for the treatment of diseases of the female genital system. BR1020210149280A2 reports the use of a topical formulation, in gel form, specifically for the genital area, with anti-herpetic properties, aiding in the treatment and regression of viral infection, containing Trichilia catigua A. Juss. extract as an antiviral active ingredient.WO / 2024 / 117921 (2024) describes a pollen-based composition, wherein the composition or extract comprises at least glucose-6-phosphate, as a substrate or precursor for the production of hyaluronic acid for the treatment of GMS. US10357527B2 (2018) refers to a composition based on xylose and sage extract for improving homeostasis and physiological conditions of the female reproductive tract. US20210299151 A1 (2021) describes a mixture of prebiotic oligosaccharide, metallic cofactor and essential oil of pine needles, aiming to support the genital microbiota, acting as a moisturizer, lubricant, cleanser and anti-inflammatory agent in the urogenital region.

[0015] Brassica oleracea var. capitata (cabbage), used in this patent, is an annual herbaceous vegetable of the Brassicaceae family and originates from the Northern Mediterranean Coast, Asia Minor, and the western European coast. Its composition includes components such as glucosinolates, sulforaphane, and tannins (phenolic acids). Petition 870250020852, dated 03 / 17 / 2025, page 10 / 43e flavonoids that possess curative, antimicrobial and antioxidant activities (https: / / doi.Org / 10.1002 / jsfa.8037).

[0016] In the state of the art, technology BR1020160063078 is described, which claims processes for obtaining its extract using different solvents, as well as compositions containing the extract incorporated into emulsions and gels for the purpose of healing various wounds. Patent BR1020220012156A2 describes a nanostructured phytotherapeutic ointment, based on Brassica oleracea var. capitata extract, anhydrous lanolin, and castor oil, for the treatment of burns and their complications. Both technologies are based on the potential to promote wound debridement, favoring healing.

[0017] On the INPI website, searching for formulations containing natural extracts in patent abstracts, using the keywords "vaginal" and "extract," yielded 13 applications. Using the keywords "menopause" and "extract," yielded 8 applications. A similar search on WIPO (https: / / patentscope.wipo.int / search / pt / search.jsf), using the keywords "vaginal" and "extract," yielded 348 applications. Using the keywords "menopause" and "extract," yielded 244 applications. On Espacenet, using the keywords "vaginal" and "extract" retrieved 71,882 applications, while using the keywords "menopause" and "extract" retrieved 14,264 applications. On Google Patents, the result was over 100,000 patents for both groups of keywords "vaginal" and "extract".

[0018] When the same search pattern was performed, adding the keyword “Brassica oleracea” or “Brassica oleracea”, no results were retrieved from the INPI and WIPO websites. On Espacenet, using the keywords “vaginal”, “extract”, and “Brassica oleracea”, 162 applications were retrieved, while using the keywords “menopause”, “extract”, and “Brassica oleracea”, 53 applications were retrieved. On Google Patents, for the keywords “vaginal”, “extract”, and “Brassica oleracea”, 72 applications were retrieved, while using the keywords “menopause”, “extract”, and “Brassica oleracea”, 75 applications were retrieved. Petition 870250020852, dated 03 / 17 / 2025, page 11 / 43

[0019] Although the present technology is based on a formulation containing Brassica oleracea as the main active ingredient, incorporated into a formulation for intravaginal use, as will be described below, its composition makes use of emollient, thickening, and lubricating agents, which enhance its action in the formulation as a whole.

[0020] An important component of the formulation is polyacrylic acid (PAA). PAA is a high molecular weight synthetic polymer composed of acrylic acid monomers, with low commercial value, hygroscopic, water-soluble, biocompatible, biodegradable, non-toxic and recyclable. Due to its chemical structure rich in carboxylate groups, it can easily interact with wet surfaces or aqueous media, which gives it high adhesive capacity. It is also capable of incorporating large amounts of water, thus exhibiting a high thickening effect (https: / / d0i.0rg / l0.3390 / polym14061259). PAA is able to promote the emulsification of the hydrophobic components of Brassica, as can be seen in the examples below.

[0021] Thus, when the keyword “Polyacrylic Acid” is entered along with others, no patent records are found on Google Patents and only 5 patent records on Espacenet (CN102844319A (2012), JP2022526678A (2022), CN108473484A (2015), CN103442567A (2011), JP2022529503A (2019)). However, from the records found in the European Patent Office database, it is observed that none of them have a configuration or use similar to the composition reported here, so the present technology meets the novelty requirement of Law 9279 / 96.

[0022] The present technology also makes use of anhydrous lanolin, not yet described in the prior art, in combination with Brassica oleracea and PAA for the treatment of vaginal disorders, which reinforces the thesis that the formulation is completely novel. Regarding lanolin, although it does not have a direct effect on microorganisms or on the re-epithelialization process, it has a waxy characteristic due to the presence of a complex mixture of macromolecules, especially high molecular weight lipid compounds (W02002100990A1), thus contributing to the viscoelasticity of the formulation. As for petrolatum, being a mixture of inert hydrocarbons of a completely hydrophobic nature, together with lanolin, it favors a lubricating and protective action, which Petition 870250020852, dated 03 / 17 / 2025, page 12 / 43 certainly contributes to improving the parameters related to the vaginal health index (VHI) and reducing the symptoms of vaginal atrophy (VAS).

[0023] In light of the foregoing, the combination of the constituents described above is, to date, completely novel in the state of the art. As will be demonstrated in the examples below, this combination results in a formulation whose components interact and act synergistically in a non-obvious way, generating new colloidal and mechano-rheological characteristics that enhance the action of the active ingredients, conferring inventive activity according to Law 9279 / 96. The nanostructured character and the ability to self-emulsify, forming hydrophilic microstructures, facilitates the adhesion process and controlled release of the active ingredients on the surface of the vaginal epithelium, thus qualifying the present technology as a public utility agent for the treatment of genitourinary syndrome and related vaginal problems, capable of large-scale industrial production.Therefore, in the current state of the art, there is no similar technology that is non-toxic and guarantees the solution to so many problems, as will be described below. Brief description of the figures Figure 1: Average values ​​of hydrodynamic diameters (Dh / nm) obtained from the dispersion of the formulations in water, at a concentration of 0.01 g / mL. Experiments performed at 25 °C, scattering angle of 90°. The values ​​correspond to the mean ± SD. Values ​​marked with (*) showed statistical differences between them by Tukey's test for p < 0.05. Figure 2: Average zeta potential (ZP / mV) values ​​obtained from the dispersion of the formulations in water, at a concentration of 0.01 g / mL. Experiments were performed at 25 °C, a scattering angle of 170°, and an alternating voltage of ±40 V. The values ​​correspond to the mean ± SD. Values ​​marked with (*) showed statistically significant differences between them according to Tukey's test for p < 0.05. Figure 03: Values ​​of storage moduli (G7 Pa) and loss moduli (G'7 Pa), obtained by oscillatory rheological analysis as a function of the strain rate, from 0.01% to 100%, at 25 °C, ® = 1 Hz; FC, FCB, FPAA and Base. Petition 870250020852, dated 03 / 17 / 2025, page 13 / 43 Figure 04: Tan(θ) values ​​obtained by oscillatory rheological analysis as a function of the deformation rate, from 0.01% to 100%, at 25 °C, α = 1 Hz; for FC, FCB, FPAA and Base. Figure 05: Complex viscosity values ​​(77* / Pa.s), obtained by oscillatory rheological analysis as a function of deformation frequency from 1 to 100 Hz, at 25 °C, with % = 2% (maintained within the LVE); for FC, FCB, FPAA and Base. Figure 06: Tan(θ) values, obtained by oscillatory rheological analysis as a function of the deformation frequency from 1 to 100 Hz, at 25 °C, with y% = 2% (maintained within the LVE); for FC, FCB, FPAA and Base. Figure 7: Thermorheological analyses as a function of temperature, from 5 to 60 °C, heating rate of 5 °C / min, y% = 1% and ® = 1 Hz, for FC, FCB, FPAA and Base. Figure 8: Clinical and Sociodemographic Characteristics of the patients. Figure 9: Information regarding the menopausal conditions of the patients included in the study. Figure 10: Comparative analysis of VHI parameters between the experimental and control groups after 12 weeks of treatment. Figure 11: Comparative analysis of ESA parameters between the experimental and control groups after 12 weeks of treatment. Figure 12: Difference in scores between initial and final visits by Group in participants of the randomized clinical trial of Brassica oleracea - ISF. Figure 13: Analysis of liver and kidney profile tests of the patients. Detailed description of the invention

[0024] This invention application consists of the steps described below to obtain a NANOSTRUCTURED EMULSION BASED ON BRASSICA OLERACEA, POLYACRYLIC ACID GEL, EMOLLIENTS, VASELINE AND LANOLIN, FOR GYNECOLOGICAL APPLICATIONS. From this point on, to facilitate the textual description of the technology, the aforementioned formulation will be referred to as the “Complete Formulation (CF)”. Petition 870250020852, dated 03 / 17 / 2025, page 14 / 43A. Stage I: Consists of obtaining glycolic / ethanolic extracts from Brassica oleracea var. capitata leaves, by adaptation to that described in the state of the art (BR 102016006307-8). After collecting Brassica oleracea var. capitata leaves, they are sanitized by immersion in a mixture of aqueous sodium hypochlorite solution (0.5 to 2%) for 2-5 minutes. Then, the leaves are washed in distilled water and autoclaved for 10-20 minutes. The extraction should be done by static maceration with ethyl alcohol (ethanol) at 15 to 30% and propylene glycol at a concentration of 15 to 30% as the extraction solvent (glycoethanolic solution). Every week, an equal volume of solvent is used for remaceration. The solution is subjected to ultrasound, vacuum filtration, and heated to 55°C. eIt is then left for 4 hours to remove excess ethanol. It is then frozen at -20°C and subsequently lyophilized. The extract can be reconstituted by solubilization in hydroethanolic or hydroglycolic solution.

[0025] Stage II, called formulation, consists of obtaining a semi-solid, viscoelastic, nanostructured formulation by combining the extract with the other constituents, in order to obtain a formulation that is still novel in the state of the art. For this, in a main tank, the constituents are mixed as follows:

[0026] a) In an automatic propeller mixer (maintaining agitation between 300 and 700 rpm) and heating (50-80 °C), the formulation constituents are added in the following order: 4 to 15% of emulsifying wax based on cetearyl alcohol and polysorbate-60 (CAS: 67762-27-0); 3 to 9% of emollient isopropyl palmitate (CAS: 142-91-6); 0.5 to 5% of emulsifier glyceryl stearate (CAS: 31566-31-1); 0.5 to 5% of glycerin (CAS: 56-81-5); 0.5 to 4% of surfactants containing cetearyl alcohol and behentrimonium methosulfate (CAS: 81646-13-1); 0.1 to 1.0% of Preservative: phenoxyethanol; 0.1 to 1.0% preservative: methylisothiazolinone; 0.02 to 0.2% stabilizer: Na2EDTA; antioxidant: 0.1 to 0.5% BHT (CAS 128-37-0). The emulsifying mixture is kept heated at 50-80 °C for 20-40 minutes for complete homogenization and then cooled to 30 °C, being designated "Fraction 1".

[0027] b) In another automatic mixer, at room temperature, dissolve in demineralized water (20% to 40% by weight), under agitation at 200 to 400 rpm, the amount of PAA to obtain a quantity corresponding to 15-30% of the total percentage of the formulation. Then, add the preservatives phenoxyethanol-96.6% (0.01 to 0.05%), methylisothiazolinone-3.4% (0.01 to 0.05%). Still under agitation. Petition 870250020852, dated 03 / 17 / 2025, page 15 / 43e, with real-time pH monitoring, the mixture must have its pH adjusted to values ​​around 5.0-6.0 by titration with a 5 M sodium hydroxide solution. This hydrophilic mixture is called "Fraction 2".

[0028] c) In the main tank, Fraction 2 is mixed into Fraction 1 under agitation at 300 to 700 rpm and heating between 30-60 °C. Subsequently, the hydrophobic components are added: petrolatum (5% to 10% by weight), anhydrous lanolin (5% to 15% by weight), hydrogenated castor oil (2% to 10% by weight), polyol fatty acid esters (5% to 10% by weight) under agitation. This mixture is called “Combined 1”.

[0029] d) Once the fluidity and mixing of all constituents are ensured, a previously reconstituted glycolic / ethanolic solution of Brassica oleracea var. capitata is added to "Combination 1" in a mass proportion of 5-20%, at a constant flow rate, maintaining agitation between 300 and 700 rpm, until the product is completely homogenized, thus obtaining the "Complete Formulation" (CF). At the end, the CF can be subjected to spontaneous cooling to room temperature and then packaged in an appropriate container.

[0030] As shown in the examples below, the present technology is not characterized by mere dilution of the active ingredients in the encapsulation matrix and vehicle; the presence of intermolecular interactions between the components of the extract and the other constituents of the formulation can be demonstrated. Through a double-blind randomized clinical trial, the new formulation as a whole showed clinical efficacy for gynecological applications, especially in the treatment of genitourinary syndrome.

[0031] To aid in the interpretation of the non-limiting examples below, in addition to the Complete Formulation, formulations containing Brassica without polyacrylic acid (FCB); a formulation containing polyacrylic acid without Brassica (FPAA); and a formulation without Brassica and without polyacrylic acid (Base) were produced, keeping the concentrations of the other constituents constant. EXAMPLE 1: Colloidal characterization: Determination of the hydrodynamic diameter and zeta potential of the formulations in the presence of water. Petition 870250020852, dated 03 / 17 / 2025, page 16 / 43

[0032] The colloidal characterization of the formulations, focusing on the investigation of the interactions of the two active components, Brassica and PAA, with the other components of the formula, in excess water, was performed by measuring hydrodynamic diameter (Dh / nm) and zeta potential (ZP / mV), adapting methodologies described in the state of the art (BR1020220012156 and BR 102015017574-4). For this, 0.1 g of each formulation was dissolved in 10 mL of milli-Q® water and subjected to vigorous agitation until total dispersion of the components (emulsification), in order to obtain emulsions with a final concentration of 0.01 g / mL. Subsequently, the emulsions were subjected to dynamic light scattering (DLS) analysis for Dh measurements and Doppler velocimetry analysis with phase scattering (PALS) for ZP measurements. For the measurements of the average hydrodynamic diameter Dh, a DTS0012 square polyethylene cuvette was used. For the ZP measurements, a DTS-1070 polyethylene capillary cuvette was used.All measurements were performed using a NANO-ZS-90 zetasizer photometric module.

[0033] This formulation consists of a combination of hydrophilic agents (polysorbate, propylene glycol, Na2EDTA, behentrimonium methosulfate, and polyacrylic acid) and hydrophobic agents (Brassica extract, cetearyl alcohol, isopropyl palmitate, glyceryl monostearate, polyol fatty acid esters, petrolatum, anhydrous lanolin, hydrogenated castor oil). The high solids content combined with the high molar mass of some constituents (whose size is nanometric) gives the formulation and subformulations a semi-solid appearance due to nanostructuring. When this type of formulation is applied to the epithelium or any other surface, the existing nanostructures interact with the epithelial cells, forming a protective micro or nanolayer with moisturizing, antimicrobial, and healing action, acting as a controlled release system for the constituents in the environment.

[0034] In situations where surfaces are cleaned with water, some of the material deposited on the epithelium undergoes emulsification, forming nano- or microstructures containing components of the formulation. Therefore, solubility and residual action depend on the size, surface charge, and ion concentration. Size (Dh) and surface charge (ZP) are parameters that reflect the interactions between the components. Petition 870250020852, dated 03 / 17 / 2025, page 17 / 43

[0035] Initially, Dh measurements were performed to determine the average size of nanostructures dispersed in water (Figure 1). As observed in Figure 1, the Dh values ​​were close to 1500 nm, except for the formulation containing only Brassica (FCB), which showed a Dh close to 3000 nm. This set of data demonstrates that the formulas, in excess water, tend to stabilize in the micrometer range. Also in Figure 1, it can be observed that FBC was the one that presented the largest particle size, with a significant difference of p < 0.05 between the other formulations. All the others did not present significant mutual differences.

[0036] This data demonstrates that the incorporation of Brassica into the Base formulation (FCB subformulation) tends to form larger particles, with emulsification difficulties, due to the hydrophobic constituents of its composition. When Brassica and PAA are simultaneously incorporated (in the Complete Formulation), the PAA tends to compensate for the hydrophobicity of the extract, favoring its emulsification in a non-obvious way, which, from the application point of view, is potentially advantageous by favoring the interactions of the extract components with hydrophilic surfaces.

[0037] Figure 2 shows the ZP values ​​for the four formulations. As can be observed, all of them present negative ZP values, which were attributed to the presence of acidic surfactants, capable of ionization in water, such as isopropyl palmitate, polysorbate, and phenoxyethanol.

[0038] In the formulation containing only Brassica (FCB), the zeta potential of the resulting emulsion remains practically unchanged compared to the Base (values ​​close to -10 mV with no significant difference, p < 0.05). These low ZP values ​​for FCB were attributed to the hydrophobic character and low ionization potential of the extract constituents. These lower ZP values ​​for FCB are consistent with the larger particle sizes observed for this formulation. On the other hand, although the Base has particle sizes close to FC and FPAA, it should be emphasized that this formula does not contain the hydrophobic components of the extract, which contributes to the smaller particle sizes.

[0039] The FPAA formulation exhibited high zeta potential values ​​(-21.5 ± 1.1 mV), which were attributed to the presence of PAA, a polymer capable of undergoing deprotonation. Petition 870250020852, dated 03 / 17 / 2025, page 18 / 43 of its carboxylate groups, forming negatively charged species. Due to the presence of PAA in the FC formulation, an intensification in the ZP value was observed even in the presence of Brassica (-22.3 ± 1.4 mV), demonstrating that the incorporation of PAA into the formula inhibits the hydrophobic character of Brassica, inhibiting coalescence and indicating potentiation of the emulsification of the extract components. Thus, FPAA and FC did not show mutually significant differences, but showed differences in relation to the Base and the FCB sample (p < 0.05). This indicates that the presence of PAA is capable of inducing the formation of charged species, which in turn are potentially capable of interacting more efficiently with moist surfaces, such as vaginal epithelium. EXAMPLE 2: Investigation of the Rheological Response

[0040] The mechanical properties of the FC formulation and the interactions of the Brassica extract and PAA with the other components were investigated by oscillatory rheological and thermorheological analyses, in comparison with the controls (FCB, FPAA and Base). For characterization, a Dynamic Hybrid Rheometer (DHR1; TA Instruments®) with parallel plate geometry (stainless steel, 40.0 mm diameter, DIN standard) coupled to a Peltier plate for temperature control was used.

[0041] The experiments were initially performed in oscillatory sweep mode with a strain amplitude of 0.01% to 100%, at 25 e C, keeping the angular frequency constant (1 Hz) in order to determine the linear viscoelasticity region (LVE) and the possible existence of a yield stress (TO). With the determination of the LVE, the strain amplitude was fixed at 2% (within the LVE) and the oscillation frequency varied from 1 to 100 Hz, at 25 eC. Thermorheological experiments were also performed to investigate the thermal behavior of the samples, keeping the strain amplitude fixed at 1% and the frequency at 1 Hz.

[0042] Figure 3 shows the graphs of storage modulus (GV Pa) and loss modulus (G” / Pa) as a function of shear stress τ(Pa), while Figure 4 shows the damping factor (tan(θ)) values ​​also as a function of shear stress. It is worth noting that G' is a measure of the material's stiffness (solid behavior), i.e., the higher G', the stiffer the formulation; while G” is a measure of fluidity. The damping factor, in turn, is the Petition 870250020852, dated 03 / 17 / 2025, p. 19 / 43 ratio between loss and storage moduli (tan(ô) = G7G'), being a measure of the solid or fluid character of the material. If tan(ô) > 1, the material tends towards a fluid character and if tan(ô) < 1 the material tends towards a solid character (Barnes, HA, JF Hutton, and K. Walters, An Introduction to Rheology. Vol. 3. 1989: Elsevier).

[0043] As shown in Figure 3, all formulations exhibited G' > G”, indicating a greater tendency towards solid behavior. In Figure 4, it can be observed that all formulations maintain damping factor values ​​less than 1 up to 80-110 Pa. All formulations also presented a well-defined linear viscoelasticity (LVE) region, with constant values ​​of G' and G” up to the intersection point. The shear stress value at which the intersection between G' and G” occurs is the yield stress value (σ / Pa), that is, the value from which the material loses its solid behavior and begins to flow. It is worth noting that both G' and σ can be used to measure the stiffness (solid character) of materials.

[0044] As observed in Figure 3, the pure Base exhibits intermediate values ​​of G' and to. The mixture of Brassica with the Base (in FCB) reduces the G' and to values ​​of the material in a non-obvious way. The addition of PAA (in FPAA) increases the G' and to values, also causing the damping factor values ​​to remain below 1 (tan(<5) < 1) during a wider shear stress range than the other samples. However, when PAA and Brassica are added simultaneously (in FC), a compensation of effects is observed once again, causing FC to have a response very similar to FPAA. This fact demonstrates that the presence of PAA is predominant not only in the colloidal behavior (as discussed in the Dh and ZP measurements of Example 1), but also in the mechanical response, canceling the hydrophobic effect of the Brassica components.

[0045] The fact that FCB presented larger particle sizes (see Example 1), lower ZP values, and lower G' values ​​suggests that incorporating Brassica into the formula without PAA creates a risk of structural breakdown and rupture, which could reduce its shelf life. This information reinforces the importance of PAA in the composition to provide stability and ensure mechanical response. Petition 870250020852, dated 03 / 17 / 2025, page 20 / 43

[0046] Figure 5 shows the complex viscosity values ​​(r|* / Pa.s) determined through the frequency oscillation experiment. As can be seen, the viscosity decreases with shear frequency, demonstrating pseudoplastic behavior. Here, the viscosity trend is similar to that observed in the amplitude oscillation experiments, as both the FPAA and FC samples presented the highest viscosity values ​​(resistance to flow). When evaluating the behavior of the samples in terms of tan(θ) as a function of shear frequency (λ / Hz), there is a large discrepancy between FC and the others, due to intermolecular interactions between the components (Figure 6). It is observed that FC presents tan(θ) values ​​>1 in a certain shear range, decreasing again at high frequencies, showing greater sensitivity to shear.This behavior can be explained in terms of an initial destructuring through shear (leading to an increase in tan(θ)), followed by structural reorganization (leading to a reduction in tan(θ)), which can be attributed to the interactions of the ionic components of Brassica with the polymer, in order to partially neutralize it. This behavior is of great relevance from an operational point of view, since it favors the spreadability of FC at intermediate shear frequencies and stiffness under low shear or at rest.

[0047] Finally, Figure 7 shows the tan(θ) values ​​as a function of temperature in the range of 5 to 60 °C. For all samples, an increase in tan(θ) is observed up to around 30 °C, this behavior being attributed to the fusion of nano or microdomains formed by waxes and greases present in the samples. However, the reduction of tan(θ) above 30 °C suggests that the materials begin to lose water and other small molecules, resulting in increased stiffness. It is observed that the interaction of PAA with the components of Brassica and other components of the formula confers greater stiffness to the formulation up to around 30 °C compared to FCB and Base, demonstrating once again a greater similarity in behavior between FC and FPAA than with Base or FCB, reinforcing the hypothesis that PAA prevents the reduction in stiffness due to the presence of Brassica. EXAMPLE 4: Pilot study with intravaginal moisturizing cream based on Brassica oleracea, through a randomized (1:1), triple-blind, controlled clinical trial in the management of Genitourinary Syndrome of Menopause (GSM). Petition 870250020852, dated 03 / 17 / 2025, page 21 / 43

[0048] The gynecological applicability of the new nanostructured emulsion based on Brassica oleracea, polyacrylic acid gel, emollients, petrolatum, and lanolin, for gynecological applications, specifically in the case of Genitourinary Syndrome of Menopause (GSM), was carried out in order to evaluate the effect of the formulation on genitourinary symptoms of menopause, as well as to describe and compare the Vaginal Health Index (VHI) on the Atrophy Symptom Scale (ASS); to describe and compare the Female Sexual Function Index (FSFI) and evaluate the perception of the physical and mental health of the patients based on the Women's Health Questionnaire (WHQ); and finally, to describe the results of the laboratory tests of liver and kidney function of the participants.

[0049] To this end, a Randomized (1:1), Triple-blind, Controlled Clinical Trial was conducted with a sample group of 40 postmenopausal women diagnosed with GSM, according to clinical criteria and assessment of the Vaginal Health Index (VHI). The sample size was based on similar studies, estimating a minimum improvement of 10% in quality of life scores. For statistical power of 80% to 90% and a significance level of 5%, resulting in 19 to 26 participants in each group. Thus, a study was defined with a total of 40 patients, who were distributed into two groups: the first, consisting of 22 patients, called the "Experimental Group," which received the Complete Formulation (CF); and the second, consisting of 18 patients, called the "Control Group," which received the formulation containing the Base and the PAA (FPAA) that functioned as a placebo.

[0050] As eligibility criteria for recruitment, patients aged between 50 and 65 years were selected, with at least 3 years of clinically confirmed menopause, and diagnosed with GSM based on clinical symptoms and the vaginal health index (VHI). Patients with a history of allergy to plants of the Brassicaceae family (cabbage, broccoli, kale, etc.); those with uncontrolled diabetes, active chronic diseases, and other contraindications described in a research project approved at the Central Institute of the Hospital das Clínicas of the Faculty of Medicine of USP (ICHCFMUSP); active genital infections or conditions that would hinder the use of the cream (such as an intact hymen, for example); or those who had been using gynecological hormones or herbal remedies for less than 3 months were excluded from the study for ethical and safety reasons. Petition 870250020852, dated 03 / 17 / 2025, page 22 / 43

[0051] Figure 8 summarizes the clinical and sociodemographic profile of the 40 participants. The mean age was approximately 57 years, with statistically significant differences in categories of body mass index (BMI, p = 0.005), prevalence of diabetes (p = 0.008), smoking (p = 0.002), use of antidepressants (p = 0.012), and presence of metabolic diseases (p = 0.026). Figure 9 presents information on menopause: age of onset, time elapsed, and defined categories (premature, early, timely, or late menopause) and occurrence of premature ovarian failure (POF). As can be observed, within the sample universe, the experimental group presented a significantly longer menopause time (p = 0.008), with women in menopause for more than 6 years (p = 0.003).

[0052] As a blinding criterion for the study, participants were unaware of which group they were allocated to (intervention or control); the researchers did not know which cream was being applied; and the data analyst remained blinded to the groups throughout the statistical analysis process.

[0053] The studies were conducted at the Menopause Clinic of the Gynecology Division of the Hospital das Clínicas of the Faculty of Medicine of the University of São Paulo (FMUSP), with recruitment mechanisms including internal dissemination and media linked to the Gynecology Department of FMUSP, with in-person evaluations scheduled by the Gynecology team. The study was approved by the Research Ethics Committee (CEP) under CAAE: 70147923.0.0000.0068 and registered in the Brazilian Registry of Clinical Trials (REBEC) under UTN code: U1111-1299-75.

[0054] For the study, three 50g tubes were distributed to the participants to cover the 36 applications, with the packages weighed at each appointment to verify adherence. The application method consisted of intravaginal use every 72 hours for 12 weeks, with an average of 3g per application.

[0055] The following clinical and functional assessments were performed: 1) Vaginal Health Index (VHI), 2) Scale of Symptoms of Atrophy (ESA), 3) Female Sexual Function Index (FSFI), 4) application of the “Women's Health Questionnaire” (WHQ), and 5) vaginal pH tests. Among the laboratory assessments, liver function tests were performed (with measurement of: aspartate aminotransferase - AST, Petition 870250020852, dated 03 / 17 / 2025, page 23 / 43 (pyruvic transaminase - ALT, direct bilirubin, indirect bilirubin); and renal function tests (with measurements of creatinine, urea, and uric acid).

[0056] Figure 10 shows the parameters related to the Vaginal Health Index (VHI), determined based on a comparative analysis between the Experimental and Control groups during 12 weeks of application of the formulations. The VHI is a set of parameters, such as elasticity, secretion, pH, integrity, and lubrication of the vaginal epithelium, used worldwide to assess vaginal health (https: / / doi.org / 10.1016 / j.tjog.2023.07.011). As can be observed in Figure 10, there was a significant improvement in the total VHI score in the Experimental Group compared to the Control Group (p = 0.008), with particular emphasis on the "Secretion" parameter (p = 0.05).

[0057] Vaginal atrophy, also known as atrophic vaginitis, is a common condition affecting women, primarily after menopause. It is characterized by thinning, dryness, and inflammation of the vaginal walls due to decreased estrogen levels (https: / / doi.orq / 10.1038 / nrendo.2014.94). Figure 11 shows the parameters of the Atrophy Symptom Scale (ASS) after 12 weeks of treatment. The ASS is a tool used to assess the severity of vaginal atrophy, taking into account various symptoms such as vaginal itching (itching in the vaginal area), burning (burning sensation), dryness (dryness and discomfort), pain during sexual intercourse (discomfort or pain during sexual intercourse), bleeding (small bleedings after sexual intercourse), vaginal discharge (changes in the amount or appearance of vaginal discharge), and urinary symptoms (urinary urgency, urinary frequency, and urinary incontinence).For the purposes of this technology, the parameters used were those described in Figure 11. ESA generally uses a scoring scale to classify the severity of symptoms, allowing healthcare professionals to monitor the progression of vaginal atrophy and assess the effectiveness of treatments.

[0058] As can be seen in Figure 11, the Experimental group showed a greater reduction in total atrophic symptoms (p = 0.049) compared to the control group, demonstrating the effectiveness of the formulation for the treatment of symptoms related to vaginal atrophy. Petition 870250020852, dated 03 / 17 / 2025, page 24 / 43

[0059] Analyzing the results of the Female Sexual Function Index (FSFI), determined through a questionnaire administered to patients (Figure 12), it is observed that in the Control Group, which received FPAA, no statistically significant differences were observed in any of the FSFI items between the two visits (initial and final). However, as can be seen in the "isfdor" dimension of Figure 12, there was a significant reduction in pain reports in the Experimental Group, with statistically superior reliability compared to the Control Group (p = 0.038).

[0060] In order to inspect the impact of treatment on the physical and emotional health aspects of the patients, the “Women's Health Questionnaire (WHQ)” was applied. This is a quality of life assessment instrument developed specifically for women, especially those going through menopause. It was created in 1986 in England with the aim of providing a more detailed assessment of menopause-related symptoms (doi: 10.1186 / 1477-7525-1-41). Analyzing the quality of life results according to the WHQ for the Control Group between the initial and final visits, it was found that there were no statistically significant differences in any of the domains evaluated. The p-values ​​for all domains were greater than 0.05, indicating that the participants' quality of life remained stable throughout the study period.In the total WHQ score, the mean increased slightly from 2.51 ± 0.43 at the initial visit to 2.58 ± 0.43 at the final visit, a difference that was not significant (p = 0.638). The only exception was observed in Question 34 of the Experimental Group, which addresses participants' perception of discomfort during sexual intercourse due to vaginal dryness ("My sexual intercourse is uncomfortable because my vagina is dry"). This difference demonstrates that the Brassica Group reported specific improvement in this aspect, while the other domains remained similar between the groups.

[0061] Figure 13 shows the results of laboratory tests aimed at monitoring the renal and hepatic functions of the patients, in order to assess possible metabolic changes resulting from the treatment. As can be observed, there were no hepatic or renal alterations in the laboratory tests throughout the study in either group, demonstrating the safety of the formulation for the purpose for which it was developed. This data is consistent with the fact that all the constituents of the formula are already used in the state of the art as components of other Petition 870250020852, dated 03 / 17 / 2025, page 25 / 43 formulations, but that the combination of the same in the present technology is not capable of causing any adverse effects to patients. Petition 870250020852, dated 03 / 17 / 2025, page 26 / 43

Claims

CLAIMS 1. “PROCESS FOR OBTAINING A NANOSTRUCTURED EMULSION BASED ON BRASSICA OLERACEA, POLYACRYLIC ACID GEL, EMOLLIENTS, VASELINE AND LANOLIN, FOR GYNECOLOGICAL APPLICATIONS”, characterized by the emulsion being obtained through the following steps: a) In the main tank, maintaining agitation between 300 and 700 rpm and heating at 50-80 °C, considering the final mass of the finished product, the formulation constituents are added in the following order: emulsifying wax based on cetearyl alcohol and polysorbate 60 (CAS: 67762-27-0); emollient isopropyl palmitate (CAS: 142-91-6); emulsifier glyceryl stearate (CAS: 31566-31-1), glycerin (CAS: 56-81-5); surfactants containing cetearyl alcohol and behentrimonium methosulfate (CAS: 81646-13-1); preservative phenoxyethanol; preservative methylisothiazolinone; stabilizer Na2EDTA; antioxidant BHT (CAS: 128-37-0). The emulsifying mixture is maintained at Heated to 50-80 °C for 20-40 minutes for complete homogenization and then cooled to 30 °C, being designated "Fraction 1". b) In a secondary tank at room temperature, the hydrophilic fraction is prepared by dissolving polyacrylic acid, phenoxyethanol-96.6% preservatives, and methylisothiazolinone-3.4% in demineralized water under agitation at 200 to 400 rpm. Still under the same agitation and with real-time pH monitoring, the mixture's pH should be adjusted to values ​​around 5.0-6.0 by titration with a 5 M sodium hydroxide solution. This mixture is called "Fraction 2". c) In the main tank, Fraction 2 is mixed with Fraction 1, under agitation of 300 to 700 rpm and heating between 30-60 °C. Subsequently, petrolatum, anhydrous lanolin, hydrogenated castor oil, and polyol fatty acid esters are added under the same agitation. This mixture is called “Combined 1”. d) Once the fluidity and mixing of all constituents are ensured, a previously reconstituted glycolic / ethanolic solution of Brassica oleracea var. capitata is added to "Combined 1" at a constant flow rate, maintaining agitation between 300 and 700 rpm, until the product is completely homogenized, thus obtaining the "Complete Formulation" (CF). At the end, the CF can be subjected to spontaneous cooling to room temperature and then packaged in an appropriate container.

2. “NANOSTRUCTURED EMULSION BASED ON BRASSICA OLERACEA, POLYACRYLIC ACID GEL, EMOLLIENTS, VASELINE AND LANOLIN, FOR GYNECOLOGICAL APPLICATIONS”, according to claim 1, characterized by the emulsifying fraction containing emulsifying wax based on cetearyl alcohol and polysorbate-60 (from 4 to 15%), isopropyl palmitate (from 3 to 9%), glyceryl stearate (from 0.5 to 5%), glycerin (from 0.5 to 5%), cetearyl alcohol and behentrimonium methosulfate (from 0 to 4%), phenoxyethanol (from 0.1 to 1%), methylisothiazolinone (0.1 to 1.0%), Na2EDTA (from 0.02 to 0.2%) and BHT (from 0.1 to 0.5%).

3. “NANOSTRUCTURED EMULSION BASED ON BRASSICA OLERACEA, POLYACRYLIC ACID GEL, EMOLLIENTS, VASELINE AND LANOLIN, FOR GYNECOLOGICAL APPLICATIONS”, according to claim 1, characterized by the hydrophilic fraction containing demineralized water (from 20% to 40% by weight), Polyacrylic Acid (from 15 to 30%), phenoxyethanol-96.6% (from 0.01 to 0.05%), methylisothiazolinone-3.4% (from 0.01 to 0.05%), 5 M sodium hydroxide solution until pH 5.0-6.0 is reached.

4. "NANOSTRUCTURED EMULSION BASED ON BRASSICA OLERACEA, POLYACRYLIC ACID GEL, EMOLLIENTS, VASELINE AND LANOLIN, FOR GYNECOLOGICAL APPLICATIONS", according to claim 1, characterized by the hydrophobic components containing petrolatum (5% to 10%), anhydrous lanolin (5% to 15%), hydrogenated castor oil (2% to 10%), polyol fatty acid esters (5% to 10%).

5. “NANOSTRUCTURED EMULSION BASED ON BRASSICA OLERACEA, POLYACRYLIC ACID GEL, EMOLLIENTS, VASELINE AND LANOLIN, FOR GYNECOLOGICAL APPLICATIONS”, according to claim 1, characterized by containing a glycolic / ethanolic solution of Brassica oleracea var. capitata previously reconstituted, in a mass proportion of 5-20%.

6. “NANOSTRUCTURED EMULSION BASED ON BRASSICA OLERACEA, POLYACRYLIC ACID GEL, EMOLLIENTS, VASELINE AND LANOLIN, FOR GYNECOLOGICAL APPLICATIONS”, according to claim 1, characterized by containing polyacrylic acid gel corresponding to 15-30% of the total percentage of the formulation.

7. “NANOSTRUCTURED EMULSION BASED ON BRASSICA OLERACEA, POLYACRYLIC ACID GEL, EMOLLIENTS, VASELINE AND LANOLIN, FOR GYNECOLOGICAL APPLICATIONS”, according to claim 1, characterized by containing the emulsifying, hydrophilic fractions, hydrophobic components and Brassica oleracea var. capitata described in claims 2-5.

8. “NANOSTRUCTURED EMULSION BASED ON BRASSICA OLERACEA, POLYACRYLIC ACID GEL, EMOLLIENTS, VASELINE AND LANOLIN, FOR GYNECOLOGICAL APPLICATIONS”, according to claims 1-4, characterized by: a) the FC formulation self-emulsifying in excess water, forming microstructures of 1521 ± 91 nm and a zeta potential of -22.2 ± 1.4 mV;b) the interaction of PAA with the components of the Brassica extract compensates for the hydrophobicity of the extract in the formulation, favoring emulsification, preventing particle growth, reducing the zeta potential of microstructures, coalescence and consequently, favoring interaction with moist surfaces, such as the vaginal epithelium.

9. “NANOSTRUCTURED EMULSION BASED ON BRASSICA OLERACEA, POLYACRYLIC ACID GEL, EMOLLIENTS, VASELINE AND LANOLIN, FOR GYNECOLOGICAL APPLICATIONS”, according to claims 1-5, characterized by: a) exhibiting viscoelastic behavior with a storage modulus (G') at least twice the loss modulus (G”); b) exhibiting a defined linear viscoelasticity region; c) exhibiting a damping factor less than 1 (tan(θ) < 1) up to 100 Pa; d) exhibiting a yield stress of 72 Pa; e) exhibiting pseudoplastic behavior;f) The interaction of PAA with Brassica components cancels out the hydrophobic effect of the extract on the mechanical response of the formulation; g) The interaction of PAA with Brassica and other components reduces the risk of formulation breakdown, increasing its shelf life; h) The interaction of PAA with Brassica and other components increases the rheological sensitivity of the formulation during shear, favoring its spreadability; i) The interaction of PAA with Brassica components and other components of the formula confers greater rigidity to the formulation up to around 30 °C.

10. “USE OF NANOSTRUCTURED EMULSION BASED ON BRASSICA OLERACEA, POLYACRYLIC ACID GEL, EMOLLIENTS, VASELINE AND LANOLIN, FOR GYNECOLOGICAL APPLICATIONS”, according to claims 1-8, characterized by being for gynecological use.

11. “USE OF NANOSTRUCTURED EMULSION BASED ON BRASSICA OLERACEA, POLYACRYLIC ACID GEL, EMOLLIENTS, VASELINE AND LANOLIN, FOR GYNECOLOGICAL APPLICATIONS”, according to claims 1-8, characterized by being applicable to the treatment of Genitourinary Syndrome.

12. “USE OF A NANOSTRUCTURED EMULSION BASED ON BRASSICA OLERACEA, POLYACRYLIC ACID GEL, EMOLLIENTS, VASELINE AND LANOLIN, FOR GYNECOLOGICAL APPLICATIONS”, according to claims 1-9, characterized by improving the vaginal health index (VHI), with emphasis on the parameter “Vaginal discharge”.

13. “USE OF NANOSTRUCTURED EMULSION BASED ON BRASSICA OLERACEA, POLYACRYLIC ACID GEL, EMOLLIENTS, VASELINE AND LANOLIN, FOR GYNECOLOGICAL APPLICATIONS”, according to claims 1-9, characterized by reducing the parameters of the Vaginal Atrophy Symptoms Scale (VAS), especially itching, burning, dryness and pain.

14. “USE OF NANOSTRUCTURED EMULSION BASED ON BRASSICA OLERACEA, POLYACRYLIC ACID GEL, EMOLLIENTS, VASELINE AND LANOLIN, FOR GYNECOLOGICAL APPLICATIONS”, according to claims 1-8, characterized by reducing pain symptoms and promoting healing by mucosal reptelization during treatment.

15. “USE OF NANOSTRUCTURED EMULSION BASED ON BRASSICA OLERACEA, POLYACRYLIC ACID GEL, EMOLLIENTS, VASELINE AND LANOLIN, FOR GYNECOLOGICAL APPLICATIONS”, according to claims 1-8, characterized by not interfering with the quality of life of patients during treatment.

16. “USE OF NANOSTRUCTURED EMULSION BASED ON BRASSICA OLERACEA, POLYACRYLIC ACID GEL, EMOLLIENTS, VASELINE AND LANOLIN, FOR GYNECOLOGICAL APPLICATIONS”, according to claims 1-8, characterized by promoting improvements in sexual relations and reducing pain during sexual intercourse in menopausal patients during treatment.

17. “USE OF NANOSTRUCTURED EMULSION BASED ON BRASSICA OLERACEA, POLYACRYLIC ACID GEL, EMOLLIENTS, VASELINE AND LANOLIN, FOR GYNECOLOGICAL APPLICATIONS”, according to claims 1-8, characterized by not affecting the hepatic or renal functions of patients undergoing treatment.

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