Nanostructured lipid carrier formulated from tucumã butter, pracaxi oil, and seriguela bark extract and its uses.

Description

/ 18 Nanostructured lipid carrier formulated from tucumã butter, pracaxi oil, and seriguela bark extract and its uses. FIELD OF THE INVENTION

[001] The present invention is situated in the field of nanobiotechnology and consists of a composition containing a nanostructured lipid carrier formulated with agro-industrial co-products: tucumã butter, pracaxi oil and seriguela peel extract, as well as its production process and its use in pharmacological or cosmetic preparations in various forms. STATE OF THE ART

[002] Nanostructured lipid carriers (NLCs) are lipid-based nanoparticles containing a core formed by combining a liquid lipid (oil) and a solid lipid (butter) (Beloqui, A. et al. Nanomedicine: Nanotechnology, Biology and Medicine, 12(1): 143-161, 2016; Luchini, A.; Vitiello, G. Front. Chem, v.7: 343, 16p., 2019). This combination offers several advantages to the industry, as it results in a less structured matrix allowing for better drug accommodation, protecting against degradation, and enabling controlled release. CLNs have high encapsulation efficiency, low toxicity, and stability after storage (Naseri, N. et al. Advanced pharmaceutical bulletin, 5, 3: 305-13, 2015; Yingchoncharoen, P.; Kalinowski, DS; Richardson, DR Pharmacol Rev, 68: 701-87, 2016; SOUTO, E. et al. Expert Opinion on Drug Delivery, v.17, p,357-377, 2020; Dhiman, N. et al. Frontiers in chemistry, v. 9 580118, 2021; LUZ, G.Postgraduate Program in Pharmaceutical Sciences Cipharma - School of Pharmacy - UFOP [Dissertation] 78p., 2022). Petition 870250085364, dated 09 / 22 / 2025, page 7 / 25 / 18

[003] Other advantages obtained through the structural characteristics are the reduction of the melting point of the solid lipid, the nanocarrier becomes stable in aqueous dispersions with the use of surfactants. With the use of oil, there is no recrystallization of the solid lipid. In this way, the system remains thermodynamically more stable, consequently improving the release of particles (MULLER, R., SHEGOKAR, R., KECK, C. Curr Drug Discov Technol, v.8, n.3, p.207-227, 2011; SOUTO, E. et al. Expert Opinion on Drug Delivery, v.17, p, 357-377, 2020).

[004] CLNs are considered versatile drug delivery systems because they can be used for different administrations: topical, oral, inhalation, ocular, and parenteral. The various formulation techniques also add to the attractive characteristics of CLNs. Furthermore, CLNs are biocompatible, biodegradable, non-irritating, and non-sensitizing. These carriers can be designed according to the physicochemical properties of the active pharmaceutical ingredients, as well as the route of administration and targeting sites (Iqbal, MA, et al. Journal of Drug Targeting, 20(10): 813-830, 2012).

[005] Lipid carriers and other nanostructures, in addition to being studied for a wide range of applications, can also help the industry achieve the United Nations Sustainable Development Goals (SDGs), established in 2017 as a global appeal aimed at changing consumption patterns, and the conscious production and use of natural resources (UNITED NATIONS. Sustainable Development Goals in Brazil. Agenda 2030. Available at: https: / / brasil.un.org / pt-br / sdgs. Accessed in September 2024; SANTANA; DA SILVA. Journal of Law, Innovation, Intellectual Property and Competition, [S. l.], v. 10, n. 1, 2024). Petition 870250085364, dated 09 / 22 / 2025, page 8 / 25 / 18

[006] As an example, the use of agro-industrial co-products, which would be discarded in food production, for the production of lipid carriers emerges as a more sustainable alternative for the industry. New inventions that reinforce the use of agro-industrial co-products in Brazil are essential, as their inadequate disposal aggravates environmental pollution and can increase processing costs. Reuse goes beyond its use as animal feed or organic fertilizer. Its use in new products helps strengthen traditional communities and environmental preservation, strengthening sustainability and the bioeconomy (Nascimento Filho; Franco. Revista Virtual de Química, v.7, n.6, 2015; Aschemann-Witzel; Stangherlin. Technological Forecasting and Social Change, v.168: 120749, 2021; Chiaraluce; Bentivoglio; Finco. Sustainability, 3(16), 9294 2021).These co-products, composed of husks, seeds, and pits, represent an opportunity for the development of new materials with higher added value and sustainability (Nascimento Filho; Franco. Revista Virtual de Química, v.7, n.6, 2015). The cosmetics industry can also benefit from this market (BARBOSA, NP; CONCEIÇÃO, EC DA. Revista Processos Químicos, v. 10, n. 20, p. 127-131, 2016).

[007] In this context, Brazilian industry, being a country rich in different biomes with natural resources, has a great opportunity in the sustainable use of its resources. Among the different resources with significant potential for scientific research and sustainable technological development are the extract of seriguela bark (Spondias purpurea L.), tucumã butter (Astrocaryum vulgare) and pracaxi oil (Pentaclethra macroloba), as they have nutritional, agricultural, cosmetic and pharmaceutical applications and represent an opportunity for the valorization of the country's natural resources. Petition 870250085364, dated 09 / 22 / 2025, page 9 / 25 / 18

[008] Tucumã (Astrocaryum vulgare) is widely distributed throughout the Brazilian Amazon, originating from the tucumã palm, a palm tree of the Arecaceae family (SILVEIRA, LS et al. Disciplinarum Scientia. Série: Naturais e Tecnológicas, v.21, n.3, p.157-174, 2020). Tucumã fruits are sold fresh and consumed in various ways (CASAS, LL et al. Brazilian Journal of Development, [sl], v. 8, n. 2, p. 13667-13687, 2022; SOUSA, MLR et al. Revista, Valore, [sl], v. 8, n. e-8065, 2023). These fruits are valued for their nutritional properties, which include fatty acids such as oleic and linoleic acids, carotenoids, phenolic compounds, and phytosterols (PARDAUIL, JJ et al. Journal of Thermal Analysis and Calorimetry, [sl], v. 127, n. 2, p. 1221-1229, 2017; CASAS, LL et al. Brazilian Journal of Development, [sl], v. 8, n. 2, p. 13667-13687, 2022). They have a high content of lipids, carotene, fiber, and vitamin E, in addition to their high antioxidant capacity.Biological activities have already been reported in the literature, such as: anti-inflammatory, antimicrobial and antifungal action (SILVEIRA, LS et al. Disciplinarum Scientia. Series: Natural and Technological, v.21, n.3, p.157-174, 2020).

[009] Tucumã butter is already used in cosmetic formulations because it has emollient and moisturizing properties. The abundant presence of lauric fatty acid not only gives the butter ideal properties for saponification but is also qualified as an excellent vehicle for active ingredients, increasing skin permeability (SOUSA, MLR et al. Valore Magazine, [sl], v. 8, n. e-8065, 2023).

[0010] Tucumã has already been used in inventions and patents for cosmetic compositions, such as patent application BR102019011217 - Encapsulated Natural Actives for Cosmetic Applications, which describes the encapsulation of natural actives using oils (copaiba, cumaru and andiroba) and butters. Petition 870250085364, dated 09 / 22 / 2025, page 10 / 25 / 18 (cupuaçu and tucumã). This is a different invention from the one proposed here, as the only common component is tucumã butter.

[0011] Patent application EP3878428, published in Brazil under number BR102018072738 - Cosmetic composition, method for producing oil and / or butter from Atrocaryum vulgare, use of the cosmetic composition and method for producing and / or protecting against degradation of hyaluronic acid in the skin, presents a cosmetic composition and method for producing tucumã butter and / or oil. Unlike that proposed in this invention, nanoparticles are not used for the production of the described cosmetic, the only common component being tucumã.

[0012] Regarding the production of scientific articles and papers, Nascimento (2019) developed tucumã oil nanocapsules for the treatment of breast cancer; 213 nm nanocapsules were developed with promising results (NASCIMENTO, K. Postgraduate Program in Pharmaceutical Sciences, Federal University of Santa Maria [Doctoral Thesis], RS, 113p., 2019). This thesis differs from the present invention because it does not contain pracaxi oil and seriguela bark extract. Nascimento and colleagues also developed two articles on the subject, entitled: Phytochemical analysis and evaluation of the antioxidant and antiproliferative effects of Tucumã oil nanocapsules in breast adenocarcinoma cells (MCF-7) (NASCIMENTO, K. et al. Natural Product Research, 35(12), 2060-2065, 2019) and Evaluation of the in vivo safety of tucumã oil nanocapsules in an experimental model of silver catfish Rhamdia quelen (NASCIMENTO, K. et al.Natural Product Research, 36(2), 649-653, 2020), neither report the use of pracaxi oil and seriguela bark extract, as proposed here.

[0013] Cordenonsi et al. (2019) synthesized fucoxanthin loaded with lipid nanoparticles for topical administration. Petition 870250085364, dated 09 / 22 / 2025, p. 11 / 25 / 18 containing a combination of bacuri butter and tucumã oil (CORDENOSI, LM et al. AAPS PharmSciTech v.21,n.1, 10p., 2019). The present invention relates to a CLN containing, in addition to tucumã butter, pracaxi oil and seriguela peel extract; thus, different proposals are made.

[0014] Rossato and research group published three articles on nanostructured lipid carriers containing tucumã. According to the following titles: Safety profile, antimicrobial and antibiofilm activities of a nanostructured lipid carrier containing oil and butter from Astrocaryum vulgare: in vitro studies (ROSSATO, A. et al. International Journal for Innovation Education and Research, 9(5), 478-497, 2021), Evaluation of anti-inflammatory and healing activity of a nano-structured lipid carrier containing tucuman butter oil and butter (ROSSATO, et al. Disciplinarum Scientia | Naturais E Tecnológicas, 21(3), 99-108, 2021) and Pharmacological safety profile and hemocompatibility of lipid nanocarriers based on tucuman butter (SILVEIRA, LS et al. Disciplinarum Scientia | Naturais e Tecnológicas, 21, 3, 157-174, 2021). However, none of these studies include seriguela bark extract or pracaxi oil.

[0015] Furthermore, patent application (discontinued application) number US7045154 entitled: “Use Of Fats Derived From Palm Trees To Increase Dermal Hydration” describes the use of lipids extracted from the tucumã fruit to increase dermal and capillary hydration. It also describes the use of lipids in hygiene products, cosmetics and pharmaceutical products. Compared to the present invention, the other components present herein were not mentioned and there is no use of nanostructures.

[0016] Patent application US20140179581, published in Brazil under number BRPI1101136 (both discontinued), entitled Petition 870250085364, dated 09 / 22 / 2025, p. 12 / 25 / 18, describes a cosmetic composition for skin cleansing containing vegetable oils, a manufacturing process for said composition, and the use of said composition. Unlike what is proposed in this invention, the cited patent applications may contain tucumã oil, but do not contain the other components present in this invention (pracaxi oil and seriguela bark extract).

[0017] Similarly, patent application WO2023137532 Nanostructured Lipid Carrier, Use Of The Nanostructured Lipid Carrier, Photoprotective Composition And Method For Skin Photoprotection, differs from the technology described herein, as the cited invention may contain tucumã oil, but does not contain the other components present in this invention (pracaxi oil and seriguela bark extract).

[0018] Pracaxi (Pentaclethra macroloba Kuntze) is native to the Amazon. It has an oil with high concentrations of oleic, linoleic, and behenic fatty acids. The oil has reported therapeutic activities for wound and cut healing, skin hydration and cell renewal, anti-inflammatory, antimicrobial, and cicatrizing properties, among others (dos Santos Costa, MNF et al. J Therm Anal Calorim, 115: 2269-2275, 2014; BEZERRA, CV et al. Food Chemistry, v. 221: 1466-147, 2017; AFONSO, MS et al. Journal of Oleo Science, 73 (1): 11-23, 2024).

[0019] Pracaxi oil has been reported to have cytotoxic activity in tumor cells (PIRES, CL et al. Toxicology in Vitro, v. 83:105392, 2022), and is useful in the treatment of diabetic ulcers (SIMMONS, CV; BANOV, F.; BANOV, D. SAGE Open Medical Case Reports, v. 3, 2015). It can also be used for biodiesel production (LIMA, RP et al. Industrial Crops and Products, v. 97: 536-544, 2017).

[0020] Regarding patent applications for pracaxi, the following patent applications: BR1020120262630, Petition 870250085364, dated 09 / 22 / 2025, page 13 / 25 / 18 Patents BR1020120262819, BR1020120223813, BR1020120195836, BR1020150056230, BR1120130201673; and patent BR1020150316046, refer to the use of pracaxi oil in cosmetic compositions. However, they are not nanostructured and do not contain the other components present in this technology: tucumã butter and seriguela bark extract.

[0021] Patent number US11839687 entitled “Solid composition” discloses a solid composition containing a mixture of liquid oils and solid lipids. This invention describes microparticles that may contain pracaxi and tucumã oil. However, it does not contain seriguela bark extract and is not a nanostructured lipid carrier as provided herein.

[0022] Another noteworthy patent is number US8906397 Permeation enhancers for topical formulations. This patent presents a cosmetic that has 10-50% pracaxi oil in its composition and mentions tucumã in the descriptive report. However, it does not include tucumã butter in the claims. It also does not contain seriguela bark extract and does not present a nanostructured technology.

[0023] Patent application BR102019013856, titled Solid lipid composition for the production of nanostructured lipid carrier, presents the process for preparing the solid lipid composition and its use as a former of nanostructured lipid carrier. Although the inventors mention tucumã butter and pracaxi oil in the report, they do not cite the components in the claims, nor is there any mention of seriguela bark extract.

[0024] Furthermore, patent application BR102017004724 - Process for obtaining and functionalizing a nanostructured lipid carrier based on vegetable lipids, nanostructured lipid carrier and uses, refers to a process for obtaining Petition 870250085364, dated 09 / 22 / 2025, page 14 / 25 / 18 nanostructured lipid carriers, composed of a mixture of two solid vegetable lipids. This document indicates that tucumã or pracaxi oil can be used as one of the carrier lipids, but buriti oil is preferable. Therefore, the invention proposed here cannot be formed, as there is no mention of seriguela bark extract.

[0025] Another patent application, number KR102003186 and named Cosmetic composition containing Andiroba oil and pracaxi oil and method for producing the same, also needs to be cited. This application presents a cosmetic composition containing, among other constituents, pracaxi oil. The cited invention contains pracaxi oil, but does not contain the other components present in this invention (tucumã butter and seriguela bark extract).

[0026] Several academic reports are found in articles, theses, dissertations and other research on pracaxi oil. Mattiazzi and colleagues (2014) developed the work entitled: Validation of a RP-HPLC-UV Method for the Assay of Ubiquinone in Pracaxi Oil-core Nanocapsules, on nanocapsules containing pracaxi oil (MATTIAZZI, J.; PEGORARO, NS; SCHAFFAZICK, SR; CRUZ, L. Lat. Am. J. Pharm. 33 (2): 347-51, 2014). In this nanostructure, the only thing in common is pracaxi oil; the nanocapsule does not contain tucumã butter or seriguela peel extract as proposed here.

[0027] Duarte Junior, in his doctoral thesis entitled: Preparation of nanostructured lipid carriers from carnauba wax and pracaxi oil containing dexamethasone for topical treatment of skin inflammations, developed CLN containing, among other components, pracaxi oil (Duarte Junior, AP Postgraduate Program in Pharmaceutical Nanotechnology Federal University of Pernambuco [THESIS - Doctorate], PE, 191p., 2016). This technology differs from the present invention by Petition 870250085364, dated 09 / 22 / 2025, page 15 / 25 / 18 containing carnauba wax and due to the absence of tucumã butter and seriguela bark extract.

[0028] The seriguela (Spondias purpurea L.) belongs to the Anacardiaceae family. It originates from Central America and is mainly consumed as food, although it has potential for other uses due to its oil. Among the properties that can be highlighted, it has good levels of phenolic compounds, consequently possessing related antioxidant activity (RAMOS, RS et al. 71st Annual Meeting of the SBPC - July 21-27, 2019 - UFMS - Campo Grande / MS. Available at: http: / / reunioessbpc.org.br / campogrande / inscritos / resumos / 3091_1a12f86d8f324720641dbfaf4d24f03cd.pdf accessed in September 2024; BEZERRA DA SILVA, AP; AGRA, MDDiversitas Journal, [S. l.], v. 7, n. 4, 2022).

[0029] Extracts from the bark of the seriguela tree contain flavonoids, cinnamic derivatives, terpenes and steroids, relevant antioxidant activity in vitro, low toxicity and have shown gastroprotective activity (ALMEIDA, CLF Thesis (Doctorate) - Federal University of Pernambuco, CCS. Postgraduate Program in Pharmaceutical Sciences, 138p., 2018).

[0030] Microencapsulation of the seriguela fruit was proposed in Final Course Project by Quintão (2016) entitled Microencapsulation of Bioactive Compounds from Seriguela Peels Cultivated in the Cerrado (QUINTÃO, TSC Monograph, Graduation in Pharmacy, University of Brasília, 50p., 2016). This work presents a microencapsulation and not nanoencapsulation, which is different from the invention proposed here.

[0031] Another research on the microencapsulation of seriguela was proposed by ALMEIDA (2019) in a master's dissertation entitled: Microencapsulation by atomization of the extract of seriguela residue and its characterization (ALMEIDA, HRM Postgraduate Program Petition 870250085364, dated 09 / 22 / 2025, page 16 / 25 / 18 Graduation in Food Science and Technology - Federal Rural University of Pernambuco [MASTER'S DISSERTATION], PE, 84p., 2019). What differentiates this research from the present invention is that it is not a nanostructured product. Furthermore, it does not contain tucumã butter and pracaxi oil.

[0032] Another report on the microencapsulation of seriguela was written by Silva Junior (2023), in an article entitled: Microencapsulation by spray-drying and freeze-drying of extract of phenolic compounds obtained from ciriguela peel (SILVA JUNIOR, ME et al. Scientific Reports, 13:15222, 16p., 2023). The main differences from the present invention are that a microcapsule, not a nanostructure, was proposed, and the only common component is seriguela (without pracaxi oil or tucumã butter).

[0033] Preparations of nanostructures with seriguela were also found in the literature. Arshadi and team (2015), in an article entitled: Preparation of iron nanoparticles-loaded Spondias purpurea seed waste as an excellent adsorbent for removal of phosphate from synthetic and natural waters, produced iron nanoparticles containing seriguela (Spondias purpurea) (Arshadi, M.; Foroughifard, S.; Etemad Gholtash, J.; Abbaspourrad, A. Journal of Colloid and Interface Science, 452, 69-77, 2015). The only thing in common between the article and the present invention is the seriguela fruit; however, in this case, the seed was used and not the bark extract. The nanostructure does not contain tucumã and pracaxi as proposed here.

[0034] Regarding patents on seriguela, the granted patent number BR102018004126 - Cosmetic preparations with moisturizing, antioxidant and photoprotective action containing extracts of the species Spondias purpurea L., carried or not in lipid and polymeric nanoparticles. It describes the process of obtaining the Petition 870250085364, dated 09 / 22 / 2025, page 17 / 25 / 18 plant extracts and use in cosmetic preparations. Although the patent described above also contains extracts of Spondias purpurea in its composition, it does not contain other components described here: tucumã butter and pracaxi oil.

[0035] It is noteworthy that several studies indicate that, among new trends, the search for cosmetic products based on natural resources, combined with technological principles, such as nanotechnology, brings competitive advantages to companies (ZUCCO, A.; SOUSA, FS de; ROMEIRO, M. do C. Brazilian Journal of Business, [sl], v. 2, n. 3, p. 2.684-2.701, 2020). Therefore, the invention of new lipid carriers based on agro-industrial co-products from Brazilian flora is extremely relevant in the current scenario, representing a market differentiator for Brazilian companies and research groups. In light of the above, the nanostructured lipid carrier proposed here, formulated from tucumã butter, pracaxi oil, and seriguela peel extract, is sustainable and has a diversity of uses to be explored. BRIEF DESCRIPTION OF THE FIGURES

[0036] The invention could be better understood based on Figures 1 to 4, the description of which follows below:

[0037] Figure 1 presents the results of the stability study of inert CLN formulations at room temperature (25°C) and 4°C from 24h to 90 days after preparation. A-1) White nanostructured lipid carriers (without seriguela peel extract): CLNs-WHITE (tucumã butter, pracaxi oil and Brij®O10 surfactant (0.25:0.75:1 w / w), in a lipid mixture (solid and liquid) and surfactant mixture ratio of 1:3:4 w / w) and A-2) Nanostructured lipid carriers with seriguela peel extract: CLNs-BIO (tucumã butter, pracaxi oil, Petition 870250085364, dated 09 / 22 / 2025, p. 18 / 25 / 18 surfactant Brij®O10 and bioactive seriguela bark extract (0.25:0.75:1:4 W / W)).

[0038] Figure 2 shows the stability over time of CLNs under various storage conditions. In a) Hydrodynamic diameter; b) Polydispersity index; c) pH.

[0039] Figure 3 illustrates the results of the transmission electron microscopy (TEM) analysis.

[0040] Figure 4 shows the results of antioxidant activity (a) Antioxidant activity of the CLN-BIO, CLN-BRANCO formulations, and the extract of the seriguela peel measured by the DPPH radical method at concentrations of 625 μg / mL, 1,250 μg / mL, and 2,500 μg / mL. The bars represent the mean ± standard error (n=3). ns indicates a non-significant difference; a, b, c indicate statistically significant differences (p < 0.05) between the samples. (b) Representative images of the assay plates showing the coloration after the reaction with the DPPH radical, where a lighter coloration indicates greater antioxidant activity.

[0041] Figure 5 presents an overview of the embryotoxicity test with zebrafish embryos (FET). The concentrations tested were: 0 (negative control, with system water); 2.5; 6.25; 12.5; 25; 50; 100; and 300 μg / mL and the total exposure time was 96h. DETAILED DESCRIPTION OF THE INVENTION

[0042] This invention proposes a new nanostructured lipid carrier formulated with tucumã butter, pracaxi oil and seriguela peel extract.

[0043] It is an invention that uses agro-industrial by-products, promoting the use of components that could otherwise be discarded. Furthermore, it has a natural formulation and... Petition 870250085364, dated 09 / 22 / 2025, page 19 / 25 / 18 low toxicity ideal for industrial use. As previously stated, tucumã butter possesses several qualities already described such as antioxidant capacity, anti-inflammatory, antimicrobial and antifungal action (SILVEIRA, LS et al. Disciplinarum Scientia. Series: Natural and Technological, v.21, n.3, p.157-174, 2020). Pracaxi oil can be used for wound healing, skin hydration, among other things (dos Santos Costa, MNF et al. J Therm Anal Calorim, 115: 2269-2275, 2014; BEZERRA, et al. Food Chemistry, v. 221: 1466-147, 2017; AFONSO, MS et al. Journal of Oleo Science, 73 (1): 11-23, 2024). And the extract of the seriguela bark has antioxidant, anti-inflammatory, photoprotective activity, low toxicity and gastroprotective activity (ALMEIDA, CLF Thesis (Doctorate) -, Federal University of Pernambuco, CCS. Postgraduate Program in Pharmaceutical Sciences, 138f., 2018).However, the combination of these components brings new functionalities to the final nanoformulation, making it unique.

[0044] The CLN has an average size of 32.94 nm, and the nanoformulation is within the desirable range for drug delivery systems and cosmetics. Nanoformulations with sizes below 100 nm are efficient in penetrating biological barriers, such as the skin and cell membrane, facilitating the effective delivery of active ingredients (Ziel^ska, A. et al. Molecules, 25(16), 3731, 2020). Furthermore, the described size is also advantageous for the bioavailability of the active ingredients and allows for uniform distribution at the application site (Huang, X., Brazel, CS Journal of Controlled Release, 73(2-3): 121-136, 2010).

[0045] CLN has a PDI of 0.14, exhibiting a homogeneous particle size distribution, which demonstrates the stability of the nanoformulation. According to literature data, PDI values ​​below 0.2 are considered indicators of a monodisperse distribution, a characteristic that ensures the consistency of the Petition 870250085364, dated 09 / 22 / 2025, page 20 / 25 / 18 physical properties and the stability of the formulation over time (DANAEI, M. et al. Pharmaceuticals, 11(2), 29, 2018). It is highlighted that a homogeneous distribution is crucial to avoid particle aggregation, which can compromise the efficacy and stability of the formulation.

[0046] Another feature of the invention is its zeta potential (ζ) of -14.27 mV, indicating that the nanoformulation has moderate physical stability. BEST EXECUTION OF THE INVENTION

[0047] The present invention relates to a method for producing lipid carrier nanoparticles using the phase inversion method adapted from GORDILLO-GALEANO, A. & MORA-HUERTAS, C. (European Journal of Pharmaceutics and Biopharmaceutics, v.133, p.285-308, 2018) and SILVA, VCM (Postgraduate Program in Nanoscience and Nanobiotechnology of the Institute of Biological Sciences of the University of Brasília [TESE], 120p., 2022), using three main steps: (i) heating, (ii) cooling and (iii) lipid precipitation as described in the following protocol: a. Weigh the tucumã butter, pracaxi oil, and seriguela bark extract and Brij®O10 in the same beaker in the proportions 0.25:0.75:1:4 w / w, respectively. b. The beaker containing the lipids and Brij O10 is heated until the components melt at a temperature of 65 °C; c. 40 mL of water preheated to 70 °C is then added to the beaker containing the lipids (tucumã butter and pracaxi oil); d. The beaker containing the previously mixed components is kept under agitation at 350 rpm and a temperature of 80 °C in the heating equipment; Petition 870250085364, dated 09 / 22 / 2025, page 21 / 25 / 18 e. The temperature of the mixture must be controlled with a thermometer; f. After low-energy agitation, the formulation was transferred to an Erlenmeyer flask and cooled under running water for approximately 1 minute, until reaching a temperature range of 25 to 30°C, leading to the formation of a nanostructured lipid carrier (NLC). g. The next step is to observe the Tyndall effect to verify the formation of the nanoformulation and check it using the ZetaSizer equipment. EXAMPLES OF CONCRETIZATIONS OF THE INVENTION

[0048] The following examples are presented to illustrate the best implementation of the invention. It should be noted that the present invention is not limited to the examples cited and can be used in all the applications described or in any other equivalent variations. Example 1: Nanoparticle parameters

[0049] As described above, several parameters were evaluated which allow us to affirm that the invention has a sound character and different drugs can be added without changes in stability, allowing a range of industrial applications.

[0050] Figure 1 presents the evaluation of the colloidal stability of the CLNs. This parameter is essential to confirm that the structural properties were preserved during storage without affecting the pharmacological action. In Figure 1, the stability study of the formulations was carried out at room temperature (25°C) and 4°C from 24h to 90 days after preparation. Under all conditions studied, the average particle diameters remained almost constant for 60 days. The PDI also remained constant; the CLNs under the tested conditions maintained a varying zeta potential. Petition 870250085364, dated 09 / 22 / 2025, page 22 / 25 / 18 within the same range, indicating that these particles remained stable during storage without aggregation of CLNs.

[0051] Figure 2 shows the stability of CLN-BIO over time under different storage conditions. It is possible to see that the nanostructure remained stable. This result indicates that its use as a medicine or drug is favorable, as CLN will remain viable for longer, providing a good shelf life for its commercialization.

[0052] Figure 3 shows the electron microscopy analysis images. The CLNs presented spherical morphology with a monodisperse size distribution among the samples evaluated, demonstrating the reproducibility and consistency of the manufacturing process, which is an important aspect evaluated for industrial-scale production.

[0053] Spherical nanoparticles have proven to be more effective in drug delivery, as they are absorbed more easily and quickly by cells compared to nanoparticles of other shapes (Danhier, F. et al. Journal of controlled release: official journal of the Controlled Release Society. 161, 2, 505-22, 2012). In addition, the CLNs obtained were small, below 50 nm, and could cross biological barriers.

[0054] Another interesting parameter supporting future industrial applications of the technology was the pH: an average of 4.60 – which is suitable for dermal applications, as it aligns with the natural pH of human skin, which ranges between 4 and 6. Maintaining the formulation's pH within this range is essential to preserve the integrity of the skin barrier, promote hydration, and prevent disorders such as dry skin (LAMBERS, H. et al. International Journal of Cosmetic Science, 28(5): 359-370, 2006; Petition 870250085364, dated 09 / 22 / 2025, page 23 / 25 / 18 Schmid-Wendtner, MH, & Korting, HC Skin Pharmacology and Physiology, 19(6): 296-302, 2006).

[0055] The centrifugation test, performed three days after obtaining the nanostructured lipid carriers (NLCs), subjected the samples to a centrifugal force of 14,000 rpm for 1 hour at room temperature. The results indicated that the formulations showed good physical stability, with no phase separation or visible precipitation in the samples after centrifugation. This is an ideal result for the application of the nanostructure in formulations. The absence of phase separation after this test suggests that the NLCs should remain stable during storage (SCHMIDTS, T. et al. Journal of Colloid and Interface Science, 338(1), 184-192, 2010; BHATTACHARJEE, S. Journal of Controlled Release, 235, 337-351, 2016). Example 2: Antioxidant activity of CLN

[0056] Another parameter analyzed was the free radical scavenging capacity of the CLN-BIO, CLN-BRANCO formulations and the seriguela peel extract, using the DPPH radical scavenging method, the result of which is shown in Figure 4. The results showed that CLN-BIO presented a good antioxidant capacity. This is an important result of the pharmacological action of the nanocarrier. Example 3: CLN embryototoxicity

[0057] As observed in Figure 5, the only CLN concentration that demonstrated 100% lethality was 300 μg / mL, which killed all individuals within the first 24 hours post-fertilization. Throughout the test, a correlation was observed between mortality and increasing concentration over time. This result indicates that the carrier can be used in small doses in pharmaceutical compositions without exhibiting toxicity. Petition 870250085364, dated 09 / 22 / 2025, page 24 / 25

Claims

CLAIMS 1. PROCESS FOR FORMULATING A NANOSTRUCTURED LIPID CARRIER characterized by being formulated with tucumã butter, pracaxi oil and seriguela peel extract.

2. PROCESS FOR FORMULATING A NANOSTRUCTURED LIPID CARRIER, according to claim 1, characterized by following the following production steps: a) Weigh tucumã butter, pracaxi oil, and Brij®O10 seriguela peel extract in the proportions 0.25:0.75:1:4 w / w, respectively, maintaining a temperature of 65 °C until all components are melted; b) Heat 40 mL of distilled water to a temperature of 70 °C in another container; c) Add the contents of container (a) to container (b) containing the lipids (tucumã butter and pracaxi oil) and maintain under agitation at 350 rpm and a temperature of 80 °C; d) The temperature of the mixture must be controlled with a thermometer; e) After low-energy stirring, the formulation was transferred to a container and cooled under running water (25 °C) for 1 minute, until reaching a temperature range of 25 to 30 °C, leading to the formation of nanostructured lipid carrier (NLC).

3. USE of nanostructured lipid carriers, according to claims 1 and 2, characterized by being used in the preparation of a cosmetic and pharmaceutical composition with antioxidant, photoprotective, anti-inflammatory, antimicrobial, antifungal properties and for cancer treatment. Petition 870250014341, dated 21 / 02 / 2025, p. 29 / 97

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