BR102020016142A2 - Antiseptic and moisturizing lotion for hands and face - Google Patents

Abstract

The present invention proposes an antiseptic and moisturizing lotion for hands and face that includes: water - 90% (vehicle); Stearic acid -2.0% (emulsifier); Ceteareth-20 - 2.0% (emulsifier); Glyceryl Stearate - 3.0% (emulsifier); Methylisothiazolinone - 0.01% (preservative); Phenoxyethanol -0.34% (preservative); Aminomethyl propanol - 0.10% (neutralizing); Triclosan -0.3% (antiseptic); BHT - 0.05% (antioxidant); Disodium EDTA - 0.1% (sequestrant/chelator); Glycerin - 0.5% (humectant); Tea tree oil alternifolia - 0.3% (antimicrobial); Cetrimonium chloride - 0.2% (antiseptic); Cyclopentasiloxane - 1.0% (emollient); and Carica papaya extract - 0.1% (moisturizing). The lotion treated here is intended to be used as an alternative to the use of gel alcohol in the prevention and fight against coronavirus and is therefore useful today in the face of the scourge that the COVID-19 pandemic is imposing on the world. The Lotion treated here can also have a formula that includes: water - 89.9% (vehicle); Stearic acid - 2.0% (emulsifier); Ceteareth-20 - 2.0% (emulsifier); Glyceryl Stearate - 3.0% (emulsifier); Methylisothiazolinone - 0.01% (preservative); Phenoxyethanol - 0.34% (preservative); Aminomethyl propanol - 0.10% (neutralizing); Copaifera officinalis resin - 0.4% (film former); BHT - 0.05% (antioxidant); Disodium EDTA - 0.1% (sequestrant/chelator); Glycerin - 0.5% (humectant); Tea tree oil alternifolia - 0.3% (antimicrobial); Cetrimonium chloride - 0.2% (antiseptic); Cyclopentasiloxane - 1.0% (emollient); and Carica papaya extract - 0.1% (moisturizing).

Description

ANTISEPTIC AND MOISTURIZING LOTION FOR HANDS AND FACE APPLICATION FIELD

[001] This patent application proposes an antiseptic and moisturizing lotion for hands and face, which integrates the field of products intended for personal care.

PREAMBLE

[002] This descriptive report deals with an antiseptic and moisturizing lotion for hands and face, which had its formula specially developed to present effective action in the fight against coronavirus, being therefore useful today in the face of the scourge that the Pandemic of COVID-19 is imposing on the world.

STATUS OF THE TECHNIQUE

[003] According to a fact sheet released by the Ministry of Health, coronaviruses are a large family of viruses common in many different species of animals, including camels, cattle, cats and bats. Rarely, coronaviruses that infect animals can infect people, for example MERS-CoV and SARS-CoV.

[004] Recently, in December 2019, there was the transmission of a new coronavirus (SARS-CoV-2), which was identified in Wuhan in China and caused COVID-19, after which this disease was disseminated and transmitted from person to person. for person.

[005] Also according to the Ministry of Health, COVID-19 is a disease caused by the coronavirus, called SARS-CoV-2, which has a clinical spectrum ranging from asymptomatic to severe infections.

[006] According to the World Health Organization, the majority (about 80%) of patients with COVID-19 may be asymptomatic or oligosymptomatic (few symptoms), and approximately 20% of detected cases require hospital care due to respiratory distress. , of which approximately 5% may require ventilatory support.

[007] The Ministry of Health also informs that the symptoms of COVID-19 can range from a cold, to an Influenza-SG Syndrome (presence of an acute respiratory condition, characterized by at least two of the following symptoms: feverish sensation or fever associated with sore throat, headache, cough, runny nose) to severe pneumonia. The most common symptoms are: a) cough, b) fever; c) coryza; d) sore throat; e) difficulty breathing; f) loss of smell (anosmia); g) taste alteration (ageusia); h) gastrointestinal disorders (nausea/vomiting/diarrhoea); i) tiredness (asthenia); j) decreased appetite (hyporexia); and k) dyspnea (shortness of breath).

[008] The transmission of COVID-19 happens from one sick person to another or by close contact through: a) touching contaminated hands; b) saliva droplets; c) sneeze; d) cough; e) catarrh; f) contaminated objects or surfaces, such as cell phones, tables, cutlery, doorknobs, toys, computer keyboards, etc.

[009] After the emergence and spread of the disease around the world, the various governments began to adopt, as a measure to combat or at least mitigate the spread, the "lockdown" that can be translated directly into the vernacular as "confrnamento" , a measure whose main focus is to reduce the movement of people in order to reduce the possibility of contagion, a procedure adopted by more than eighty percent of the countries facing the current pandemic caused by COVID-19.

[010] At the same time, governments sought to expand the supply of hospital beds, even resorting to the implementation of "campaign hospitals", which are temporary facilities where patients who were unable to receive care in regular, public or private hospital networks , are targeted.

[011] COVID-19 imposed and still imposes drastic changes in people's daily lives, since the government measures adopted ended up directly influencing the movement of people, a fact that is having serious implications in various branches of the formal economy. and informal.

[012] At the present time, according to data from the WHO-World Health Organization, the number of cases in the world reaches more than sixteen million four hundred thousand for a number of fatal victims that already exceeds six hundred and fifty thousand.

[013] In its most serious occurrence, patients have serious respiratory complications, among others, which requires that the treatment has to be done concomitantly with the intubation of the patient, thus demanding the use of devices that assist in the respiratory function, popularly called " respirators”.

[014] Within this context, in addition to the measures already taken, there is an intense search, worldwide, for the development of vaccines, new drugs or even for the definition of protocols for the administration of drugs that are already known and that may present some type of more effective action in combating or at least alleviating the symptoms of the disease, with a focus on use, more particularly, in the most serious cases.

[015] Within this context, heated discussions emerged regarding the use of chloroquine or hydroxychloroquine, the latter being already used to combat some types of malaria and rheumatological diseases.

[016] To date, there has been no definition of the effectiveness or otherwise of these two drugs in combating the symptoms of COVID-19, with fervent advocates both in the field of those who propose their use, as well as in the field of those who do not agree with such form of use.

[017] On the other hand, Brazil is the country with the greatest biodiversity on the planet which, associated with a rich ethnic and cultural diversity, holds valuable traditional knowledge associated with the use of medicinal plants, having, for this reason, the necessary potential for development. of research with results in appropriate technologies and therapies.

[018] Encouraging the use of herbal products provides improved health care, sustainable use of Brazilian biodiversity and strengthening of family farming, generation of employment and income, industrial and technological development and the prospect of social and regional inclusion, in addition to popular participation and social control over all actions resulting from this initiative. The need to minimize technological dependence and to establish a prominent position for our country in the international scenario should also be highlighted (MS, 2019).

[019] It is defined as herbal medicine, the medicine obtained using exclusively plant active raw materials. It is characterized by knowledge of the effectiveness and risks of its use, as well as by the reproducibility and consistency of its quality. Its efficacy and safety are validated through ethnopharmacological surveys of use, technoscientific documentation in publications or clinical trials. A herbal medicine is not considered to be one that, in its composition, includes isolated active substances of any origin, or their association with plant extracts (RDC No. 48/2004 - ANVISA).

[020] In this context, the potential for the use of medicinal plants is far from being exhausted, a statement endorsed by the new paradigms of social and economic development based on renewable resources. New knowledge and new needs will certainly find solutions in the plant kingdom, through the discovery and development of new molecules with therapeutic activity or applications, both in pharmaceutical technology and in the development of herbal medicines with greater efficiency of action.

[021] Herbal medicines are also effective in viral infections such as those caused by the coronavirus. This virus belongs to a family of viruses that cause respiratory infections. The new agent of the coronavirus was discovered, as already reported, in China at the end of 2019, and the first human coronaviruses were isolated, for the first time, in 1937. However, it was in 1965 that the virus was described as coronavirus, due to the profile on microscopy, resembling a crown (WHO, 2020).

[022] Most people become infected with the common coronaviruses throughout their lives, with young children being more likely to become infected with the more common type of the virus. The most common coronaviruses that infect humans are alpha coronavirus 229E and NL63 and beta coronavirus OC43, HKU1.

[023] ANVISA - National Health Surveillance Agency, in March 2020, published the Collegiate Board Resolution (RDC) 350/2020 which defined criteria and procedures for the manufacture and sale of hygiene products without prior authorization from the body. The rules apply to antiseptic preparations and workshop sanitizers (obtained through manipulation). Some examples of these products are alcohol gel, which is used to sanitize hands and objects, and disinfectants for cleaning surfaces and environments.

[024] As a solvent, alcohol has the ability to dissolve fats (lipids) present in the skin. By performing hand disinfection much more times a day because of the Pandemic, the result is the loss of the protective layer on the skin, leading to skin drying. As a result, it becomes rougher and cracks, irritation and dermatitis may occur.

[025] In addition to the adverse reactions evidenced by the increased use of alcohol gel, the arrival of the Pandemic has put pressure on the price of the product, making its use by a large part of the Brazilian population unfeasible. In addition, one of the fundamental chemical constituents for the production of alcohol gel, Carbopol, is lacking in the market, increasing the final price of alcohol gel.

TECHNICAL STATUS PROBLEMS

[026] As seen above, the current state of the art still does not contemplate the existence of vaccines, new medicines or protocols for the use of known drugs that can effectively face the advance of COVID-19, a fact that crystallizes, in a complete way. , all the concern and even the terror that COVID-19 is imposing on the world.

OBJECTIVES OF THE INVENTION

[027] In view of the state of the art narrated above and which is generally known, the Applicant has been researching solutions that aim to raise the level of protection of people in their daily activities, inside and outside the home, considering that until the present moment there are restrictions , albeit moderate, to circulation and agglomeration.

[028] Therefore, one of the objectives of this Patent Application is to propose a new product that can be an alternative to the use of alcohol gel, which is configured in the present ANTISEPTIC AND MOISTURIZING LOTION FOR HANDS AND FACE, which can be used for protection against coronavirus.

[029] It is also one of the objectives of this Invention Patent application to propose an ANTISEPTIC AND MOISTURIZING LOTION FOR HANDS AND FACE that can be produced on a large scale, through processes and equipment dominated by the cosmetic/pharmaceutical industry.

BRIEF DESCRIPTION OF THE INVENTION

[030] The ANTISEPTIC AND MOISTURIZING LOTION FOR HANDS AND FACE, object of this patent application, is a herbal product based on Cyclopentasiloxane (silicone), Triclosan, Malaleuca alternifolia oil, Carica papaya extract, water, glycerin, Aminomethyl Propanol, BHT, EDTA and Cetrimonium chloride. The product is an alternative to gel alcohol and offers antiseptic protection against germs and bacteria, for hand antisepsis, with antiseptic, bacteriostatic and bactericidal action, making a protective glove for the skin.

[031] Melaleuca alternifolia belongs to species of the Myrtaceae family. They are distributed in tropical and subtropical regions, being divided into two subfamilies: Myrtoidea, which occurs widely in tropical America and Leptospermoideae, which occurs mainly in Australia, Malaysia and Polynesia. The genus Melaleuca, belonging to the subfamily Leptospermoideae, includes approximately 100 species native to Australia and the Indian Ocean Islands. Melaleuca alternifolia Cheel is commonly known in Australia as the "tea tree", flowering mainly in swamp areas near rivers. The chemical constitution of the essential oil from the leaves of M. alternifolia is well known, which is rich in terpinen-4-ol, which is primarily responsible for its medicinal properties, mainly antimicrobial (RUSSEL, 2002).

[032] The papaya plant (Carica papaya) is used widely in food and in ingredients in jellies, preserves or stews in various ways. Papain, the proteolytic enzyme, is widely used for a variety of purposes. It is used for meat tenderizers and chewing gum. Cosmetically, it is used in some toothpastes, shampoos, and facelift preparations. Fruit and seed extracts have a pronounced antimicrobial effect against Staphylococcus aureus, Bacillus cereus, Esherischia coli, Pseudomanas aeruginosa and HPV (Papillomavirus).

[033] The other chemical constituents of the ANTISEPTIC AND MOISTURIZING LOTION FOR HANDS AND FACE proposed here -Cyclopentasiloxane (silicone), Triclosan, water, glycerin, Aminomethyl Propanol, BHT, EDTA and Cetrimonium chloride (cetrimonium chloride) give the product the cosmetic characteristics .

[034] Cyclopentasiloxane (silicone) is a synthetically produced volatile silicone polymer that acts especially as a conditioning agent.

[035] Triclosan is an antibacterial agent and has a preservative effect in cosmetic products, with a slightly aromatic odor, belonging to the group of polychlorinated phenoxyphenols.

[036] Glycerin has emollient, lubricating, humectant, moisturizing and hygroscopic properties that contribute to the absorption of water in the skin, promoting hydration and softness.

[037] Aminomethyl Propanol is a pH adjuster to improve product stability.

[038] BHT (2,6-ditert-butyl-p-creso) acts as a preservative and antioxidant. With a preservative function, it inhibits the growth of microorganisms and as an antioxidant the compounds prevent oxidation and scavenge free radicals.

[039] EDTA (Ethylenediamine tetraacetic acid) or ethylenediamine tetraacetic acid is an organic compound that acts as a chelating agent, forming stable complexes with various metal ions. In cosmetic products, EDTA prevents calcium and magnesium ions from precipitating and interfering with the foaming of the products.

[040] Cetrimonium chloride is a quaternary ammonium polymeric salt with antistatic action, that is, it controls or reduces the static electricity of electrically charged objects or surfaces. The antistatic action of cationic surfactants is responsible for promoting the conditioning effect. In addition to the conditioning effect, cetrimonium chloride, as well as other quaternary ammonium salts, has antimicrobial action.

[041] In view of the various characteristics described, the ANTISEPTIC AND MOISTURIZING LOTION FOR HANDS AND FACE, object of this patent application, is an alternative to the use of ethyl alcohol gel as a degerming antiseptic because of different aspects, namely: a) less irritability of the skin product; b) use of medicinal plants available in Brazil, which also favors the integration and development of local communities such as those living in the Amazon region, contributing to the preservation of the environment; and c) decrease in dependence on reagents produced abroad, mainly the product Carbopol, a base for alcohol gel, a major reason for the excessive increase in the value of the product.

DESCRIPTION OF THE FIGURES

[042] The ANTISEPTIC AND MOISTURIZING LOTION FOR HANDS AND FACE, object of this Invention Patent application will be described in detail with reference to the drawings listed below, in which:
Figure 1 depicts a view of a representation, for illustrative purposes only, of an Alphacoronavirus viral particle and its structures, where the arrows “A”, “B”, “C” and “D” correspond, respectively, to “Glycoprotein Spike (S)”, “Nucleoprotein (N) and RNA genome”; “Membrane Protein (M)” and “Membrane Protein Envelope (E)”,
Figure 2 illustrates a sequence of photographs that are representative images of cell cultures, where the groups are portrayed: “Control group”, “Virus exposure group” and “Group NV.55.02”; and
Figure 3 illustrates a sequence of photographs that are representative images of cell cultures, where the groups are portrayed: “Control group”, “Virus exposure group” and “Group NV.57.02”.

DETAILED DESCRIPTION OF THE INVENTION

[043] The ANTISEPTIC AND MOISTURIZING LOTION FOR HANDS AND FACE, object of this patent application, in its two formulation versions, was the object of a study carried out by the laboratory NÚCLEO VITRO located at Rua da Várzea, 22 - Jardim - São Pedro - Porto Alegre - RS.

[044] The studies carried out took place between the dates of 05/12/2020 (Sample Receipt) to 07/23/2020 (Issuance of the Report) for SAMPLE NV.55.02; and between the dates of 05/22/2020 (Sample Receipt) and 07/23/2020 (Report Issuance) for SAMPLE NV.57.02.

[045] The studies evaluated the IN VITRO ANTIVIRAL ACTIVITY of the referred samples of the ANTISEPTIC AND MOISTURIZING LOTION FOR HANDS AND FACE regarding exposure to two viruses: Herpes simplex virus (HSV-1); and Canine Coronavirus (CCoV) in a VERO cell line, the study on Canine Coronavirus (CCoV) being of particular interest for the purpose of this Patent Application.

[046] SAMPLE NV.5502, of the ANTISEPTIC AND MOISTURIZING LOTION FOR HANDS AND FACE submitted to the study and which is treated in this Invention Patent application has the following formula:

[047] In turn, SAMPLE NV.5702, also submitted to the same type of study and which also integrates the matter addressed by this Invention Patent application, has the following formula:

[048] In the study of the two samples, VERO cells were used, maintained in cultivation with DMEM (Dulbecco's Modified Eagle's Medium) with the addition of supplements, in an oven at 37°C and 5% CO2 and manipulated inside the laminar flow hood. In passage 03, after thawing, the cells were distributed in plates suitable for monolayer culture.

[049] With regard to virus cultivation, Herpes simplex virus (HSV-1) and Canine Coronavirus (CCoV) were used, previously titrated in order to determine the amount of stock virus.

[050] The virus was inoculated on a standardized surface in the virus exposure group and in the product application group. The formula of the ANTISEPTIC AND MOISTURIZING LOTION FOR HANDS AND FACE, object of this Invention Patent application, was applied on the inoculation. Then, it was collected with culture medium and applied to the cell culture to assess virus viability and replication potential in cells.

[051] The analysis of the results took place after the stipulated time of contact of the virus with the cell culture, and the viral titer was evaluated. Cells evaluated according to morphology changes characterized by the cytopathogenic effect (CPE) caused by the virus under test. Visualization of changes through images compared to cell control indicated that there was viral replication in the period evaluated.

[052] After the application of samples NV.55.02 and NV.57.02 with the Herpes Simplex Virus (HSV-1) and Canine Coronavirus (CCoV) viral particles, these were exposed so that the viability of the virus and its ability to to replicate.

• 1- “Grupo controle": cultura de células sem presença de partículas virais;
• 2- “Grupo exposição ao vírus": cultura de células com a presença de partículas virais; e
• 3- “Grupo NV.55.02”e “Grupo NV.57.02”: culturas de células (para cada amostra distintamente) com a presença de partículas virais que foram expostas, respectivamente, as amostras da LOÇÃO ANTISSÉPTICA E HIDRATANTE PARA MÃOS E FACE (NV.55.02 e NV.57.02).

[053] In the aforementioned studies, the following groups were evaluated:

• 1- “Control group”: cell culture without the presence of viral particles;
• 2- "Virus exposure group": cell culture with the presence of viral particles; and
• 3- “Group NV.55.02” and “Group NV.57.02”: cell cultures (for each sample separately) with the presence of viral particles that were exposed, respectively, to samples of ANTISEPTIC AND MOISTURIZING LOTION FOR HANDS AND FACE (NV .55.02 and NV.57.02).

[054] In the group “exposure to the virus” in the case of the two samples of the ANTISEPTIC AND MOISTURIZING LOTION FOR HANDS AND FACE, the cytopathogenic effect was observed in the cells, thus confirming the presence of viability and viral replication, and in the groups NV.55.02 and NV.57.02, no cytopathogenic effect was observed in the cell cultures, which demonstrated that there was a 99.9% reduction in the presence of the virus, as shown, respectively, in figures 2 and 3, this effect having been observed for both HSV-1, as well as for the CCoV, the latter being the focus of the present patent application.

[055] Therefore, the studies carried out with samples NV.55.02 and NV.57.02 of the ANTISEPTIC AND MOISTURIZING LOTION FOR HANDS AND FACE, showed, according to a report issued by the laboratory NÚCLEO VITRO, that there was a reduction of 99.9 % of the viability of the viruses evaluated and, on the other hand, the effect of Antiviral Activity was detected.

[056] The formulas described above may present alternative versions, in which a substance can be introduced, that is, aluminum hydrochloride:

[057] Aluminum chloridroxide acts against gram positive organisms, in addition to having an astringent, antiperspirant action and also having an action in cases of hyperhidrosis, the latter being perfectly suited to the type of product discussed here, that is, a lotion for hands and face.

Claims (3)

"ANTISEPTIC AND MOISTURIZING LOTION FOR HANDS AND FACE", which has action in the fight against coronavirus and is characterized by having the following formula: water - 90% (vehicle); Stearic acid - 2.0% (emulsifier); Ceteareth-20 - 2.0% (emulsifier); Glyceryl Stearate - 3.0% (emulsifier); Methylisothiazolinone - 0.01% (preservative); Phenoxyethanol - 0.34% (preservative); Aminomethyl propanol - 0.10% (neutralizer) ); Triclosan - 0.3% (antiseptic); BHT - 0.05% (antioxidant); Disodium EDTA - 0.1% (sequestrant/chelator); Glycerin - 0.5% (humectant); Tea tree oil alternifolia - 0.3% (antimicrobial); Cetrimonium chloride -0.2% (antiseptic); Cyclopentasiloxane - 1.0% (emollient); and Carica papaya extract - 0.1% (moisturizer). "ANTISEPTIC AND MOISTURIZING LOTION FOR HANDS AND FACE", according to claim 1, characterized by having the following formula: water - 89.9% (vehicle); Stearic acid - 2.0% (emulsifier); Ceteareth-20 - 2.0% (emulsifier); Glyceryl Stearate - 3.0% (emulsifier); Methylisothiazolinone - 0.01% (preservative); Phenoxyethanol - 0.34% (preservative); Aminomethyl propanol - 0.10% (neutralizer) ; Copaifera officinalis resin - 0.4% (film former); BHT - 0.05% (antioxidant); disodium EDTA - 0.1% (sequestering/chelating agent); Glycerin - 0.5% (humectant); tea tree alternifolia - 0.3% (antimicrobial); Cetrimonium chloride - 0.2% (antiseptic); Cyclopentasiloxane - 1.0% (emollient); and Carica papaya extract - 0.1% (moisturizer). "ANTISEPTIC AND MOISTURIZING LOTION FOR HANDS AND FACE", according to claims 1 or 2, characterized in that it can include in its formula Aluminum Hydrochloride - 1% (antiseptic).

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