WO2022120450A1 - Antimicrobial composition for topical and/or external use - Google Patents

Antimicrobial composition for topical and/or external use Download PDF

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Publication number
WO2022120450A1
WO2022120450A1 PCT/BR2021/050538 BR2021050538W WO2022120450A1 WO 2022120450 A1 WO2022120450 A1 WO 2022120450A1 BR 2021050538 W BR2021050538 W BR 2021050538W WO 2022120450 A1 WO2022120450 A1 WO 2022120450A1
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WIPO (PCT)
Prior art keywords
antimicrobial
cream
add
mixture
agents
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PCT/BR2021/050538
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French (fr)
Portuguese (pt)
Inventor
Jefferson Luis BRAGA DA SILVA
Maria Martha Campos
André ARIGONY SOUTO
Jerônimo PIETROBON MARTINS
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União Brasileira De Educação E Assistência
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Publication of WO2022120450A1 publication Critical patent/WO2022120450A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
    • A01N37/00—Biocides, pest repellants or attractants, or plant growth regulators containing organic compounds containing a carbon atom having three bonds to hetero atoms with at the most two bonds to halogen, e.g. carboxylic acids
    • A01N37/36—Biocides, pest repellants or attractants, or plant growth regulators containing organic compounds containing a carbon atom having three bonds to hetero atoms with at the most two bonds to halogen, e.g. carboxylic acids containing at least one carboxylic group or a thio analogue, or a derivative thereof, and a singly bound oxygen or sulfur atom attached to the same carbon skeleton, this oxygen or sulfur atom not being a member of a carboxylic group or of a thio analogue, or of a derivative thereof, e.g. hydroxy-carboxylic acids
    • A—HUMAN NECESSITIES
    • A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
    • A01N33/00—Biocides, pest repellants or attractants, or plant growth regulators containing organic nitrogen compounds
    • A01N33/02—Amines; Quaternary ammonium compounds
    • A01N33/12—Quaternary ammonium compounds
    • A—HUMAN NECESSITIES
    • A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
    • A01N43/00—Biocides, pest repellants or attractants, or plant growth regulators containing heterocyclic compounds
    • A01N43/02—Biocides, pest repellants or attractants, or plant growth regulators containing heterocyclic compounds having rings with one or more oxygen or sulfur atoms as the only ring hetero atoms
    • A01N43/04—Biocides, pest repellants or attractants, or plant growth regulators containing heterocyclic compounds having rings with one or more oxygen or sulfur atoms as the only ring hetero atoms with one hetero atom
    • A01N43/06—Biocides, pest repellants or attractants, or plant growth regulators containing heterocyclic compounds having rings with one or more oxygen or sulfur atoms as the only ring hetero atoms with one hetero atom five-membered rings
    • A01N43/08—Biocides, pest repellants or attractants, or plant growth regulators containing heterocyclic compounds having rings with one or more oxygen or sulfur atoms as the only ring hetero atoms with one hetero atom five-membered rings with oxygen as the ring hetero atom
    • A—HUMAN NECESSITIES
    • A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
    • A01N47/00—Biocides, pest repellants or attractants, or plant growth regulators containing organic compounds containing a carbon atom not being member of a ring and having no bond to a carbon or hydrogen atom, e.g. derivatives of carbonic acid
    • A01N47/40—Biocides, pest repellants or attractants, or plant growth regulators containing organic compounds containing a carbon atom not being member of a ring and having no bond to a carbon or hydrogen atom, e.g. derivatives of carbonic acid the carbon atom having a double or triple bond to nitrogen, e.g. cyanates, cyanamides
    • A01N47/42—Biocides, pest repellants or attractants, or plant growth regulators containing organic compounds containing a carbon atom not being member of a ring and having no bond to a carbon or hydrogen atom, e.g. derivatives of carbonic acid the carbon atom having a double or triple bond to nitrogen, e.g. cyanates, cyanamides containing —N=CX2 groups, e.g. isothiourea
    • A01N47/44—Guanidine; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
    • A01N59/00—Biocides, pest repellants or attractants, or plant growth regulators containing elements or inorganic compounds
    • A—HUMAN NECESSITIES
    • A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
    • A01N65/00—Biocides, pest repellants or attractants, or plant growth regulators containing material from algae, lichens, bryophyta, multi-cellular fungi or plants, or extracts thereof
    • A01N65/08—Magnoliopsida [dicotyledons]
    • A01N65/28—Myrtaceae [Myrtle family], e.g. teatree or clove
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/74—Synthetic polymeric materials
    • A61K31/755—Polymers containing halogen
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/61—Myrtaceae (Myrtle family), e.g. teatree or eucalyptus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient

Definitions

  • the present invention describes an antimicrobial composition for external use, intended for microbiological control of topical/external use, forming an active layer that can be visualized by means of staining during the period of action. More specifically, the composition comprises antimicrobial agents and coloring agents that demonstrate their presence and permanence on the hands, as long as there is an antimicrobial action. Its use is recommended in clinical, industrial and/or commercial environments, such as hospitals, offices, clinics, aesthetic centers, shopping centers and/or industrial plants, etc., preventing topical contamination of the applied region, throughout its period of action and having its color intensity gradually decreased with time and decreasing the spread of microorganisms.
  • the present invention belongs to the field of Medicine, Dentistry, Pharmacy, Chemistry and Chemical Engineering, more precisely to Technological Innovation in the Health Area.
  • the present invention proposes a solution to the problems of the state of the art, presenting a new and inventive composition, conceived as an alternative to the current antimicrobial/microbicide compositions, so that its action time and its permanence can be visualized and/or monitored by means of indicator coloring agents and which, over time, have their tonality intensity reduced as their effect also reduces.
  • Such composition acts for an average period of two hours in labor activity, maintaining during this time its apparent color on the skin. In this way, its reapplication will only be necessary when the presence and permanence indicator disappears. Consequently, it is more economical and its use can be rationalized, in addition to maintaining hydration in the region of the skin where it was applied.
  • CN 1 11012717 describes an antiviral compound in cream used to moisturize the skin and prevent viral infections.
  • Your composition is for topical use, containing vitamin E, interferon and rhubarb as main components, among other components. It is mainly applied to the skin of the hand, playing a dual role of skin protection and viral prevention, reducing the possibility of contamination and transmission of microbial agents. It differs from the present invention because it does not present coloring agents that indicate its time of action and visualization of its presence and permanence.
  • Document AU2007100851-A4 describes an antiviral compound in hand cream that contains four components in common with the present technology: antiviral agent (iodine, tincture of iodine, Povidone-iodine (PVPI)), antibacterial agent (chlorhexidine, white vinegar), antiseptic agent (tea tree oil, pomegranate seed extract, lemon seed extract) and antifungal agent (terbinafine, tolnafiata, miconazalone or clotrimazole). It differs from the present invention because the formulation of said document presents action only when it comprises all agents simultaneously, does not determine time of action and/or protection, nor does it include dyes indicating presence and permanence by the intensity of coloring directly proportional to the time of action.
  • antiviral agent iodine, tincture of iodine, Povidone-iodine (PVPI)
  • antibacterial agent chlorhexidine, white vinegar
  • antiseptic agent tea tree oil, pomegran
  • composition NANOPROTECT BRASIL in the form of a spray for hands, contains an antiseptic agent, 1% hydrogen peroxide, has antiviral action, including SARS-COV-2, and bactericidal activity, used for hand antisepsis. However, it does not describe an indication of a prolonged effect, nor dyes that indicate presence, permanence and/or action time.
  • LUVEX biological protective cream has bacteriostatic action that prevents the proliferation of microorganisms on the skin, forming an inhibitory film for the growth of bacteria. However, it differs from the present invention in that it does not describe the action time, nor does it present a dye indicating the presence/permanence of its activity.
  • the present invention demonstrates an excellent cost-benefit ratio, protection against external/topical contamination for a long time, as the existing ones do not promise such an effect or demonstrate their action because they do not include an indicator of presence, permanence and/or time of activity according to the coloring scale, protection activity being directly proportional to the intensity of the indicator/dye tone.
  • the present formulation contains ingredients that keep the skin hydrated, preventing the very common dryness caused by 70% alcohol and other antiseptic formulations, even protecting against damage to its integrity and permeability.
  • the present technology also has a positive impact on economic-financial factors, such as: reduction of contamination and infections in health and/or hospital environments, reducing costs related to resistant infections, mainly antibiotic-resistant.
  • therapies protection against the transmission of infectious agents between professionals from different areas, such as health, aesthetics, food, etc., reducing time away from work due to infectious diseases, including COVID-19, rationalization of the use of topical microbicidal agents /external, etc.
  • the present formulation can also be used by other professionals who work in other segments and environments, such as in industries and/or production and trade of food, reducing the rates of general contamination. It can also be used in places with the same need for asepsis and/or with large circulation/agglomeration of people, such as industrial kitchens, cafeterias, airports, commercial environments and/or industrial plants, preventing the spread of microbial agents and/or contamination in mass of people in these environments.
  • an object of the present invention is a antimicrobial/microbicidal pharmaceutical composition
  • active agents such as antimicrobial agents, coloring agents and/or their mixtures and acceptable vehicles, acting as indicators of presence, coverage and permanence, duration of action and antimicrobial/microbicidal activity.
  • the antimicrobial/microbicidal composition additionally comprises thickening agents, preservatives, fixatives, pH regulators, components for maintaining hydration and/or skin integrity, emulsifiers, skin-forming agents. film, sensory modifiers and acceptable vehicles.
  • the antimicrobial/microbicide agent and the coloring agent have complementary and/or synergistic activities, so that the presence of the dye remains visible in the applied region in shade intensity directly proportional to the antimicrobial activity and the time of action.
  • the antimicrobial/microbicidal agents comprise: lactic acid, povidone iodine, chlorhexidine digluconate, hydrogen peroxide, tea tree oil, benzalkonium chloride and/or a combination thereof.
  • the coloring agents comprise: yellow pigments, for example, Pigment Yellow 42 (77492); white pigments, such as titanium dioxide and/or zinc oxide; beige pigments, such as, for example, Titanium Dioxide, talc, CI 77491, CI 77492, and/or CI 77499; black pigments, such as Triiron Tetraoxide; red pigments, such as for example Diiron Trioxide and/or Ferric Oxide and/or a combination thereof.
  • yellow pigments for example, Pigment Yellow 42 (77492); white pigments, such as titanium dioxide and/or zinc oxide; beige pigments, such as, for example, Titanium Dioxide, talc, CI 77491, CI 77492, and/or CI 77499; black pigments, such as Triiron Tetraoxide; red pigments, such as for example Diiron Trioxide and/or Ferric Oxide and/or a combination thereof.
  • the composition additionally comprises components for maintaining hydration and/or skin integrity, selected from the group among humectants, emollients and moisturizers and/or a combination thereof.
  • the composition has antimicrobial activity by a period between 1 and 4 hours, preferably an average of 2 hours.
  • the composition can be easily removed by washing the region where it was applied, without difficulty in removing the color of the indicator agent.
  • the object of the present invention is a process for obtaining said antimicrobial/microbicidal composition, comprising the preparation of a "Premix” in cream and a "Mixture” of active agents.
  • the Premix comprises the steps of: a. Weigh water and propylene glycol and heat to 70-80 s C; B. Weigh out emulsifying wax and mineral oil and heat to 70-80 s C. c. Pour mixture from step a. in the mixture of step b. and emulsify; d. When the temperature has cooled to 50 s C, add the preservative agent; and. Homogenize until the cream is formed and the temperature is below 40 s C; f.
  • the “Mixture” n s 1 comprises the steps of: a. Solubilize the povidone-iodine in water, add it to the Premix cream and homogenize; B. Add to the cream from step a. the VP/VA copolymer, the alcohol and homogenize; ç. Weigh trimethylsiloxysilicate and add isododecane to it and mix until completely solubilized, breaking up the lumps.
  • the pH of the "Mixture" n s 1 is 5.5.
  • the “Mixture” n s 2 comprises the steps of: a. Prepare a lactic acid solution with 8N sodium hydroxide neutralizer to pH 4.0-4.5; B. Add the neutralized lactic acid solution to the cream, little by little, homogenizing; ç. Add Melaleuca oil to the cream and homogenize; d. Add the VP/VA copolymer, alcohol and homogenize to the cream; and. Weigh the trimethylsiloxysilicate and add the isododecane to it and mix until completely solubilized, breaking up the lumps.
  • the pH of the "Mixture" n s 2 is 4.0.
  • Figure 1 demonstrates the final appearance of the Antimicrobial/Microbicide Composition comprising Formulation 1 and the active agent povidone iodine.
  • Figure 2 demonstrates the final appearance of the Antimicrobial/Microbicide Composition comprising Formulation 2 and the active agents lactic acid and tea tree oil.
  • Figure 3 demonstrates the appearance of culture plates with BHI medium, from microbiological collection from the hands of professionals who applied or not Formulation 1, after two hours of work, where pairs A and B; C and D; E and F demonstrate the absence of proliferation of microorganisms from the right and left hands of three subjects who applied Formulation 1;
  • G the presence of proliferation of microorganisms is observed from the collection of the hand of an individual who did not apply the product;
  • H it is possible to observe the microbial growth when the collection was performed 4 h after the application, indicating that the product's action time has already expired in that period of time.
  • Figure 4 demonstrates the appearance of culture plates with BHI medium, from microbiological collection from the hands of professionals who applied or not Formulation 2, after two hours of work, where pairs A and B; C and D demonstrate the absence of proliferation of microorganisms on the right and left hands of two subjects who applied Formulation 2; In G, the presence of proliferation of microorganisms is observed from the collection of the hand of an individual who did not apply the product.
  • Figure 5 shows the results of spectrometric evaluation indicating the presence of the product in the hands for an approximate period of 2 (two) hours, and it was possible to detect the presence of the product, according to the analysis of the back and different fingers of the hands.
  • This data is indicative of the presence and permanence of the product, and can also be correlated to the active antimicrobial/microbicide effect, after application on the skin of the hands, indicating the comprehensive and lasting effect of the action in all regions of the hand that were evaluated.
  • Figure 6 demonstrates the color of the hands after the application of Formulation 1, indicating the presence of the product up to the period of two hours after application on the back (A) and palm of the hands (B).
  • the color intensity is light in order to avoid any discomfort on the part of users and/or patients/clients to be treated, representing another differential of the product;
  • the red dotted lines delimit the region up to where the product was applied;
  • the absence of staining is observed after 4 hours of application, with no visible staining intensity, proportional to the absence of the antimicrobial/microbicidal effect.
  • the present invention describes a topical and long-lasting antiseptic composition for preventive use against infectious agents, providing antimicrobial/microbicidal action, hydration and protection to the skin in the application areas, mainly on the hands. More precisely, it describes an antimicrobial/microbicide formulation composition comprising active agents such as antimicrobial agents and/or coloring agents, which form a visible and active layer, protecting against microbial agents such as bacteria, fungi and/or viruses, preventing contamination. of the skin during the time of use and demonstrating its presence, scope, permanence and antimicrobial/microbicidal activity for an average period of 2 (two) hours, after its application, preventing the spread of infectious agents .
  • the development of cream formulations with antimicrobial/microbicidal action for an average period of two hours after application on the hands was conceived, in order to meet a demand from society, promoting technical and economic-financial improvements, allowing that, in a single composition, the formulation comprises action antimicrobial/microbicide, maintenance of skin hydration and action time, identification of the presence/permanence/range of the product, through the light yellowish coloration, having the advantage of not causing disturbances to the activities carried out by professionals from different areas that can be used for this product.
  • Antimicrobial/Microbicide Composition
  • antimicrobial/microbicidal composition is understood to mean the composition obtained by the Process that comprises a step of preparing the "Premix” (Cream base) and one of the “Mixtures” (Mixture 1 or 2 ), obtaining different formulations according to the need and/or objective of the segment or use.
  • Figures 1 and 2 demonstrate the antimicrobial/microbicide compositions of the present invention in more detail. As can be seen, Formulations 1 and 2, respectively, present a cream form with a vivid and intense yellowish color.
  • Formulation 1 the antimicrobial/microbicide agent used was povidone iodine, which has a yellow color.
  • Formulation 2 the antimicrobial agents/microbicides used were Lactic Acid and Tea Tree Oil and the dye Pigment Yellow 42 (77492).
  • the Process for obtaining an Antimicrobial/Microbicide Composition comprises two main steps, the objective of which is the first preparation of a "Premix” that will be used as a base, in the form of a cream, and which will receive later to “Mixture” (Mixtures 1 or 2), according to the desired active agent, according to the need to be employed or segment of use.
  • the steps are complementary and should not be carried out separately, at different times, they only comprise common purposes, varying one or another active agent, so that their incorporation takes place through small adaptations in the technique in the stage of preparing the "Mixture", meeting the different needs desired for the final product.
  • the “Mixture” comprising the active agents must be prepared. Afterwards, homogenize the Pre-mix cream with the active solution (Mixture), in order to obtain the antimicrobial composition of the aforementioned process.
  • the preparation of the “Pre-mix” in cream comprises the following steps: a. Weigh water and propylene glycol and heat to 70-80 s C; B. Weigh out emulsifying wax and mineral oil and heat to 70-80 s C. c. Pour mixture from step a. in the mixture of step b. and emulsify; d. When the temperature has cooled to 50 s C, add 2-methyl-4-isothiazolin-3-one and Phenoxyethanol; and. Homogenize until the cream is formed and the temperature is below 40 s C; f. Follow the protocol according to the “Mixture” of the desired active agent, preparing it, adding it to the cream and homogenizing it; g. Adjust pH to the range between 4.0 to 5.5; H. Add the coloring agent (pigment), incorporating it directly into the cream.
  • the preparation of “Mixtures” 1 or 2 of the Active Agents of this Antimicrobial Composition comprises the following steps: [0048] “Mixture” n s 1 comprises the following steps: a. Solubilize the povidone-iodine in water, add it to the Premix cream and homogenize; B. Add to the cream from step a. the VP/VA copolymer, the alcohol and homogenize; ç. Weigh trimethylsiloxysilicate and add isododecane to it and mix until completely solubilized, breaking up the lumps.
  • n s 2 comprises the following steps: a. Prepare a lactic acid solution with 8N sodium hydroxide neutralizer to pH 4.0-4.5; B. Add the neutralized lactic acid solution to the cream, little by little, homogenizing; ç. Add Melaleuca oil to the cream and homogenize; d. Add the VP/VA copolymer, alcohol and homogenize to the cream; and. Weigh the trimethylsiloxysilicate and add the isododecane to it and mix until completely solubilized, breaking up the lumps.
  • the coloring agent (pigment) is homogenized in a part of cream in order to mix it, later completing with the rest of the cream and homogenizing completely.
  • active agent is understood to mean any antimicrobial/microbicidal agent and/or coloring agent that act complementary and/or synergistically, in order to obtain the advantages of the present invention, that is, being the antimicrobial effect directly proportional to the intensity of staining. In this way, the action time and the permanence of the antimicrobial effect can be visualized through presence indicator dyes, which have their intensity of tone reduced, as their antimicrobial effect also reduces.
  • the active agents of the present invention comprise the agents antimicrobials/microbicides chosen from the group of: lactic acid, povidone iodine, chlorhexidine digluconate, hydrogen peroxide, tea tree oil, benzalkonium chloride, or a combination thereof.
  • the active agents of the present invention further comprise coloring agents selected from the group among: yellow pigments such as Pigment Yellow 42 (77492); white pigments, such as titanium dioxide and/or zinc oxide; beige pigments, such as Titanium Dioxide, Talc, CI 77491, CI 77492, and/or CI 77499; black pigments, such as Triiron Tetraoxide; red pigments, such as Diiron Trioxide and/or Ferric Oxide.
  • yellow pigments such as Pigment Yellow 42 (77492); white pigments, such as titanium dioxide and/or zinc oxide; beige pigments, such as Titanium Dioxide, Talc, CI 77491, CI 77492, and/or CI 77499
  • black pigments such as Triiron Tetraoxide
  • red pigments such as Diiron Trioxide and/or Ferric Oxide.
  • Active agents comprising complementary and/or synergistic activity determine an average period of action of 1 to 4 hours, preferably 2 (two hours), guaranteeing during this time the presence of the yellowish color and the antimicrobial/microbicidal activity. In this way, the need for reapplication is only necessary when the presence and permanence indicator disappears or after its removal, by washing the region where it was applied.
  • One of the great advantages of their effect is that they can be removed easily and without difficulty in removing the indicator stain, avoiding the presence of staining when the antimicrobial/microbicide agent is no longer present/active.
  • Table 1 Formulation 1 of the Antimicrobial Composition.
  • Mixture 1 a. Continuing the Pre-Mixing protocol incorporating Mix 1 of the active agents, preparing it, adding it to the cream and homogenizing it; B. Solubilize the povidone-iodine in water, add to the cream and homogenize; ç. Add the VP/VA copolymer and the alcohol to the cream and homogenize; d. Weigh the trimethylsiloxysilicate, add the isododecane to it and mix until completely solubilized, breaking up the lumps; and. Adjust the pH to 5.5.
  • Table 2 Formulation 2 of the Antimicrobial Composition.
  • Mixture 2 a. Continuing with the Pre-Mixing protocol incorporating Mix 2 of the active agents, preparing it, adding it to the cream and homogenizing it; B. Prepare lactic acid solution with 8N sodium hydroxide neutralizer to pH 4.0-4.5; ç. Add the neutralized lactic acid solution to the cream, little by little, homogenizing; d. Add Melaleuca oil to the cream and homogenize; and. Add the VP/VA copolymer, alcohol and homogenize to the cream; f. Weigh the trimethylsiloxysilicate and add the isododecane to it and mix until completely solubilized, breaking up the lumps; g. Adjust pH to 4.0; H. Add the coloring agent.

Abstract

The present invention relates to an antimicrobial/microbicidal composition for topical/external and preventative use against infectious agents, useful in healthcare environments, such as hospitals, clinics and/or aesthetic centres, commercial environments and/or industrial environments. Said composition comprises antimicrobial agents and colouring agents, inter alia, that demonstrate its presence, coverage, continued presence and antimicrobial activity; it can be seen and, as time passes, indicates when reapplication is necessary. In addition, it contains hydrating ingredients that prevent the skin from drying out.

Description

Relatório Descritivo de Patente de Invenção Invention Patent Descriptive Report
COMPOSIÇÃO ANTIMICROBIANA PARA USO TÓPICO E/OU EXTERNO ANTIMICROBIAL COMPOSITION FOR TOPICAL AND/OR EXTERNAL USE
Campo da Invenção Field of Invention
[0001] A presente invenção descreve uma composição antimicrobiana de uso externo, destinada ao controle microbiológico de uso tópico/externo, formando uma camada ativa que pode ser visualizada por meio de coloração durante o período de ação. Mais especificamente, a composição compreende agentes antimicrobianos e agentes corantes que demonstram sua presença e permanência nas mãos, enquanto houver ação antimicrobiana. Seu uso é recomendado em ambientes clínicos, industriais e/ou comerciais, tais como hospitais, consultórios, clínicas, centros estéticos, centros comerciais e/ou plantas industriais, etc., prevenindo a contaminação tópica da região aplicada, durante todo o seu período de ação e tendo sua intensidade de coloração diminuída de forma gradual com o tempo e diminuindo a disseminação de microrganismos. A presente invenção pertence ao campo da Medicina, Odontologia, Farmácia, Química e Engenharia Química, mais precisamente de Inovação Tecnológica na Área da Saúde. [0001] The present invention describes an antimicrobial composition for external use, intended for microbiological control of topical/external use, forming an active layer that can be visualized by means of staining during the period of action. More specifically, the composition comprises antimicrobial agents and coloring agents that demonstrate their presence and permanence on the hands, as long as there is an antimicrobial action. Its use is recommended in clinical, industrial and/or commercial environments, such as hospitals, offices, clinics, aesthetic centers, shopping centers and/or industrial plants, etc., preventing topical contamination of the applied region, throughout its period of action and having its color intensity gradually decreased with time and decreasing the spread of microorganisms. The present invention belongs to the field of Medicine, Dentistry, Pharmacy, Chemistry and Chemical Engineering, more precisely to Technological Innovation in the Health Area.
Antecedentes da Invenção Background of the Invention
[0002] Tendo em vista o atual cenário pandémico, iniciado em 2019 e ainda instalado mundialmente, devido à presença do agente etiológico Coronavirus-2 (CoV-2), e o acometimento da população com a Síndrome Respiratória Aguda Grave de Coronavirus 2 (SARS-CoV-2) (do Inglês, Severe Acute Respiratory Syndrome Coronavirus 2) que caracteriza a COVID-19 (do inglês, Coronavirus Disease 2019), os cuidados com a higiene pessoal, o uso de EPls e os hábitos de limpeza de ambientes e superfícies estão sendo redobrados. Sendo assim, a higiene das mãos, juntamente com o uso de máscaras e face shield, além do distanciamento social, têm sido as condutas preventivas mais efetivas para garantir a redução do risco de contaminação e a diminuição da circulação do vírus, freando a disseminação da doença e evitando a saturação e o colapso dos Sistemas de Saúde. [0002] In view of the current pandemic scenario, which started in 2019 and is still installed worldwide, due to the presence of the etiological agent Coronavirus-2 (CoV-2), and the involvement of the population with Severe Acute Respiratory Syndrome of Coronavirus 2 (SARS). -CoV-2) (from the English, Severe Acute Respiratory Syndrome Coronavirus 2) that characterizes the COVID-19 (from the English, Coronavirus Disease 2019), the care with personal hygiene, the use of EPls and the habits of cleaning environments and surfaces are being redoubled. Therefore, hand hygiene, together with the use of masks and face shields, in addition to social distancing, have been the most effective preventive measures to ensure the reduction of the risk of contamination and the decrease in the circulation of the virus, stopping the spread of the disease and preventing the saturation and collapse of Health Systems.
[0003] À medida que a epidemia foi progredindo e houve o descontrole da contenção pela disseminação do vírus em diferentes limites territoriais, as populações promoveram uma corrida em busca de suprimentos de alimentação, higiene e limpeza para garantir a manutenção do isolamento domiciliar e a para a prevenção de eventos de novas contaminações. Aos poucos, o conhecimento sobre a doença e as formas de transmissão foram sendo apropriados pelas autoridades técnicas de saúde, pelas comunidades científicas da mesma área e pelos governos, reduzindo o isolamento como única medida cabível e sugerindo o manejo da pandemia também por meio do distanciamento social e de medidas sanitárias gerais. [0003] As the epidemic progressed and there was a lack of control due to the spread of the virus in different territorial limits, the populations promoted a race in search of food, hygiene and cleaning supplies to guarantee the maintenance of home isolation and the prevention of new contamination events. Gradually, knowledge about the disease and the forms of transmission were being appropriated by technical health authorities, by scientific communities in the same area and by governments, reducing isolation as the only appropriate measure and suggesting the management of the pandemic also through distancing. social and general health measures.
[0004] Neste sentido, a demanda por agentes antimicrobianos e/ou microbicidas cresceu, principalmente pelo álcool 70%, em forma líquida ou em gel, por ser útil tanto para uso tópico, quanto para higienização de superfícies. No entanto, a ação do álcool, por exemplo, não pode ser visualizada, não sendo possível determinar seu período de ação e/ou permanência na pele e/ou local de aplicação. Por mais efetivo que seja o seu uso, não há garantias em relação ao seu período de ação, uma vez que seu efeito e sua permanência não podem ser visualizados/monitorados, sendo por muitas vezes, utilizado até de forma excessiva, exagerada e não racionalizada, levando a alterações na pele decorrentes do ressecamento, à falta de disponibilidade do produto e à demanda excessiva de distribuição. [0004] In this sense, the demand for antimicrobial agents and/or microbicides has grown, mainly for 70% alcohol, in liquid or gel form, as it is useful both for topical use and for surface hygiene. However, the action of alcohol, for example, cannot be visualized, and it is not possible to determine its period of action and/or permanence on the skin and/or application site. No matter how effective its use, there are no guarantees regarding its period of action, since its effect and its permanence cannot be visualized/monitored, and it is often used even in an excessive, exaggerated and non-rationalized way. , leading to skin changes resulting from dryness, lack of product availability and excessive demand for distribution.
[0005] Outra questão já bem conhecida, é a dificuldade/inabilidade que profissionais da saúde têm de lavar as suas mãos, frequentemente na prática clínica, seja por descuido, seja por falta de acesso a ambientes próprios a todo o instante necessário. Neste cenário, um produto com tempo de ação prolongado, bem como compreendendo indicador de ação e presença, vem a ser extremamente útil e, justamente por ser visualizado, pode ser, inclusive, fiscalizado e evidenciado por colegas de trabalho, responsáveis por ações sanitárias, controle de infecção, autoridades do segmento, etc. [0005] Another well-known issue is the difficulty/inability that health professionals have to wash their hands, often in clinical practice, either due to carelessness or lack of access to proper environments at all times necessary. In this scenario, a product with a prolonged action time, as well as comprising an action and presence indicator, becomes extremely useful and, precisely because it is visualized, it can even be inspected and evidenced by co-workers, responsible for actions sanitation, infection control, sector authorities, etc.
[0006] Neste sentido, a presente invenção propõe uma resolução aos problemas do estado da técnica, apresentando uma composição nova e inventiva, concebida como alternativa frente às atuais composições antimicrobianas/microbicidas, de forma que seu tempo de ação e sua permanência podem ser visualizados e/ou monitorados por meio de agentes corantes indicadores e que, com o passar do tempo, têm sua intensidade de tonalidade diminuída à medida que seu o efeito também reduz. Tal composição age por um período médio de duas horas em atividade laborai, mantendo durante esse tempo sua cor aparente na pele. Desta forma, sua reaplicação só será necessária quando o indicador de presença e permanência desaparecer. Consequentemente, é mais econômico e sua utilização pode ser racionalizada, além de manter a hidratação da região da pele onde foi aplicada. [0006] In this sense, the present invention proposes a solution to the problems of the state of the art, presenting a new and inventive composition, conceived as an alternative to the current antimicrobial/microbicide compositions, so that its action time and its permanence can be visualized and/or monitored by means of indicator coloring agents and which, over time, have their tonality intensity reduced as their effect also reduces. Such composition acts for an average period of two hours in labor activity, maintaining during this time its apparent color on the skin. In this way, its reapplication will only be necessary when the presence and permanence indicator disappears. Consequently, it is more economical and its use can be rationalized, in addition to maintaining hydration in the region of the skin where it was applied.
[0007] A medida que a higiene das mãos é realizada com água e sabão, nova aplicação se faz necessária, uma vez que o mesmo pode ser removido com facilidade e sem dificuldades de retirada da coloração indicadora, demonstrando desta forma, que o modo de ação do produto é seguro e eficaz e não há erro na indicação de sua presença. [0007] As hand hygiene is performed with soap and water, a new application is necessary, since it can be removed easily and without difficulties in removing the indicator color, thus demonstrating that the method of The product's action is safe and effective and there is no error in the indication of its presence.
[0008] No estado da arte, não foram identificadas tecnologias que antecipem ou sugiram uma composição antisséptica semelhante que, uma vez aplicada, forneça proteção contra agentes microbianos, tenha indicador de atividade/presença e que apresente tempo de ação de, em média, duas horas, sem causar ressecamento das mãos, garantindo a eficiência com uso racionalizado. Tampouco o uso de produtos corantes que saiam com facilidade, uma vez que a presença não deve ser visualizada na ausência do agente antimicrobiano/microbicida, garantindo que a intensidade de tonalidade do indicador de presença seja diretamente proporcional ao seu efeito antimicrobiano/microbicida. [0008] In the state of the art, no technologies have been identified that anticipate or suggest a similar antiseptic composition that, once applied, provides protection against microbial agents, has an activity/presence indicator and has an action time of, on average, two hours, without causing dry hands, ensuring efficiency with rational use. Nor the use of coloring products that come off easily, since the presence should not be visualized in the absence of the antimicrobial/microbicide agent, ensuring that the intensity of the shade of the presence indicator is directly proportional to its antimicrobial/microbicidal effect.
[0009] O documento CN 1 11012717 descreve um composto antiviral em creme utilizado para hidratar a pele e prevenir infecções virais. Sua composição é de uso tópico, contendo vitamina E, interferon e ruibarbo como componentes principais, dentre outros componentes. É aplicado principalmente à pele da mão, desempenhando um duplo papel de proteção da pele e prevenção virai, reduzindo a possibilidade de contaminação e de transmissão de agentes microbianos. Difere da presente invenção porque não apresenta agentes corantes que indiquem seu tempo de ação e visualização de sua presença e permanência. [0009] CN 1 11012717 describes an antiviral compound in cream used to moisturize the skin and prevent viral infections. Your composition is for topical use, containing vitamin E, interferon and rhubarb as main components, among other components. It is mainly applied to the skin of the hand, playing a dual role of skin protection and viral prevention, reducing the possibility of contamination and transmission of microbial agents. It differs from the present invention because it does not present coloring agents that indicate its time of action and visualization of its presence and permanence.
[0010] O documento AU2007100851 -A4 descreve um composto antiviral em creme utilizado nas mãos que contém quatro componentes em comum com a presente tecnologia: agente antiviral (iodo, tintura de iodo, Povidona- iodo (PVPI)), agente antibacteriano (clorexidina, vinagre branco), agente antisséptico (óleo de arvore de chá, extrato de semente de romã, extrato de semente de limão) e agente antifúngico (terbinafina, tolnafiata, miconazalona ou clotrimazol). Difere da presente invenção porque a formulação do referido documento apresenta ação somente quando compreende todos os agentes simultaneamente, não determina tempo de ação e/ou proteção, e tampouco compreende corantes indicadores de presença e permanência pela intensidade de coloração diretamente proporcional ao tempo de ação. [0010] Document AU2007100851-A4 describes an antiviral compound in hand cream that contains four components in common with the present technology: antiviral agent (iodine, tincture of iodine, Povidone-iodine (PVPI)), antibacterial agent (chlorhexidine, white vinegar), antiseptic agent (tea tree oil, pomegranate seed extract, lemon seed extract) and antifungal agent (terbinafine, tolnafiata, miconazalone or clotrimazole). It differs from the present invention because the formulation of said document presents action only when it comprises all agents simultaneously, does not determine time of action and/or protection, nor does it include dyes indicating presence and permanence by the intensity of coloring directly proportional to the time of action.
[0011] A composição NANOPROTECT BRASIL, em forma de Spray para as mãos, contém agente antisséptico, peróxido de hidrogênio 1 %, possui ação antiviral, incluindo SARS-COV-2, e atividade bactericida, utilizada para antissepsia das mãos. No entanto, não descreve indicação de efeito prolongado, tampouco corantes indicadores de presença, permanência e/ou tempo de ação. [0012] O creme protetor biológico LUVEX possui ação bacteriostática que impede a proliferação de microrganismos sobre a pele, formando uma película inibidora para o crescimento de bactérias. No entanto, difere da presente invenção por não descrever o tempo de ação, tampouco apresenta corante indicador de presença/ permanência da sua atividade. [0011] The composition NANOPROTECT BRASIL, in the form of a spray for hands, contains an antiseptic agent, 1% hydrogen peroxide, has antiviral action, including SARS-COV-2, and bactericidal activity, used for hand antisepsis. However, it does not describe an indication of a prolonged effect, nor dyes that indicate presence, permanence and/or action time. [0012] LUVEX biological protective cream has bacteriostatic action that prevents the proliferation of microorganisms on the skin, forming an inhibitory film for the growth of bacteria. However, it differs from the present invention in that it does not describe the action time, nor does it present a dye indicating the presence/permanence of its activity.
[0013] Em relação ao uso de géis e cremes antissépticos disponíveis no mercado para a assepsia de uso tópico, principalmente das mãos, a presente invenção demonstra excelente relação custo-benefício, proteção contra contaminação externa/tópica por tempo prolongado, pois os existentes não prometem tal efeito ou demonstram sua ação por não compreenderem indicador de presença, permanência e/ou tempo de atividade de acordo a escala de coloração, sendo a atividade da proteção diretamente proporcional à intensidade da tonalidade do indicador/corante. Além disso, a presente formulação contém ingredientes que mantêm a pele hidratada, evitando o ressecamento muito comum provocado pelo álcool 70% e outras formulações antissépticas, protegendo inclusive contra danos à sua integridade e permeabilidade. [0013] Regarding the use of antiseptic gels and creams available on the market for topical asepsis, mainly of the hands, the present invention demonstrates an excellent cost-benefit ratio, protection against external/topical contamination for a long time, as the existing ones do not promise such an effect or demonstrate their action because they do not include an indicator of presence, permanence and/or time of activity according to the coloring scale, protection activity being directly proportional to the intensity of the indicator/dye tone. In addition, the present formulation contains ingredients that keep the skin hydrated, preventing the very common dryness caused by 70% alcohol and other antiseptic formulations, even protecting against damage to its integrity and permeability.
[0014] Além das vantagens técnicas já descritas, a presente tecnologia também impacta positivamente em fatores económico-financeiros, tais como: redução de contaminação e infecções em ambientes de saúde e/ou hospitalares, diminuindo custos relacionados com infecções resistentes, principalmente a antibiótico-terapias, proteção contra a transmissão de agentes infecciosos entre profissionais de diferentes áreas, tais como saúde, estética, alimentícia, etc., reduzindo tempo de afastamento laborai por doenças infectocontagiosas, incluindo a COVID-19, racionalização do uso de agentes microbicidas de uso tópico/externo, etc. [0014] In addition to the technical advantages already described, the present technology also has a positive impact on economic-financial factors, such as: reduction of contamination and infections in health and/or hospital environments, reducing costs related to resistant infections, mainly antibiotic-resistant. therapies, protection against the transmission of infectious agents between professionals from different areas, such as health, aesthetics, food, etc., reducing time away from work due to infectious diseases, including COVID-19, rationalization of the use of topical microbicidal agents /external, etc.
[0015] Além do uso por profissionais da área da saúde e hospitalares, a presente formulação pode ser ainda utilizada por outros profissionais que trabalham em outros segmentos e ambientes, tais como nas indústrias e/ou produção e comércio de alimentos, reduzindo os índices de contaminação geral. Pode também ser utilizado em locais com igual necessidade de assepsia e/ou com grande circulação/aglomeração de pessoas, tais como cozinhas industriais, refeitórios, aeroportos, ambientes comerciais e/ou plantas industriais, impedindo a disseminação de agentes microbianos e/ou contaminação em massa de pessoas nesses ambientes. [0015] In addition to the use by health and hospital professionals, the present formulation can also be used by other professionals who work in other segments and environments, such as in industries and/or production and trade of food, reducing the rates of general contamination. It can also be used in places with the same need for asepsis and/or with large circulation/agglomeration of people, such as industrial kitchens, cafeterias, airports, commercial environments and/or industrial plants, preventing the spread of microbial agents and/or contamination in mass of people in these environments.
Sumário da Invenção Summary of the Invention
[0016] Em um primeiro aspecto, é objeto da presente invenção uma composição farmacêutica antimicrobiana/microbicida compreendendo agentes ativos tais como agentes antimicrobianos, agentes corantes e/ou suas misturas e veículos aceitáveis, atuando como indicadores de presença, abrangência e permanência, do tempo de ação e de atividade antimicrobiana/microbicida. [0016] In a first aspect, an object of the present invention is a antimicrobial/microbicidal pharmaceutical composition comprising active agents such as antimicrobial agents, coloring agents and/or their mixtures and acceptable vehicles, acting as indicators of presence, coverage and permanence, duration of action and antimicrobial/microbicidal activity.
[0017] Em uma realização preferencial, além dos agentes ativos, a composição antimicrobiana/microbicida compreende, adicionalmente, agentes espessantes, conservantes, fixadores, reguladores de pH, componentes para manutenção da hidratação e/ou integridade da pele, emulsificantes, agentes formadores de filme, modificadores sensoriais e veículos aceitáveis. [0017] In a preferred embodiment, in addition to the active agents, the antimicrobial/microbicidal composition additionally comprises thickening agents, preservatives, fixatives, pH regulators, components for maintaining hydration and/or skin integrity, emulsifiers, skin-forming agents. film, sensory modifiers and acceptable vehicles.
[0018] Em uma realização preferencial, o agente antimicrobiano/microbicida e o agente corante possuem atividades complementares e/ou sinérgicas, de forma que a presença do corante permaneça visível na região aplicada em intensidade de tonalidade diretamente proporcional à atividade antimicrobiana e ao tempo de ação. [0018] In a preferred embodiment, the antimicrobial/microbicide agent and the coloring agent have complementary and/or synergistic activities, so that the presence of the dye remains visible in the applied region in shade intensity directly proportional to the antimicrobial activity and the time of action.
[0019] Em uma realização preferencial, os agentes antimicrobianos/microbicidas compreendem: ácido lático, iodo povidona, digluconato de clorexidina, peróxido de hidrogênio, óleo de melaleuca, cloreto de benzalcônio e/ou a combinação dos mesmos. [0019] In a preferred embodiment, the antimicrobial/microbicidal agents comprise: lactic acid, povidone iodine, chlorhexidine digluconate, hydrogen peroxide, tea tree oil, benzalkonium chloride and/or a combination thereof.
[0020] Em uma realização preferencial, os agentes corantes compreendem: pigmentos amarelos, como exemplo, o Pigment Yellow 42 (77492); pigmentos brancos, como por exemplo dióxido de titânio e/ou óxido de zinco; pigmentos beges, como por exemplo Dióxido de Titânio, talco, Cl 77491 , Cl 77492, e/ou Cl 77499; pigmentos pretos, como por exemplo Tetraóxido de Triiron; pigmentos vermelhos, como por exemplo Trióxido de Diiron e/ou Óxido Férrico e/ou a combinação dos mesmos. [0020] In a preferred embodiment, the coloring agents comprise: yellow pigments, for example, Pigment Yellow 42 (77492); white pigments, such as titanium dioxide and/or zinc oxide; beige pigments, such as, for example, Titanium Dioxide, talc, CI 77491, CI 77492, and/or CI 77499; black pigments, such as Triiron Tetraoxide; red pigments, such as for example Diiron Trioxide and/or Ferric Oxide and/or a combination thereof.
[0021] Em uma realização preferencial, a composição compreende adicionalmente componentes para manutenção da hidratação e/ou integridade da pele, selecionados do grupo dentre umectantes, emolientes e hidratantes e/ou a combinação dos mesmos. [0021] In a preferred embodiment, the composition additionally comprises components for maintaining hydration and/or skin integrity, selected from the group among humectants, emollients and moisturizers and/or a combination thereof.
[0022] Em uma realização, a composição tem atividade antimicrobiana por um período entre 1 e 4 horas, preferencialmente médio de 2 horas. [0022] In one embodiment, the composition has antimicrobial activity by a period between 1 and 4 hours, preferably an average of 2 hours.
[0023] Em uma realização preferencial, a composição pode ser removida com facilidade com a lavagem da região onde foi aplicado, sem dificuldade de remoção da coloração do agente indicador. [0023] In a preferred embodiment, the composition can be easily removed by washing the region where it was applied, without difficulty in removing the color of the indicator agent.
[0024] Em um segundo aspecto, é objeto da presente invenção um processo de obtenção da referida composição antimicrobiana/microbicida, compreendendo o preparo de uma “Pré-mistura” em creme e uma “Mistura” de agentes ativos. [0024] In a second aspect, the object of the present invention is a process for obtaining said antimicrobial/microbicidal composition, comprising the preparation of a "Premix" in cream and a "Mixture" of active agents.
[0025] Em uma realização preferencial, a Pré-mistura compreende as etapas de: a. Pesar água e propilenoglicol e aquecer a 70-80sC; b. Pesar cera emulsificante e óleo mineral e aquecer a 70-80sC. c. Verter mistura da etapa a. na mistura da etapa b. e emulsificar; d. Quando resfriar a temperatura a 50sC, adicionar o agente conservante; e. Homogeneizar até que o creme esteja formado e a temperatura inferior a 40sC; f. Seguir protocolo conforme a “Mistura” do agente ativo desejada, preparando-a, adicionando-a ao creme e homogeneizando-a; g. Ajustar pH para a faixa entre 4,0 a 5,5; h. Por fim, adicionar o pigmento, incorporando-o diretamente ao creme. [0025] In a preferred embodiment, the Premix comprises the steps of: a. Weigh water and propylene glycol and heat to 70-80 s C; B. Weigh out emulsifying wax and mineral oil and heat to 70-80 s C. c. Pour mixture from step a. in the mixture of step b. and emulsify; d. When the temperature has cooled to 50 s C, add the preservative agent; and. Homogenize until the cream is formed and the temperature is below 40 s C; f. Follow the protocol according to the desired “Mixture” of the active agent, preparing it, adding it to the cream and homogenizing it; g. Adjust pH to the range between 4.0 to 5.5; H. Finally, add the pigment, incorporating it directly into the cream.
[0026] Em uma realização preferencial, a “Mistura” ns1 compreende as etapas de: a. Solubilizar a iodo-povidona em água, adicionar ao creme da Pré- mistura e homogeneizar; b. Adicionar ao creme da etapa a. o copolímero VP/VA, o álcool e homogeneizar; c. Pesar trimetilsiloxisilicato e adicionar a ele o isododecano e misturar até completa solubilização, desfazendo os grumos. [0027] Em uma realização preferencial, o pH da “Mistura” ns1 é de 5,5. [0026] In a preferred embodiment, the “Mixture” n s 1 comprises the steps of: a. Solubilize the povidone-iodine in water, add it to the Premix cream and homogenize; B. Add to the cream from step a. the VP/VA copolymer, the alcohol and homogenize; ç. Weigh trimethylsiloxysilicate and add isododecane to it and mix until completely solubilized, breaking up the lumps. [0027] In a preferred embodiment, the pH of the "Mixture" n s 1 is 5.5.
[0028] Em uma outra realização, a “Mistura” ns2 compreende as etapas de: a. Preparar uma solução de ácido lático com neutralizante hidróxido de sódio 8N para pH 4, 0-4, 5; b. Adicionar a solução de ácido lático neutralizada ao creme, aos poucos, homogeneizando; c. Adicionar ao creme o óleo de Melaleuca e homogeneizar; d. Adicionar ao creme o copolímero VP/VA, álcool e homogeneizar; e. Pesar o trimetilsiloxisilicato e adicionar a ele o isododecano e misturar até completa solubilização, desfazendo os grumos. [0028] In another embodiment, the “Mixture” n s 2 comprises the steps of: a. Prepare a lactic acid solution with 8N sodium hydroxide neutralizer to pH 4.0-4.5; B. Add the neutralized lactic acid solution to the cream, little by little, homogenizing; ç. Add Melaleuca oil to the cream and homogenize; d. Add the VP/VA copolymer, alcohol and homogenize to the cream; and. Weigh the trimethylsiloxysilicate and add the isododecane to it and mix until completely solubilized, breaking up the lumps.
[0029] Em uma realização preferencial, o pH da “Mistura” ns2 é de 4,0. [0029] In a preferred embodiment, the pH of the "Mixture" n s 2 is 4.0.
[0030] Em uma realização do processo compreendendo a “Mistura” ns2, o pigmento é homogeneizado na etapa final do processo. [0030] In a realization of the process comprising the "Mixture" n s 2, the pigment is homogenized in the final step of the process.
Breve Descrição das Figuras Brief Description of Figures
[0031] A Figura 1 demonstra o aspecto final da Composição Antimicrobiana/microbicida compreendendo a Formulação 1 e o agente ativo iodo povidona. [0031] Figure 1 demonstrates the final appearance of the Antimicrobial/Microbicide Composition comprising Formulation 1 and the active agent povidone iodine.
[0032] A Figura 2 demonstra o aspecto final da Composição Antimicrobiana/microbicida compreendendo a Formulação 2 e os agentes ativos ácido lático e óleo de melaleuca. [0032] Figure 2 demonstrates the final appearance of the Antimicrobial/Microbicide Composition comprising Formulation 2 and the active agents lactic acid and tea tree oil.
[0033] A Figura 3 demonstra o aspecto de placas de cultura com meio BHI, oriundas de coleta microbiológica das mãos de profissionais que aplicaram ou não a Formulação 1 , após o tempo de trabalho de duas horas, onde os pares A e B; C e D; E e F demonstram a ausência de proliferação de microrganismos das mãos direita e esquerda de três indivíduos que aplicaram a Formulação 1 ; Em G, observa-se a presença de proliferação de microrganismos a partir da coleta da mão de um indivíduo que não aplicou o produto; Em H, é possível observar a crescimento microbiano quando a coleta foi realizada 4 h após a aplicação, indicando que o tempo de ação do produto já expirou nesse período de tempo. [0033] Figure 3 demonstrates the appearance of culture plates with BHI medium, from microbiological collection from the hands of professionals who applied or not Formulation 1, after two hours of work, where pairs A and B; C and D; E and F demonstrate the absence of proliferation of microorganisms from the right and left hands of three subjects who applied Formulation 1; In G, the presence of proliferation of microorganisms is observed from the collection of the hand of an individual who did not apply the product; In H, it is possible to observe the microbial growth when the collection was performed 4 h after the application, indicating that the product's action time has already expired in that period of time.
[0034] A Figura 4 demonstra o aspecto de placas de cultura com meio BHI, oriundas de coleta microbiológica das mãos de profissionais que aplicaram ou não a Formulação 2, após o tempo de trabalho de duas horas, onde os pares A e B; C e D demonstram a ausência de proliferação de microrganismos nas mãos direita e esquerda de dois indivíduos que aplicaram a Formulação 2; Em G, observa-se a presença de proliferação de microrganismos a partir da coleta da mão de um indivíduo que não aplicou o produto. [0034] Figure 4 demonstrates the appearance of culture plates with BHI medium, from microbiological collection from the hands of professionals who applied or not Formulation 2, after two hours of work, where pairs A and B; C and D demonstrate the absence of proliferation of microorganisms on the right and left hands of two subjects who applied Formulation 2; In G, the presence of proliferation of microorganisms is observed from the collection of the hand of an individual who did not apply the product.
[0035] A Figura 5 mostra os resultados de avaliação espectrométrica indicando a presença do produto nas mãos pelo período aproximado de 2 (duas) horas, sendo que foi possível detectar a presença do produto, de acordo com a análise do dorso e de diferentes dedos das mãos. Esse dado é indicativo da presença e da permanência do produto, podendo também ser correlacionada ao efeito antimicrobiano/microbicida ativo, após a aplicação na pele das mãos, indicando o efeito abrangente e duradouro da ação em todas as regiões da mão que foram avaliadas. [0035] Figure 5 shows the results of spectrometric evaluation indicating the presence of the product in the hands for an approximate period of 2 (two) hours, and it was possible to detect the presence of the product, according to the analysis of the back and different fingers of the hands. This data is indicative of the presence and permanence of the product, and can also be correlated to the active antimicrobial/microbicide effect, after application on the skin of the hands, indicating the comprehensive and lasting effect of the action in all regions of the hand that were evaluated.
[0036] A Figura 6 demonstra a coloração das mãos após a aplicação da Formulação 1 , indicando a presença do produto até o período de duas horas após a aplicação no dorso (A) e na palma das mãos (B). Cabe destacar que a intensidade da cor é leve com o intuito de evitar qualquer desconforto por parte usuários e/ou dos pacientes/clientes a serem atendidos, representando outro diferencial do produto; Em A e B, as linhas pontilhadas em vermelho delimitam a região até onde o produto foi aplicado; Em C, observa-se a ausência de coloração após 4 horas da aplicação, com nenhuma intensidade de coloração visível, proporcional à ausência do efeito antimicrobiano/microbicida. [0036] Figure 6 demonstrates the color of the hands after the application of Formulation 1, indicating the presence of the product up to the period of two hours after application on the back (A) and palm of the hands (B). It should be noted that the color intensity is light in order to avoid any discomfort on the part of users and/or patients/clients to be treated, representing another differential of the product; In A and B, the red dotted lines delimit the region up to where the product was applied; In C, the absence of staining is observed after 4 hours of application, with no visible staining intensity, proportional to the absence of the antimicrobial/microbicidal effect.
Descrição Detalhada da Invenção Detailed Description of the Invention
[0037] A presente invenção descreve uma composição antisséptica de uso tópico e de longa duração para uso preventivo contra agentes infecciosos, conferindo ação antimicrobiana/microbicida, hidratação e proteção à pele nas regiões de aplicação, principalmente das mãos. Mais precisamente, descreve uma composição de formulação antimicrobiana/microbicida compreendendo agentes ativos tais como agentes antimicrobianos e/ou agentes corantes, que formam uma camada visível e ativa, protegendo contra agentes microbianos, tais como bactérias, fungos e/ou vírus, impedindo a contaminação da pele durante o tempo de utilização e demonstrando sua presença, abrangência, permanência e atividade antimicrobiana/microbicida por um período médio de 2 (duas) horas, após sua aplicação, prevenindo a disseminação de agentes infecciosos . [0037] The present invention describes a topical and long-lasting antiseptic composition for preventive use against infectious agents, providing antimicrobial/microbicidal action, hydration and protection to the skin in the application areas, mainly on the hands. More precisely, it describes an antimicrobial/microbicide formulation composition comprising active agents such as antimicrobial agents and/or coloring agents, which form a visible and active layer, protecting against microbial agents such as bacteria, fungi and/or viruses, preventing contamination. of the skin during the time of use and demonstrating its presence, scope, permanence and antimicrobial/microbicidal activity for an average period of 2 (two) hours, after its application, preventing the spread of infectious agents .
[0038] Trata-se de um creme aderente para uso tópico e de proteção pessoal com atividade antimicrobiana/microbicida visível e duradoura. O diferencial do invento em relação ao estado da técnica é seu tempo de permanência e ação, que pode ser visualizada pelo corante que atua como agente indicador de atividade e da área de abrangência alcançada na pele (região onde foi aplicada). Por conta disto, a atividade das substâncias ativas pode ser acompanhada durante o uso, pois à medida que o tempo transcorre, a intensidade da coloração vai diminuindo gradativamente, indicando também a diminuição da intensidade da ação, bem como a necessidade de reaplicação da composição. [0038] It is an adherent cream for topical use and personal protection with visible and long-lasting antimicrobial/microbicidal activity. The differential of the invention in relation to the state of the art is its permanence time and action, which can be visualized by the dye that acts as an agent indicating activity and the area of coverage reached on the skin (region where it was applied). Because of this, the activity of the active substances can be monitored during use, because as time passes, the intensity of the coloring gradually decreases, also indicating a decrease in the intensity of the action, as well as the need to reapply the composition.
[0039] A partir de um processo, adaptado a diferentes necessidades, foram conduzidas diferentes etapas para obtenção de formulações diferentes, por meio de adaptações ao creme base, denominado “Pré-mistura”, agregando com uma das “Misturas” (Mistura 1 ou 2) que compreendem diferentes agentes ativos, atendendo a diferentes necessidades, mas de forma a manter as mesmas propriedades das melhorias técnicas e vantajosas frente ao estado da arte. [0039] From a process, adapted to different needs, different steps were carried out to obtain different formulations, through adaptations to the base cream, called "Pre-mix", adding with one of the "Mixtures" (Mixture 1 or 2) that comprise different active agents, meeting different needs, but in order to maintain the same properties of technical and advantageous improvements in the face of the state of the art.
[0040] Neste sentido, o desenvolvimento de formulações em creme com ação antimicrobiana/microbicida por um período médio de duas horas após a aplicação nas mãos foi concebido, de forma a atender uma demanda da sociedade, promovendo melhorias técnicas e económico-financeiras, permitindo que, em uma única composição, a formulação compreenda ação antimicrobiana/microbicida, manutenção da hidratação da pele e do tempo de ação, identificação da presença/permanência/abrangência do produto, através da coloração amarelada de intensidade leve, tendo a ainda a vantagem de não gerar transtornos às atividades realizadas pelos profissionais de diferentes áreas que podem se utilizar deste produto. [0040] In this sense, the development of cream formulations with antimicrobial/microbicidal action for an average period of two hours after application on the hands was conceived, in order to meet a demand from society, promoting technical and economic-financial improvements, allowing that, in a single composition, the formulation comprises action antimicrobial/microbicide, maintenance of skin hydration and action time, identification of the presence/permanence/range of the product, through the light yellowish coloration, having the advantage of not causing disturbances to the activities carried out by professionals from different areas that can be used for this product.
Composição Antimicrobiana/Microbicida: Antimicrobial/Microbicide Composition:
[0041] Para fins da presente invenção, entende-se por composição antimicrobiana/microbicida a composição obtida pelo Processo que compreende uma etapa de preparação da “Pré-mistura” (Creme base) e de uma das “Misturas” (Mistura 1 ou 2), obtendo-se diferentes formulações de acordo com a necessidade e/ou objetivo do segmento ou uso. [0041] For the purposes of the present invention, antimicrobial/microbicidal composition is understood to mean the composition obtained by the Process that comprises a step of preparing the "Premix" (Cream base) and one of the "Mixtures" (Mixture 1 or 2 ), obtaining different formulations according to the need and/or objective of the segment or use.
[0042] As figuras 1 e 2 demonstram as composições antimicrobianas/microbicidas da presente invenção em mais detalhes. Como pode ser visto, as Formulações 1 e 2, respectivamente, apresentam forma de creme com coloração amarelada viva e intensa. [0042] Figures 1 and 2 demonstrate the antimicrobial/microbicide compositions of the present invention in more detail. As can be seen, Formulations 1 and 2, respectively, present a cream form with a vivid and intense yellowish color.
[0043] Na Formulação 1 (figura 1 ), o agente antimicrobiano/microbicida utilizado foi iodo povidona, sendo que o mesmo apresenta coloração amarela. Já na Formulação 2 (figura 2), os agentes antimicrobianos/microbicidas utilizados foram Ácido Lático e Óleo de melaleuca e o corante Pigment Yellow 42 (77492). [0043] In Formulation 1 (figure 1), the antimicrobial/microbicide agent used was povidone iodine, which has a yellow color. In Formulation 2 (figure 2), the antimicrobial agents/microbicides used were Lactic Acid and Tea Tree Oil and the dye Pigment Yellow 42 (77492).
[0044] As diferentes formulações foram testadas em relação aos aspectos organolépticos e em relação aos seus efeitos antimicrobianos, conforme pode ser visto nas figuras de 3 a 6. [0044] The different formulations were tested in relation to organoleptic aspects and in relation to their antimicrobial effects, as can be seen in figures 3 to 6.
Processo de Obtenção da Composição Antimicrobiana/Microbicida: Process for Obtaining the Antimicrobial/Microbicide Composition:
[0045] Para fins da presente invenção, o Processo de obtenção de Composição Antimicrobiana/Microbicida compreende duas principais etapas, cujo objetivo é a preparação primeiramente de uma “Pré-mistura” que será utilizada como base, na forma de creme, e que receberá posteriormente a “Mistura” (Misturas 1 ou 2), de acordo com o agente ativo desejado, conforme a necessidade a ser empregada ou segmento de uso. As etapas são complementares e não devem ser realizadas separadamente, em momentos diferentes, apenas compreendem finalidades em comum, variando um ou outro agente ativo, de forma que a sua incorporação se dá por pequenas adaptações na técnica na etapa do preparo da “Mistura”, atendendo às diferentes necessidades desejadas para o produto final. Imediatamente, após o preparo da “Pré-mistura”, a “Mistura” compreendendo os agentes ativos deve ser preparada. Após, homogeneizar o creme da Pré-mistura com a solução ativa (Mistura), de forma a obter a composição antimicrobiana do referido processo. [0045] For the purposes of the present invention, the Process for obtaining an Antimicrobial/Microbicide Composition comprises two main steps, the objective of which is the first preparation of a "Premix" that will be used as a base, in the form of a cream, and which will receive later to “Mixture” (Mixtures 1 or 2), according to the desired active agent, according to the need to be employed or segment of use. The steps are complementary and should not be carried out separately, at different times, they only comprise common purposes, varying one or another active agent, so that their incorporation takes place through small adaptations in the technique in the stage of preparing the "Mixture", meeting the different needs desired for the final product. Immediately after preparing the “Premix”, the “Mixture” comprising the active agents must be prepared. Afterwards, homogenize the Pre-mix cream with the active solution (Mixture), in order to obtain the antimicrobial composition of the aforementioned process.
“Pré-mistura”: Creme Base “Premix”: Foundation Cream
[0046] O preparo da “Pré-mistura” em creme, compreende as seguintes etapas: a. Pesar água e propilenoglicol e aquecer a 70-80sC; b. Pesar cera emulsificante e óleo mineral e aquecer a 70-80sC. c. Verter mistura da etapa a. na mistura da etapa b. e emulsificar; d. Quando resfriar a temperatura a 50sC, adicionar 2-metil-4- isotiazolin-3-ona e Fenoxietanol; e. Homogeneizar até que o creme esteja formado e a temperatura inferior a 40sC; f. Seguir protocolo conforme a “Mistura” do agente ativo desejada, preparando-a, adicionando-a ao creme e homogeneizando-a; g. Ajustar pH para a faixa entre 4,0 a 5,5; h. Adicionar o agente corante (pigmento), incorporando-o diretamente ao creme. [0046] The preparation of the “Pre-mix” in cream comprises the following steps: a. Weigh water and propylene glycol and heat to 70-80 s C; B. Weigh out emulsifying wax and mineral oil and heat to 70-80 s C. c. Pour mixture from step a. in the mixture of step b. and emulsify; d. When the temperature has cooled to 50 s C, add 2-methyl-4-isothiazolin-3-one and Phenoxyethanol; and. Homogenize until the cream is formed and the temperature is below 40 s C; f. Follow the protocol according to the “Mixture” of the desired active agent, preparing it, adding it to the cream and homogenizing it; g. Adjust pH to the range between 4.0 to 5.5; H. Add the coloring agent (pigment), incorporating it directly into the cream.
“Misturas”: Agentes Ativos “Mixtures”: Active Agents
[0047] O preparo das “Misturas” 1 ou 2 dos Agentes Ativos da presente Composição Antimicrobiana, compreende as seguintes etapas: [0048] A “Mistura” ns1 compreende as seguintes etapas: a. Solubilizar o povidona-iodo em água, adicionar ao creme da Pré- mistura e homogeneizar; b. Adicionar ao creme da etapa a. o copolímero VP/VA, o álcool e homogeneizar; c. Pesar trimetilsiloxisilicato e adicionar a ele o isododecano e misturar até completa solubilização, desfazendo os grumos. [0047] The preparation of “Mixtures” 1 or 2 of the Active Agents of this Antimicrobial Composition comprises the following steps: [0048] “Mixture” n s 1 comprises the following steps: a. Solubilize the povidone-iodine in water, add it to the Premix cream and homogenize; B. Add to the cream from step a. the VP/VA copolymer, the alcohol and homogenize; ç. Weigh trimethylsiloxysilicate and add isododecane to it and mix until completely solubilized, breaking up the lumps.
[0049] A “Mistura” ns2 compreende as seguintes etapas: a. Preparar uma solução de ácido lático com neutralizante hidróxido de sódio 8N para pH 4, 0-4, 5; b. Adicionar a solução de ácido lático neutralizada ao creme, aos poucos, homogeneizando; c. Adicionar ao creme o óleo de Melaleuca e homogeneizar; d. Adicionar ao creme o copolímero VP/VA, álcool e homogeneizar; e. Pesar o trimetilsiloxisilicato e adicionar a ele o isododecano e misturar até completa solubilização, desfazendo os grumos. [0049] “Mixture” n s 2 comprises the following steps: a. Prepare a lactic acid solution with 8N sodium hydroxide neutralizer to pH 4.0-4.5; B. Add the neutralized lactic acid solution to the cream, little by little, homogenizing; ç. Add Melaleuca oil to the cream and homogenize; d. Add the VP/VA copolymer, alcohol and homogenize to the cream; and. Weigh the trimethylsiloxysilicate and add the isododecane to it and mix until completely solubilized, breaking up the lumps.
[0050] Ao final de cada processo, o agente corante (pigmento) é homogeneizado em uma parte de creme a fim de misturá-lo, completando posteriormente com o restante do creme e homogeneizando completamente. [0050] At the end of each process, the coloring agent (pigment) is homogenized in a part of cream in order to mix it, later completing with the rest of the cream and homogenizing completely.
Agentes Ativos Active Agents
[0051] Para fins da presente invenção, entende-se por agente ativo todo o agente antimicrobiano/microbicida e/ou agente corante que atuam complementarmente e/ou em sinergia, a fim de obter as vantagens da presente invenção, ou seja, o sendo o efeito antimicrobiano diretamente proporcional à intensidade da coloração. Desta forma, o tempo de ação e a permanência do efeito antimicrobiano podem ser visualizados por meio de corantes indicadores de presença, que têm sua intensidade de tonalidade diminuída, à medida que seu o efeito antimicrobiano também reduz. [0051] For the purposes of the present invention, active agent is understood to mean any antimicrobial/microbicidal agent and/or coloring agent that act complementary and/or synergistically, in order to obtain the advantages of the present invention, that is, being the antimicrobial effect directly proportional to the intensity of staining. In this way, the action time and the permanence of the antimicrobial effect can be visualized through presence indicator dyes, which have their intensity of tone reduced, as their antimicrobial effect also reduces.
[0052] Os agentes ativos da presente invenção compreendem os agentes antimicrobianos/microbicidas escolhidos do grupo dentre: ácido lático, iodo povidona, digluconato de clorexidina, peróxido de hidrogênio, óleo de melaleuca, cloreto de benzalcônio, ou a combinação dos mesmos. [0052] The active agents of the present invention comprise the agents antimicrobials/microbicides chosen from the group of: lactic acid, povidone iodine, chlorhexidine digluconate, hydrogen peroxide, tea tree oil, benzalkonium chloride, or a combination thereof.
[0053] Os agentes ativos da presente invenção compreendem adicionalmente os agentes corantes escolhidos do grupo dentre: pigmentos amarelos como por exemplo o Pigment Yellow 42 (77492); pigmentos brancos, como por exemplo o dióxido de titânio e/ou óxido de zinco; pigmentos beges, como por exemplo o Dióxido de Titânio, Talco, Cl 77491 , Cl 77492, e/ou Cl 77499; pigmentos pretos, como por exemplo Tetraóxido de Triiron; pigmentos vermelhos, como por exemplo o Trióxido de Diiron e/ou Óxido Férrico. [0053] The active agents of the present invention further comprise coloring agents selected from the group among: yellow pigments such as Pigment Yellow 42 (77492); white pigments, such as titanium dioxide and/or zinc oxide; beige pigments, such as Titanium Dioxide, Talc, CI 77491, CI 77492, and/or CI 77499; black pigments, such as Triiron Tetraoxide; red pigments, such as Diiron Trioxide and/or Ferric Oxide.
[0054] Os agentes ativos compreendendo atividade complementar e/ou sinérgica determinam um período médio de ação de 1 a 4 horas, preferencialmente de 2 (duas horas), garantindo durante esse tempo a presença da cor amarelada e da atividade antimicrobiana/microbicida. Desta forma, a necessidade de reaplicação só é necessária quando o indicador de presença e permanência desaparecer ou após sua remoção, pela lavagem da região onde foi aplicada. Uma das grandes vantagens de seu efeito é que podem ser removidos com facilidade e sem dificuldades de retirada da coloração indicadora, evitando a presença da coloração quando o agente antimicrobiano/microbicida não está mais presente/ativo. [0054] Active agents comprising complementary and/or synergistic activity determine an average period of action of 1 to 4 hours, preferably 2 (two hours), guaranteeing during this time the presence of the yellowish color and the antimicrobial/microbicidal activity. In this way, the need for reapplication is only necessary when the presence and permanence indicator disappears or after its removal, by washing the region where it was applied. One of the great advantages of their effect is that they can be removed easily and without difficulty in removing the indicator stain, avoiding the presence of staining when the antimicrobial/microbicide agent is no longer present/active.
[0055] Os exemplos aqui apresentados têm o intuito de demonstrar as diferentes possibilidades de variações, sem, no entanto, limitar ou restringir o escopo e as diferentes formas de obtenção da presente tecnologia. [0055] The examples presented here are intended to demonstrate the different possibilities of variations, without, however, limiting or restricting the scope and the different ways of obtaining the present technology.
Exemplo 1. Realização Preferencial Example 1. Preferred Realization
[0056] A Formulação 1 pode ser visualizada na Figura 1 e foi desenvolvida utilizando os componentes de acordo com a Tabela 1 : [0056] Formulation 1 can be seen in Figure 1 and was developed using the components according to Table 1:
Tabela 1 : Formulação 1 da Composição Antimicrobiana.
Figure imgf000016_0001
Figure imgf000017_0001
Table 1: Formulation 1 of the Antimicrobial Composition.
Figure imgf000016_0001
Figure imgf000017_0001
[0057] Mistura 1 : a. Dar continuidade ao protocolo da Pré-Mistura incorporando a Mistura 1 dos agentes ativos, preparando-a, adicionando-a ao creme e homogeneizando-a; b. Solubilizar o povidona-iodo em água, adicionar ao creme e homogeneizar; c. Adicionar ao creme o copolímero VP/VA, o álcool e homogeneizar; d. Pesar o trimetilsiloxisilicato, adicionar a ele o isododecano e misturar até completa solubilização, desfazendo os grumos; e. Ajustar o pH a 5,5. [0057] Mixture 1 : a. Continuing the Pre-Mixing protocol incorporating Mix 1 of the active agents, preparing it, adding it to the cream and homogenizing it; B. Solubilize the povidone-iodine in water, add to the cream and homogenize; ç. Add the VP/VA copolymer and the alcohol to the cream and homogenize; d. Weigh the trimethylsiloxysilicate, add the isododecane to it and mix until completely solubilized, breaking up the lumps; and. Adjust the pH to 5.5.
Exemplo 2: Example 2:
[0058] A Formulação 2 pode ser visualizada na Figura 2 e foi desenvolvida utilizando os componentes de acordo com a Tabela 2: [0058] Formulation 2 can be seen in Figure 2 and was developed using the components according to Table 2:
Tabela 2: Formulação 2 da Composição antimicrobiana.
Figure imgf000017_0002
Figure imgf000018_0001
Table 2: Formulation 2 of the Antimicrobial Composition.
Figure imgf000017_0002
Figure imgf000018_0001
[0059] Mistura 2: a. Dar continuidade ao protocolo da Pré-Mistura incorporando a Mistura 2 dos agentes ativos, preparando-a, adicionando-a ao creme e homogeneizando-a; b. Preparar solução de ácido lático com neutralizante hidróxido de sódio 8N para pH 4, 0-4, 5; c. Adicionar a solução de ácido lático neutralizada ao creme, aos poucos, homogeneizando; d. Adicionar ao creme o óleo de Melaleuca e homogeneizar; e. Adicionar ao creme o copolímero VP/VA, álcool e homogeneizar; f. Pesar o trimetilsiloxisilicato e adicionar a ele o isododecano e misturar até completa solubilização, desfazendo os grumos; g. Ajustar o pH a 4,0; h. Adicionar o agente corante. [0059] Mixture 2: a. Continuing with the Pre-Mixing protocol incorporating Mix 2 of the active agents, preparing it, adding it to the cream and homogenizing it; B. Prepare lactic acid solution with 8N sodium hydroxide neutralizer to pH 4.0-4.5; ç. Add the neutralized lactic acid solution to the cream, little by little, homogenizing; d. Add Melaleuca oil to the cream and homogenize; and. Add the VP/VA copolymer, alcohol and homogenize to the cream; f. Weigh the trimethylsiloxysilicate and add the isododecane to it and mix until completely solubilized, breaking up the lumps; g. Adjust pH to 4.0; H. Add the coloring agent.

Claims

Reivindicações claims
1. Composição farmacêutica antimicrobiana/microbicida caracterizada por compreender agentes ativos tais como agentes antimicrobianos, agentes corantes e/ou suas misturas e veículos farmaceuticamente aceitáveis, atuando como indicadores de presença, abrangência, permanência, tempo de ação e de atividade antimicrobiana/microbicida. 1. Antimicrobial/microbicidal pharmaceutical composition characterized by comprising active agents such as antimicrobial agents, coloring agents and/or their mixtures and pharmaceutically acceptable vehicles, acting as indicators of presence, scope, permanence, time of action and antimicrobial/microbicidal activity.
2. Composição, de acordo com a reivindicação 1 , caracterizada por compreender adicionalmente agentes espessantes, conservantes, fixadores, reguladores de pH, componentes para manutenção da hidratação e/ou integridade da pele, emulsificantes, agentes formadores de filme, modificadores sensoriais e veículos aceitáveis. Composition according to claim 1, characterized in that it additionally comprises thickening agents, preservatives, fixatives, pH regulators, components for maintaining hydration and/or skin integrity, emulsifiers, film-forming agents, sensory modifiers and acceptable vehicles. .
3. Composição, de acordo com a reivindicação 1 , caracterizada pelo agente antimicrobiano/microbicida e o agente corante possuírem atividades complementares e/ou sinérgicas, de forma que a presença do corante permaneça visível na região aplicada em intensidade de tonalidade diretamente proporcional à atividade antimicrobiana e ao tempo de ação. 3. Composition, according to claim 1, characterized in that the antimicrobial/microbicide agent and the coloring agent have complementary and/or synergistic activities, so that the presence of the dye remains visible in the applied region in shade intensity directly proportional to the antimicrobial activity. and action time.
4. Composição, de acordo com a reivindicação 1 , caracterizada pelos agentes antimicrobianos/microbicidas compreenderem: ácido lático, iodo povidona, digluconato de clorexidina, peróxido de hidrogênio, óleo de melaleuca, cloreto de benzalcônio e/ou a combinação dos mesmos. Composition according to claim 1, characterized in that the antimicrobial/microbicide agents comprise: lactic acid, povidone iodine, chlorhexidine digluconate, hydrogen peroxide, tea tree oil, benzalkonium chloride and/or a combination thereof.
5. Composição, de acordo com a reivindicação 1 , caracterizada pelos agentes corantes compreenderem: pigmentos amarelos, como por exemplo, Pigment Yellow 42 (77492); pigmentos brancos, como por exemplo dióxido de titânio e/ou óxido de zinco; pigmentos beges, como por exemplo Dióxido de Titânio, talco, Cl 77491 , Cl 77492, e/ou Cl 77499; pigmentos pretos, como por exemplo Tetraóxido de Triiron; pigmentos vermelhos, como por exemplo Trióxido de Diiron e/ou Óxido Férrico, e/ou a combinação dos mesmos. Composition according to claim 1, characterized in that the coloring agents comprise: yellow pigments, for example Pigment Yellow 42 (77492); white pigments, such as titanium dioxide and/or zinc oxide; beige pigments, such as, for example, Titanium Dioxide, talc, CI 77491, CI 77492, and/or CI 77499; black pigments, such as Triiron Tetraoxide; red pigments, such as for example Diiron Trioxide and/or Ferric Oxide, and/or a combination thereof.
6. Composição, de acordo com a reivindicação 1 , caracterizada por compreender adicionalmente componentes para manutenção da hidratação e/ou integridade da pele, selecionados do grupo dentre umectantes, emolientes e hidratantes e/ou a combinação dos mesmos. Composition according to claim 1, characterized in that it additionally comprises components for maintaining hydration and/or integrity of the skin, selected from the group among humectants, emollients and moisturizers and/or a combination thereof.
7. Composição, de acordo com a reivindicação 1 , caracterizada por apresentar atividade antimicrobiana/microbicida por um período entre 1 e 4 horas. Composition, according to claim 1, characterized in that it has antimicrobial/microbicidal activity for a period between 1 and 4 hours.
8. Composição, de acordo com a reivindicação 7, caracterizada por apresentar atividade antimicrobiana/microbicida por um período de 2 horas. 8. Composition according to claim 7, characterized in that it has antimicrobial/microbicidal activity for a period of 2 hours.
9. Processo de obtenção de composição antimicrobiana/microbicida caracterizado por compreender o preparo de uma “Pré-mistura” em creme e uma “Mistura” de agentes ativos, de acordo com as seguintes etapas: a. Pesar água e propilenoglicol e aquecer a 70-80sC; b. Pesar cera emulsificante e óleo mineral e aquecer a 70-80sC. c. Verter mistura da etapa a. na mistura da etapa b. e emulsificar; d. Quando resfriar a temperatura a 50sC, adicionar o agente conservante; e. Homogeneizar até que o creme esteja formado e a temperatura inferior a 40sC; f. Preparo da “Mistura” do agente ativo desejada, adicionando-a ao creme e homogeneizando-a; g. Ajustar pH para a faixa entre 4,0 a 5,5; h. Adicionar o corante (pigmento), incorporando-o diretamente ao creme. 9. Process for obtaining an antimicrobial/microbicidal composition characterized by the preparation of a “Premix” in cream and a “Mixture” of active agents, according to the following steps: a. Weigh water and propylene glycol and heat to 70-80 s C; B. Weigh out emulsifying wax and mineral oil and heat to 70-80 s C. c. Pour mixture from step a. in the mixture of step b. and emulsify; d. When the temperature has cooled to 50 s C, add the preservative agent; and. Homogenize until the cream is formed and the temperature is below 40 s C; f. Preparation of the “Mixture” of the desired active agent, adding it to the cream and homogenizing it; g. Adjust pH to the range between 4.0 to 5.5; H. Add the dye (pigment), incorporating it directly into the cream.
10. Processo, de acordo com a reivindicação 9, caracterizado pela Mistura da etapa “f” ser a Mistura 1 e compreender as seguintes etapas: i. Solubilizar a iodo-povidona em água, adicionar ao creme da Pré- mistura e homogeneizar; j. Adicionar ao creme da etapa a. o copolímero VP/VA, o álcool e homogeneizar; k. Pesar trimetilsiloxisilicato e adicionar a ele o isododecano e misturar até completa solubilização, desfazendo os grumos. 19 Processo, de acordo com a reivindicação 9, caracterizado pela Mistura da etapa “f” ser a Mistura 2 e compreender as seguintes etapas: a. Preparar uma solução de ácido lático com neutralizante hidróxido de sódio 8N para pH 4, 0-4, 5; b. Adicionar a solução de ácido lático neutralizada ao creme, aos poucos, homogeneizando; c. Adicionar ao creme o óleo de Melaleuca e homogeneizar; d. Adicionar ao creme o copolímero VP/VA, álcool e homogeneizar; e. Pesar o trimetilsiloxisilicato e adicionar a ele o isododecano e misturar até completa solubilização, desfazendo os grumos. Process according to claim 9, characterized in that the Mixture of step "f" is Mixture 1 and comprises the following steps: i. Solubilize the povidone-iodine in water, add it to the Premix cream and homogenize; j. Add to the cream from step a. the VP/VA copolymer, the alcohol and homogenize; k Weigh trimethylsiloxysilicate and add isododecane to it and mix until completely solubilized, breaking up the lumps. Process according to claim 9, characterized in that the Mixture of step "f" is Mixture 2 and comprises the following steps: a. Prepare a lactic acid solution with 8N sodium hydroxide neutralizer to pH 4.0-4.5; B. Add the neutralized lactic acid solution to the cream, little by little, homogenizing; ç. Add Melaleuca oil to the cream and homogenize; d. Add the VP/VA copolymer, alcohol and homogenize to the cream; and. Weigh the trimethylsiloxysilicate and add the isododecane to it and mix until completely solubilized, breaking up the lumps.
PCT/BR2021/050538 2020-12-07 2021-12-07 Antimicrobial composition for topical and/or external use WO2022120450A1 (en)

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