Antimicrobial gel composition

Description

1 / 35 “ANTIMICROBIAL GEL COMPOSITION” Field of Invention

[001] The present invention relates to an antimicrobial composition, a method for producing said antimicrobial composition, and a valve system, as well as a method for treating wounds comprising said antimicrobial composition. Basis of the Invention

[002] In general, wounds are a hidden epidemic among the world's population, with significant social and economic consequences that impair the quality of life of millions of people. While the treatment of acute wounds in a healthy patient is relatively manageable, patients with chronic wounds can be difficult to assess and manage. Cases of chronic wounds are increasing, but existing standard treatment solutions do not meet the principles of treatment. Although bandages and gauze are useful for reducing bleeding, they have a number of disadvantages. They are not biodegradable, are prone to infection, and are unsuitable for irregularly shaped wounds. They have the potential to cause secondary tissue destruction and are ineffective for wound healing.

[003] Antibiotic resistance, as well as a weak immune response, creates challenges in the treatment of chronic infections. Because of this, extensive studies have been conducted on the topic of wound healing processes and devices for their treatment. Existing research recognizes the critical role played by hydrogels in wound healing. Providing moisture to the wound allows for painless debridement of necrotic and infected tissue, as well as granulation and complete healing. However, since current hydrogels have a high water content, they are not fully absorbent, and are therefore more suitable for wounds with light to moderate exudation. In line with this, a Petition 870260073974, dated 07 / 24 / 2026, page 8 / 85 2 / 35 antimicrobial action is necessary to combat infection and aid in the wound healing process. Therefore, in light of the previous discussion, there is a need to overcome the aforementioned disadvantages associated with currently available antimicrobial hydrogels.

[004] US Patent Application 20200138953A1 describes a stabilized hypohalous acid solution, particularly a stabilized solution or formulation comprising hypobromous acid and a stabilizing amount of dissolved inorganic carbon in the form of bicarbonate or alkaline earth metal carbonate.

[005] US Patent Application 20200138953A1 describes a can with a bag over a valve containing a solution of hypochlorous acid and a chlorine stabilizer, which is suitable for use in disinfecting food processing surfaces and sanitizing medical equipment in hospitals.

[006] Document CN 113069413 A describes a hypochlorous acid gel that aids in sterilization by electron beam irradiation. The hypochlorous acid gel is prepared from the following raw materials, in parts by mass: 50 to 70 parts of a gel matrix, 27.4 to 49.979 parts of a phosphate buffer solution, 0.001 to 0.6 parts of hypochlorous acid and 0.02 to 2 parts of sodium hypochlorite, wherein the phosphate buffer solution is prepared from boric acid, potassium dihydrogen phosphate, sodium chloride and pure water. The hypochlorous acid gel has a neutral pH and does not cause irritation to the wound surface. Preferably, the pH of the hypochlorous acid gel is 5.5 to 8.0. The only example has a pH of 6.8. The gel matrix powder is preferably composed of one or more of the following: magnesium lithium silicate, magnesium aluminum silicate, and magnesium sodium fluorosilicate.It should also be noted that a phosphate buffer solution is mandatory and that the gel therefore possesses a certain β-buffering capacity relative to the pH value, a β-buffering capacity that is quite high. The buffering capacity, according to... Petition 870260073974, dated 07 / 24 / 2026, page 9 / 85 3 / 35 the formulation of the example from document CN 113069413, was calculated as β = 0.189 « 0.19 « 0.2.

[007] For prior art compositions comprising sodium hypochlorite and hypochlorous acid, it has been found that the shelf life is often not satisfactory for convenient use.

[008] In addition, it is desirable to improve wound treatment by providing additional ways of administering antibacterial agents.

[009] One problem with the technique is that antimicrobial compositions are irritating to the skin. For hypochlorite and hypochlorous acid, the ideal pH value for the antimicrobial effect is an acidic pH, such as, for example, pH 3-7. At the same time, an acidic pH is more irritating to the skin and can cause an uncomfortable sensation to the user. Summary of the Invention

[010] One objective of the present invention is to overcome at least some of the disadvantages of the prior art and to provide an improved antibacterial composition in gel form.

[011] In a first aspect, an antimicrobial composition is provided, comprising sodium hypochlorite (NaOCl) in an amount in the range of 0.015 to 0.15% by weight, hypochlorous acid (HOCl) in an amount in the range of 0.002 to 0.1% by weight, a thickening agent based on synthetic silicate clay in an amount in the range of 1 to 10% by weight, sodium chloride (NaCl) in an amount in the range of 0.03 to 0.3% by weight and purified water, wherein the purified water before addition to the composition has a hardness measured in accordance with ISO 15923-2:2017 of less than 5 ppm and a resistivity measured in accordance with ISO 3696:1987 of greater than 15 MΩ / cm, and wherein the composition has a pH in the range of 7.5 to 10.0. Petition 870260073974, dated 07 / 24 / 2026, page 10 / 85 4 / 35

[012] In a second aspect, a method (400) is provided for the manufacture of an antimicrobial composition, the method comprising the steps of: a) provide I. purified water, wherein the purified water, prior to addition to the composition, has a hardness measured according to ISO 159232:2017 of less than 5 ppm and a resistivity measured according to ISO 3696:1987 of greater than 15 MΩ / om; ii. a thickening agent based on synthetic silicate clay; iii. a sodium hypochlorite solution, and iv. sodium chloride; and b) Mix purified water, a synthetic silicate clay-based thickening agent, a sodium hypochlorite solution, and sodium chloride to obtain an antimicrobial composition with a pH in the range of 7.5 to 10.0.

[013] In a third aspect, a valve system apparatus for wound treatment is provided, said valve system apparatus comprising a bag-over-valve (Bov) within a pressurized storage container;and an antimicrobial composition for wound treatment contained in said bag, said antimicrobial composition comprising sodium hypochlorite (NaOCl) in an amount ranging from 0.015 to 0.15% by weight, hypochlorous acid (HOCl) in an amount ranging from 0.003 to 0.03% by weight, a thickening agent based on synthetic silicate clay in an amount ranging from 1 to 10% by weight, sodium chloride (NaCl) in an amount ranging from 0.03 to 0.3% by weight and purified water, wherein the purified water, prior to addition to the composition, has a hardness measured in accordance with ISO 15923-2:2017 of less than 5 ppm and a resistivity measured in accordance with ISO 3696:1987 of greater than 15 MΩ / cm, wherein the composition has a pH of; Petition 870260073974, dated 07 / 24 / 2026, page 11 / 85 5 / 35 range from 7.5 to 10.0, and in which the β buffering capacity measured at pH 8.0 is 0.15 or less.

[014] In a fourth aspect, a method is provided for the production of a valve system apparatus for wound treatment, comprising the steps of: a) placing a bag over a valve (BoV) inside a storage container; b) pressing the BoV into the storage container, followed by filling said storage container with propellant gas to obtain a pressurized storage container; and c) Filling the BoV bag with the antimicrobial composition, as described above, via the BoV valve.

[015] In a fifth aspect, a method is provided for administering an antimicrobial composition to a wound, said method comprising the step of applying an antimicrobial composition to a wound, said antimicrobial composition comprising sodium hypochlorite (NaOCl) in an amount in the range of 0.015 to 0.15% by weight, hypochlorous acid (HOCl) in an amount in the range of 0.003 to 0.03% by weight, a synthetic silicate clay-based thickening agent in an amount in the range of 1 to 10% by weight, sodium chloride (NaCl) in an amount in the range of 0.03 to 0.3% by weight and purified water, wherein the purified water, prior to addition to the composition, has a hardness measured in accordance with ISO 15923-2:2017 of less than 5 ppm and a resistivity measured in accordance with ISO 3696:1987 of greater than 15 MΩ / ot, where the composition has a pH in the range of 7.5 to 10.0, and where the β buffering capacity measured at pH 8.0 is 0.15 or less.

[016] In a sixth aspect, a method is provided for the treatment of a wound, in which an antimicrobial composition comprising is applied to the wound Petition 870260073974, dated 07 / 24 / 2026, p. 12 / 85 6 / 35 Sodium hypochlorite (NaOCl) in an amount ranging from 0.015 to 0.15% by weight, hypochlorous acid (HOCl) in an amount ranging from 0.002 to 0.1% by weight, synthetic silicate clay-based thickening agent in an amount ranging from 1 to 10% by weight, sodium chloride (NaCl) in an amount ranging from 0.03 to 0.3% by weight and purified water, wherein the purified water prior to addition to the composition has a hardness measured in accordance with ISO 15923-2:2017 of less than 5 ppm and a resistivity measured in accordance with ISO 3696:1987 of greater than 15 MΩ / ot, wherein the composition has a pH ranging from 7.5 to 10.0, and wherein the buffering capacity β measured at pH 8.0 is 0.15 or less.

[017] In a seventh aspect, a composition is provided comprising sodium hypochlorite (NaOCl) in an amount ranging from 0.015 to 0.15% by weight, hypochlorous acid (HOCl) in an amount ranging from 0.002 to 0.1% by weight, a thickening agent based on synthetic silicate clay in an amount ranging from 1 to 10% by weight, sodium chloride (NaCl) in an amount ranging from 0.03 to 0.3% by weight and purified water, wherein the purified water before addition to the composition has a hardness measured according to ISO 159232:2017 of less than 5 ppm and a resistivity measured according to ISO 3696:1987 of greater than 15 MΩ / ot, wherein the composition has a pH ranging from 7.5 to 10.0, and wherein the buffering capacity β measured at pH 8.0 is 0.15 or lower for the prevention or treatment of wound infections.

[018] Other embodiments of the present invention are defined in the appended dependent claims.

[019] These and other aspects of the modalities described herein will be better appreciated and understood when considered together with the attached description and drawings. It should be understood, however, that the following descriptions, while indicating certain modalities and numerous specific details thereof, are provided for illustrative purposes only and are not limiting. Many alterations and modifications may occur. Petition 870260073974, dated 07 / 24 / 2026, p. 13 / 85 7 / 35 to be performed within the scope of the modalities described herein without departing from their spirit, and the modalities described herein include all such modifications.

[020] One advantage of the invention is that the sensation of pain on the skin can be suppressed while simultaneously increasing the antimicrobial effect locally in an open wound where it is needed. This is due to the low buffering capacity. The pH is slightly higher than neutral, i.e., above 7.5, and is therefore less irritating to the skin. In a wound, the pH is typically lower than 7.5, and due to the low buffering capacity of the antimicrobial gel, the pH of the antimicrobial gel will be lower than 7.5 when mixed with the fluid in the wound. Due to the lower pH, the antimicrobial effect will be greater locally in the wound. Thus, the improved antimicrobial effect is localized where needed, i.e., in the wound. At the same time, the skin is not irritated by a low pH.

[021] One advantage of the invention is that the antimicrobial composition is provided in gel form, which makes possible additional treatment methods compared with an aqueous solution, which is not in gel form. A gel can be applied, for example, to a skin wound and will remain on the skin with a certain thickness and moist for a time, so that it can exert its antimicrobial action over a long period of time.

[022] The shelf life is significantly improved, which is an advantage compared with many other compositions comprising sodium hypochlorite and hypochlorous acid, particularly in gel form. For many similar compositions in the prior art, a short shelf life is a problem. Brief Description of the Drawings

[023] Other objects, features and advantages of the invention will become apparent from the following description, when read with reference to the accompanying drawings. In the drawings, where similar reference numbers denote corresponding parts along the various views: Petition 870260073974, dated 07 / 24 / 2026, page 14 / 85 8 / 35

[024] Table 1 illustrates the composition of each ingredient of the antimicrobial composition of the present technology, according to one embodiment. The composition of the active ingredient is determined by the Iodometric Titration Method, following the ISO 7393-3: 1990 (E) Water Quality - Determination of Free Chlorine and Total Chlorine - Part 3: Iodometric Titration Method for the Determination of Total Chlorine. Table 1 INGREDIENT COMPOSITION SODIUM HYPOCHLORITE (NaOCl) 0.05% by weight HYPOCHLOROUS ACID (HOCl) 0.01% by weight SODIUM CHLORIDE (NaCl) 0.10% by weight LITHIUM, MAGNESIUM AND SODIUM SILICATE 4.00% by weight PURIFIED WATER 95.85% by weight

[025] Table 2 illustrates the results of the preservative test, according to the USP preservative efficacy test, according to an exemplary scenario. The USP 41 NF 36 method, Chapter 51, is used in conducting the antimicrobial efficacy challenge test. Table 2 Microorganism Inoculum cfu / ml 0 h Red Log 14d Red Log 28d Red Log Apr / Rep S. aureus AMS 027 (ATCC 6538) 5.7 x 10⁵ <10⁵ 5.8 <10⁵ 5.8 <10⁵ 5.8 Approved P. aeruginosa AMS 095 7.5 x 10⁵ <10⁵ 5.9 <10⁵ 5.9 <10⁵ 5.9 Approved (ATCC 9027) E. coli AMS 006 (ATCC 8739) 6.2 x 10⁵ <10⁵ 5.8 <10⁵ 5.8 <10⁵ 5.8 Approved C. albicans AMS 003 (ATCC 10231) 8.1 x 10⁵ 7.0 x 10³ 2.1 <10⁵ 5.9 <10⁵ 5.9 Approved A. brasiliensis AMS 032 (ATCC 16404) 2.9 x 10⁵ 8 x 10¹ 3.6 <10 5.5 <10 5.5 Approved Petition 870260073974, dated 07 / 24 / 2026, page 15 / 85 9 / 35 Enterococcus faecalis (VRE) (ATCC 51299) 6.2 x 10⁵ <10⁵ 5.8 <10⁵ 5.8 <10⁵ 5.8 Approved Staphylococcus aureus (MRSA) (ATCC 33591) 5.2 x 10⁵ <10⁵ 5.7 <10⁵ 5.7 <10⁵ 5.7 Approved Escherichia coli (CRE) ATCC BAA-2452 6.3 x 10⁵ <10⁵ 5.8 <10⁵ 5.8 <10⁵ 5.8 Approved Serratia marcescens* 1.5 x 10⁶ <10⁵ 0.0 <10⁵ 5.5 <10⁵ 5.5 Approved

[026] Table 3 illustrates the results of biocompatibility tests of the antimicrobial composition of the present technology, according to ISO 10993 Biological evaluation of medical devices for in vivo and in vitro studies, according to an exemplary scenario. Biocompatibility tests, including cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity and material-mediated pyrogen tests, were conducted. Table 3 Biocompatibility Test Result Intracutaneous reactivity irritation No evidence of erythema or edema Cytotoxicity No cytotoxic effect Acute oral toxicity No oral toxicity Skin sensitization study Not sensitizing Pyrogen test No

[027] Figure 1 is a flowchart illustrating the steps involved in the production method of the antimicrobial composition of the present technology, according to one embodiment.

[028] Figure 2 provides an example of the process of packaging the antimicrobial composition of the present invention in a valve system apparatus comprising BoV. Detailed Description of the Invention Petition 870260073974, dated 07 / 24 / 2026, page 16 / 85 10 / 35

[029] Before disclosing and describing the invention in detail, it should be understood that it is not limited to the specific configurations, process steps, and materials described herein, as such configurations, process steps, and materials may vary somewhat. It should also be understood that the terminology employed herein is used only to describe specific embodiments and is not intended to be limiting, since the scope of the present invention is limited only by the appended and equivalent claims thereof.

[030] It should be noted that, as used in this descriptive report and the attached claims, the singular forms a, an and the include plural referents, unless the context clearly indicates otherwise.

[031] The following terms are used throughout the description and claims.

[032] Antimicrobial, as used herein, is the property of suppressing or eliminating microbial growth. Microbial growth includes, but is not limited to, bacterial growth.

[033] Buffer capacity, as used herein, is a quantitative measure of the resistance to pH change of a solution containing a buffering agent with respect to a change in the concentration of acid or alkali. It can be defined as β = díC! , d(pH) where d(C) is an infinitesimal amount of base added or acid added and where d(pH) is an infinitesimal change in pH.

[034] Buffer capacity depends on pH. For a weak acid, buffer capacity increases to a local maximum at pH = pKa. The height of this peak depends on the pKa value. Buffer capacity is negligible when the concentration Petition 870260073974, dated 07 / 24 / 2026, page 17 / 85 11 / 35 [HA] of the buffering agent is very small and increases with increasing concentration of the buffering agent.

[035] The buffering capacity β of the gel present must be less than 0.15. Buffering capacity is measured at pH 8.0. A lower buffering capacity is generally better, as the pH in an open wound containing a fluid with a pH lower than the pH of the gel will decrease more. This, in turn, will result in more pronounced antimicrobial activity. Therefore, a lower buffering capacity is generally better than a higher buffering capacity. The upper limit of buffering capacity β = 0.15 should be considered an upper limit, and therefore a lower buffering capacity is still better. Thus, the buffering capacity can, in different embodiments, be less than β = 0.15, 0.14, 0.13, 0.12, 0.11, 0.10, 0.090, 0.080, 0.070, 0.060, 0.050, 0.040, 0.030, 0.020 and 0.010. The buffering capacity is measured at pH 8.0. In one embodiment, the upper limit for the buffering capacity is such that it corresponds to the buffering capacity of the ingredients according to claim 1, i.e., without added buffer.In an alternative embodiment, the limit for buffering capacity is replaced by a restriction that no buffer may be added beyond the ingredients according to claim 1.

[036] The current buffering capacity of 0.15 or less is lower than the buffering capacity in document CN 113069413, which is about 0.19. Thus, the pH of the current gel changes more in a wound, so that the pH becomes more similar to that of the wound, which is typically less than pH 7.5. At a lower pH, the composition is more antimicrobial.

[037] In the table below, the buffering capacity of document CN 113069413 and the contents of the present formulation are investigated. For the actual gel, the contents are shown for the minimum and maximum quantities of the ingredients. Petition 870260073974, dated 07 / 24 / 2026, page 18 / 85 12 / 35 Table 4 CN 113069413 Actual Gel Min Actual Gel Max % by weight % by weight % by weight Lithium magnesium silicate 4.000 1.000 10.000 Pure water 52.538 98.953 89.450 Phosphate buffer Boric acid diphosphate Potassium Hydrogen Sodium chloride Pure water 1.600 1.600 0.200 40.000 Sodium chloride 0.000 0.030 0.300 Hypochlorous acid 0.002 0.002 0.100 Sodium hypochlorite 0.060 0.015 0.150 100.000 100.000 100.000

[038] Using the Henderson-Hasselbalch equation, the numbers above were redefined / calculated theoretically using the formula below. pH = pKa + Log (A) / (HA) Table 5 CN 113069413 Current gel min Current gel max Sodium hypochlorite pKa 7.52 7.52 7.52 Base concentration (A) 0.2 0.03 0.3 Acid concentration (HA) 1.602 0.002 0.1 Estimated pH 6.62 8.70 8.00

[039] The buffering capacity for document CN 113069413 is calculated using the molarity of Boric Acid, as shown below: Table 6 Using β = η / ΔρH Molarity of boric acid 0.0378 Buffer limits for D1 β 0.189

[040] It can be clearly observed that the buffering capacity of the current gel must be considerably lower than the buffering capacity of document CN 113069413, since document CN 113069413 contains a phosphate buffer, which the current gel does not contain. Petition 870260073974, dated 07 / 24 / 2026, page 19 / 85 13 / 35

[041] Based on the calculation above, the buffer capacity for D1 is estimated to be 0.189.

[042] In the detailed description that follows, several specific details are presented to provide a complete understanding of the invention. However, it will be understood by those skilled in the art that the invention can be practiced without these specific details. In other cases, well-known methods, procedures and / or components have not been described in detail so as not to obscure the invention.

[043] In the first aspect, an antimicrobial composition is provided, comprising sodium hypochlorite (NaOCl) in an amount ranging from 0.015 to 0.15% by weight, hypochlorous acid (HOCl) in an amount ranging from 0.002 to 0.1% by weight, a thickening agent based on synthetic silicate clay in an amount ranging from 1 to 10% by weight, sodium chloride (NaCl) in an amount ranging from 0.03 to 0.3% by weight and purified water, wherein the purified water before addition to the composition has a hardness measured according to ISO 15923-2:2017 of less than 5 ppm and a resistivity measured according to ISO 3696:1987 of greater than 15 MΩ / cm, wherein the composition has a pH ranging from 7.5 to 10.0 and wherein the buffering capacity measured in pH 8.0 is 0.15 or less.

[044] One advantage of the present invention is that the composition increases moisture within the wound, making it effective in aiding the debridement and desquamation process in dry necrotic wounds. The composition is indicated for moistening and debriding acute and chronic wounds, such as stage I-IV ulcers, venous stasis and diabetic ulcers, post-surgical wounds, first and second-degree burns, and pressure sores. The antimicrobial composition of the present technology helps maintain a moist wound environment, promotes granulation and epithelialization, and facilitates autolytic debridement. The composition possesses antimicrobial properties. Sodium hypochlorite provides properties Petition 870260073974, dated 07 / 24 / 2026, page 20 / 85 14 / 35 bacteriostatic. The antimicrobial composition is a transparent composition that helps maintain a moist wound environment that is conducive to wound healing.

[045] Several additives have been found to impair the shelf life of compositions containing sodium hypochlorite and hypochlorous acid. For example, several impurities, as well as additives in the water used to prepare the composition, have been found to accelerate the degradation of active antimicrobial substances, so that the activity of the composition decreases and the shelf life becomes unacceptably short. Although the detailed reaction mechanism is not known at a molecular level, the inventors have found that high water hardness and the presence of metal ions accelerate the degradation of the active compounds.

[046] Water hardness is measured according to ISO 15923-2:2017 as total hardness and is shown in ppm. In one embodiment, hardness does not exceed 5 ppm. In one embodiment, hardness does not exceed 4 ppm. In one embodiment, hardness does not exceed 3 ppm. In one embodiment, hardness does not exceed 2 ppm. In one embodiment, hardness does not exceed 1 ppm.

[047] The content of metal ions is measured by the resistivity of the water. This is a good approximation, since the positive counter-ions are, in most cases, metal ions and it is also assumed that H+ contributes to the degradation of the active ingredients. The conductivity of the water (i.e., the inverse of the resistivity) is measured as described in ISO 3696: 1987 and then the resistivity is calculated as the inverse. The resistivity is, in one instance, greater than 15 MΩ / ot. In one instance, the resistivity is greater than 16 MΩ / cm. In one instance, the resistivity is greater than 17 MΩ / cm. In one instance, the resistivity is greater than 17.2 MΩ / cm. In one instance, the resistivity is greater than 17.5 MΩ / cm.

[048] In particular, the inventors believe that the combination of high water hardness and the presence of metal ions contributes to accelerated degradation. Petition 870260073974, dated 07 / 24 / 2026, p. 21 / 85 15 / 35 of the active components. Therefore, it is important that both the amount of metallic ions and the water hardness are kept low for the water used to prepare the composition. When water hardness and resistivity are kept within the above limits (i.e., resistivity greater than 15 MΩ / ot and hardness less than 5 ppm), the shelf life of the composition increases.

[049] In addition, other quality criteria are also appropriate for the water used in the preparation of the product, mainly because the composition is a medical product and must meet high standards.

[050] TOC is measured according to ISO 20236:2018 and recalculated to ppb by weight. In one modality, the TOC does not exceed 50 ppb. In one modality, the TOC is less than 10 ppb. All values ​​are calculated by weight.

[051] The TDS measured in accordance with ASTM D5907-10 does not exceed, in one embodiment, 50 ppm by weight. In one embodiment, the TDS does not exceed 15 ppm. In another embodiment, the TDS does not exceed 5 ppm. All values ​​are calculated by weight.

[052] In addition, heavy metal levels must be low. In one embodiment, the amount of the heavy metals arsenic, cadmium and lead is together less than 0.1 ppm by weight.

[053] In fact, it has been found that the selection of the thickener is not trivial, since it must be medically acceptable and must not accelerate the decomposition of the active antimicrobial components. All additives in the composition have the potential to accelerate the decomposition of the active ingredients and, therefore, all additives must be carefully selected so that they do not accelerate the decomposition of the antimicrobial compounds in the composition. The selected synthetic silicate clay-based thickening agent has been found to meet these requirements. In particular, the antimicrobial ingredients are not degraded when a synthetic silicate clay-based thickening agent is used and when Petition 870260073974, dated 07 / 24 / 2026, page 22 / 85 16 / 35 the amount of metallic ions and the hardness of the water are within the necessary limits.

[054] The use of a synthetic silicate clay-based thickening agent, together with the use of water with a resistivity above 15 MΩ / ot and a hardness below 5 ppm, provides an improved service life, as it does not accelerate the decomposition of antimicrobial agents.

[055] All the above limits for water apply to purified water before the addition of water to the blend.

[056] In one embodiment, the amount of sodium hypochlorite is in the range of 0.04 to 0.06% by weight.

[057] In one embodiment, the amount of hypochlorous acid (HOCl) is in the range of 0.005 to 0.02% by weight. This range of NaOCl and HOCl concentrations has demonstrated good biocompatibility and efficacy against microorganisms.

[058] In one embodiment, the amount of sodium chloride is in the range of 0.05 to 0.2% by weight. This range of NaCl is suitable for use as stabilizing and preservative ingredients.

[059] In one embodiment, the synthetic silicate clay-based thickening agent comprises lithium, magnesium and sodium silicate.

[060] In one embodiment, the synthetic silicate clay-based thickening agent is present in an amount in the range of 3 to 5% by weight. This synthetic silicate clay is considered suitable for retaining the active ingredients in semi-liquid form. Other thickeners, such as dimethicone, carboxymethylcellulose, xanthan gum, and carbomer, were unable to retain the active ingredients and did not produce the desired gel.

[061] In one embodiment, purified water constitutes the remaining part of the composition, in addition to sodium hypochlorite (NaOCl), hypochlorous acid (HOCl), a thickening agent based on synthetic silicate clay, and sodium chloride (NaCl). Water Petition 870260073974, dated 07 / 24 / 2026, page 23 / 85 17 / 35 purified water is necessary to ensure that there are no other ions present in the gel that could compromise the stability of the active ingredients.

[062] The composition has a pH above 7.5. In one embodiment, the composition has a pH in the range of 7.5 to 10.0. The growth of wound healing cells, including fibroblasts and keratinocytes, is facilitated by an alkaline pH (Teshima et al., 2020). In an alternative embodiment, the composition has a pH in the range of 7.5 9.5 In an alternative version, the composition has a pH in the range of 7.5. 9.0. In an alternative embodiment, the composition has a pH in the range of 8.0. 9.0. In an alternative embodiment, the composition has a pH in the range of 8.0. 9.5 In an alternative embodiment, the composition has a pH in the range of 8.0. 10.0. For the invention in general, including the description, examples and claims, pH is measured following the method described in the standard. ASTM E70-19.

[063] In relation to the state of the art, including document CN 113069413 A, the prior art of the present invention exhibits a much lower buffering capacity. It is known that the intensity of pain sensation is much lower at a high pH compared to a lower pH. (Amiloride-blockable acid-sensing ion channels are leading acid sensors expressed in human nociceptors, Shinya Ugawa, J. Clin. Invest. 110:1185-1190 (2002). doi: 10.1172 / JCI200215709). Therefore, a pH higher than neutral is suitable in relation to pain sensation.

[064] However, the pH decreases in a wound with a lower pH due to the low buffering capacity. A wound normally has a pH less than 7.5. This provides a greater antimicrobial effect locally in the wound.

[065] Hypochlorous acid (HOCl) is present in an equilibrium such that, at a very low pH, below about 1.5, Cl2 is the dominant species; between pH 1.5 and 7.5, HOCl is the dominant species; and above pH 7.5, (OCl)- is the dominant species. Hypochlorous acid (HOCl) is present in different forms Petition 870260073974, dated 07 / 24 / 2026, p. 24 / 85 18 / 35 depending on the pH; although it is mainly present as (OCl)- in the present invention, at a pH above 7.5, it is referred to as hypochlorous acid (HOCl). It is also known that the HOCl species, which is the dominant species at pH 1.5 to 7.5, is the most antibacterial compared to (OCl)-. In view of this, it is natural that many antibacterial compositions involving hypochlorous acid (HOCl) have a pH in the range of 1.5 to 7.5. Due to the low buffering capacity of the gel, it mixes with fluids in a wound, so that the pH becomes lower and HOCl becomes the dominant species with a greater antimicrobial effect locally in the wound. Normally, wounds have a pH below 7.5. Therefore, the composition is particularly suitable for the treatment of wounds with neutral or acidic pH.

[066] The pH of the present invention above 7.5 provides sufficient antimicrobial activity for wound treatment. At the same time, there is an additional effect that provides further antimicrobial activity. Most wounds have a neutral pH, and for an open wound, the composition of the present invention will be mixed with fluid in the open wound, and then the pH of the mixture will be less than 7.5. This reduction in pH will increase the antimicrobial effect of the composition. It should be noted that this effect is present in the wound and very close to it, where the composition is mixed with wound fluid. This provides the advantage of a local increase in the antimicrobial effect exactly where it is desired, i.e., within and / or near the wound. Further away from the open wound, the composition according to the present invention will be less irritating to the skin due to the higher pH value. Thus, the invention combines less irritation with an antimicrobial effect when needed.

[067] It should be noted that the buffering capacity in the composition according to the present invention is low, so the pH value is affected by the fluid in an open wound. In relation to this, it should be noted that document CN 113069413 comprises a phosphate buffer, so that the pH in an open wound does not change. Petition 870260073974, dated 07 / 24 / 2026, p. 25 / 85 19 / 35 noticeably. Therefore, it is an advantage that the composition according to the present invention does not contain a buffer.

[068] In one embodiment, the viscosity of the composition is in the range of 8000-10000 cp. This high viscosity allows the gel to remain in the wound cavity and provide more moisture. Viscosity is measured using a Brookfield viscometer, in accordance with ISO 2555:2018 Plastics — Liquid resins or as emulsions or dispersions — Determination of apparent viscosity using a single-cylinder type rotational viscometer method.

[069] In the second aspect, a method (400) is provided for the manufacture of an antimicrobial composition, the method comprising the steps of: a) provide i. purified water, wherein the purified water, prior to addition to the composition, has a hardness measured in accordance with ISO 159232:2017 of less than 5 ppm and a resistivity measured in accordance with ISO 3696:1987 of greater than 15 MΩ / om; ii. a thickening agent based on synthetic silicate clay; iii. a sodium hypochlorite solution; and iv. sodium chloride, and b) Mix purified water, the synthetic silicate clay-based thickening agent, sodium hypochlorite solution, and sodium chloride to obtain the antimicrobial composition, wherein the composition has a pH in the range of 7.5 to 10.0, and wherein the β buffering capacity measured at pH 8.0 is 0.15 or less. [0 70] In a specific modality of the second aspect, the method comprises the following steps: a) fill (402) a container with purified water; Petition 870260073974, dated 07 / 24 / 2026, p. 26 / 85 20 / 35 b) add (406) Lithium, Magnesium and Sodium Silicate during mixing and stir (408) for at least 90 seconds; c) add (410) a sodium hypochlorite solution and stir for at least 30 seconds; and d) add (412) sodium chloride (NaCl) to the mixture and stir for at least 120 seconds.

[071] This specific modality is illustrated in Figure 1. In one modality, steps b) ad) in Figure 1 are performed in sequential order.

[072] In one embodiment, the sodium hypochlorite solution in step c) has a concentration in the range of 4 to 8% by weight.

[073] In the third aspect, a valve system apparatus for wound treatment is provided, said valve system apparatus comprising: a bag over valve (Bov) within a pressurized storage container;and an antimicrobial composition for wound treatment contained in said bag, said antimicrobial composition comprising sodium hypochlorite (NaOCl) in an amount ranging from 0.015 to 0.15% by weight, hypochlorous acid (HOCl) in an amount ranging from 0.003 to 0.03% by weight, a thickening agent based on synthetic silicate clay in an amount ranging from 1 to 10% by weight, sodium chloride (NaCl) in an amount ranging from 0.03 to 0.3% by weight and purified water, wherein the purified water, prior to addition to the composition, has a hardness measured according to ISO 159232:2017 of less than 5 ppm and a resistivity measured according to ISO 3696:1987 of greater than 15 MΩ / ot, wherein the composition has a pH in the range of 7.5 to 10.0 and wherein the buffering capacity β measured at pH 8.0 is 0.15 or less.

[074] In one embodiment, the pressurized storage container comprises a non-flammable propellant. Petition 870260073974, dated 07 / 24 / 2026, p. 27 / 85 21 / 35

[075] In one embodiment, the said pressurized storage container is an aerosol spray container.

[076] In the fourth aspect, a method is provided for producing a valve system apparatus for wound treatment, comprising the steps of: a) placing the bag over the valve (BoV) inside the storage container; b) pressing the BoV into the storage container, followed by filling said storage container with propellant gas to obtain a pressurized storage container; and c) Filling the BoV bag with the antimicrobial composition, as described above, through the BoV valve.

[077] In one embodiment, the aforementioned steps a) ac) of the aforementioned method for producing a valve system apparatus for wound treatment are performed sequentially.

[078] In the fifth aspect, a method is provided for administering an antimicrobial composition to a wound, said method comprising the step of applying an antimicrobial composition to a wound, said antimicrobial composition comprising sodium hypochlorite (NaOCl) in an amount in the range of 0.015 - 0.15% by weight, hypochlorous acid (HOCl) in an amount in the range of 0.003 - 0.03% by weight, synthetic silicate clay-based thickening agent in an amount in the range of 1 to 10% by weight, sodium chloride (NaCl) in an amount in the range of 0.03 to 0.3% by weight and purified water, wherein the purified water before addition to the composition has a hardness measured in accordance with ISO 15923-2:2017 of less than 5 ppm and a resistivity measured in accordance with ISO 3696:1987 of greater than 15 MΩ / ot, wherein the composition has a pH in the range of 7.5 to 10.0, and wherein the β buffering capacity measured at pH 8.0 is 0.15 or less. Petition 870260073974, dated 07 / 24 / 2026, page 28 / 85 22 / 35

[079] Several embodiments of the present invention provide an antimicrobial composition for the treatment of wounds and a method for producing the antimicrobial composition. The antimicrobial composition comprises sodium hypochlorite (NaOCl), hypochlorous acid (HOCl), a thickening agent based on synthetic silicate clay, sodium chloride (NaCl), and purified water, wherein the purified water must meet certain hardness and resistivity criteria.

[080] In the sixth aspect, a method is provided for treating a wound, in which an antimicrobial composition is applied to the wound comprising sodium hypochlorite (NaOCl) in an amount ranging from 0.015 to 0.15% by weight, hypochlorous acid (HOCl) in an amount ranging from 0.002 to 0.1% by weight, a thickening agent based on synthetic silicate clay in an amount ranging from 1 to 10% by weight, sodium chloride (NaCl) in an amount ranging from 0.03 to 0.3% by weight and purified water, wherein the purified water before addition to the composition has a hardness measured according to ISO 15923-2:2017 of less than 5 ppm and a resistivity measured according to ISO 3696:1987 of greater than 15 MΩ / ot, wherein the composition has a pH in the range of 7.5 to 10.0, and where the β buffering capacity measured at pH 8.0 is 0.15 or less.

[081] In the seventh aspect, a composition is provided comprising sodium hypochlorite (NaOCl) in an amount ranging from 0.015 to 0.15% by weight, hypochlorous acid (HOCl) in an amount ranging from 0.002 to 0.1% by weight, a thickening agent based on synthetic silicate clay in an amount ranging from 1 to 10% by weight, sodium chloride (NaCl) in an amount ranging from 0.03 to 0.3% by weight and purified water, wherein the purified water before addition to the composition has a hardness measured according to ISO 159232:2017 of less than 5 ppm and a resistivity measured according to ISO 3696:1987 of greater than 15 MΩ / ot, wherein the composition has a pH ranging Petition 870260073974, dated 07 / 24 / 2026, p. 29 / 85 23 / 35 from 7.5 to 10.0, and where the β buffering capacity measured at pH 8.0 is equal to or less than 0.15 for the prevention or treatment of wound infections.

[082] Thus, the sixth and seventh aspects provide for the treatment of wounds and, in particular, the prevention and / or treatment of wound infections.

[083] The antimicrobial composition of the present technology has a pH above 7.5 and available free chlorine (30 ppm to 200 ppm) and will be able to eliminate a wide range of microorganisms, including bacteria and fungi. In one embodiment, the available free chlorine, as measured according to ISO 73932:2017, is in the range of 30 to 200 ppm. The available free chlorine gives the composition the ability to eliminate a wide range of microorganisms, including bacteria and fungi.

[084] In one embodiment, the antimicrobial composition of the present invention is a hemostatic agent. In another embodiment, the antimicrobial composition of the present invention is a chemical hemostatic agent. Said antimicrobial composition, when applied, promotes hemostasis and is capable of stopping or delaying bleeding from a wound.

[085] In one embodiment of the invention, a valve system for wound treatment is provided. Said valve system comprises or consists of a bag within a pressurized storage container, and an antimicrobial composition for wound treatment contained in said bag. Said antimicrobial composition comprises sodium hypochlorite (NaOCl), hypochlorous acid (HOCl), a thickening agent based on synthetic silicate clay, sodium chloride (NaCl), and purified water. In one embodiment, the antimicrobial composition of the invention is a composition when stored within said valve system apparatus. In another embodiment, the antimicrobial composition of the invention is an aerosol spray composition when sprayed out of said valve system apparatus or when applied to a wound through said apparatus. Petition 870260073974, dated 07 / 24 / 2026, p. 30 / 85 24 / 35 valve system apparatus. In one embodiment, the antimicrobial composition of the invention, when applied from the valve system apparatus to a wound, becomes aerated and becomes a pulverized composition in the form of foam on the wound. In another embodiment, the bag containing an antimicrobial composition for wound treatment is propellant-free or free of chemical propellant. The present invention of a valve apparatus does not use a chemical propellant in contact with the antimicrobial composition of the present invention.

[086] In one embodiment, said pressurized storage container of the valve system apparatus of the invention comprises a chemical propellant. In particular, the present invention does not use any flammable material, nor any flammable propellant, which also provides a reduced risk when handling said valve system apparatus when exposed to high temperatures or ignition. The fact that the valve system apparatus of the present invention does not use any flammable material also allows for a prolonged and preserved service life, since flammability is not a concern, especially when said valve system apparatus is stored.

[087] The chemical propellant contained in the pressurized storage container provides pressure to the bag within the pressurized storage container, which allows the composition within said bag to be indirectly propelled out of the valve system apparatus when the composition is being applied. Because the chemical propellant is contained outside the bag, the separation of the chemical propellant into the bag prevents any alteration in the quality or properties of the antimicrobial composition stored in said bag. In one embodiment, said chemical propellant is nitrogen gas. The use of nitrogen gas as a propellant is not only non-flammable, inert, and has an extremely low boiling point (-195°C), but also helps maintain the flow of Petition 870260073974, dated 07 / 24 / 2026, page 31 / 85 25 / 35 more viscous liquids pass through the tubing, allowing for the distribution of approximately 99.9% by weight of the compositions stored in the bag.

[088] In one embodiment, the pressurized storage container used in the aforementioned valve system apparatus of the invention is an aerosol spray container suitable for use in spraying foams or foam-like compositions. The utility of a valve system in the apparatus of the present invention allows the product to be dispensed in its pure form, i.e., without the mixing of any other unnecessary components, allowing storage through said valve system to receive larger quantities of composition compared to traditional and pre-existing bag-on-valve packaging. Furthermore, the valve system of the present invention allows the distribution of the stored antimicrobial composition at 99.99% by weight, avoiding any remaining unused composition.The present valve system apparatus can also be used for continuous and uninterrupted spraying at any angle with uniform / controlled flow and spray pattern, unlike traditional aerosol spray systems, which vary in spray quantity when tilted. This property of the valve system apparatus allows it to be used in the application of first aid solutions in unusual or difficult injury cases, such as accidents involving severely immobilized persons, or accidents requiring precise movements and handling. Therefore, the valve system of the present invention provides improved overall efficiency in wound treatment, superior to that of the prior art. Furthermore, the aerated compositions produced from said valve system provide a cooling effect to the wound, thus providing greater pain relief to the injured individual. Petition 870260073974, dated 07 / 24 / 2026, p. 32 / 85 26 / 35

[089] In one embodiment, said valve system comprises a bag-over-valve (BoV) system. In one embodiment, where said valve system comprises a BoV system, said BoV comprises a bag coupled to a valve. Said bag coupled to a valve is folded, rolled or compressed, not containing any material configured to receive any liquid or fluid material that enters the bag through the valve.

[090] In another embodiment of the invention, a method is presented for producing a valve system apparatus for wound treatment. Said method comprises the steps of placing a bag over valve (BV) inside a storage container, pressing the BV into the storage container, followed by filling said storage container with propellant gas to obtain a pressurized storage container, and filling the BV bag with an antimicrobial composition through the BV valve.

[091] With reference to Table 1, Table 1 illustrates the composition of each ingredient of the antimicrobial composition, according to a specific embodiment. The antimicrobial composition of the present technology possesses antimicrobial properties. In one embodiment, as shown in Table 1, in the antimicrobial composition, sodium hypochlorite is 0.05% by weight, hypochlorous acid (HOCl) is 0.01% by weight, sodium chloride is 0.10% by weight, the synthetic silicate clay-based thickening agent is 4.0% by weight, and purified water is 95.85% by weight. In one embodiment, the synthetic silicate clay-based thickening agent includes lithium, magnesium, and sodium silicate. In one embodiment, the lithium, magnesium, and sodium silicate composition is 4.0% by weight.

[092] Table 2 presents the results of the preservative test, according to the USP (United States Pharmacopeia) preservative efficacy test, in an exemplary scenario. The antimicrobial composition of the present technology was Petition 870260073974, dated 07 / 24 / 2026, p. 33 / 85 27 / 35 tested according to USP 51 and preservative efficacy test by an accredited laboratory to demonstrate the bacteriostatic effect. Table 2 presents the result of the preservative test of the composition. As can be observed in Table 2, the bacteriostatic properties were conferred, among other things, by the addition of sodium hypochlorite, which causes alterations in the biosynthesis of cellular metabolism and inhibits the growth of bacteria in the action of the preservative. The effect on reducing the microbial population was proven in vitro for clinically relevant strains known to cause wound infection, both gram-positive and gram-negative bacteria, as well as fungi.

[093] Table 3 presents the biocompatibility test results of the antimicrobial composition of the present technology, according to ISO 10993 (International Organization for Standardization), for in vivo and in vitro studies, according to an exemplary scenario. As shown in Table 3, there is no evidence of erythema or edema during the intracutaneous reactivity irritation test with the antimicrobial composition of the present technology. Furthermore, there is no cytotoxic effect or oral toxicity from the antimicrobial composition of the present technology.

[094] Figure 1 is a flowchart describing the steps involved in a specific embodiment of the manufacturing method of the antimicrobial composition of the present technology. The method produces approximately 3 liters of composition. In step 402, the method includes filling 3 liters of purified water into a container. In step 404, the method includes operating a high-shear mixing machine and setting a speed of 2000 rpm. In step 406, it includes the slow addition of 120 g ± 1 g of lithium magnesium sodium silicate (thickening agent) to the solution, starting from the edge of the container. In step 408, the method includes continuous stirring of the mixture at 2000 rpm for 30 minutes. In step 410, the method includes adding 30 mL ± 0.05 mL of sodium hypochlorite solution (4% by weight - 8% by weight). Petition 870260073974, dated 07 / 24 / 2026, page 34 / 85 28 / 35 slowly from the edge to the mixture and stir for 5 minutes at 5500 rpm. In step 412, the method includes adding 3.0 g ± 0.1 g of vacuum-dried (PDV) pure salt (NaCl) to the mixture. In step 414, the method includes stirring the mixture at 5,500 rpm for 15 minutes until the mixture is completely homogenized. In one embodiment, the sodium hypochlorite solution is 4% by weight to 8% by weight. EXAMPLES Example 1

[095] Example 1 included filling three liters of purified water into a container. The example also included connecting a high-shear mixing machine and setting a speed of 2,000 rpm. The example also included adding 120 g ± 1 g of lithium magnesium sodium silicate (thickening agent) slowly, from the edge of the container, into the solution. The example also included continuously stirring the mixture at 2,000 rpm for 30 minutes. The example also included adding 30 mL ± 0.05 mL of sodium hypochlorite solution slowly, from the edge, into the mixture and stirring for 5 minutes at 5,500 rpm. The example also included adding 3.0 g ± 0.1 g of PDV salt (NaCl) to the mixture. The example also included stirring the mixture until it was completely homogenized, where the mixture was stirred at 5,500 rpm for 15 minutes. The sodium hypochlorite solution was in the range of 4 to 8% by weight. Example 2

[096] In an example provided, illustrated in Figure 2, a semi-automatic crimping, gassing and filling machine (AM-04) was used to fill pressurized storage containers with a form of an antimicrobial composition. First, a bag over valve (BoV) was placed inside a storage container. The BoV valve was crimped onto the storage container, followed by filling said storage container with the propellant gas, nitrogen, to obtain a storage container. Petition 870260073974, dated 07 / 24 / 2026, page 35 / 85 29 / 35 pressurized container containing a BoV. The BoV bag was then filled with the antimicrobial composition through the valve on the attached bag (BOV). This feature allows the product to be physically separated from the propellant gas used.

[097] Below is a summary of the process parameter settings for small (50 g) and large (100 g) containers: Table 7 Container Crimping depth defined, CSD (revolutions in degrees) Crimping width defined, CSW (revolutions in degrees) Propellant pressure defined, PN (MPa) Mass defined MSET (Steering wheel position) Air pressure (MPa) Small (50 g) 3420 1270 0.30 35.8 0.6 Large (100 g) 3420 1270 0.60 58.5 0.6 *1 turn = 360 degrees (BOV, non-aerosol) is classified as a non-flammable product, according to EC Council Directive 75 / 324 / EEC (Annex 1 - Definition 1.9).

[098] In one example provided, the main components of this product, particularly the valve system apparatus for wound treatment, are: - Antimicrobial composition for wounds: 0% by weight of flammable components (water-based). - Nitrogen gas: an inert gas containing 0% by weight of flammable components. The term aerosol here refers to the nature of the product, which depends on the force of the pressure to expel the contents of the container (US FDA - Tamper Resistance Regulation - 21 CFR 700.25).

[099] In one embodiment, the bag-on-valve technology wound care valve apparatus of the present invention is a compartmentalized aerosol dispenser comprising a metal / plastic bag attached to the valve or valve body. There is no mixing of propellant gas and product (NIST Guideline on Aerosol Definition and Bag-On-Valve (DDF 1 / 28 / 12) - February 2012). Petition 870260073974, dated 07 / 24 / 2026, p. 36 / 85 30 / 35

[0100] Various embodiments of the present invention provide an antimicrobial composition developed for moistening and debriding acute and chronic wounds, such as stage I-IV ulcers, venous stasis and diabetic ulcerations, post-surgical wounds, first and second degree burns and pressure sores, helping to maintain a moist wound environment, promoting granulation and epithelialization, and facilitating autolytic debridement. Example 3

[0101] In an example provided, illustrated in Table 2, the USP 51 preservative efficacy test was used to evaluate the antimicrobial properties of the gel when tested against selected bacteria, fungi, and yeasts, respectively.

[0102] In this method, the gel is inoculated with a controlled quantity of specific microorganisms. The test then compares the initial level of microorganisms with that of the test samples at various time intervals over a 28-day period at a specified temperature. A logarithmic reduction in organisms is assessed at the prescribed time interval to quantitatively evaluate the effectiveness of the gel's antimicrobial properties in preventing microbial proliferation and / or eliminating or reducing the organism population.

[0103] For topical products, the preservative is effective in the product examined if:

[0104] Bacteria - Not less than a 2.0 log reduction from the baseline count at 14 days and no increase from the 14-day count at 28 days was observed for bacteria (Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa and Burkholderia cepacia).

[0105] Yeasts and molds - No increase from the initial count calculated at 14 and 28 days observed for yeasts and molds (Candida albicans and Aspergillus brasiliensis). Example 4 Petition 870260073974, dated 07 / 24 / 2026, page 37 / 85 31 / 35

[0106] In one example provided, an iodometric titration was performed to determine hypochlorous acid and sodium hypochlorite in the raw material used in the preparation of the hydrogel composition of the present invention.

[0107] Initially, the reagents used were prepared according to the following procedures: Table 8 Reagent Preparation 0.2N sodium thiosulfate solution (Na2S2O35H2O) Weigh 4.96 g of Na2S2O35H2O into a 100 mL volumetric flask; add distilled water to the mark and mix to dissolve. 0.05N sodium thiosulfate solution (Na2S2O35H2O) Weigh 1.24 g of Na2S2C>3 5H2O into a 100 mL volumetric flask; add distilled water to the mark and mix to dissolve. 10% potassium iodide solution Weigh 10 g of KI and dissolve it in 100 mL of distilled water. Starch Weigh 0.5 g of starch and dissolve it in 100 mL of distilled water. Heat the mixture to (40°C) and stir well until the solution becomes almost transparent and produces a slight condensation. Cool the starch solution to room temperature before use. 100% Acetic (Glacial) Acid: Measure 35 mL of acetic acid using a measuring cylinder and transfer it to a 250 mL conical flask.

[0108] The prepared samples were sodium hypochlorite, an aqueous antimicrobial solution (Hydrocyn® aqua, which is identical to Bactiguard® Wound Care solution), and an antimicrobial gel composition (Hydrocyn® aqua gel, which is identical to Bactiguard® Wound Care gel with the content according to Table 1 and fitting claim 1) of the present invention, according to the following preparations: Table 9 Reagent Preparation Sodium hypochlorite in raw material (10%) 1 ml of the sample was pipetted into a 100 ml volumetric flask and filled with distilled water to the mark. The prepared solution was transferred to a 250 ml conical flask. Antimicrobial aqueous solution (Hydrocyn® aqua, which is a Bactiguard® wound care solution) 100 ml of the sample were transferred to a 250 ml conical flask. Petition 870260073974, dated 07 / 24 / 2026, page 38 / 85 32 / 35 Antimicrobial gel composition (Hydrocyn® aqua, which is a Bactiguard® wound care gel, see Table 1 for contents): 5 g of sample were weighed and dissolved in 100 ml of distilled water, then transferred to a 250 ml conical bottle.

[0109] The samples were subjected to titration. A burette was rinsed with small amounts of sodium thiosulfate solution and then filled with sodium thiosulfate just above the 0 mark. A small amount of the solution was released from the burette tip to release any trapped bubbles. Approximately 25 ml of 10% potassium iodide solution was added to the sample solution. Approximately 10 ml of acetic acid was added to achieve an acidic condition. The addition of acetic acid and potassium iodide caused the sample solution to change from colorless to amber-brown. The sample solution was then titrated using 0.2N / 0.05N sodium thiosulfate until a straw-yellow color was obtained. The titration was performed rapidly because iodine is released quickly. Approximately 5 ml of starch indicator was added and the titration was continued until the blue color disappeared.The added starch indicator reacts with the iodine to form a very intense blue / purple complex. The titration was stopped as soon as a clear solution was obtained. The volume of the titrated sodium solution was then recorded for later calculation.

[0110] The number of moles of sodium thiosulfate for each titration was calculated using the equation: Moles of N^SjOj ~ (Molarity X (Volume of NtbSjOs) of 0.2NX Titrated Volume 1000 and, through the calculated moles of sodium thiosulfate, the stoichiometric reaction was used to calculate the moles of hypochlorite. H+(aq) + HOCI (aq) + 2S2O32*(aq) S4O62' (aq) + Cf (aq) + H2O (aq) Petition 870260073974, dated 07 / 24 / 2026, p. 39 / 85 33 / 35

[0111] The stoichiometry of the equation shows that there are 2 moles of thiosulfate ion per mole of hypochlorous acid: Mole of HOCI = 1 / 2mol of S2O32Mol of HOCI = Mole of NaOCI.

[0112] The concentration (% by weight) of NaOCl in the raw material was calculated using the following calculation: %NaOCL in sample = Mass of NaOCtfX) x 100 Sample mass (0.05)(V)( / V)(74.44 g.mol) M xlOO

[0113] V is the volume of the titrant (in ml), N for the normality of the sodium thiosulfate used (N), and M for the sample mass. The calculated molecular weight (mw) of NaOCl is 74.44 g / mol.

[0114] The concentration (% by weight) of NaOCl and HOCl in the aqueous antimicrobial solution (Hydrocyn® aqua, which is a wound care solution from Bactiguard®) was calculated using the following calculation: Mass of NaOCl(X) % NaOClemamam = ---------------xi00 Sample mass ' %NaOCL in sample = NaOCl mold x 74.44 g / mol 100 x 100 Mass of % HOCL in sample = HOCl(X) Sample mass x 100 Mol de % HOCl em amostra = NaOCI x 52.46 g / mol 1ÕÕ x 100 Petition 870260073974, dated 07 / 24 / 2026, p. 40 / 85 34 / 35

[0115] In the calculations provided, the normality of the sodium thiosulfate used was 0.05 N, the molecular weight of NaOCl is 74.44 g / mol, and the molecular weight of HOCl is 52.46 g / mol.

[0116] As will be readily apparent to those skilled in the art, the present invention can be easily produced in other specific forms without departing from its essential characteristics. The present embodiments should therefore be considered merely illustrative and not restrictive, the scope of the invention being indicated by the claims and not by the preceding description, and all alterations contained therein should therefore be included. Example 5

[0117] Since the quality of the water used in the manufacture of the composition is of great importance, an example of the purification of the water to be used in the preparation of the composition is presented.

[0118] First, tap water was fed into a first stage of an RO / DI system, which consists of a sediment filter (comprising mainly sands of various sizes) and a carbon filter. The sediment filter was used to retain large floating particles or contaminants. While the carbon filter consisted of granular carbon and absorbed organic compounds and other dissolved contaminants such as chlorine and chloramines.

[0119] After the carbon filtration stage, the water entered the softening column and the hard mineral ions (such as magnesium, Mg2+, and calcium, Ca2+) present in the water were removed. When the hard water entered the mineral tank, it flowed through a bed of resin spheres. These spheres are charged with a sodium ion. The resin spheres are negatively charged anions. The minerals calcium and magnesium have a positive charge, making them cations. As the hard water passed through the resin, the spheres captured the mineral ions and removed them from the water. When the sphere captured the mineral ions, the sodium ions were released. Petition 870260073974, dated 07 / 24 / 2026, page 41 / 85 35 / 35

[0120] Subsequently, the water was fed into a Reverse Osmosis (RO) system and filtered through multiple layers of thin film that removed most contaminants, such as salts, bacteria, heavy metals, and other organic compounds. From there, the water was divided into two different water lines: a wastewater line and a product water line. The product water was nearly pure and was transported to the storage tank which acted as a reservoir for the deionization (DI) system. While a certain percentage of the wastewater was recirculated to the reverse osmosis (RO) system, the remainder was discharged to a drain line.

[0121] Before being fed into the deionization (DI) system, the reverse osmosis water was cooled to a temperature in the range of 20 to 25°C by a chiller. The cooled water passed through an ultraviolet (UV) purifier to undergo a disinfection process. The UV purifier exposed living organisms, such as bacteria, viruses, or cysts (such as Cryptosporidium and Giardia), to germicidal ultraviolet radiation to break down the DNA of pathogenic microorganisms, preventing their reproduction.

[0122] After UV disinfection, the water passed through three identical deionization columns, composed of a resin. In the deionization stage, an ion exchange process was used that attracts mineral impurities, such as sodium and other metallic elements. The negatively charged cationic resin attracts positively charged ions in the water, while the positively charged anionic resin attracts negative ions. Finally, the deionized water passed through an ultrafine filter cartridge (i.e., 0.45 μm and 0.2 μm) and then the water was fed through pipes to points of use in the production area. The unused purified water was circulated back to the storage tank and fed back into the deionization system to repeat the same deionization process continuously. Petition 870260073974, dated 07 / 24 / 2026, page 42 / 85

Claims

1 / 5 CLAIMS 1. Antimicrobial composition, CHARACTERIZED in that it comprises (OCl)- ions in an amount ranging from 0.03 to 0.2% by weight with counter-ions Na+ ions in an amount ranging from 0.005 to 0.05% by weight and H+, thickening agent based on synthetic silicate clay in an amount ranging from 1 to 10% by weight, sodium chloride (NaCl) in an amount ranging from 0.03 to 0.3% by weight and purified water, wherein the purified water, before addition to the composition, has a hardness measured according to ISO 15923-2:2017 of less than 5 ppm and a resistivity measured according to ISO 3696:1987 of greater than 15 MΩ / ot, wherein the composition has a pH in the range of 7.5 to 10.0, and wherein the The β buffering capacity measured at pH 8.0 is less than 0.

10.

2. Antimicrobial composition, according to claim 1, CHARACTERIZED in that the amount of sodium hypochlorite is in the range of 0.04 to 0.06% by weight.

3. Antimicrobial composition, according to claim 1 or 2, CHARACTERIZED in that the amount of hypochlorous acid (HOCl) is in the range of 0.005 to 0.02% by weight.

4. Antimicrobial composition, according to any one of claims 1 to 3, CHARACTERIZED in that the amount of sodium chloride is in the range of 0.05 to 0.2% by weight.

5. Antimicrobial composition, according to any one of claims 1 to 4, CHARACTERIZED in that the synthetic silicate clay-based thickening agent comprises lithium, magnesium and sodium silicate.

6. Antimicrobial composition, according to any one of claims 1 to 5, CHARACTERIZED in that the thickening agent based on synthetic silicate clay is present in an amount in the range of 3 to 5% by weight.

7. Antimicrobial composition, according to any one of claims 1 to 6, CHARACTERIZED in that purified water constitutes the remaining part of the composition, in addition to sodium hypochlorite (NaOCl), hypochlorous acid (HOCl), a thickening agent based on synthetic silicate clay, and sodium chloride (NaCl).

8. Antimicrobial composition, according to any one of claims 1 to 7, CHARACTERIZED in that said composition has available free chlorine in the range of 30 to 200 ppm.

9. Method (400) for the manufacture of an antimicrobial composition, CHARACTERIZED in that the method comprises the steps of: a) providing i. purified water, wherein the purified water before addition to the composition has a hardness measured in accordance with ISO 15923-2:2017 of less than 5 ppm and a resistivity measured in accordance with ISO 3696:1987 of greater than 15 MΩ / cm; ii. a thickening agent based on synthetic silicate clay; iii. a sodium hypochlorite solution; and iv. sodium chloride; and b) mixing the purified water, the thickening agent based on synthetic silicate clay, the sodium hypochlorite solution, and the sodium chloride to obtain the antimicrobial composition, wherein the composition has a pH in the range of 7.5 to 10.0, and wherein the buffering capacity β measured at pH 8.0 is less than 0.

10.

10. Method according to claim 9, CHARACTERIZED in that the sodium hypochlorite solution has a concentration in the range of 4 to 8% by weight. Petition 870250060988, dated 07 / 16 / 2025, pp. 65 / 68 3 / 5 11. Method according to claim 9 or 10, CHARACTERIZED in that the synthetic silicate clay-based thickening agent comprises lithium, magnesium and sodium silicate.

12. Valve system apparatus for wound control, CHARACTERIZED in that said valve system apparatus comprises: a bag-on-valve (BOV) inside a pressurized storage container;and an antimicrobial composition for wound care contained in said bag, said antimicrobial composition comprising (OCl)- ions in an amount in the range of 0.03 to 0.2% by weight with counterions Na+ ions in an amount of 0.005 to 0.05% by weight and H+, thickening agent based on synthetic silicate clay in an amount in the range of 1 to 10% by weight, sodium chloride (NaCl) in an amount in the range of 0.03 to 0.3% by weight and purified water, wherein the purified water before addition to the composition has a hardness measured in accordance with ISO 15923-2:2017 of less than 5 ppm and a resistivity measured in accordance with ISO 3696:1987 of greater than 15 MΩ / ot, wherein the composition has a pH in the range of 7.5 to 10.0, and wherein the buffering capacity β measured at pH 8.0 is less than 0.

10.

13. A valve system apparatus for wound control, according to claim 12, CHARACTERIZED in that said pressurized storage container comprises a non-flammable propellant.

14. Valve system apparatus for wound control, according to claim 12 or 13, CHARACTERIZED in that said pressurized storage container is an aerosol spray container.

15. Method for producing a valve system apparatus for wound control, CHARACTERIZED in that it comprises the steps of: Petition 870250060988, dated 07 / 16 / 2025, page 66 / 68 4 / 5 a) placing a valve bag (BoV) inside a storage container; b) pressing the BoV into the storage container, followed by filling said storage container with propellant gas to obtain a pressurized storage container; and c) filling the BoV bag with the antimicrobial composition, as defined in any one of claims 1 to 8, through the BoV valve.

16. Method for administering an antimicrobial composition to a wound, CHARACTERIZED in that said method comprises the step of applying an antimicrobial composition to a wound, said antimicrobial composition comprising (OCl)- ions in an amount in the range of 0.03 to 0.2% by weight with counterions Na+ ions in an amount of 0.005 to 0.05% by weight and H+, thickening agent based on synthetic silicate clay in an amount in the range of 1 to 10% by weight, sodium chloride (NaCl) in an amount in the range of 0.03 to 0.3% by weight and purified water, wherein the purified water before addition to the composition has a hardness measured according to ISO 15923-2:2017 of less than 5 ppm and a resistivity measured according to ISO 3696:1987 of greater than 15 MΩ / ot, wherein the composition has a pH in the range of 7.5 to 10.0, and in which the β buffering capacity measured at pH 8.0 is less than 0.

10.

17. Method according to claim 16, CHARACTERIZED in that the application of the antimicrobial composition to the wound is made from a valve system apparatus, said valve system apparatus comprising a bag inside a pressurized storage container and the antimicrobial composition for wound control contained in said bag.

18. Use of an antimicrobial composition CHARACTERIZED by the fact that it is in the manufacture of a medicament for the treatment of a wound or treatment of infections in wounds, in which the antimicrobial composition Petition 870250060988, dated 07 / 16 / 2025, page. 67 / 68 5 / 5 comprising (OCl)- ions in an amount in the range of 0.03 to 0.2% by weight with counterions Na+ ions in an amount of 0.005 to 0.05% by weight and H+, thickening agent based on synthetic silicate clay in an amount in the range of 1 to 10% by weight, sodium chloride (NaCl) in an amount in the range of 0.03 to 0.3% by weight and purified water, wherein the purified water before addition to the composition has a hardness measured in accordance with ISO 15923-2:2017 of less than 5 ppm and a resistivity measured in accordance with ISO 3696:1987 of greater than 15 MΩ / ot, wherein the composition has a pH in the range of 7.5 to 10.0, and wherein the buffering capacity β measured at pH 8.0 is less than 0.

10.

19. Composition, CHARACTERIZED in that it comprises (OCl)- ions in an amount ranging from 0.03 to 0.2% by weight with counter-ions Na+ ions in an amount ranging from 0.005 to 0.05% by weight and H+, a thickening agent based on synthetic silicate clay in an amount ranging from 1 to 10% by weight, sodium chloride (NaCl) in an amount ranging from 0.03 to 0.3% by weight and purified water, wherein the purified water, prior to addition to the composition, has a hardness measured according to ISO 15923-2:2017 of less than 5 ppm and a resistivity measured according to ISO 3696:1987 of greater than 15 MΩ / ot, wherein the composition has a pH in the range of 7.5 to 10.0, and wherein the buffering capacity β measured at pH 8.0 is less than 0.10 for use in the prevention or treatment of wound infections. Petition 870250060988, dated 07 / 16 / 2025, pp. 68 / 68

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