Gel and suppository, and method for manufacturing the gel and suppository.
Gels and suppositories with lactic acid and hydrogen peroxide address vaginal microbiota imbalance, effectively preventing and treating infections by restoring vaginal pH balance.
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- BONAFIDE HEALTH LLC
- Filing Date
- 2026-02-13
- Publication Date
- 2026-05-26
AI Technical Summary
The disruption of vaginal microbiota balance, leading to increased vaginal pH and infections such as bacterial vaginosis, trichomoniasis, and candidiasis, is not adequately addressed by existing treatments.
Gels and suppositories containing lactic acid and hydrogen peroxide are developed to restore the vaginal pH balance by releasing these compounds, which can be formulated with additional elements like probiotics, prebiotics, and humectants to enhance their effectiveness.
These formulations help restore vaginal pH balance, preventing and treating infections by promoting a healthy vaginal microbiota environment.
Smart Images
Figure 2026086732000001_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to gels, solutions, and suppositories, and methods for producing such gels and suppositories.
Background Art
[0002] The pH of a healthy vagina is acidic and ranges from pH 3.8 to 4.5. An increase in the vaginal pH is a sign that the balance of the microbiota is disrupted, leading mainly to vaginal infections such as bacterial vaginosis (BV), trichomoniasis, candidiasis (vaginal candidiasis), and / or other infectious diseases. The vaginal pH can also rise to 7 or more. The healthy vaginal microbiota is mainly occupied by Lactobacillus bacteria that release lactic acid and hydrogen peroxide to lower the pH and increase oxygen.
Summary of the Invention
[0003] One aspect of the present invention relates to gels and suppositories that contain and release lactic acid and hydrogen peroxide. Such a combination of compounds can compensate for the deficiency of naturally released lactic acid and hydrogen peroxide, lower the vaginal pH, and improve the health of the vaginal microbiota. The gel may contain 50 - 150 mM (millimolar) concentrated lactic acid, 0.5 - 10 mM concentrated hydrogen peroxide, and / or other elements. The suppository may contain 22.5 - 67.5 mg (milligram) concentrated lactic acid, 1 - 20 mg concentrated hydrogen peroxide, and / or other elements. By providing these gels and suppositories, it is possible to promote the adjustment of the balance of the vaginal pH level of the user for the prevention and / or treatment of infections and / or discomfort.
[0004] These and other features, as well as the technical features, the function of the elements relating to the method of operation and configuration, and the economics of the combination of parts and manufacture will become more apparent when considered in conjunction with the following description and the attached claims with reference to the attached drawings (all of which constitute part of this specification, and the same reference numbers indicate the corresponding parts in each drawing). However, it should be clearly understood that the drawings are intended to be illustrative and explanatory only and are not intended to define any limitations of the invention. Where used herein and in the claims, the singular forms "a," "an," and "the" refer to plural subjects unless the context explicitly states otherwise. [Brief explanation of the drawing]
[0005] [Figure 1] Figure 1 shows gels and suppositories in one or more embodiments. [Figure 2] Figure 2 shows gels and suppositories in one or more embodiments. [Figure 3] Figure 3 shows gels and suppositories in one or more embodiments. [Figure 4] Figure 4 shows gels and suppositories in one or more embodiments. [Figure 5] Figure 5 shows gels and suppositories in one or more embodiments. [Figure 6] Figure 6 shows a method for manufacturing the gel in one or more embodiments. [Figure 7] Figure 7 shows a method for manufacturing suppositories in one or more embodiments. [Modes for carrying out the invention]
[0006] Figure 1 shows gel 100a and suppositories 200a in one or more embodiments. Gel 100a may contain 50-150 mM concentrated lactic acid 102, 0.5-10 mM concentrated hydrogen peroxide 104, and / or other elements. Gel 100a may be constructed by combining 50-150 mM concentrated lactic acid 102 with 0.5-10 mM concentrated hydrogen peroxide 104.
[0007] In certain embodiments, gel 100a may contain concentrated lactic acid 102 at a concentration of approximately 50 to 150 mM. In certain embodiments, the millimolar concentration (mM) of concentrated lactic acid 102 in gel 100a may be greater than or less than approximately 50 mM, 100 mM, or 150 mM, and / or within the range bounded by the upper limit of any concentration in the former concentration list and the lower limit of any concentration in the latter concentration list.
[0008] In certain embodiments, gel 100a may contain concentrated hydrogen peroxide 104 at a concentration of approximately 0.5 to 10 mM. In certain embodiments, the millimolar concentration (mM) of concentrated hydrogen peroxide 104 in gel 100a may be greater than or approximately less than 0.5 mM, 5 mM, or 10 mM, and / or within the range bounded by the upper limit of any concentration in the former concentration list and the lower limit of any concentration in the latter concentration list. In certain embodiments, gel 100a may be in the range of 2 to 20 mL (milliliters) when combining concentrated lactic acid 102 with concentrated hydrogen peroxide 104. In certain embodiments, gel 100a may be in the range of approximately 2 to 20 mL when combining concentrated lactic acid 102 with concentrated hydrogen peroxide 104.
[0009] The use of the term "approximately" applies to all numerical values, whether explicitly stated or not. Generally, this term refers to a range of numerical values (i.e., numerical values with equivalent function or results) that a person skilled in the art would consider to be a reasonable deviation from the cited numerical value. For example, this term can be considered to include a deviation of ±0.5 mM from a given numerical value, provided that the deviation does not alter the intended function or numerical result. Thus, a value of approximately 2 mM can be considered to be in the range of 1.5 mM to 2.5 mM. Furthermore, the range can be considered to include the beginning and end of that range. For example, the range of 50 mM to 150 mM (i.e., the range of 50 to 150 mM) includes 50 mM, 150 mM, and millimolar concentrations (mM) between 50 mM and 150 mM, unless otherwise explicitly stated herein.
[0010] Suppository 200a may contain 22.5 to 67.5 mg of concentrated lactate 202, 1 to 20 mg of concentrated hydrogen peroxide 204, and / or other elements. Suppository 200a may be composed of 22.5 to 67.5 mg of concentrated lactate 202 combined with 1 to 20 mg of concentrated hydrogen peroxide 204.
[0011] In certain embodiments, the suppository 200a may contain approximately 22.5 to 67.5 mg of concentrated lactic acid 202. In certain embodiments, the milligrams of concentrated lactic acid 202 in the suppository 200a may be more than approximately 22.5 mg, 35 mg, or 67.5 mg, or approximately less, and / or within the range bounded by the upper end of any weight in the former weight list and the lower end of any weight in the latter weight list.
[0012] The term "approximately" can be considered to include a deviation of ±1 mg from a given value, provided that the deviation does not alter the intended function or numerical result. Therefore, a value of approximately 22.5 mg can be considered to be within the range of 21.5 mg to 23.5 mg. Furthermore, the range can be considered to include the beginning and end of that range. For example, the range of 22.5 mg to 67.5 mg (i.e., the range of 22.5 to 67.5 mg) includes 22.5 mg, also includes 67.5 mg, and also includes milligrams between 22.5 mg and 67.5 mg, unless otherwise explicitly stated herein.
[0013] In certain embodiments, suppositories 200a may contain approximately 1 to 20 mg of concentrated hydrogen peroxide 204. In certain embodiments, the milligrams of concentrated hydrogen peroxide 204 in suppositories 200a may be more than 1 mg, 5 mg, 10 mg, or 20 mg, and / or within the range bounded by the upper end of any weight in the former weight list and the lower end of any weight in the latter weight list. In certain embodiments, when suppositories 200a combine concentrated lactic acid 202 with concentrated hydrogen peroxide 204, the amount may be in the range of 100 to 2000 mg. In certain embodiments, when suppositories 200a combine concentrated lactic acid 202 with concentrated hydrogen peroxide 204, the amount may be in the range of approximately 100 to 2000 mg.
[0014] In certain embodiments, the suppository 200a may further contain cocoa butter, polyethylene glycol, hydrogel, glycerinated gelatin, and / or other components that encapsulate concentrated lactic acid 202, concentrated hydrogen peroxide 204, and / or other elements. Thus, the suppository 200a can be easily inserted into the user's body orifice and deliver concentrated lactic acid 202, concentrated hydrogen peroxide 204, and / or other elements to the user. In certain embodiments, the suppository 200a may be inserted into the body orifice by utilizing an applicator.
[0015] Figure 2 shows gel 100b and suppository 200b in one or more embodiments. Gel 100b, like gel 100a in Figure 1, may include 50-150 mM concentrated lactic acid 102, 0.5-10 mM concentrated hydrogen peroxide 104, and / or other elements, as well as various embodiments described in Figure 1 that may be combined. Suppository 200b, like suppository 200a in Figure 1, may include 22.5-67.5 mg concentrated lactic acid 202, 1-20 mg concentrated hydrogen peroxide 204, and / or other elements, as well as various embodiments described in Figure 1 that may be combined. Gel 100b and / or suppository 200b may further contain probiotics 106(plural), other vitamins, and / or other elements. Probiotics 106(plural) may include lactic acid bacteria (lactobacilli) and / or other probiotics.
[0016] In certain embodiments, the gel 100b and / or suppository 200b may contain approximately 1 to 30 billion colony-forming units (CFUs) of probiotics 106. In certain embodiments, the CFUs of the probiotics 106 in the gel 100b and / or suppository 200b may be more than approximately 1 billion CFUs, 15 billion CFUs, 20 billion CFUs, or 30 billion CFUs, and / or within the range bounded by the upper limit of any bacterial count in the former bacterial count list and the lower limit of any bacterial count in the latter bacterial count list.
[0017] Figure 3 shows gel 100c and suppository 200c in one or more embodiments. Gel 100c, like gel 100a in Figure 1, may include 50-150 mM concentrated lactic acid 102, 0.5-10 mM concentrated hydrogen peroxide 104, and / or other elements, as well as various embodiments described in Figure 1 that may be combined. Suppository 200c, like suppository 200a in Figure 1, may include 22.5-67.5 mg concentrated lactic acid 202, 1-20 mg concentrated hydrogen peroxide 204, and / or other elements, as well as various embodiments described in Figure 1 that may be combined. Gel 100c and / or suppository 200c may further include a humectant 108, and / or other elements for promoting and improving hydration. In certain embodiments, the humectant 108 may be aqueous or oily. In certain embodiments, the humectant 108 may include glycerin, cocoa butter, aloe vera, and / or other humectants.
[0018] Figure 4 shows gel 100d and suppositories 200d in one or more embodiments. Gel 100d, similar to gel 100b in Figure 2, may include 50-150 mM concentrated lactic acid 102, 0.5-10 mM concentrated hydrogen peroxide 104, probiotics 106(plural), and / or other elements, as well as various embodiments described in Figure 2 that may be combined. Suppository 200d, similar to suppository 200b in Figure 2, may include 22.5-67.5 mg concentrated lactic acid 202, 1-20 mg concentrated hydrogen peroxide 204, probiotics 106(plural), and / or other elements, as well as various embodiments described in Figure 2 that may be combined. Gel 100d and / or suppository 200d may further include prebiotics 110(plural), and / or other elements. Prebiotics 110(or more) may include lactose, fructooligosaccharides, and / or other prebiotics.
[0019] In certain embodiments, the gel 100d and / or suppository 200d may contain approximately 10 to 100 mg of prebiotics 110(pl). In certain embodiments, the milligrams of prebiotics 110(pl) in the gel 100d and / or suppository 200d may be more than approximately 10 mg, 25 mg, 50 mg, or 100 mg, and / or within the range bounded by the upper end of any weight in the former weight list and the lower end of any weight in the latter weight list.
[0020] Figure 5 shows gel 100e and suppositories 200e in one or more embodiments. Gel 100e may include, in addition to the humectant 108 as described in Figure 3, 50-150 mM concentrated lactic acid 102, 0.5-10 mM concentrated hydrogen peroxide 104, probiotics 106(multiple), prebiotics 110(multiple), and / or other elements, as well as various embodiments as described in Figure 4 that may be combined (similar to gel 100d in Figure 4). Suppositories 200e may include, in addition to the humectant 108 as described in Figure 3, 22.5-67.5 mg concentrated lactic acid 202, 1-20 mg concentrated hydrogen peroxide 204, probiotics 106(multiple), prebiotics 110(multiple), and / or other elements, as well as various embodiments as described in Figure 4 that may be combined (similar to suppository 200d in Figure 4).
[0021] In certain embodiments, the concentrated lactic acid 102, concentrated hydrogen peroxide 104, and / or other elements provided in the gels 100a-e of Figures 1-5, as well as the various embodiments of concentrations described herein, may include a liquid rinse solution (not shown in photograph). This rinse solution may allow the user to circulate the concentrated lactic acid 102, concentrated hydrogen peroxide 104, and / or other elements into the body via one or more of the liquid storage unit, pressure pump, tubing, nozzles, and / or other components, thereby enabling their application.
[0022] FIG. 6 shows a method 600 for manufacturing a gel in one or more embodiments. The operations of method 600 shown below are intended to be illustrative. In certain embodiments, method 600 can be achieved by one or more additional operations not described and / or without one or more of the described operations. Further, the order shown in FIG. 6 and described below for the operations of method 600 is not intended to be limiting.
[0023] Operation 602 can include combining 50 - 150 mM concentrated lactic acid and 0.5 - 10 mM concentrated hydrogen peroxide to make a gel.
[0024] FIG. 7 shows a method 700 for manufacturing a suppository in one or more embodiments. The operations of method 700 shown below are intended to be illustrative. In certain embodiments, method 700 can be achieved by one or more additional operations not described and / or without one or more of the described operations. Further, the order shown in FIG. 7 and described below for the operations of method 700 is not intended to be limiting.
[0025] Operation 702 can include combining 22.5 - 67.5 mg concentrated lactic acid and 1 - 20 mg concentrated hydrogen peroxide to make a suppository.
[0026] The present technology has been described in detail for illustrative purposes based on what is currently considered to be the most practical and preferred embodiments, but such details are for that purpose only, and the present technology is not limited to the disclosed embodiments. On the contrary, it should be understood that the present technology is intended to include modifications and equivalent configurations within the spirit and scope of the appended claims. For example, it should be understood that the present technology contemplates that, to the extent possible, one or more features of any embodiment can be combined with one or more features of any other embodiment.
Claims
1. Concentrated lactic acid of 50-150 mM, It contains concentrated hydrogen peroxide at a concentration of 0.5 to 10 mM, A gel comprising a combination of 50-150 mM concentrated lactic acid and 0.5-10 mM concentrated hydrogen peroxide.
2. The gel according to claim 1, wherein the amount of gel is 2 to 20 mL.
3. Probiotics containing 1 to 30 billion colony-forming units, and / or The gel according to claim 1, further comprising 10 to 100 mg of prebiotics.
4. The aforementioned probiotics contain lactic acid bacteria, The gel according to claim 4, wherein the prebiotic comprises lactose and / or fructooligosaccharides.
5. The gel according to claim 1, further comprising a moisturizer.
6. 22.5 to 67.5 mg of concentrated lactic acid, It contains 1 to 20 mg of concentrated hydrogen peroxide, A suppository comprising 22.5 to 67.5 mg of concentrated lactic acid and 1 to 20 mg of concentrated hydrogen peroxide.
7. The suppository according to claim 6, wherein the suppository is 100 to 2000 mg.
8. Probiotics containing 1 to 30 billion colony-forming units, and / or The suppository according to claim 6, further comprising 10 to 100 mg of a prebiotic.
9. The aforementioned probiotics contain lactic acid bacteria, The suppository according to claim 8, wherein the prebiotic comprises lactose and / or fructooligosaccharides.
10. The suppository according to claim 6, further comprising a moisturizer.
11. A method for producing a gel, comprising preparing a gel by combining 50-150 mM concentrated lactic acid and 0.5-10 mM concentrated hydrogen peroxide.
12. The method according to claim 11, wherein the amount of gel is 2 to 20 mL.
13. Combining a probiotic containing 1 to 30 billion colony-forming units with the concentrated lactic acid and the concentrated hydrogen peroxide, The method of claim 11, further comprising combining 10 to 100 mg of prebiotics with the concentrated lactic acid and the concentrated hydrogen peroxide.
14. The aforementioned probiotics contain lactic acid bacteria, The method according to claim 13, wherein the prebiotic comprises lactose and / or fructooligosaccharides.
15. The method according to claim 11, further comprising combining a humectant with the concentrated lactic acid and the concentrated hydrogen peroxide.
16. A method for producing suppositories, comprising preparing suppositories by combining 22.5 to 67.5 mg of concentrated lactic acid and 1 to 20 mg of concentrated hydrogen peroxide.
17. The method according to claim 16, wherein the suppository is 100 to 2000 mg.
18. Combining a probiotic containing 1 to 30 billion colony-forming units with the concentrated lactic acid and the concentrated hydrogen peroxide, The method of claim 16, further comprising combining 10 to 100 mg of prebiotics with the concentrated lactic acid and the concentrated hydrogen peroxide.
19. The aforementioned probiotics contain lactic acid bacteria, The method according to claim 18, wherein the prebiotic comprises lactose and / or fructooligosaccharides.
20. The method according to claim 16, further comprising combining a humectant with the concentrated lactic acid and the concentrated hydrogen peroxide.