A gel and a suppository and methods to provide the gel and suppository

Abstract

A gel and suppository and method to provide the gel and the suppository, are disclosed herein. The gel comprising: between 50 and 150 millimolar of lactic acid concentrate; and between 0.5 and 10 millimolar of hydrogen peroxide concentrate. The suppository comprising: between 22.5 and 67.5 milligrams of lactic acid concentrate; and between 1 and 20 milligrams of hydrogen peroxide concentrate. 20 25 20 22 09 27 M ar 2 02 5 A G E L A N D A S U P P O S I T O R Y A N D M E T H O D S T O P R O V I D E T H E G E L A N D S U P P O S I T O R Y 2 0 2 5 2 0 2 2 0 9 2 7 M a r 2 0 2 5 A B S T R A C T

Description

FIELD OF THE DISCLOSURE

[0000] The present application is a divisional application of Australian Application No. 2021369204, filed 8 May 2023, which is related to International Application No. PCT / US2021 / 051130, filed 20 September 2021, the entire contents of which are hereby incorporated by reference.

[0001] The present disclosure relates to a gel, a liquid, and a suppository and methods to provide the gel and suppository. BACKGROUND

[0002] The pH of a healthy vagina is acidic and ranges between 3.8 and 4.5. Rising vaginal pH is a sign of imbalance in the microbiome and leads to vaginal infections, primarily bacterial vaginosis (BV), trichomoniasis, candidiasis (yeast infection), and / or other infections. Vaginal pH may rise to 7 or above. Healthy vaginal microbiomes are dominated by lactobacillus bacteria that release lactic acid and hydrogen peroxide which lower pH and increase oxygen. [0002a] It is an object of the present invention to overcome or ameliorate at least one of the disadvantages of the prior art, or to provide a useful alternative. [0002b] Any discussion of the prior art throughout the specification should in no way be considered as an admission that such prior art is widely known or forms part of common general knowledge in the field. [0002c] Unless the context clearly requires otherwise, throughout the description and the claims, the words “comprise”, “comprising”, and the like are to be construed in an inclusive sense as opposed to an exclusive or exhaustive sense; that is to say, in the sense of “including, but not limited to”. SUMMARY

[0003] One aspect of the present disclosure relates to a gel and a suppository that release comprise lactic acid and hydrogen peroxide. Such a combination of compounds may compensate for a lack of naturally released lactic acid and hydrogen peroxide to lower vaginal pH and improve the health of the vaginal microbiome. The gel may comprise of between 50 and 150 millimolar of lactic acid concentrate, between 0.5 and 10 millimolar of hydrogen peroxide concentrate, and / or other elements. The suppository may comprise of between 22.5 and 67.5 milligrams of lactic acid concentrate, between 1 and 20 milligrams of hydrogen peroxide concentrate, and / or other elements. By providing the gel and suppository, 2025202209   06 Aug 2026 a consumer may facilitate balancing their vaginal pH level to prevent and / or treat infections and / or discomfort. [0003a]      In one aspect, the present invention provides use of a gel in the manufacture of a medicament for balancing the vaginal pH level in a subject, wherein the gel comprises between 50 and 150 millimolar of lactic acid concentrate and between 0.5 and 10 millimolar of hydrogen peroxide concentrate, wherein the between 50 and 150 millimolar of lactic acid concentrate is combined with the between 0.5 and 10 millimolar of hydrogen peroxide concentrate. [0003b]      In another aspect, the present invention provides use of a suppository in the manufacture of a medicament for balancing the vaginal pH level in a subject, wherein the suppository comprises between 22.5 and 67.5 milligrams of lactic acid concentrate; and between 1 and 20 milligrams of hydrogen peroxide concentrate, wherein the between 22.5 and 67.5 milligrams of lactic acid concentrate is combined with the between 1 and 20 milligrams of hydrogen peroxide concentrate. [0003c]       In again another aspect, the present invention provides a method for balancing the vaginal pH level in a subject comprising administering a gel to the subject, wherein the gel comprises between 50 and 150 millimolar of lactic acid concentrate and between 0.5 and 10 millimolar of hydrogen peroxide concentrate, wherein the between 50 and 150 millimolar of lactic acid concentrate is combined with the between 0.5 and 10 millimolar of hydrogen peroxide concentrate. [0003d]      In a further aspect, the present invention provides a method for balancing the vaginal pH level in a subject comprising administering a suppository to the subject, wherein the suppository comprises between 22.5 and 67.5 milligrams of lactic acid concentrate; and between 1 and 20 milligrams of hydrogen peroxide concentrate, wherein the between 22.5 and 67.5 milligrams of lactic acid concentrate is combined with the between 1 and 20 milligrams of hydrogen peroxide concentrate.

[0004] These and other features, and characteristics of the present technology, as well as the methods of operation and functions of the related elements of structure and the combination of parts and economies of manufacture, will become more apparent upon consideration of the following description and the appended claims with reference to the accompanying drawings, all of which form a part of this specification, wherein like reference numerals designate corresponding parts in the various figures. It is to be expressly 2025202209   27 Mar 2025 understood, however, that the drawings are for the purpose of illustration and description only and are not intended as a definition of the limits of the invention. As used in the specification and in the claims, the singular form of 'a', 'an', and 'the' include plural referents unless the context clearly dictates otherwise. 5                BRIEF DESCRIPTION OF THE DRAWINGS

[0005] FIG. 1 illustrates a gel and a suppository, in accordance with one or more implementations.

[0006] FIG. 2 illustrates the gel and the suppository, in accordance with one or more implementations. 10

[0007] FIG. 3 illustrates the gel and the suppository, in accordance with one or more implementations.

[0008] FIG. 4 illustrates the gel and the suppository, in accordance with one or more implementations.

[0009] FIG. 5 illustrates the gel and the suppository, in accordance with one or more 15   implementations.

[0010] FIG. 6 illustrates a method to provide a gel, in accordance with one or more implementations.

[0011] FIG. 7 illustrates a method to provide a suppository, in accordance with one or more implementations. 20                      DETAILED DESCRIPTION

[0012] FIG. 1 illustrates a gel 100a and a suppository 200a, in accordance with one or more implementations. Gel 100a may comprise between 50 and 150 millimolar of lactic acid concentrate 102, between 0.5 and 10 millimolar of hydrogen peroxide concentrate 104, and / or other elements. The between 50 and 150 millimolar of lactic acid concentrate 102 25 may be combined with the between 0.5 and 10 millimolar of hydrogen peroxide concentrate 104 to comprise gel 100a.

[0013] In some implementations, gel 100a may comprise of between about 50 and 150 millimolar of lactic acid concentrate 102. In some implementations, the millimolar of lactic acid concentrate 102 in gel 100a may be greater than about 50 millimolar, 100 millimolar, 30   150 millimolar, may be less than about, and / or may be within a range bounded at the upper 2025202209   27 Mar 2025 end by any concentration in the former listing of concentrations and bounded at the lower end by any concentration in the latter listing of concentrations.

[0014] In some implementations, gel 100a may comprise of about between 0.5 and 10 millimolar of hydrogen peroxide concentrate 104. In some implementations, the millimolar 5 of hydrogen peroxide concentrate 104 in gel 100a may be greater than 0.5 millimolar, 5 millimolar, 10 millimolar, may be less than about, and / or may be within a range bounded at the upper end by any concentration in the former listing of concentrations and bounded at the lower end by any concentration in the latter listing of concentrations. In some implementations, gel 100a may be between 2 and 20 milliliters upon combining lactic acid 10 concentrate 102 with hydrogen peroxide concentrate 104. In some implementations, gel 100a may be between about 2 and 20 milliliters upon combining lactic acid concentrate 102 with hydrogen peroxide concentrate 104.

[0015] The use of the term “about” applies to all numeric values, whether or not explicitly indicated. This term generally refers to a range of numbers that one of ordinary 15 skill in the art would consider as a reasonable amount of deviation to the recited numeric values (i.e., having the equivalent function or result). For example, this term can be construed as including a deviation of ±0.5 millimolar of the given numeric value provided such a deviation does not alter the end function or result of the value. Therefore, a value of about 2 millimolar can be construed to be a range from 1.5 millimolar to 2.5 millimolar. 20 Furthermore, a range may be construed to include the start and the end of the range. For example, a range of 50 millimolar to 150 millimolar (i.e., range of 50-150 millimolar) includes 50 millimolar and also includes 150 millimolar, as well as millimolar in between 50 millimolar and 150 millimolar, unless explicitly stated otherwise herein.

[0016] Suppository 200a may comprise between 22.5 and 67.5 milligrams of lactic acid 25 concentrate 202, between 1 and 20 milligrams of hydrogen peroxide concentrate 204, and / or other elements. The between 22.5 and 67.5 milligrams of lactic acid concentrate 202 may be combined with the between 1 and 20 milligrams of hydrogen peroxide concentrate 204 to comprise suppository 200a.

[0017] In some implementations, suppository 200a may comprise of between about 22.5 30 and 67.5 milligrams of lactic acid concentrate 202. In some implementations, the milligram of lactic acid concentrate 202 in suppository 200a may be greater than about 22.5 milligram, 35 milligram, 67.5 milligram, may be less than about, and / or may be within a range bounded 2025202209   27 Mar 2025 at the upper end by any weight in the former listing of weights and bounded at the lower end by any weight in the latter listing of weights.

[0018] The term “about” can be construed as including a deviation of ±1 milligram of the given numeric value provided such a deviation does not alter the end function or result of the 5 value. Therefore, a value of about 22.5 milligrams can be construed to be a range from 21.5 milligrams to 23.5 milligrams. Furthermore, a range may be construed to include the start and the end of the range. For example, a range of 22.5 milligrams to 67.5 milligrams (i.e., range of 22.5-67.5 milligrams) includes 22.5 milligrams and also includes 67.5 milligrams, as well as milligrams in between 22.5 milligrams and 67.5 milligrams, unless explicitly stated 10 otherwise herein.

[0019] In some implementations, suppository 200a may comprise of about between 1 and 20 milligrams of hydrogen peroxide concentrate 204. In some implementations, the milligram of hydrogen peroxide concentrate 204 in suppository 200a may be greater than 1 milligram, 5 milligrams, 10 milligrams, 20 milligrams, may be less than about, and / or may be 15 within a range bounded at the upper end by any weight in the former listing of weights and bounded at the lower end by any weight in the latter listing of weights. In some implementations, suppository 200a may be between 100 and 2,000 milligrams upon combining lactic acid concentrate 202 with hydrogen peroxide concentrate 204. In some implementations, suppository 200a may be between about 100 and 2,000 milligrams upon 20 combining lactic acid concentrate 202 with hydrogen peroxide concentrate 204.

[0020] In some implementations, suppository 200a may further comprise of cocoa butter, polyethylene glycol, hydrogels, glycerinated gelatin, and / or other ingredients to encase lactic acid concentrate 202, hydrogen peroxide concentrate 204, and / or other elements. Thus, suppository 200a may be easily inserted into a body orifice of a consumer for delivery of 25 lactic acid concentrate 202, hydrogen peroxide concentrate 204, and / or other elements to the consumer. In some implementations, suppository 200a may be inserted into the body orifice by utilizing an applicator.

[0021] FIG. 2 illustrates a gel 100b and a suppository 200b, in accordance with one or more implementations. Gel 100b may comprise of the between 50 and 150 millimolar of 30 lactic acid concentrate 102, the between 0.5 and 10 millimolar of hydrogen peroxide concentrate 104, and / or other elements and the various implementations described thereof in FIG. 1 that may be combined, similar to gel 100a of FIG. 1. Suppository 200b may comprise 2025202209   27 Mar 2025 of the between 22.5 and 67.5 milligrams of lactic acid concentrate 202, the between 1 and 20 milligrams of hydrogen peroxide concentrate 204, and / or other elements and the various implementations described thereof in FIG. 1 that may be combined, similar to suppository 200a of FIG. 1. Gel 100b and / or suppository 200b may further comprise probiotic(s) 106 5 other vitamins, and / or other elements. Probiotic(s) 106 may include lactobacilli and / or other probiotics.

[0022] In some implementations, gel 100b and / or suppository 200b may include between about 1 to 30 billion colony forming units (CFU) of probiotic(s) 106. In some implementations, the CFUs of probiotic(s) 106 in gel 100b and / or suppository 200b may be 10 greater than about 1 billion CFU, 15 billion CFUs, 20 billion CFUs, 30 billion CFUs, may be less than about, and / or may be within a range bounded at the upper end by any number of bacteria in the former listing of numbers of bacteria and bounded at the lower end by any number of bacteria in the latter listing of number of bacteria.

[0023] FIG. 3 illustrates a gel 100c and a suppository 200c, in accordance with one or 15 more implementations. Gel 100c may comprise of the between 50 and 150 millimolar of lactic acid concentrate 102, the between 0.5 and 10 millimolar of hydrogen peroxide concentrate 104, and / or other elements and the various implementations described thereof in FIG. 1 that may be combined, similar to gel 100a of FIG. 1. Suppository 200c may comprise of the between 22.5 and 67.5 milligrams of lactic acid concentrate 202, the between 1 and 20 20 milligrams of hydrogen peroxide concentrate 204, and / or other elements and the various implementations described thereof in FIG. 1 that may be combined, similar to suppository 200a of FIG. 1. Gel 100c and / or suppository 200c may further comprise moisturizer 108 to facilitate and improve hydration and / or other elements. In some implementations, moisturizer 108 may be water-based or oil-based. In some implementations, moisturizer 108 25 may include glycerin, cocoa butter, aloe vera, and / or other moisturizers.

[0024] FIG. 4 illustrates a gel lOOd and a suppository 200d, in accordance with one or more implementations. Gel lOOd may comprise of the between 50 and 150 millimolar of lactic acid concentrate 102, the between 0.5 and 10 millimolar of hydrogen peroxide concentrate 104, probiotic(s) 106, and / or other elements and the various implementations 30 described thereof in FIG. 2 that may be combined, similar to gel 100b of FIG. 2. Suppository 200d may comprise of the between 22.5 and 67.5 milligrams of lactic acid concentrate 202, the between 1 and 20 milligrams of hydrogen peroxide concentrate 204, probiotic(s) 106, and / or other elements and the various implementations described thereof in FIG. 2 that may 2025202209   27 Mar 2025 be combined, similar to suppository 200b of FIG. 2. Gel lOOd and / or suppository 200d may further comprise prebiotic(s) 110 and / or other elements. Prebiotic(s) 110 may include lactose, oligofructose, and / or other prebiotics.

[0025] In some implementations, gel lOOd and / or suppository 200d may include between 5 about 10 to 100 milligrams of prebiotic(s) 110. In some implementations, the milligram of prebiotic(s) 110 in gel lOOd and / or suppository 200d may be greater than about 10 milligrams, 25 milligrams, 50 milligrams, 100 milligrams, may be less than about, and / or may be within a range bounded at the upper end by any weight in the former listing of weights and bounded at the lower end by any weight in the latter listing of weights. 10

[0026] FIG. 5 illustrates a gel lOOe and a suppository 200e, in accordance with one or more implementations. Gel lOOe may comprise of the between 50 and 150 millimolar of lactic acid concentrate 102, the between 0.5 and 10 millimolar of hydrogen peroxide concentrate 104, probiotic(s) 106, prebiotic(s) 110 and / or other elements and the various implementations described thereof in FIG. 4 that may be combined (similar to gel lOOd of 15 FIG. 4) in addition to moisturizer 108 as described in FIG. 3. Suppository 200e may comprise of the between 22.5 and 67.5 milligrams of lactic acid concentrate 202, the between 1 and 20 milligrams of hydrogen peroxide concentrate 204, probiotic(s) 106, prebiotic(s) 110 and / or other elements and the various implementations described thereof in FIG. 4 that may be combined (similar to suppository 200d of FIG. 4) in addition to moisturizer 108 as 20 described in FIG. 3.

[0027] In some implementations, the lactic acid concentrate 102, the hydrogen peroxide concentrate 104, and / or other elements comprising gel lOOa-e of FIG. 1-5, and various implementations of concentrations described herein, may comprise a liquid rinse solution (not pictured). The liquid rinse solution may enable the consumer to stream, and thus apply, the 25 lactic acid concentrate 102, the hydrogen peroxide concentrate 104, and / or other elements into their body via one or more of a liquid storage unit, a pressure pump, a tube, a nozzle, and / or other components.

[0028] FIG. 6 illustrates a method 600 to provide a gel, in accordance with one or more implementations. The operations of method 600 presented below are intended to be 30 illustrative. In some implementations, method 600 may be accomplished with one or more additional operations not described, and / or without one or more of the operations discussed. Additionally, the order in which the operations of method 600 are illustrated in FIG. 6 and 2025202209   27 Mar 2025 described below is not intended to be limiting.

[0029] An operation 602 may include combining between 50 and 150 millimolar of lactic acid concentrate and between 0.5 and 10 millimolar of hydrogen peroxide concentrate to create the gel. 5

[0030] FIG. 7 illustrates a method 700 to provide a suppository, in accordance with one or more implementations. The operations of method 700 presented below are intended to be illustrative. In some implementations, method 700 may be accomplished with one or more additional operations not described, and / or without one or more of the operations discussed. Additionally, the order in which the operations of method 700 are illustrated in FIG. 7 and 10 described below is not intended to be limiting.

[0031] An operation 702 may include combining between 22.5 and 67.5 milligrams of lactic acid concentrate and between 1 and 20 milligrams of hydrogen peroxide concentrate to create the suppository.

[0032] Although the present technology has been described in detail for the purpose of 15 illustration based on what is currently considered to be the most practical and preferred implementations, it is to be understood that such detail is solely for that purpose and that the technology is not limited to the disclosed implementations, but, on the contrary, is intended to cover modifications and equivalent arrangements that are within the spirit and scope of the appended claims. For example, it is to be understood that the present technology 20 contemplates that, to the extent possible, one or more features of any implementation can be combined with one or more features of any other implementation.

Claims

1. Use of a gel in the manufacture of a medicament for balancing the vaginal pH level ina subject,wherein the gel comprises between 50 and 150 millimolar of lactic acid concentrate andbetween 0.5 and 10 millimolar of hydrogen peroxide concentrate, wherein the between 50 and 150 millimolar of lactic acid concentrate is combined with the between 0.5 and 10 millimolar of hydrogen peroxide concentrate.

2. The use of claim 1, wherein the gel is between 2 and 20 milliliters.

3. The use of claim 1 or 2, wherein the gel further comprises between 1 to 30 billioncolony forming units of probiotics; and / or between 10 and 100 milligrams of prebiotics.

4. The use of claim 3, wherein the probiotics comprise lactobacilli, and the prebioticscomprise lactose and / or oligofructose.

5. The use of any one of claims 1 to 4, wherein the gel further comprises a moisturizer.

6. Use of a suppository in the manufacture of a medicament for balancing the vaginal pHlevel in a subject,wherein the suppository comprises between 22.5 and 67.5 milligrams of lactic acid concentrate; and between 1 and 20 milligrams of hydrogen peroxide concentrate, wherein the between 22.5 and 67.5 milligrams of lactic acid concentrate is combined with the between 1 and 20 milligrams of hydrogen peroxide concentrate.

7. The use of claim 6, wherein the suppository is between 100 and 2,000 milligrams.

8. The use of claim 6 or 7, wherein the suppository further comprises between 1 to 30billion colony forming units of probiotics, and / or between 10 and 100 milligrams of prebiotics.2025202209  28 Mar 20259.     The use of claim 8, wherein the probiotics comprise lactobacilli, and the prebioticscomprises lactose and / or oligofructose.

10. The use of any one of claims 6 to 9, wherein the suppository further comprises a moisturizer.

11. A method for balancing the vaginal pH level in a subject comprising administering a gel to the subject,wherein the gel comprises between 50 and 150 millimolar of lactic acid concentrate andbetween 0.5 and 10 millimolar of hydrogen peroxide concentrate, wherein the between 50 and 150 millimolar of lactic acid concentrate is combined with the between 0.5 and 10 millimolar of hydrogen peroxide concentrate.

12. The method of claim 11, wherein the gel is between 2 and 20 milliliters.

13. The method of claim 11, wherein the gel further comprises between 1 to 30 billioncolony forming units of probiotics; and / or between 10 and 100 milligrams of prebiotics.

14. The method of claim 13, wherein the probiotics comprise lactobacilli, and the prebiotics comprise lactose and / or oligofructose.

15. The method of any one of claims 11 to 14, wherein the gel further comprises a moisturizer.

16. A method for balancing the vaginal pH level in a subject comprising administering a suppository to the subject,wherein the suppository comprises between 22.5 and 67.5 milligrams of lactic acid concentrate; and between 1 and 20 milligrams of hydrogen peroxide concentrate, wherein the between 22.5 and 67.5 milligrams of lactic acid concentrate is combined with the between 1 and 20 milligrams of hydrogen peroxide concentrate.

17. The method of claim 16, wherein the suppository is between 100 and 2,000 milligrams.2025202209  28 Mar 202518. The method of claim 16 or 17, wherein the suppository further comprises between 1 to 30 billion colony forming units of probiotics, and / or between 10 and 100 milligrams of prebiotics.

19. The method of claim 18, wherein the probiotics comprise lactobacilli, and the prebiotics comprise lactose and / or oligofructose.

20. The method of any one of claims 16 to 19, wherein the suppository further comprises a moisturizer.

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