WO2022018779A2

WO2022018779A2 - Safe foaming liquid composition for personal care

Info

Publication number: WO2022018779A2
Application number: PCT/JO2021/050006
Authority: WO
Inventors: Mayyas Al-Remawi
Original assignee: Petra, University of
Current assignee: Petra, University of
Priority date: 2020-07-19
Filing date: 2021-06-10
Publication date: 2022-01-27
Anticipated expiration: 2023-01-19
Also published as: WO2022018779A3

Abstract

There is provided a personal care foaming composition with natural antiseptic capabilities having alkaline pH of 7-9. The composition may include an amino acid, a fatty acid, and a silicate salt.

Description

SAFE FOAMING LIQUID COMPOSITION FOR PERSONAL CARE

TECHNICAL FIELD

[01] The present disclosure relates to personal care compositions, and more particularly to personal care foaming compositions with natural antiseptic capabilities using alkaline pH 7-10.

BACKGROUND

[02] Ideal personal care products should have cleansing, non-sensitizing and some antiseptic actions to enhance skin, mucosa and hair hygiene with an acceptable safety profile.

[03] Personal care products (“PCPs”) contain synthetic organic compounds, pharmaceutical ingredients, and as well as some heavy metals and toxic minerals. These groups represent the majority of priority of unrecognized or emerging environment pollutants in everyday urban activities resulting in contaminated sediments and subsequent, far-reaching dispersal into aquatic environments.

[04] Many PCPs contain harmful substances including surface active agents (surfactants), antimicrobials, artificial colors, synthetic fragrance, and solvents, and preservatives.

[05] Synthetic surfactants are also called detergents are important ingredients in PCPs and can be divided into amphoteric, cationic, anionic surfactants and non-ionic surfactants.

SUMMARY

[06] It is an object of the present disclosure to provide a foaming composition including an amino acid, a fatty acid, and a silicate salt.

[07] In some aspects, the foaming composition may further include an antiseptic agent.

[08] In some aspects, the antiseptic agent may be selected from a group including menthol, thymol, or a combination thereof. [09] In some aspects of the present disclosure, the amino acid may include 1-arginie.

[010] In some aspects, the fatty acid may include a medium chain fatty acid.

[Oil] In aspects of the present disclosure, the fatty acid may be selected from a group including caproic acid or hexanoic acid, caprylic acid or octanoic acid, capric acid or decanoic acid, and lauric acid or dodecanoic acid, or combinations thereof.

[012] In aspects of the present disclosure, the fatty acid may include capric acid.

[013] In aspects of the present disclosure, the silicate salt may be an alkali earth metal metasilicate.

[014] In some aspects, the silicate salt may include sodium metasilicate.

[015] In aspects of the present disclosure, the foaming composition may further include one or more excipient acting as a foam stabilizer, and enhancing antimicrobial activity.

[016] In some aspects, the one or more excipients may be EDTA, Tris, or a combination thereof.

[017] In aspects of the present disclosure, the ratio of the amino acid to the fatty acid may be from about 10 to about 1 by weight.

[018] In aspects of the present disclosure, the ratio of the amino acid to the fatty acid may be from about 0.7 to about 1 by weight.

[019] In aspects of the present disclosure, the ratio between the silicate salt to the fatty acid may be from about 10 to about 1 by weight.

[020] The foaming composition of claim 14, wherein the ratio between the silicate salt to the fatty acid may be from about 0.3 to about 1 by weight.

[021] The foaming composition of claim 1, wherein the concentrations of silicate salt, amino acid, and fatty acid may be 0.3, 0.7 and 1 by weight, respectively. BRIEF DESCRIPTION OF THE DRAWINGS

[022] The present disclosure will now be described with reference to accompanying drawings, without however limiting the scope of the disclosure thereto, and in which:

[023] FIG. 1 illustrates a column chart comparing foam density (g/ml) of a composition prepared in accordance with embodiments of the present disclosure compared to different anionic and nonionic foaming commercial products available in Jordan.

[024] FIG. 2 illustrates a column chart comparing foam density (g/ml) of a composition prepared in accordance with embodiments of the present disclosure upon dilution of with distilled water.

[025] FIG. 3 illustrates a comparison showing clarity of a composition prepared in accordance with embodiments of the present disclosure of formula F4 in example

1 (Table 1), wherein 1 represents the composition at room temperature, 25 °C, and

2 refrigerator temperature, 4- 8 °C.

[026] FIG. 4 illustrates a comparison showing clarity of a composition prepared in accordance with embodiments of the present disclosure of formula F8 in example 5 (Table 2), wherein 1 represents the composition at room temperature for about 24 hours, and 2 represents the composition in the refrigerator at a temperature from about 4-8 °C for about 48 hours.

[027] FIG. 5A illustrates a composition prepared in accordance with embodiments of the present disclosure produced as a foam mass placed on hand.

[028] FIG. 5B illustrates a composition prepared in accordance with embodiments of the present disclosure produced as a foam mass placed on hand with gentle rubbing of the foam mass by hands for few seconds.

[029] FIG. 5C illustrates disappearance of a composition prepared in accordance with embodiments of the present disclosure produced as a foam mass and placed on hand after gentle rubbing by hands for few seconds. [030] FIG. 6A illustrates a cleansing liquid solution filled in container with foaming pump dispenser showing large amount of foam, the solution prepared in accordance with embodiments of the present disclosure.

[031 ] FIG. 6B illustrates a stable foam formed at a toothbrush head and can be used to clean teeth, the foam formed in accordance with embodiments of the present disclosure.

[032] FIG. 7 illustrates a column chart comparing percent viability of dental fibroblast after dilution upon exposure to composition prepared in accordance with embodiments of the present disclosure and commercial mouthwashes available in Jordan.

[033] FIG. 8 illustrates a column chart comparing percent viability of dental fibroblast after dilution upon exposure to composition prepared in accordance with embodiments of the present disclosure and commercial toothpastes available in Jordan.

[034] FIG. 9 illustrates particle size measured determined as median size diameter of the solution prepared in accordance with embodiments of the present disclosure for hand sanitization (“HS”) and mouthwash (“MW”).

[035] FIG. 10 illustrates zeta potential measured for formulations of the solution prepared in accordance with embodiments of the present disclosure for hand sanitization (“HS”) and mouthwash (“MW”).

DETAILED DESCRIPTION

[036] Embodiments of the present disclosure provide environment friendly, biocompatible, natural and safe PCP composition that is free of synthetic surfactants. In embodiments of the present disclosure, the composition may include an amino acid, a fatty acid, and a silicate salt.

[037] In embodiments of the present disclosure, the amino acid may include 1-arginie.

[038] In embodiments of the present disclosure, the amino acid may include a medium chain fatty acid. [039] In some embodiments, the fatty acid may be selected from a group including caproic acid or hexanoic acid, caprylic acid or octanoic acid, capric acid or decanoic acid, and lauric acid or dodecanoic acid, or combinations thereof.

[040] In some embodiments of the present disclosure, the fatty acid may include capric acid.

[041] In some embodiments, the silicate salt may include an alkali earth metal metasilicate.

[042] In some embodiments, the silicate salt may include sodium metasilicate.

[043] In embodiments of the present disclosure, the composition may further include one or more excipient that may act as foam stabilizers, and that may enhance the antimicrobial activity.

[044] The one or more excipients may include EDTA, Tris, or a combination thereof.

[045] In embodiments of the present disclosure, the ratio of the amino acid to the fatty acid may range from about 10 to about 1 by weight.

[046] In some embodiments, the ratio of the amino acid to the fatty acid may range from about 0.7 to about 1 by weight.

[047] In embodiments of the present disclosure, the ratio between the silicate salt to the fatty acid is from about 10 to about 1 by weight.

[048] In some embodiments, the ratio between the silicate salt to the fatty acid is from about 0.3 to about 1 by weight.

[049] In some embodiments, the concentrations of silicate salt, amino acid, and fatty acid may be 0.3, 0.7 and 1 by weight, respectively.

[050] The composition in embodiments of the present disclosure may produce a surfactant-free foam using special foam dispenser pump installed on the container closure system. [051 ] The composition of the present disclosure can be used to produce clear stable liquid with synergistic antiseptic, antimicrobial properties, anti-biofilm formation, anti- malodor, anti-tooth decay.

[052] The composition of the present disclosure may further include an antiseptic agent.

[053] The antiseptic agent may include menthol, thymol, or a combination thereof.

[054] In embodiments of the present disclosure, the composition can be used as tooth and mouthwash foam with alkaline pH (7 to 9) properties.

[055] The composition of the present disclosure may be suitable to be on daily basis especially when formulated as mouth wash. Furthermore, the composition can replace toothpastes since it will form stable cleansing and antiseptic foam that can keep oral microbes number under control consequently reducing the tooth decay. Tooth decay usually result from bacteria called streptococcus mutans. In addition, the slight alkaline nature of the composition should preserve the organic content of the tooth enamel.

[056] Reducing huge numbers of all microbes including bacteria, viruses and fungi inside the cheeks, tongue, palate, tonsils, gums and teeth with nearly neutral to slight alkaline pH is considered a good hygienic practice because mouth is considered the main entrance the gastrointestinal and respiratory systems. In addition, microbes can cause several diseases in the oral cavity such as periodontitis. Oral cavity microbes may create infections that can affect other systems, such as the cardiovascular and renal systems. Even rheumatoid arthritis and pneumonia have been linked to gum diseases. Microbes normally present in the mouth may release toxins that make their way into the brain and it may contribute to Alzheimer’s disease.

[057] The composition of the present disclosure may be suitable to be on daily basis as hand sanitizer. The composition is surfactant-free foam producing, alcohol-free safe hand sanitizer. It can reduce the number of microbes on the hands without having a negative impact on human skin or environment on long term use. [058] The composition of the present disclosure can be included in most known in the prior art personal care products in form of solution, spray, liquid soap, solid soap, gel, cream, etc. It can possess suitable emollient and therapeutic power that can give beauty the exhausted or damaged human skin.

[059] Embodiments of the present disclosure are now further illustrated on the basis of Examples and a detailed description from which further features and advantages may be taken. It is to be noted that the following explanations are presented for the purpose of illustrating and description only; they are not intended to be exhaustive or to limit the disclosure to the precise forms disclosed.

Example 1

Preparation of liquid foam composition of arginine and capric acid

[060] The purpose is to formulate a liquid alkaline safe foaming composition having cleansing and antiseptic properties. The selected amino acid was arginine and fatty acid was capric acid. The best proportion of arginine and capric acid was determined experimentally. Arginine and capric acid were put in a stirring hot plate and mixed with water while heating up to 40 °C for 10 min. according to Table 1.

Table 1 w/w% FI F2 F3 F4

Arginine (g) 0.25 0.5 0.75 1.0

Capric acid (g) 1.0 1.0 1.0 1.0

Water q.s. (g) 100 100 100 100 pH 5M (76 12 84)

Appearance Separation of Turbid Turbid Clear foaming

(initial) small oily solution solution solution droplets [061] The best mixture is to have almost the weight ratios of 1: 1 arginine to capric acid. This is close to the molar ratio of 1:1. Where, we got alkaline foaming liquid composition. The formula (F4) was selected for further evaluation.

Example 2

Arginine capric acid foaming ability comparison with other foaming products

[062] In this example, reference is being made to FIG. 1. A composition containing ( 1 % arginine and 1% capric acid) was compared with 1% of several commercial products. The foaming commercial products were used as surfactant foaming products include Fairy® and Golden ® dish wash, Cameo® hand gel and Loyal® bath gel gels all contain anionic and non-ionic surfactant mixtures. The solutions were placed in container with a standard foaming dispenser. The weight of the foam was determined in a constant volume container. The experiment was repeated three times taking the average and standard deviation. The foam density was calculated in (g/ml) and used for comparison as shown in FIG. 1.

[063] Foam density can be used to indicate the amount of liquid required to form a large foam volume filled with air. As the foam density decreases, it indicates that small amount of liquid required to form a fixed foam volume since the volume of the container was constant for all the preparations. The low density foam means smaller solution amount is required to make a large volume of foam which is suitable for hand wash application. Thus, foam will be easily spread on the skin surface and water evaporation rate will be faster. The results of FIG. 1 indicated that suitable low density foam was prepared by formula, (F4) of Example 1, and it was even better than the already known foaming surfactants present in the commercial products available in Jordan.

Example 3

Effect of dilution on foaming ability

[064] In this example, reference will be made to FIG. 2. The purpose is to determine the effect of dilution on foam density. The selected formula of F4 (solution), in Example 1, was exposed to serial dilution to detect the change in foam density upon dilution. The dilution factor was 1, 2, 3, 4, 5 and 6 using distilled water. The density was measured for stable foam at least for 10 seconds. The experiment was repeated three times taking the average and standard deviation. The foam density was calculated and used for comparison as shown in FIG. 2.

[065] The results of FIG. 2 indicated that the density of the foam increased with dilution, the foam started to collapse rapidly upon increasing the foam density especially after 6 times dilution. Stable low density foam was achieved up to 3-4 times dilution.

Example 4

Effect of temperature on clarity of arginine to capric acid 1 to 1 by weight Solution

[066] In this example, reference will now be made to FIG. 3. The formula (F4) of example 1, was placed in a vial in the refrigerator at temperature (4-8 °C) for 24 h and the appearance was observed visually for its physical clarity. Another vial containing F4 formula was kept at temperature 25 C for 24 h for comparison purposes. Photos for the vials were taken as shown in FIG. 3.

[067] FIG. 3 indicated formation of liquid crystals of arginine capric acid compared to clear transparent solution at room temperature. Capric acid is water-insoluble, the addition of arginine enhanced its solubility at room temperature. However, turbid liquid crystalline state was formed upon cooling down to temperature below 8 C due to decrease solubility in cold conditions. Thus, the formula (F4) should be modified by the addition of another additive to keep the materials in solution state even at low temperatures.

Example 5

Addition of sodium metasilicate to solution of arginine to capric acid 1:1

[068] Reference will now be made to FIG. 4. The purpose of the experiment is to prepare a slight alkaline foaming liquid. Sodium metasilicate is an inert material with suitable alkaline property and compatible with arginine and capric acid mixture was added in different amount as shown in Table 2. Table 2 w/w% F5 F6 F7 F8

Arginine (g) 0.7 07 07 07

Capric acid(g) 1.0 1.0 1.0 1.0

Sodium silicate (g) 0 0.1 0.2 0.3

Water q.s. (g) 100 100 100 100 pH 6.9 7.2 7.4 8.2

Example 6

Preparation of personal care product to be used as cleansing liquid hand foam

[069] In this example, reference will be made to FIG. 5. In order to prepare hand foam to be used to clean hands from microbes, a basic formula was prepared according to components in Table 3. However, the formula can be modified to include other active ingredients for example ZnC12 can be added as an active ingredient as shown in Table 4.

Table 3

Item Percent by Weight (%w/w)

Water q.s. 100

Glycerin 5

Capric acid* 1

Arginine 0.7

Sodium metasilicate 0.3

Menthol 0.1

Fragrance (natural) 0.05 Wherein the solution final pH was around 8.7

*Any short or medium chain fatty acid (C4-C12) can be used or mixture of fatty acids or fatty acid derivatives or their salts.

Table 4

Item Percent by Weight (%w/w)

Water q.s. 100

Glycerin 5

Capric acid 1.0

Arginine 1.1

Zinc chloride** 0.1

Tris buffer 0.3

EDTA 0.25

Fragrance (natural) 0.05

**Other inorganic and organic antimicrobial active ingredients can be added to enhance biological activity.

[070] Tables 3 and 4 showed examples on hand foam preparations that possess cleansing and antispetic effect and can be used in hand sanitizer as shown in FIG. 5. The preparations are physically stable and did not show precipitations at room temperature or in the refrigerator for 48 hours.

Example 7

Preparation of personal care product to be used as cleansing liquid mouth and tooth foam

[071] In this example, reference is now being made to FIG. 6. To prepare a cleansing liquid mouth/tooth foam, a basic formula was prepared as in Table 5. Another formula was prepared containing additional active constituents of thymol and menthol as in Table 6.

[072] Tables 5 and 6 indicated examples on mouth/tooth foam preparations with cleansing and antiseptic actions. The preparation can be directly dispensed inside mouth for mouth washing or placed on a tooth brush head and used to clean teeth as shown in FIG. 6. The preparations are physically stable and did not show precipitations at room temperature or in the refrigerator for about 48 hours. Table 5

Item Percent by Weight (%w/w)

Water q.s. 100

Glycerin 20

Sorbitol 10

Capric acid* 1

Arginine 0.7

Tris buffer 0.3

Sodium metasilicate 0.3

EDTA _ 04_ pH of the solution 8.0

Table 6

Item Percent by Weight (%w/w)

Water q.s. 100

Glycerin 20

Sorbitol 10

Capric acid* 1

Arginine 0.7

Sodium metasilicate 0.3

EDTA 0.1

Thymol 0.06

Menthol _ 0.04 pH of the solution 8.7

Example 8

Efficacy studies of arginine/capric acid composition

[073] The antimicrobial efficacy of arginine aqueous solution (1%) and carpic acid (1%) DMSO solution and formula (Table 6, Example 7) sample was conducted using in vitro disks test procedure. In this procedure, filter paper disks (12 mm diameter) were coated with the composition to be tested and placed to the top of agar media containing the microorganisms to grow. As the test formulation diffused out the disk to the agar, the growth of microbes was inhibited. Clear zones represent the degree of antimicrobial activity of the particular composition. The antimicrobial efficacy was tested against Staphylococcus aureus, Candida albicans, E.coli, Pseudomonas aeruginosa. The results are summarized in the following Table 7. Arginine did not have antimicrobial power; however, the results indicated the synergy in antimicrobial potency upon its addition to capric acid. Furthermore, the mouth foam liquid has a power antimicrobial activity especially as antifungal anti gram positive bacteria.

Table 7

Zone of inhibition (mm)

A B C D*

C. albicans 0 13.33 ± 0.58 15.33 ± 2.52 19.33 ± 1.15

S. aureus 0 7.17 ± 0.76 7.83 ± 0.29 10.17 ± 0.76

P. aeruginosa 0 6.1 ± 0.5 6.20 ± 0.1 6.21 ± 0.52

E. Coli 0 6.0 ± 0.85 6.50 ± 0.45 6.70 ± 0.51

*Formula, Table 6, Example 7. The runs were repeated 3 times and the average ± standard deviation was reported. Synergistic action upon the addition of arginine to capric acid and the effect was further enhanced by menthol and thymol

Example 9

Determination of minimum inhibitory concentration (MIC) and minimum bactericidal concentration (MBC)

[074] The MIC and MBC of formula in Table 6 in Example 7 was determined using bacterial and fungal microbes i.e Staphylococcus aureus and Candida albican, respectively.

[075] The MIC values were assessed using the broth microdilution method by sterile 96- well microtitre plates. Bacterial strains were cultured overnight at 37 °C in Muller Hinton Broth while Sabouraud Broth was used for Candida. Two fold serial dilutions of the formula with medium were prepared in concentration of 100,000 CFU/ml of each microbe. 100 pL of prepared diluted solutions was transferred into 96-well microti tre plates, and then 20 pL of standardized microorganism suspensions was added and incubated at 37 °C for 24 h for the staph and 25 °C for Candida. 50 pF tetrazolium salt (dye) was added to all wells and incubated for 30 min, where pink color indicated growth and violet indicated no growth. The last dilution with no growth was considered MIC. Positive and negative control groups were used in the MIC test.

[076] To determine the MBC was determined based on Kirby-Bauer Disc Diffusion. Samples (5 pF) from wells, in which no growth, were cultured in a gar plate and incubated for 24 h at 37 °C. Samples were taken from wells that were considered as MIC and two wells of higher concentration in order to determine MBC for the formula of Staphylococcus aureus and Candida albican. Each experiment was performed in triplicate. All procedures were performed under sterile conditions. In each test, positive and negative controls were used.

Table 8

MIC MBC

Staphylococcus Well 5 Well 3 auerus

1)1 =32 DF =4

Candida albican Well 6 Well 4

1)1 =64 1)1 =16

MIC: minimum inhibitory concentration. MBC: minimum bactericidal concentration. DF means dilution factor

[077] Table 8 summarizes the results of MIC and MBC. The MIC for ingredients to act as bacteriostatic for gram positive and fungi microbes for formula in Table 6, Example 7 at dilution factor (DF) of 32 and 64 times for S. aureus and C. albicans. While the MBC values were at DF of 4 and 64 times for S. aureus and C. albicans.

Example 10 Cytotoxicity assay test

[078] In this example, reference will be made to FIGS. 7, 8. Several commercial mouthwashes (MW1, MW2 and MW3) and toothpastes (TB1, TB2 and TB3) were evaluated against formula in Table 6, Example7 with (4-fold concentrated formula). Where, each product was diluted in phosphate buffer saline (PBS) to start with 1 X dilution for our formula and and the 4X dilution with the commercial product. Cytotoxicity was assessed using MTT Thiazoule Blue Tetrazolium Bromide assay. Ninety-six -well microplates were seeded with dental fibroblast cells in complete DMEM at a density of 2X10⁴ cells/well. Media was changed every 24h. Before the experiment, media was aspirated and replaced with DMEM enriched with product diluted in PBS at volumes equivalent to product concentrations of dilution factor (4X,2X,1X,0.5X,0.25X and so on) ,as well as positive and negative controls. Cells were incubated for 24h at 37°C. Then sterile volume of 20 mΐ MTT reagent (5mg/ml) was added per well, and the plates incubated for additional 4 h. After that media was removed and 150 m L of the acidic isopropanol solution (1.5% (v/v) solution of hydrochloric acid in isopropanol) was added to solubilize the formed formazan crystals. Plates were incubated with shaking for 15 min. Absorbance was measured spectrophotometry at 560 nm using the microplate reader (UV ELISA reader Glomax multidetector system, Glomax, Italy). Viability of control cells was considered 100% and that of test cells expressed as a percentage of control. Each sample was applied in triplicate and the average result was used for calculations.

[079] The commercial products used as mouthwashes are: MW1 composition: chlorhexidine. Made in Jordan. MW2 composition: aqua, glycerin, propylene glycol, peg-40 hydrogenated castor oil, olaflur, aroma, KC1, chlorhexidine digluconate, aluminum lactate, aspartame, sodium chloride, sodium sulfate, CI42051: patent blue v, (banned in usa ), CI18965 (yellow 2G color E number E107 not listed in UK Food Standards Agency , among EU approved food additives. Banned in Austria, Japan, Norway, Sweden, Switzerland and USA), bis(hydroxyethyryl) aminopropyl- Nhydroxyethyl octadecylamine-dihydrofluoride) (amine fluoride), Fluoride content 250 ppm. Germany. MW3 composition: aqua, alcohol, sorbitol, poloxamer 407, benzoic acid, sodium saccharine, eucalyptol, aroma, methyl salicylate, thymol, menthol, sodium benzoate, ci 42053. Made in Italy.

[080] The reference commercial products used as toothpastes are: TB1 composition: calcium carbonate, aqua, sorbitol, hydrated silica, sodium lauryl sulfate, sodium monofluorophpsphate, aroma, cellulose gum, potssium citrate, trisodium phosphate, sodium saccharine, phenylcarbinol, glycerin, limonene, ci 12490. Made in, Egypt. TB2 composition: water, sorbitol, hydrated silica, glycerin, potassium nitrate, cocamidopropyl betaine, flavor, xanthan gum, titanium dioxide, sodium saccharine, sodium hydroxide, sucrose. Made in UK. TB3 composition: glycerin, hydrated silica, sodium hexametaphosphate, prpylene glycol, peg-6, aqua, zinc lactate, aroma, sodium gluconate, sodium lauryl sulfate, silica, chondrus crispus powder, sodium saccharin, ci 77891, sodium phosphate, stannous chloride, stannus fluoride xanthan gum, sodium fluoride, cinnamal, ci 74160, limonene. Made in UK.

[081 ] The formula in Table 6 at Example 7 and the three commercial mouthwash products (MW1, MW2 and MW3) were compared at same level of dilutions from 4 up to 128X as shown in FIG. 7. It is obvious that at 4X dilution our formula in Table 6 is safer to the dental fibroblast. Similar results were observed when compared with the three commercial toothpastes as shown in FIG. 8.

Example 11

Determination of Particle size and Zeta potential

[082] In order to determine the particle size and zeta potential two preparations were selected i.e. liquid hand solution (“HS”) in example 6, Table3 and liquid mouthwash (“MW”) in example 7, Table 5. The particle size and zeta potential measurements were carried out with Zetasizer Nano ZS (Malvern Instruments, UK) at 25 °C. Samples of HS and MW were measured in folded capillary cells. Three measurements were conducted, and the number of runs in each measurement was automatically determined by the device software. [083] Results in FIG. 9 and FIG.10 indicated the formation of nano-sized particulates with high physical stability in both HS and MW solutions. The very small size and high zeta potential of HS and MW explain the liquid clarity and transparency. It was noticed that both HS and MW solutions did not show any particle precipitation at room and cold conditions (4-8 °C) for more than 6 months.

Example 12

Kill time test for antiseptic formulation

[084] Different preparations were prepared and measured for zone of inhibition and the best one was selected for kill time test as shown in Table 9 and 10, respectively. The sanitizer efficacy test was conducted to the selected formula D* to challenge the sanitizer with a prescribed inoculum of suitable microorganisms using serial dilutions and plate counts. The number of microorganisms surviving in the test product is determined at specific interval of times (15 s and 1 min) comparing to initial inoculum. Suitable media, reagents and apparatus were used. The tested microorganisms were P. aeruginosa ATCC 9027, E. coli NCTC 10788, S. aureus NCTC 10788, C. albicans ATCC 10231 and A. Brasiliensis NCPF 2275. The test procedure was carried according to USP1072.

[085] The results at 15 s and 1 min indicated the efficacy of the selected preparation D* against bacteria and fungi as shown in Table 11. It is obvious that the preparation can easily kill microbes efficiently after exposure to short time periods i.e. 15 s and 1 min.

Table 9

Sodium metasilicate 0.7 0.7 0.7 0.7 0.7 1-Arginine 0.3 0.3 0.3 0.3 0.3 Glycerin 5.0 20 5.0 20 0 Trometh amine 0.3 0.3 0.3 0.3 0.3 Capric acid 1.0 1.0 1.0 1.0 1.0 Borax 1.0 0.1 1.0 0.1 0.1

Menthol 0.1 0.1 0.1 0.1 0.1

Phosphate buffer 0 1.0 1.0 1.0 1.0 Citrate buffer 0 0 0 0.3 0 Acetate buffer 0 0 0 0 0.3 Water qs 100 100 100 100 100

Table 10

Zone of inhibition (mm)

A B C D* E MW3

C. albicans 29.7 24.0 21.10 29.5 18.6 7.40

A. brasiliensis 20.3 21.45 22.2 21.6 17.8 NA S. aureus 8.4 11.50 12.0 12.5 10 7.30

P. aeruginosa 6.0 9.3 12.7 13.8 7.9 NA

E. Coli 6.6 6.2 12.4 12.7 8.2 6.25

NA: No activity. MW3 commercial mouthwash composition: aqua, alcohol, sorbitol, poloxamer 407, benzoic acid, sodium saccharine, eucalyptol, aroma, methyl salicylate, thymol, menthol, sodium benzoate, ci 42053. *Selected formula for kill time test.

Table 11

P. aeruginosa ATCC 9027 3xl0⁶ 15 seconds without <10 CFU/m dilution

1 minute without <10 CFU/m dilution

E. coli NCTC 10788 2.5 xl06 15 seconds without <10 CFU/m dilution

1 minute without <10 CFU/m dilution

S. aureus NCTC 10788 5.0 xlO⁶ 15 seconds without 1.50 xlO⁴ dilution

1 minute without 1.50 xlO² dilution

C. albicans ATCC 10231 1.2 xlO⁵ 15 seconds without 7.7 xlO³ dilution

1 minute without 3.1 xlO³ dilution

A. Brasiliensis NCPF 2275 6.5 xlO⁴ 15 seconds without 5 xlO³ dilution

1 minute without 2.0 xlO³ dilution

[086] In the present disclosure, the singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise.

[087] As used herein, a plurality of items, structural elements, compositional elements, and/or materials may be presented in a common list for convenience. However, these lists should be construed as though each member of the list is individually identified as a separate and unique member. Thus, no individual member of such list should be construed as a defacto equivalent of any other member of the same list solely based on their presentation in a common group without indications to the contrary.

[088] Concentrations, amounts, and other numerical data may be presented herein in a range format. It is to be understood that such range format is used merely for convenience and brevity and should be interpreted flexibly to include not only the numerical values explicitly recited as the limits of the range, but also to include all the individual numerical values or sub-ranges encompassed within that range as if each numerical value and sub-range is explicitly recited. For example, a numerical range of approximately 1 to approximately 4.5 should be interpreted to include not only the explicitly recited limits of 1 to approximately 4.5, but also to include individual numerals such as 2, 3, 4, and sub-ranges such as 1 to 3, 2 to 4, etc. The same principle applies to ranges reciting only one numerical value, such as “less than approximately 4.5,” which should be interpreted to include all of the above -recited values and ranges. Further, such an interpretation should apply regardless of the breadth of the range or the characteristic being described.

[089] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood to one of ordinary skill in the art to which the presently disclosed subject matter belongs. Although any methods, devices, and materials similar or equivalent to those described herein can be used in the practice or testing of the presently disclosed subject matter, representative methods, devices, and materials are now described.

[090] Unless otherwise indicated, all numbers expressing quantities of ingredients, reaction conditions, and so forth used in the specification and claims are to be understood as being modified in all instances by the term “about.” Accordingly, unless indicated to the contrary, the numerical parameters set forth in this specification and attached claims are approximations that can vary depending upon the desired properties sought to be obtained by the presently disclosed subject matter.

[091 ] As used herein, the term “about,” when referring to a value or to an amount of mass, weight, time, volume, concentration or percentage is meant to encompass variations of in some embodiments ±20%, in some embodiments ±10%, in some embodiments ±5%, in some embodiments ±1%, in some embodiments ±0.5%, and in some embodiments ±0.1% from the specified amount, as such variations are appropriate to perform the disclosed method.

Claims

CLAIMS What is claimed is:

1. A foaming composition comprising an amino acid, a fatty acid, and a silicate salt.

2. The foaming composition of claim 1 , further comprising an antiseptic agent.

3. The foaming composition of claim 2, wherein the antiseptic agent is selected from a group including menthol, thymol, or a combination thereof.

4. The foaming composition of claim 1, wherein the amino acid comprises 1-arginie.

5. The foaming composition of claim 1, wherein the fatty acid comprises a medium chain fatty acid.

6. The foaming composition of claim 1 , wherein the fatty acid is selected from a group including caproic acid or hexanoic acid, caprylic acid or octanoic acid, capric acid or decanoic acid, and lauric acid or dodecanoic acid, or combinations thereof.

7. The foaming composition of claim 1, wherein the fatty acid comprises capric acid.

8. The foaming composition of claim 1, wherein the silicate salt comprises an alkali earth metal metasilicate.

9. The foaming composition of claim 8, wherein the silicate salt comprises sodium metasilicate.

10. The foaming composition of claim 1, further comprises one or more excipient acting as a foam stabilizer, and enhancing antimicrobial activity.

11. The foaming composition of claim 10, wherein the one or more excipients comprises EDTA, Tris, or a combination thereof.

12. The foaming composition of claim 1 , wherein the ratio of the amino acid to the fatty acid is from about 10 to about 1 by weight.

13. The foaming composition of claim 10, wherein the ratio of the amino acid to the fatty acid is from about 0.7 to about 1 by weight.

14. The foaming composition of claim 1, wherein the ratio between the silicate salt to the fatty acid is from about 10 to about 1 by weight.

15. The foaming composition of claim 14, wherein the ratio between the silicate salt to the fatty acid is from about 0.3 to about 1 by weight.

16. The foaming composition of claim 1, wherein the concentrations of silicate salt, amino acid, and fatty acid are 0.3, 0.7 and 1 by weight, respectively.