SANITIZING COMPOSITION IN FORM OF GEL CREAM OR LOTION WITH MOISTURIZATION BENEFITS

FIELD OF THE INVENTION
[0001] The present invention relates to a sanitizing gel cream or sanitizing lotion for skin, hands, body and head, which has a persistent microbicidal activity and also provides moisturization effect.
BACKGROUND OF THE INVENTION
[0002] The present disclosure generally relates to an antimicrobial alcohol based hand sanitizer composition having effective microbicidal effect while also providing moisturizing benefit to the user's skin. More particularly, the instant alcohol-based hand sanitizers include alcohol, organic acid, emollients and excipients which allows moisturization of the skin along with exhibiting germicidal effect.
[0003] In the present scenario of Covid 19, people are aware of the notion of "germs" and germ transmission. One of the best and easiest ways of preventing germ and/or disease transmission is by routinely washing one's hand. Hand washing under certain circumstances is not convenient, such as in traveling conditions and/or time constraints. A number of manufacturers have introduced hand sanitizing products which sanitize skin surfaces without the need for water and/or drying towels.
[0004] Although alcohol and alcohol-containing sanitizers are known to possess microbicidal activity and to prevent infections, such sanitizers typically require the use of anywhere from 60% to 95% by wt. alcohol, such as ethanol, in order to be effective. Unfortunately, use of ethanol at these levels can be very drying to the skin. As such, continuous use of such products can leave the user's skin dry, often resulting in red, chapped, and cracked skin.
[0005] To improve user's skin, many companies have conventionally included moisturizers, such as humectants, emollients, and the like, as additional components in their alcohol-based hand sanitizers. Such sanitizers provide some protection against drying of the skin, but there are several drawbacks to these conventional sanitizers like

phase separation during shelf life. As a result, the added moisturizers or skin protectants do not remain evenly distributed throughout the sanitizer, rendering the moisturizing ability of the sanitizer ineffective. Additionally, the instability of the sanitizers may cause the formation of large oil layers on the skin and, as a result, the sanitizer may feel greasy and not aesthetically pleasing on the skin. Hence, there is a continuous desire to develop an alcohol based sanitizer having moisturization effect so as to protect the skin.
OBJECT OF THE INVENTION
[0006] A primary object of the present invention is to provide a sanitizing gel
cream or sanitizing lotion which overcomes the limitation of the prior art.
[0007] Another object of the present invention is to provide sanitizing gel cream
or sanitizing lotion which provides sanitizing benefits and also keeps the hand, head, body and skin hydrated and moisturized.
[0008] Yet another object of the present invention is to provide a sanitizing gel
cream or sanitizing lotion that remains stable during shelf life and there is no phase separation.
[0009] The above and other objectives are accomplished by the present invention
which is directed to a sanitizing gel cream or sanitizing lotion comprising principally ethanol, lactic acid, emollients and excipients. The sanitizing gel cream provides effective antimicrobial effect and also moisturizes hands, body and skin.
BRIEF DESCRIPTION OF THE FIGURES
[0010] Figure 1 illustrates the enhanced skin hydration values of the sanitizing
composition of the present invention on comparison to control gel sanitizer.
[0011] Figure 2 illustrates the reduced Trans-Epidermal Water Loss (TEWL)
values of the sanitizing composition of the present invention on comparison to control gel sanitizer.

SUMMARY OF THE INVENTION
[0012] The present invention discloses a sanitizing gel cream or sanitizing lotion having wide spectrum antimicrobial properties and also moisturizes the skin. The moisturizing sanitizing gel cream or lotion of the present disclosure comprises an alcohol, an organic acid and excipients wherein the alcohol is present in an amount from 5 to 20% (wt. /wt.) and organic acid is present in an amount from 0.1 to 1% (wt. /wt.) and rest are excipients.
[0013] The alcohol for the moisturizing sanitizing gel cream or sanitizing lotion is selected from the group consisting of ethanol, propanol, isopropyl alcohol, butanol and combinations thereof. Preferably, the alcohol is ethanol. The organic acid for the moisturizing sanitizing gel cream or lotion is selected from the group consisting of lactic acid, citric acid, salicylic acid and malic acid. Preferably, the organic acid is lactic acid.
[0014] The excipients in the moisturizing sanitizing gel cream or lotion include emollients, skin protectants, emulsifiers, humectants, plant extracts, fragrance and disinfectants.
[0015] The emollients are selected from the group comprising of lanolin and its derivatives, fatty esters, glycerol esters and derivatives, propylene glycol esters and derivatives, alkoxylated carboxylic acids, alkoxylated alcohols, fatty alcohols, fatty acids, and combinations thereof and is present in a range from 1 to 15% (wt. /wt.). Preferably, the emollient is Propylene glycol dicaprylate/ dicaparate, PPG-1 Trideceth-6 and caprylic/ capric triglyceride.
[0016] The skin protectants are selected from the group comprising of dimethicone, cyclomethicone, polyalkylsiloxanes, polyarylsiloxanes, polyalkylarylsiloxanes, polysiloxane gums, polyether siloxane copolymers, and combinations thereof and present in a range from 1 to 10% (wt. /wt.). Preferably, the skin protectant is DC 200/350 est.
[0017] The suitable emulsifiers for the moisturizing sanitizing gel cream or sanitizing lotion have a hydrophilic/lipophilic balance (HLB) from 8 to 16 and are selected from the group comprising of sorbitan laurate, PEG-40 hydrogenated castor oil, laureth-4, ceteth-10, ceteth-20, steareth-10, steareth-20, oleth-10, oleth-20, steareth-21, laureth-

23, PEG-8 laureate, PEG-20 stearate, ceteareth-20, or combinations thereof and present in a range from 1 to 5% (wt. /wt.). Preferably, the emulsifier is ceteareth-20.
[0018] The humectant/moisturizing components for the moisturizing sanitizing gel cream or sanitizing lotion is selected from the group comprising of glycerin, glycerin derivatives, sodium hyaluronate, hyaluronic acid, betaine, amino acids, glycosaminoglycans, honey, sorbitol, glycols such as propylene glycol, polyols, sugars, hydrogenated starch hydrolysates, salts of PCA such as sodium PCA, lactates, Methyl Gluceth 20, and urea present in a range from 0.2 to 1.0% (wt./wt). Preferably, the humectant used in the present invention are Methyl gluceth 20, glycerine or triethylene glycol.
[0019] The preservatives used in moisturizing sanitizing gel cream or sanitizing lotion is selected from the group comprising of phenoxyethanol, EDTA and triethyl amine present in a range from 0.2 to 1.0% (wt./wt.). Preferably, the preservative is phenoxyethanol.
[0020] The plant extracts used in moisturizing sanitizing gel cream or sanitizing lotion is tulsi extract, turmeric extract, neem, aloe vera extract, orange extract, pink pomelo extract and lemon extract present in a range from 0.01 to 1% (wt. /wt.).
[0021] The moisturizing sanitizing gel cream or lotion may also contain fragrance selected from the group comprising of isopropyl alcohol, eucalyptus oil, geraniol, phenyl ethyl alcohol, linalol and linalyl acetate present in a range from 0.2 to 0.8% (wt.
/wt.).
[0022] The moisturizing sanitizing gel cream or lotion may also contain disinfectant such as a quaternium salt, polyquaternium, quaternium, quaternium hectorite (e.g., quaternium-18 hectorite), silicone quaternium materials, cationic surfactant, or combination thereof preferably, polyquaternium-37 and antimicrobial agents present in a range from 1 to 5% (wt. /wt.).
[0023] The present disclosure provides the moisturizing sanitizing gel cream or sanitizing lotion in form of an oil in water emulsion.

DESCRIPTION OF THE INVENTION
[0024] The invention according to its various aspects is particularly pointed out
and distinctly claimed in the appended claims read in view of this specification and appropriate equivalents.
[0025] It is to be noted, as used in the specification and the appended claims, the singular forms "a", "an", and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to a composition containing "a compound includes a mixture of two or more compounds. It should also be noted that the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise. The expression of various quantities in the terms of "% w/w" or "%" means the percentage by weight, relative to the weight of the total composition unless otherwise specified.
[0026] It is noted that in this disclosure and particularly in the claims and/or paragraphs, terms such as "comprises", "comprised", "comprising" and the like can have the meaning attributed to it in Patent law; e.g., they can mean "includes", "included", "including", and the like; and that terms such as "consisting essentially of and "consists essentially of have the meaning ascribed to them in Patent law, e.g., they allow for elements not explicitly recited, but exclude elements that are found in the prior art or that affect a basic or novel characteristic of the invention.
[0027] The present disclosure generally relates to antimicrobial sanitizers containing alcohols that are effective in killing microorganisms while providing a moisturizing benefit to the user's skin. More particularly, the alcohol-based sanitizers are in form of gel cream or lotion which allows moisturizers or skin protectants such as emollients to be stably incorporated into the sanitizer.
[0028] In an embodiment, the antimicrobial alcohol based sanitizers is in form of oil in water emulsion. The emulsion in which oil is present as the dispersed phase and water as the dispersion medium (continuous phase) is called an oil-in-water emulsion. As a result, the moisturizing sanitizers of the present disclosure have good moisturization

effects, are substantially stable over extended periods of time, and have good aesthetics and feel on user's skin.
[0029] Additionally, the moisturization benefits of the sanitizers of the present disclosure may be long-lasting. Without wishing to be bound to any particular theory, it is believed that when the sanitizer is applied to a user's skin, the alcohol, water, and other sanitizer components evaporate off the skin, leaving behind the emollients or oil phase which forms a thin, partially occlusive film on the skin that provides a long-lasting moisturization benefit.
[0030] Thus, in one aspect, the present disclosure is directed to a moisturizing sanitizer comprising an alcohol, a carrier such as water, and an oil in water emulsion. The oil in water emulsion comprises an aqueous phase, a non-aqueous phase, and an emulsifier. The non-aqueous phase may comprise a moisturizer or skin protectant that has moisturizing and/or other skin conditioning properties, such as an emollient and essential oil. The moisturizing sanitizer may be formulated with a suitable pharmaceutically acceptable carrier into compositions such as lotions, creams, liquids, and the like, that may be applied to skin or mucosa and head. In one particularly preferred embodiment, the moisturizing sanitizer of the present invention is suitably in the form of an instant hand sanitizer in form of a gel cream or lotion. In one particularly preferred embodiment, the moisturizing sanitizer of the present invention is meant for application on hands.
[0031] The presence of the alcohol in the gel cream or lotion sanitizer provides the sanitizer with microbicidal properties against most virus, bacteria and fungi. More particularly, the alcohol is suitably capable of killing gram-positive and/or gram negative bacteria, fungi, mold, a variety of viruses, protozoans, parasites, and other microbes. Alcohol kills bacteria through a process known as denaturation. Alcohol molecules are amphiphile chemical compounds, which means that they have both water and fat-loving properties. Because microbial cell membranes have a fat-based side as well as a water-based side, alcohol molecules are able to bond with and break down the protective membrane. When this occurs, the core components of the bacteria are exposed and dissolve, losing their structure and ceasing to function. With its organs essentially melting away, the bacteria dies quickly.

[0032] Suitable alcohols for use in sanitizing gel cream or sanitizing lotion of the present invention includes any water-soluble alcohol known in the art. Typically, the alcohol will be a short chain alcohol. Non-limiting examples of suitable alcohols include ethanol, propanol, isopropyl alcohol, butanol, or there combinations. Generally the alcohol is ethanol, isopropyl alcohol or combinations of both. More typically, the alcohol is ethanol/ethyl alcohol.
[0033] Usually, the antimicrobial effect of the alcohol increases with concentration of the alcohol in the sanitizer. However, high concentration of alcohol has the detrimental effect of increasing the level of skin irritancy for users of the sanitizer. The commercially available hand sanitizer comprises alcohol in an amount of from about 20% (by weight of the sanitizer) to about 95% (by weight of the sanitizer). In one particular embodiment, the gel cream and lotion sanitizer of the present disclosure comprises ethanol in an amount from 5 to 20% (wt. /wt. of the sanitizer composition).
[0034] In an embodiment of the present invention, the gel cream moisturizing sanitizer or sanitizing lotion comprises organic acid. The organic acids are selected from the group comprising of lactic acid, citric acid, salicylic acid, malic acid and combinations thereof. The organic acid is preferably lactic acid. The organic acid is present in a range from 0.1 to 1%> (wt. /wt. of the sanitizer composition). Lactic acid has antibacterial and antiviral properties. It is fragrance-free and contains moisturising and anti-aging properties that make it suitable for moisturizing sanitizers of the present invention.
[0035] In an embodiment of the invention, the moisturizing sanitizing gel cream or lotion in addition to alcohol and organic acid comprises excipients. The excipients comprises of emollients, skin protectants, emulsifiers, humectants, plant extracts, fragrance and disinfectants.
[0036] In an embodiment of the invention, the moisturizing sanitizing gel cream or sanitizing lotion comprises an emollient. Emollients are moisturising compounds applied directly to the skin to soothe and hydrate it. They cover the skin with a protective film to trap in moisture and make the skin soft. Suitable emollients that can be incorporated into the moisturizing sanitizing gel cream or lotion of the present invention include lanolin and its derivatives, fatty esters, glycerol esters and derivatives, propylene

glycol esters and derivatives, alkoxylated carboxylic acids, alkoxylated alcohols, fatty alcohols, fatty acids, and combinations thereof. Preferably, the emollient is Propylene glycol dicaprylate/ dicaparate and PPG-1 Trideceth-6. Propylene glycol dicaprylate/dicaprate is made from propylene glycol and capric acid, a fatty acid derived from plants. PPG-1 Trideceth-6 is a polyoxypropylene, polyoxyethylene ether of tridecyl alcohol. PPG-1 Trideceth-6 function as skin conditioning agent and surfactant which blends all formula ingredients into a stable and uniformly dispersed product. The emollients are present in a range from 1 to 5% (wt. /wt. of the sanitizer composition).
[0037] In an embodiment of the present invention, the gel cream or lotion moisturizing sanitizer comprises emollient caprylic/capric triglyceride present in a range from 1 to 10% (wt. /wt. of the sanitizer composition). Caprylic/ capric triglyceride are compound obtained on esterification of capric and caprylic acid found in coconut oil with glycerine. Caprylic/ capric triglyceride helps in maintaining smooth skin and also works as an antioxidant. Addition of Caprylic/ capric triglyceride provides a spore killing activity and a widened microbicidal spectrum to the sanitizer of the present invention.
[0038] In an embodiment of the present invention, the moisturizing sanitizer composition comprises skin protectants, such as a silicone. These materials help improve the barrier properties of the skin and protect them from external irritants or sensitizers. The silicones are present in a range from 1 to 10% (wt. /wt. of the sanitizer composition).
[0039] Suitable silicone materials include, for example, a silicone surfactant, a volatile silicone oil, a non-volatile silicone oil, or combinations thereof. More particularly, the silicone material may be, for example, dimethicone, cyclomethicone, polyalkylsiloxanes, polyarylsiloxanes, polyalkylarylsiloxanes, polysiloxane gums, polyether siloxane copolymers, and combinations thereof. Exemplary silicone and silicone derivatives also include branched or linear cyclic silicone or silicone derivatives, cyclomethicone, dimethicone polysiloxane, dimethiconol, polysiloxanes, polysiloxane copolymers, polyalkyl aryl silanes, polyaryl siloxanes, polyalkyl siloxanes, polyalkyl aryl silanes, polysiloxane copolymers, alkyl dimethicones, alkyl methicones, alkyldimethicone copolyols, phenyl silicones, alkyl trimethylsilanes, cyclopentasiloxane, dimethicone crosspolymer, trisiloxane, and combinations thereof.

Preferred example of silicones include silicone fluid DC 200/350 est (available from Dow Corning) which is found suitable for use in the present invention.
[0040] In an embodiment of the present invention, the moisturizing sanitizer comprises emulsifiers. Emulsifiers are molecules with non-polar and polar regions that are able to reside at the interface of the water and oil components of the emulsion. Emulsifiers according to the present disclosure are not particularly limited and will preferably have a hydrophilic/lipophilic balance (HLB) from 8 to 16, and behave as oil-in-water emulsifiers. Suitable emulsifiers for the present invention include sorbitan laurate, PEG-40 hydrogenated castor oil, laureth-4, ceteth-10, ceteth-20, steareth-10, steareth-20, oleth-10, oleth-20, steareth-21, laureth-23, PEG-8 laureate, PEG-20 stearate, ceteareth-20, or combinations thereof. Preferably, the emulsifier used in the present invention is Ceteareth-20. Ceteareth-20 is the polyethylene glycol ether of cetearyl alcohol. It also function as a surfactant and emollient. The emulsifiers are present in a range from 1 to 5% (wt. /wt. of the sanitizer composition).
[0041] In one embodiment, the moisturizing sanitizer further comprises a humectant. Humectant present in the sanitizer may advantageously be deposited on the skin upon use of the sanitizer, thus helping to maintain lipids and essential oils present in the skin. Particular examples of suitable humectants include glycerin, glycerin derivatives, sodium hyaluronate, hyaluronic acid, betaine, amino acids, glycosaminoglycans, honey, sorbitol, glycols such as propylene glycol, polyols, sugars, hydrogenated starch hydrolysates, salts of PCA such as sodium PC A, lactates, urea, methyl gluceth 20 and the like. A particularly preferred humectant is Methyl gluceth 20, glycerine or triethylene glycol. The humectant is preferably present in a range from 0.2 to 1.0% (wt. /wt. of the sanitizer composition).
[0042] In an embodiment of the present invention, the moisturizing sanitizer may further comprise preservatives like phenoxyethanol, EDTA and triethyl amine. Phenoxyethanol prevents microbial growth, helps in stabilizing and increasing shelf life of the sanitizing gel cream or lotion. Phenoxyethanol is preferably present in a range from 0.2 to 1.0% (wt. /wt. of the sanitizer composition).

[0043] In an embodiment of the present invention, the moisturizing sanitizer comprises plant extracts. The extracts capture the plant's scent and flavour, or "essence." Unique aromatic compounds give plant extract its characteristic properties. Plant extracts are obtained through processes well known to a person skilled in art. The plant extract used in the present invention are turmeric extract, tulsi extract, neem, aloe vera extract, orange extract, pink pomelo extract and lemon extract. The plant extracts are present in the moisturizing sanitizing gel cream or sanitizing lotion in a range from 0.01 to 1 % (wt. /wt. of the sanitizer composition).
[0044] Tulsi extract (basil) is obtained from the Ocimum sanctum. Tulsi extract has healing effect, antibacterial, antifungal and anti-inflammatory properties. Turmeric extract is obtained from {Curcuma longa). Turmeric extract has antioxidant and anti-inflammatory properties. The presence of extracts of tulsi and turmeric helps in reducing inflammation that may occur to hand because of regular and extensive use of alcohol based sanitizers.
[0045] The moisturizing sanitizer of the present invention may comprise a fragrance if needed. The fragrance may be any kind as long as it is suitably used in products for skin external use, such as drugs and cosmetics, and is not particularly limited. Examples of such a fragrance include isopropyl alcohol, eucalyptus oil, geraniol, phenyl ethyl alcohol, linalol and linalyl acetate. The fragrance is present in a range from 0.2 to 0.8% (wt. /wt. of the sanitizer composition).
[0046] In addition to the alcohol, in certain embodiments, the moisturizing sanitizer of the present disclosure may optionally further comprise other disinfectants or antimicrobial agents that contribute to the anti-microbial effect of the sanitizer.
[0047] Suitable disinfectants include, for example, quaternium compounds, biguanidines, halogenated compounds, and combinations thereof.
[0048] In one particular embodiment, the disinfectant is a cationic compound such as a quaternium salt, polyquaternium, quaternium, quaternium hectorite (e.g., quaternium-18 hectorite), silicone quaternium materials, cationic surfactant, or combination thereof. One particularly preferred example is a quaternary ammonium compound, such as a

quaternary ammonium salt. The quaternary ammonium salt is present in a range from 1 to 5% (wt. /wt. of the sanitizer composition).
[0049] Suitable polyquaterniums for use in the moisturizing hand sanitizers include
Polyquatemium-1, Polyquatemium-2, Polyquaternium-3, Polyquaternium-4,
Polyquaternium-5, Polyquaternium-6, Polyquaternium-7, Polyquaternium-8,
Polyquaternium-9, Polyquatemium-10, Polyquaternium-11, Polyquatemium-12,
Polyquatemium-13, Polyquatemium-14, Polyquatemium-15, Polyquatemium-16,
Polyquatemium-17, Polyquatemium-18, Polyquatemium-19, Polyquaternium-20,
Polyquaternium-21, Polyquatemium-22, Polyquatemium-23, Polyquaternium-24,
Polyquaternium-25, Polyquatemium-26, Polyquatemium-27, Polyquatemium-28,
Polyquaternium-29, Polyquatemium-30, Polyquatemium-31, Polyquatemium-32,
Polyquaternium-3 3, Polyquaternium-3 4, Polyquaternium-3 5, Polyquaternium-3 6,
Polyquaternium-3 7, Polyquaternium-3 8, Polyquaternium-3 9, Polyquaternium-40,
Polyquaternium-41, Polyquaternium-42, Polyquatemium-43, Polyquaternium-44,
Polyquaternium-45, Polyquatemium-46, Polyquatemium-47, Polyquatemium-48,
Polyquaternium-49, Polyquatemium-50, Polyquatemium-51, Polyquatemium-52,
Polyquaternium-53, Polyquaternium-54, Polyquatemium-55, Polyquatemium-56,
Polyquaternium-57, Polyquatemium-58, Polyquaternium-59, Polyquatemium-60,
Polyquaternium-61, Polyquatemium-62, Polyquatemium-63, Polyquaternium-64,
Polyquaternium-65, Polyquatemium-66, Polyquatemium-67, Polyquatemium-68,
Polyquaternium-69, Polyquatemium-70, Polyquatemium-71, Polyquatemium-72,
Polyquaternium-73, Polyquatemium-74, Polyquaternium-75, Polyquaternium-76, and
Polyquaternium-79. Preferably the polyquatemium used in the present invention is
Polyquatemium -37.
[0050] As noted above, in addition to acting as a disinfectant and moisturizer, the sanitizers of the present disclosure may also be formulated to provide additional skin health benefits to a user, such as soothing, anti-irritation effect. For instance, the sanitizer can contain further additional components such as humectants, carriers, dyes, fragrances, chelating agents, rheology modifiers, thickeners, pH modifiers, and various other optional components.

[0051] The moisturizing sanitizer composition has pH between 5-6 and viscosity ranges between 8000 -25000 cps at room temperature. The instrument used for viscosity is Brookfield Model RV DV 2, spindle S92, 6 rpm.
The following examples illustrate, but in no way are intended to limit the present invention.
Example 1: Method for preparing sanitizing gel cream
[0052] The components of sanitizing gel cream are taken in predefined ranges as illustrated in Table 1 and are added in following manner.
In step 1: DM water, Ceteareth 20 are mixed at high speed of 150 rpm followed by addition of glycerine with further high speed stirring at 150 rpm for approx.30 min. The aqueous phase is ready and its temperature is about 35 °C ± 2 °C.
In step 2: Polyquaternium-37 (and) Propylene Glycol Dicaprylate/Dicaprate (and) PPG-1 Trideceth-6 is added with high speed stirring for 15 minutes followed by addition of Caprylic/capric triglyceride and Dimethicone during stirring and continuing stirring for further 10 minutes.
In step 3: The batch is cooled to room temperature and Phenoxyethanol, Triethylene glycol and Lactic Acid are added and stirred for 15 minutes at 150 rpm.
In step 4: In fourth step Turmeric Extract, Tulsi Extract and Pink Pomelo Extract are added and stirred at 150 rpm for 15 minutes.
In step 5: In fifth step ethanol is added while filtering through Nylon cloth 200# and continue stirring at medium speed followed by addition of fragrance and stirred for 10 minutes. The sanitizing composition so prepared has pH between 5-6 and viscosity in in range between 8000 -25000 cps on measuring by Brookfield Model RV DV 2, spindle S92, 6 rpm.
Table 1: Composition of Sanitizing gel cream or lotion

S.No. Ingredients % w/w (Range)
1 Polyquaternium-37, Propylene Glycol Dicaprylate/Dicaprate (and) PPG-1 Trideceth-6 (1-5%) 1-5 %
2 Caprylic/capric triglyceride 1-10%
3 Ceteareth 20 1-5 %
4 Alcohol 5-20 %
5 Lactic acid 0.1-1%
6 DC 200/350 est 1-10%
7 Turmeric Extract WS 0.01-1%
8 Tulsi Extract WS 0.01-1%
9 Perfume 0.2- 0.8%
10 Phenoxyethanol, triethylene glycol 0.2- 1.0
11 Water Q.S.
12 Aloe vera Juice 0.01-1%
13 Methyl gluceth 20 0.2-1.0%
14 Triethyl Amine 0.02-0.5
15 EDTA 0.05-0.5
16 Pink Pomelo Extract 0.01-1%
Example 2: Different formulations of the sanitizing gel cream or lotion
[0053] The components as illustrated in Table 1 are taken in predefined amount as shown in Table 2. The formulation 1, 2 and 3 are prepared by the process as illustrated in Example 1.
Table 2: Different Formulations of the Sanitizing gel cream or lotion

S.No Ingredients Function % w/w (Range) Formulation 1 Formulation
2 Formulation 3

1 Polyquaternium-3 7, Propylene Glycol Dicaprylate/Dicaprate (and) PPG-1 Trideceth-6 Emollient 1-5 1.5 1.5 1.5
2 Caprylic/capric triglyceride Emollient 1-10 3 3 3
3 Ceteareth 20 Emulsifier 1-5 2 2 2
4 Ethyl Alcohol Antimicrobial effect 5-20 15 15 20
5 Lactic acid Antimicrobial effect 0.1-1 0.1 0.125 0.125
6 DC 200/350 est Silicones 1-10 1 1 1
7 Turmeric Extract WS Antioxidant and anti-inflammatory 0.01-1 0.05 0.05 0.05
8 Tulsi Extract WS Antioxidant and anti-inflammatory 0.01-1 0.05 0.05 0.05
9 Perfume Fragrance 0.2-0.8 0.4 0.4 0.4
10 Triethylene glycol Humectant 0.2-1.0 0.8 0.8 0.8
11 Aloe vera Juice Plant extract 0.01 -1 1 1 1
12 Methyl Gluceth 20 Humectant 0.2-1.0 1.5 1.5 1.5
13 Triethyl Amine Preservative 0.02-0.5 0.1 0.1 0.1
14 EDTA Preservative/
Chelating
agent 0.05-0.5 0.1 0.1 0.1
15 Pink Pomelo Extract Active 0.01-1% 0.05 0.05 0.05
15 Water Carrier Q.S. to
100 Q.S. to 100 Q.S. to 100 Q.S. to 100

[0054] Example 3: In vitro data on efficacy of moisturizing composition on different microorganism.
Different formulation were prepared in accordance with Table 3 varying the amount of lactic acid and alcohol to study the effect of alcohol and lactic acid on killing microbes and the spectrum of microbes against which they are active. A control study was performed on microbes E.coli ATCC 8739, S.aureus ATCC 6538, P.aeruginosa ATCC 902 7, and Salmonella typhimurium A TCC14028. For the study test method of reference: ASTM 2315-16 was followed.
Table 3: Different formulations and their efficacy studies

S/No. Ingredients Test formulation 1
(wt.%) Test
formulation 2
(wt.%) Test formulation 3
(wt.%)
1 DM Water 86.575 66.58 86.70
2 Glycerine 4.5000 4.5000 4.5000
3 Polyquaternium-3 7, Propylene Glycol Dicaprylate/Dicaprate (and) PPG-1 Trideceth-6 1.5000 1.5000 1.5000
4 Caprylic/capric triglyceride 3.0000 3.0000 3.0000
5 Ethyl Alcohol 0 20 0
6 Perfume 0.3500 0.3500 0.3500
7 Lactic Acid 0.125 0.125 0
8 DC 200/350 est 1.0000 1.0000 1.0000
9 Cresmer 1000
( emulsion stabilizer
and surfactant) 2.0000 2.0000 2.0000

10 Turmeric Extract WS 0.0500 0.0500 0.0500
11 Tulsi Extract WS 0.0500 0.0500 0.0500
12 Pink Pomelo Extract 0.0500 0.0500 0.0500
13 Iscaguard PEG (preservative) 0.8000 0.8000 0.8000
[0055] For Test formulation 1 without alcohol and only having lactic acid following
observations were made in time kill assay:
Table 3.1: Neutralization validation assay results for test formulation 1 without alcohol and only having lactic acid

Test Organism Exposur e time (min) Neutralization challenge microbial suspension Neutralization effectiveness Test A Neutralization
toxicity
TestB Test Organism
Viability
Test C

Count (cfu/ml) Logio Count (cfu/g) Logio Count (cfu/ml) Logio Count (cfu/ml) Logio
E. coli 0 min 5.9xl03 3.77 50 1.70 51 1.71 55 1.74

30 min 5.5xl03 3.74 48 1.68 47 1.67 50 1.70
S. aureus 0 min 5.5xl03 3.74 51 1.71 48 1.68 51 1.71

30 min 5.3xl03 3.72 44 1.64 46 1.66 47 1.67
S. typhimurium 0 min 5.6xl03 3.75 51 1.71 52 1.72 52 1.72

30 min 5.4xl03 3.73 48 1.68 47 1.67 50 1.70
Table 3.2: Test Suspension for Test formulation 1 without alcohol and only having lactic acid

Test Organism Initial count (cfu/ml) log (initial count)
E.coli 2.5xl06 6.40

S.aureus 1.9xl06 6.28
S. typhimurium 1.9xl06 6.28
Table 3.3: Test Count for Test formulation 1 without alcohol and only having lactic acid

Test Organism Contact Time Cone, of product
% Test
count
(cfu/g) Test log value Log Reduction % Reduction
E.coli 5 minutes neat 2.7xl05 5.43 0.97 89.2
S.aureus 5 minutes neat 2.0xl03 3.30 2.98 99.89
S. typhimurium 5 minutes neat 7.2xl05 5.86 0.42 62.11
[0056] On testing test formulation 1, antimicrobial efficacy was found to be in the range of 99.8%) to 62.11%) reduction against test microorganisms {S.aureus, E.coli, & S.typhimurium respectively) with least efficacy of 62.11% for S.typhimurium.
[0057] For Test formulation 2 with alcohol and lactic acid following observations were made in time kill assay:
Table 3.4: Neutralization validation assay results for test formulation 2 with alcohol and lactic acid

Test Organism Exposur e time Neutralization challenge microbial suspension Neutralization effectiveness Test A Neutralization
toxicity
TestB Test Organism
Viability
Test C

Count (cfu/ml) Logio Count (cfu/g) Logio Count (cfu/ml) Logio Count (cfu/ml) Logio
E. coli 0 min 4.6xl03 3.66 42 1.62 43 1.63 44 1.64

30 min 4.2xl03 3.62 40 1.60 39 1.59 40 1.60
S.aureus 0 min 5.5xl03 3.74 47 1.67 48 1.68 50 1.70

30 min 5.2xl03 3.72 43 1.63 46 1.66 48 1.68

S. typhimurium 0 min 5.2xl03 3.72 42 1.62 44 1.64 47 1.67

30 min 4.9xl03 3.70 37 1.57 40 1.60 43 1.63
Table 3.5: Test Suspension for Test formulation 2 with alcohol and lactic acid

Test Organism Initial count (cfu/ml) log (initial count)
E.coli 2.3xl06 6.36
S.aureus 2.4xl06 6.38
S. typhimurium 1.8xl06 6.26
Table 3.6: Test Count for Test formulation 2 with alcohol and lactic acid

Test Organism Contact Time Cone. of product % Test
count
(cfu/g) Test log value Log Reduction % Reduction
E.coli 5 minutes Neat <10 <1 >5.36 99.9996
S.aureus 5 minutes Neat <10 <1 >5.38 99.9996
S.typhimurium 5 minutes Neat <10 <1 >5.26 99.9994
[0058] On testing test formulation 2, antimicrobial efficacy was found to be in the range of 99.9996% to 99.9994% log reduction against test microorganisms {E.coli, S.aureus, & S.typhimurium respectively) with 99.99%) efficacy against all strains of microbes.
[0059] For Test formulation 3 without alcohol and without lactic acid following observations were made in time kill assay:
Table 3.7: Neutralization validation assay results for test formulation 3 without alcohol and without lactic acid

Test Organism Exposure time Neutralization challenge microbial suspension Neutralization effectiveness Test A Neutralization
toxicity
TestB Test Organism
Viability
Test C

Count (cfu/ml) Logio Count (cfu/g) Logio Count (cfu/ml) Logio Count (cfu/ml) Logio
E.coli 0 min 4.6xl03 3.66 41 1.61 43 1.63 44 1.64

30 min 4.2xl03 3.62 38 1.58 39 1.59 40 1.60
S. aureus 0 min 5.5xl03 3.74 46 1.66 48 1.68 50 1.70

30 min 5.2xl03 3.72 42 1.62 46 1.66 48 1.68
S. typhimurium 0 min 5.2xl03 3.72 41 1.61 44 1.64 47 1.67

30 min 4.9xl03 3.70 38 1.58 40 1.60 43 1.63
Table 3.8: Test Suspension for Test formulation 3 without alcohol and without lactic acid

Test Organism Initial count (cfu/ml) log (initial count)
E.coli 2.3xl06 6.36
S. aureus 2.4xl06 6.38
S. typhimurium 1.8xl06 6.26
Table 3.9: Test Count for Test formulation 3 without alcohol and without lactic acid

Test Organism Contact Time Cone. of product % Test
count
(cfu/g) Test log value Log Reduction % Reduction
E.coli 5 minutes Neat 4.3xl04 4.63 1.73 98.13
S. aureus 5 minutes Neat 2.2xl05 5.34 1.04 90.83
S. typhimurium 5 minutes Neat 8.3xl05 5.92 0.34 53.89

[0060] On testing test formulation 3, antimicrobial efficacy was found to be in the range of 98.13% to 53.89%) log reduction against test microorganisms (E.coli, S.aureus & S.typhimurium respectively) with least efficacy of 53.89% for S.typhimurium.
[0061] Hence, it can be seen that the test formulation 2 with both alcohol and lactic acid provides 99.99%> efficacy against all microbes providing a broader spectrum of protection.
Example 4: In-vivo evaluation of hydration and TEWL (Trans-Epidermal Water Loss) of Gel Cream of present invention vs control i.e. Gel Sanitizer
[0062] The formulations of the present invention were tested for their hydration and moisturization benefits. The formulation of the present invention and control gel sanitizer were evaluated on following test parameters:
[0063] Hydration (Hydration Index) is measured using Comeometer® CM 825 which measures the change in the dielectric constant due to skin surface hydration changing the capacitance of a precision capacitor; and Trans-Epidermal Water Loss (evaporation rate in g/h/m2) is measured using Tewameter® TM 300 probe measures the density gradient of the water evaporation from the skin indirectly by the two pairs of sensors inside the hollow cylinder.
[0064] The observation are taken at following time: Baseline (Before application) vs 10 minutes post application of formulation of present invention and control.
[0065] Test formulation 2 with Ethyl Alcohol (20%) and Lactic acid is prepared in a
cold emulsion format with caprylic capric triglycerides (CCTG), glycerine and herbal ingredients include Tumeric, Tulsi extract. The control sample comprises 60%> w/w ethyl alcohol, glycerine. For the purpose of testing hydration and moisturization 15 volunteer in age group of 27 years to 45 years are selected in which 9 are female and 6 are male volunteer. The formulations of the present invention and control are tested on inner forearm at room conditions of 25±2°C temperature, 60 ± 5% R.H.

TEST PROCEDURE
[0066] Test area i.e. inner forearm is washed with neutral cleansing soap (any sanitizing soap) and wiped thoroughly, subsequently, the volunteers waited in controlled condition room (temperature 25±2°C and humidity 60±5% R.H.) for minimum 15-20 minutes for acclimatization.
• 2 nos. of 5 X 4 cm2 mini zones are marked on one forearm of each volunteer.
• Baseline Hydration and TEWL measurements are taken using Comeometer® CM 825 and Tewameter® TM 300 respectively, 3 readings per test area are taken.
• 0.1ml of test product was applied evenly with gloved finger on each test site.
• 10 minutes after test product application, Hydration and TEWL measurements were taken using Comeometer® CM 825 and Tewameter® TM 300, 3 readings per test area.
The results of the test are summarized below in Table 4.
Table 4: Skin Hydration Values

Hydration Control: Gel Sanitizer Test Formulation 2
Parameter Baseline Post application Change from Baseline (CFB) Baseline Post application CFB
Average 38.80 40.99 2.19 36.17 75.54 39.37
SD 5.90 5.85 5.76 11.19
Table 5: TEWL (Trans-Epidermal Water Loss) Values

TEWL Control: Gel Sanitizer Test Formulation 2
Parameter Baseline Post application Change from Baseline (CFB) Baseline Post application CFB
Average 9.9 11.3 1.4 9.8 9.8 0.0
SD 3.2 2.9 2.9 2.4
[0067] Increase in hydration values and no change/ decrease in TEWL (Trans-Epidermal Water Loss) values as shown in Table 4 and Table 5 indicate better efficacy of formulations of the present invention when compared to the control.
[0068] Following observations are made from Table 4 and Table 5 (A Significance concluded at 95% level of confidence on basis of Independent sample T-test): significant increase in skin hydration is observed with test formulation 2 of the present invention. No significant change in skin hydration is observed with Control sample. Test formulation 2 of the present invention maintains TEWL (Trans-Epidermal Water Loss) values, i.e. no significant increase in water loss observed contrary to this significant increase in TEWL is observed with control sample.
[0069] The formulations of the present invention presents significantly hydrated and moisturised skin from first use, maintains skin barrier, are non-drying formulations, provide upto 2X and 100% instant hydration vs baseline and 80% more hydration vs control.
[0070] While particular embodiments of the present invention have been illustrated and described, it will be obvious to those skilled in the art that various changes and modifications may be made without departing from the spirit and scope of the invention. It is therefore intended to cover in the appended claims all such changes and modifications that are within the scope of the invention.

We claim:

1. A sanitizing composition in form gel cream or lotion with moisturization benefits
comprising:
- an alcohol present in a range from 5% to 20% (wt./wt);
- an organic acid present in a range from 0.1% to 1% (wt./wt.); and excipients wherein the excipients comprises of emollients, skin protectants, emulsifiers, humectants, plant extracts, fragrance and disinfectants;
characterized in that the sanitizing composition has pH between 5-6 and viscosity in in range between 8000 -25000 cps and the sanitizing composition is in form of an oil in water emulsion.
2. The sanitizing composition as claimed in claim 1, wherein the alcohol is selected from the group consisting of ethanol, propanol, isopropyl alcohol, butanol and combinations thereof preferably, the alcohol is ethanol.
3. The sanitizing composition as claimed in claim 1, wherein the organic acid is selected from the group consisting of lactic acid, citric acid, salicylic acid and malic acid and combinations thereof preferably, the organic acid is lactic acid.
4. The sanitizing composition as claimed in claim 1, wherein the emollient is selected from group comprising of lanolin its derivatives, fatty esters, glycerol esters and derivatives, propylene glycol esters and derivatives, alkoxylated carboxylic acids, alkoxylated alcohols, fatty alcohols, fatty acids, and combinations thereof present in a range from 1% to 15% (wt./wt.).

5. The sanitizing composition as claimed in claim 4, wherein the emollient is Propylene glycol dicaprylate/ dicaparate, PPG-1 Trideceth-6 and caprylic/capric triglyceride.
6. The sanitizing composition as claimed in claim 1, wherein the skin protectant is silicone selected from the group comprising of dimethicone, cyclomethicone, polyalkylsiloxanes, polyarylsiloxanes, polyalkylarylsiloxanes, polysiloxane gums, poly ether siloxane copolymers, and combinations thereof present in a range from 1% to 10% (wt./wt.).

7. The sanitizing composition as claimed in claim 6, wherein the skin protectant is silicone fluid DC 200/350 est.
8. The sanitizing composition as claimed in claim 1, wherein the emulsifier have a hydrophilic/lipophilic balance (HLB) from 8 to 16 and selected from the group comprising of sorbitan laurate, PEG-40 hydrogenated castor oil, laureth-4, ceteth-10, ceteth-20, steareth-10, steareth-20, oleth-10, oleth-20, steareth-21, laureth-23, PEG-8 laureate, PEG-20 stearate, ceteareth-20, or combinations thereof present in a range from 1% to 5% (wt./wt).
9. The sanitizing composition as claimed in claim 8, wherein the emulsifier is Ceteareth-20.

10. The sanitizing composition as claimed in claim 1, wherein the humectant is selected from the group comprising of glycerin, glycerin derivatives, sodium hyaluronate, hyaluronic acid, betaine, amino acids, glycosaminoglycans, honey, sorbitol, glycols such as propylene glycol, polyols, sugars, hydrogenated starch hydrolysates, salts of PCA such as sodium PCA, lactates, urea, methyl gluceth 20 present in a range from 0.2 to 1.0% (wt./wt.).
11. The sanitizing composition as claimed in claim 10, wherein the humectant is Methyl gluceth 20, glycerine or triethylene glycol.

12. The sanitizing composition as claimed in claim 1, wherein the preservative is selected from the group comprising of phenoxyethanol, EDTA and triethyl amine present in a range from 0.2 to 1.0% (wt./wt.).
13. The sanitizing composition as claimed in claim 12, wherein the preservative is phenoxyethanol.
14. The sanitizing composition as claimed in claim 1, wherein the plant extracts is selected from the group comprising of turmeric extract, tulsi extract, neem, aloe vera extract, orange extract, pink pomelo extract and lemon extract present in a range from 0.01 to 1 % (wt./wt.).
15. The sanitizing composition as claimed in claim 1, wherein the fragrance is selected from the group comprising of isopropyl alcohol, eucalyptus oil, geraniol, phenyl ethyl

alcohol, linalol and linalyl acetate present in a range from 0.2 to 0.8% (wt. /wt. of the sanitizer).
16. The sanitizing composition as claimed in claim 1, wherein the composition further
comprises disinfectants and antimicrobial agents present in a range from 1 to 5% (wt.
/wt.).
17. The sanitizing composition as claimed in claim 16, wherein the disinfectant is a
cationic compound such as a quaternium salt, polyquatemium, quaternium, quaternium
hectorite (e.g., quaternium-18 hectorite), silicone quaternium materials, cationic
surfactant, or combination thereof.