FIELD OF THE INVENTION
[0001] The present invention relates to a surgical hand-rub composition. Specifically, the present invention relates to a waterless surgical hand-rub composition having antimicrobial, antifungal, and cleansing properties. The present invention further relates to a waterless surgical hand-rub composition comprising one or more biosurfactants, chlorhexidine digluconate and Tea tree oil.
BACKGROUND OF THE INVENTION
[0002] Background description includes information that may be useful in understanding the present invention. It is not an admission that any of the information provided herein is prior art or relevant to the presently claimed invention, or that any publication specifically or implicitly referenced is prior art. [0003] Hygiene is a major concern for the health industry. Hospitals are a source of many microbes like bacteria, fungi, protozoa etc. which when exposed to patients, who are already prone to catching infections, may lead to post-operative or nosocomial infections. Additionally, patients after being discharged from hospitals may act as carriers of these microbes. This may lead to further complications including prolonging their recovery, multiple follow up visits, risks of spreading infections to near ones and enhanced treatment costs. One of the main areas of concern in hospital hygiene is surgical site infections (SSIs). These, as the name suggests, are caused at the site of surgery, primarily due to exposure of the wound or site to microbes. Surgeons are known to use gloves to cover their hands from coming in direct contact with the surgery site. However, gloves may undergo perforations during the course of a surgery, exposing the microbes on the skin. As a precautionary method, medical care-givers are known to practice hand-rubbing before surgery wherein the hands, up to the elbows are washed clean. [0004] Various surgical solutions have been known for washing hands of surgeons. Some common surgical solutions are alcohol-based solutions, chlorhexidine solutions, iodine-based solutions etc. Alcohol-based solutions are known to be effective in only visibly clean hands and are flammable. Usage of iodine-solutions, example povidone iodine, was stopped because of the

discoloration caused by iodine. Chlorhexidine is a biguanide compound used as an antiseptic agent in hand washes. Chlorhexidine is mostly used in its digluconate form. It is a broad spectrum antibiotic active on gram positive bacteria, gram negative bacteria and viruses. Studies have shown that chlorhexidine shows both bactericidal and bacteriostatic activity. It is particularly useful for its tendency to stick onto the surface of the skin without much absorption, slowly killing the microbes over a longer period of time. This gives chlorhexidine a long lasting effect. Owing to its fast action, persistent nature, harmlessness on humans, and ease of use chlorhexidine has been widely used.
[0005] Many chlorhexidine solutions have been known in the art however,
there is a need for a better composition that is effective against a broad range of bacteria, including the multi-drug resistant, Methicillin-resistant Staphylococcus Aureus (MRSA), thereby providing an effective anti-microbial solution. While being strong antiseptics the solutions must also be gentle on the skin, as they are frequent use products in the industry. The waterless surgical hand-rub composition of the present invention provides an effective anti-microbial composition that is active against a host of bacteria, including MRSA. Said composition also provides a soothing effect and is suitable for all skin types. The present invention additionally provides the advantage of being capable of use for hair as well as skin disinfection. [0006] The prior arts available in this field are generally composed of alcohol with one or two active ingredients and lacking cleansing action. Alcohol itself causes skin irritation and rashes making it a secondary choice. Additionally, the effectiveness of the prior arts has been compromised due to short term activity. [0007] Thus, there is a great need in the art for pharmaceutical composition that is free of alcohol and comprising one or more biosurfactants along with chlorhexidine digluconate and Tea tree oil for effective and long lasting action in comparison to prior arts.
[0008] The present invention satisfies the existing needs, as well as others, and generally overcomes the deficiencies found in the prior art.

OBJECTS OF THE INVENTION
[0009] An object of the present invention is to provide a waterless surgical
hand-rub composition comprising Chlorhexidine digluconate (CHG).
[0010] An object of the present invention is to provide a waterless surgical
hand-rub composition comprising Tea tree oil.
[0011] An object of the present invention is to provide a waterless surgical
hand-rub composition comprising Sophorolipid. [0012] An object of the present invention is to provide a waterless surgical hand-rub composition comprising ethyl alcohol.
[0013] Another object of the present invention is to provide a composition that is a waterless surgical hand-rub composition having excellent antimicrobial, antifungal, and cleansing activities.
[0014] Another object of the present invention is to provide a composition that is effective even on Methicillin Resistant Staphylococcus Aureus (MRSA). [0015] Another object of the present invention is to provide an antiseptic and antimicrobial solution which is suitable for all skin types.
[0016] Another object of the present invention is to provide a composition which is suitable for cleaning and disinfecting the hands instantly. [0017] Another object of the present invention is to provide a composition that has a mild and gentle action on the hands skin of the individual. [0018] Another object of the present invention is to provide a composition that maintains the smoothening and soothing effect on the skin while providing protection from germs.
[0019] Another object of the present invention is to provide a single composition for hand hygiene.
[0020] Another object of the present invention is to provide a composition that can be used during pre-&-post- surgical hand disinfection applications. [0021] Yet another object of the present invention is to provide a composition that can be used in home as well as hospital settings.
[0022] Yet another object of the present invention is to provide a composition that can be used as rubbing composition.

[0023] Yet another object of the present invention is to provide a composition that meets the acceptance criteria as per "BS EN 13697:2015" and that shows more than 3 log reduction at 3-minutes contact time using the challenge organism Staphylococcus epidermidis, Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans.
[0024] Yet another object of the present invention is to provide a composition that is helpful in increasing the moisture and oil content of the skin immediately after its application from around 0 hours and to around 8 hours with a negligible change.
[0025] Yet another object of the present invention is to provide a composition that is Non-irritant/ Dermatologically safe and Dermatologically tested: safe for human skin for long term use.
SUMMARY OF THE INVENTION
[0026] This summary is provided to introduce a selection of concepts in a simplified form that is further described below in the detailed description section. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used as an aid in determining the scope of the claimed subject matter.
[0027] The present invention relates to a surgical hand-rub composition.
Specifically, the present invention relates to a waterless surgical hand-rub
composition having antimicrobial, antifungal, and cleansing properties.
[0028] In an aspect, the present invention relates to a waterless surgical hand-rub
composition which essentially comprises ethyl alcohol.
[0029] In an aspect, the present invention relates to a waterless surgical hand-rub composition which is suitable for all skin types.
[0030] In an aspect, the present invention relates to a waterless surgical hand-rub composition for cleaning and disinfecting the hands, instantly. [0031] In an aspect, the present invention provides a waterless surgical hand-rub composition that has a mild and gentle action on the skin of the individual.

[0032] In an aspect, the present invention provides a waterless surgical hand-rub composition that maintains the smoothening and soothing effect on the skin while providing protection from germs.
[0033] In an aspect, the present invention provides a single waterless surgical hand-rub composition for limb hygiene.
[0034] In an aspect, the present invention provides a waterless surgical hand-rub composition that can be used during pre-&-post-surgical applications. [0035] In one aspect, the present invention relates to a waterless surgical hand-rub composition comprising three active agents and a natural cleansing agent. [0036] In one aspect, the present invention relates to a waterless surgical hand-rub composition comprising three active agents and a biosurfactant selected from sophorolipid.
[0037] In one aspect, the present invention relates to a waterless surgical hand-rub composition comprising a) alcohol; b) one or more biosurfactants; c) chlorhexidine digluconate; and d) Tea tree oil.
[0038] In another aspect, the present invention relates to a waterless surgical hand-rub composition further comprising moisturizer.
[0039] In another aspect, the present invention relates to a waterless surgical hand-rub composition further comprising natural gel.
[0040] In another aspect, the present invention relates to a waterless surgical hand-rub composition further comprising natural emulsifier. [0041] In another aspect, the present invention relates to a waterless surgical hand-rub composition further comprising natural emollient. [0042] In another aspect, the present invention relates to a waterless surgical hand-rub composition further comprising one or two thickener. [0043] In another aspect, the present invention relates to a waterless surgical hand-rub composition comprising a solvent.
[0044] In another aspect, the present invention relates to a waterless surgical hand-rub composition comprising preservatives.
[0045] In yet another aspect, the present invention relates to a waterless surgical hand-rub composition comprising a natural fragrance.

[0046] In still another aspect, the present invention relates to a waterless surgical hand-rub composition comprising a pH regulator.
[0047] In an aspect, the present invention relates to a waterless surgical hand-rub composition wherein the alcohol is a lower alcohol (C1-C5 alcohol) including but not limited to, ethyl alcohol, isopropanol, or combinations thereof. Most preferably ethyl alcohol.
[0048] In an aspect, the present invention relates to a waterless surgical hand-rub composition wherein the biosurfactant can be selected from glycolipids, lipopeptides, phospholipids, fatty acids, neutral lipids, polymeric and particulate compounds, and the like.
[0049] In another aspect, the present invention relates to a waterless surgical hand-rub composition wherein the glycolipids can be selected from rhamnolipid, Sophorolipids, Trehalolipids, Mannosylerythritol lipids, and the like. [0050] In still another aspect, the present invention relates to a waterless surgical hand-rub composition wherein the bio-surfactant is preferably sophorolipid or rhamnolipid or combinations thereof.
[0051] In yet another aspect, the present invention relates to a waterless surgical hand-rub composition wherein the bio-surfactant is preferably a combination of rhamnolipid and sophorolipid.
[0052] In an aspect, the present invention relates to a waterless surgical hand-rub composition wherein the natural gel is aloe gel, wherein the aloe gel is extracted from Aloe vera, Aloe Petricola, Aloe Ciliaris, Aloe Ferox, Aloe Striata, Aloe Aristata, Aloe Arborescens, Aloe Humilis, and the like. [0053] In an aspect, the present invention relates to a waterless surgical hand-rub composition wherein the moisturizer can be selected from Coco-glucoside, Shea butter, Cocoa butter, Argan oil, Aloe Vera, Olive oil, Sunflower oil, Avocado oil, Butylene glycol, Vegetable glycerin, jojoba oil, cucumber extract, and the like.
[0054] In an aspect, the present invention relates to a waterless surgical hand-rub composition wherein the preservative can be selected from sorbic acid, calendula oil, Benzoic acid, Citric acid, Triclosan, Triclocarban, Phenoxyethanol,

Benzyl benzoate, Benzyl alcohol, Zinc pyrithione, Benzalkonium chloride, and the like.
[0055] In an aspect, the present invention relates to a waterless surgical hand-rub composition wherein the natural emollient can be selected from aloe vera, shea butter, cocoa butter, argan oil, jojoba oil, cucumber extract, olive oil, sunflower oil, oil of Melaleucae alternifolia (tea tree oil), avocado oil, and the like. Most preferably tea tree oil.
[0056] In an aspect, the present invention relates to a waterless surgical hand-rub composition wherein the emollient is natural glycerine. [0057] In an aspect, the present invention relates to a waterless surgical hand-rub composition wherein the thickener can be selected from methyl cellulose (HPMC), CMC, guar gum, Xanthan gum, Carbopol, Gum Arabic, Cornstarch, Gelatin, or the combinations thereof.
[0058] In an aspect, the present invention relates to a waterless surgical hand-rub composition wherein the pH regulator can be selected from sodium hydroxide, Citric acid, Lactic acid, Triethanolamine, Glacial acetic acid, Sodium carbonate, Acetic acid, and the like.
[0059] In an aspect, the present invention relates to a waterless surgical hand-rub composition wherein the solvent is purified water or pharmaceutical grade water.
[0060] In an aspect, the present invention relates to a waterless surgical hand-rub composition wherein the fragrance can be selected from Lemon, Jasmine, Lavender, Mint Ice, Peach, Red Berry, Apple, Vanilla, Rose, Rosemary, Mogra, Sandalwood, Orange, and the like.
[0061] In an aspect, the present invention provides a waterless surgical hand-
rub composition comprising, by weight of the composition:
a) Ethyl Alcohol: 60.0%
b) Sophorolipid: 1.0%
c) CHG:2.0%
d) Tea tree Oil: 0.1%
e) Jojoba Oil: 1.0%

f) Glycerine: 2.0%
g) Aloe Vera Gel: 0.1%
h) Guar gum/Xanthum Gum/HPMC/CMC: 0.1/2.0 gm
i) Citric acid: 0.6%
j) Fragrance
k) Sodium Hydroxide (pH 6.8-7.0, Adjusted using 10M Stock solution)
1) Colour: 0.1-0.3%
m) Distilled waterq.s to 100 % [0062] In another aspect, the present invention also relates to a process of preparing the waterless surgical hand-rub composition.
[0063] In yet another aspect, the present invention relates to a process of preparing the waterless surgical hand-rub composition comprising the steps of a) emulsifier/thickening agent is mixed in the oil or water depending on the solubility of the ingredient with constant stirring at 400 rpm/using a homogenizer system; b) preservatives, biosurfactants and emollients are mixed in the water; c) both the solutions are mixed together with constant stirring at higher speed (1000 rpm-2000 rpm); and d) chlorhexidine and octenidine are added to the solution with gentle stirring and without heating.
[0064] Various objects, features, aspects and advantages of the inventive subject matter will become more apparent from the following detailed description of preferred embodiments.
DETAILED DESCRIPTION OF THE INVENTION
[0065] The following is a detailed description of embodiments of the disclosure. The embodiments are in such detail as to clearly communicate the disclosure. However, the amount of detail offered is not intended to limit the anticipated variations of embodiments; on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure.
[0066] All publications herein are incorporated by reference to the same extent as if each individual publication or patent application were specifically and

individually indicated to be incorporated by reference. Where a definition or use of a term in an incorporated reference is inconsistent or contrary to the definition of that term provided herein, the definition of that term provided herein applies and the definition of that term in the reference does not apply.
[0067] Reference throughout this specification to "one embodiment" or "an embodiment" means that a particular feature, structure or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, the appearances of the phrases "in one embodiment" or "in an embodiment" in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.
[0068] In some embodiments, numbers have been used for quantifying weight percentages, ratios, and so forth, to describe and claim certain embodiments of the invention and are to be understood as being modified in some instances by the term "about." Accordingly, in some embodiments, the numerical parameters set forth in the written description and attached claims are approximations that can vary depending upon the desired properties sought to be obtained by a particular embodiment. In some embodiments, the numerical parameters should be construed in light of the number of reported significant digits and by applying ordinary rounding techniques. Notwithstanding that the numerical ranges and parameters setting forth the broad scope of some embodiments of the invention are approximations, the numerical values set forth in the specific examples are reported as precisely as practicable. The numerical values presented in some embodiments of the invention may contain certain errors necessarily resulting from the standard deviation found in their respective testing measurements.
[0069] Various terms as used herein are shown below. To the extent a term used in a claim is not defined below, it should be given the broadest definition persons in the pertinent art have given that term as reflected in printed publications and issued patents at the time of filing.

[0070] As used in the description herein and throughout the claims that follow, the meaning of "a," "an," and "the" includes plural reference unless the context clearly dictates otherwise. Also, as used in the description herein, the meaning of "in" includes "in" and "on" unless the context clearly dictates otherwise. [0071] Unless the context requires otherwise, throughout the specification which follow, the word "comprise" and variations thereof, such as, "comprises" and "comprising" are to be construed in an open, inclusive sense that is as "including, but not limited to."
[0072] The recitation of ranges of values herein is merely intended to serve as a shorthand method of referring individually to each separate value falling within the range. Unless otherwise indicated herein, each individual value is incorporated into the specification as if it were individually recited herein. [0073] All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g. "such as") provided with respect to certain embodiments herein is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention otherwise claimed. No language in the specification should be construed as indicating any non-claimed element essential to the practice of the invention. [0074] Groupings of alternative elements or embodiments of the invention disclosed herein are not to be construed as limitations. Each group member can be referred to and claimed individually or in any combination with other members of the group or other elements found herein. One or more members of a group can be included in, or deleted from, a group for reasons of convenience and/or patentability. When any such inclusion or deletion occurs, the specification is herein deemed to contain the group as modified.
[0075] The description that follows, and the embodiments described therein, is provided by way of illustration of an example, or examples, of particular embodiments of the principles and aspects of the present disclosure. These examples are provided for the purposes of explanation, and not of limitation, of those principles and of the disclosure.

[0076] It should also be appreciated that the present disclosure can be implemented in numerous ways, including as a system, a method or a device. In this specification, these implementations, or any other form that the invention may take, may be referred to as processes. In general, the order of the steps of the disclosed processes may be altered within the scope of the invention. [0077] The headings and abstract of the invention provided herein are for convenience only and do not interpret the scope or meaning of the embodiments. [0078] The following discussion provides many example embodiments of the inventive subject matter. Although each embodiment represents a single combination of inventive elements, the inventive subject matter is considered to include all possible combinations of the disclosed elements. Thus if one embodiment comprises elements a, b, and c, and a second embodiment comprises elements b and d, then the inventive subject matter is also considered to include other remaining combinations of a, b, c, or d, even if not explicitly disclosed. [0079] While a particular form of the invention has been illustrated and described, it will be apparent that various modifications can be made without departing from the spirit and scope of the invention.
[0080] The present invention relates to a surgical hand-rub composition. Specifically, the present invention relates to a waterless surgical hand-rub composition having antimicrobial, antifungal, and cleansing properties. [0081] In some embodiments, the present invention provides a waterless surgical hand-rub composition that is effective on Staphylococcus epidermidis, Pseudomonas aeruginosa, Candida albicans, and even on Methicillin Resistant Staphylococcus Aureus (MRS A).
[0082] In some embodiments, the present invention provides an antiseptic and antimicrobial waterless surgical hand-rub which is suitable for all skin types, preferably is suitable for cleaning the limbs, preferably hands. [0083] In some embodiments, the present invention relates to a waterless surgical hand-rub composition comprising three or four active agents plus natural cleansing agent.

[0084] In some embodiments, the present invention relates to a waterless
surgical hand-rub composition comprising a) alcohol; b) one or more
biosurfactants; c) chlorhexidine digluconate; and d) Tea tree oil.
[0085] In some embodiments, the present invention relates to a waterless
surgical hand-rub composition further comprises a moisturizer.
[0086] In some embodiments, the present invention relates to a waterless
surgical hand-rub composition further comprises a natural gel.
[0087] In some embodiments, the present invention relates to a waterless
surgical hand-rub composition further comprises a natural or safe synthetic
emul sifier/thickener.
[0088] In some embodiments, the present invention relates to a waterless
surgical hand-rub composition further comprises a natural emollient.
[0089] In some embodiments, the present invention relates to a waterless
surgical hand-rub composition further comprises a thickener.
[0090] In some embodiments, the present invention relates to a waterless
surgical hand-rub composition comprises a solvent.
[0091] In some embodiments, the present invention relates to a waterless
surgical hand-rub composition comprises a preservative.
[0092] In some embodiments, the present invention relates to a waterless
surgical hand-rub composition wherein the composition further comprises an
aromatic or fragrance generating agent.
[0093] In some embodiments, the present invention provides a waterless
surgical hand-rub composition optionally including a pH regulator.
[0094] In an embodiment, the present invention provides a waterless surgical
hand-rub composition comprising the following ingredients:
Table 1: Waterless surgical hand-rub composition

Ingredients Composition (%) Component
Ethyl Alcohol 60.0%
Sophorolipid 1.0

CHG 2.0 Active
Antimicrobial
Agents
Tea tree Oil 0.1

Jojoba Oil 1.0 Emollients
Glycerine 2.0

Aloe Vera Gel 0.1

Guar gum/Xanthum Gum/HPMC/CMC 1.0/1.0/0.25/0.25 gm Thickening Agent
Citric acid 0.6 Preservative
Fragrance Natural Boutique Floral Fragrance (0.1%/1.0%) Fragrance
Sodium Hydroxide pH 6.8-7.0
(Adjusted using 10M Stock
solution) pH adjuster
Colour 0.1-0.3% Coloring Agent
Distilled water q.sto 100% Solvent
[0095] In an embodiment, the waterless surgical hand-rub composition of the present invention comprises alcohol in an amount ranging from about 1% to about 80%), preferably in the amount ranging from about 50% to about 70% by weight with respect to the overall composition.
[0096] In an embodiment, the waterless surgical hand-rub composition of the present invention comprises biosurfactant in an amount ranging from about 0.001%) to about 4.0%), preferably in the amount ranging from about 0.01% to about 3.2% by weight with respect to the overall composition.

[0097] In an embodiment, the waterless surgical hand-rub composition of the
present invention comprises biosurfactant in an amount ranging from about 0.1%>
to 1.1%), preferably in the amount ranging from about 0.01%> to about 2.0% by
weight with respect to the overall composition.
[0098] In an embodiment, the waterless surgical hand-rub composition of the
present invention comprises Chlorhexidine digluconate in an amount ranging from
about 0.01%o to about 5.0%, preferably in the amount ranging from about 0.1%> to
about 3.0%) by weight with respect to the overall composition.
[0099] In an embodiment, the waterless surgical hand-rub composition of the
present invention comprises Tea tree oil in an amount ranging from about 0.001%>
to about 1.0%, preferably in the amount ranging from about 0.01%> to about 0.3%
by weight with respect to the overall composition.
[00100] In an embodiment, the waterless surgical hand-rub composition of the
present invention comprises the natural gel in an amount ranging from about
0.001%) to about 1.0%, preferably in the amount ranging from about 0.01% to about
0.3%) by weight with respect to the overall composition.
[00101] In an embodiment, the waterless surgical hand-rub composition of the
present invention comprises the moisturizer in an amount ranging from about
0.01%) to about 5.0%), preferably in the amount ranging from about 0.01% to about
3.0%) by weight with respect to the overall composition.
[00102] In an embodiment, the waterless surgical hand-rub composition of the
present invention comprises the preservative in an amount ranging from about
0.01%) to about 27.0%o by weight with respect to the overall composition.
[00103] In an embodiment, the waterless surgical hand-rub composition of the
present invention comprises the preservative preferably in an amount ranging from
about 0.01%) to about 5.0%, more preferably in the amount ranging from about
0.01%) to about 2.0%) by weight with respect to the overall composition.
[00104] In an embodiment, the waterless surgical hand-rub composition of the
present invention comprises the emulsifier in an amount ranging from about 0.01%
to about 10.0 %>, preferably in the amount ranging from about 1.0% to about 8.0%>
by weight with respect to the overall composition.

[00105] In an embodiment, the waterless surgical hand-rub composition of the
present invention comprises the thickener in an amount ranging from about 0.1%
(wt/wt) to about 5% (wt/wt), preferably in the amount ranging from about 0.01 %
(wt/wt) to about 3.0 % (wt/wt) by weight with respect to the overall composition.
[00106] In an embodiment, the waterless surgical hand-rub composition of the
present invention optionally comprises the pH regulator in an amount ranging from
about 0.01% to about 4.0%, preferably in the amount ranging from about 0.01% to
about 2.0%) by weight with respect to the overall composition.
[00107] In an embodiment, the waterless surgical hand-rub composition of the
present invention optionally comprises the colour in the amount ranging from about
0.01%) to about 1.0%) by weight with respect to the overall composition.
[00108] In an embodiment, the waterless surgical hand-rub composition of the
present invention optionally comprises the fragrance in the amount ranging from
about 0.01%o to about 1.0% by weight with respect to the overall composition.
[00109] In another embodiment, the waterless surgical hand-rub composition of
the present invention comprises the solvent in a quantity sufficient to make up the
weight percentage to 100%>.
[00110] In an embodiment, the present invention relates to a waterless surgical
hand-rub composition wherein the alcohol is a lower alcohol (C1-C5 alcohol)
including but not limited to, ethyl alcohol, isopropanol, or combinations thereof.
Most preferably ethyl alcohol.
[00111] In an embodiment, the present invention relates to a waterless surgical
hand-rub composition wherein the biosurfactant can be selected from glycolipids,
Lipopeptides, phospholipids, fatty acids, neutral lipids, polymeric and particulate
compounds, and the like.
[00112] In an embodiment, the present invention relates to a waterless surgical
hand-rub composition wherein the glycolipids can be selected from the group
comprising rhamnolipid, sophorolipid, Trehalolipids, Mannosylerythritol lipids,
Surfactin, Viscosin, Ornithine, and the like.
[00113] In an embodiment, the present invention relates to a waterless surgical
hand-rub composition wherein the bio-surfactant is preferably sophorolipid.

[00114] In an embodiment, the present invention relates to a waterless surgical
hand-rub composition wherein the sophorolipid is present in the weight ranging
from about 0.01% to about 2.0%.
[00115] In an embodiment, the present invention relates to a waterless surgical
hand-rub composition wherein the natural gel is aloe vera gel.
[00116] In an embodiment, the present invention relates to a waterless surgical
hand-rub composition wherein the moisturizer can be selected from jojoba oil,
cucumber extract, Coco-glucoside, Shea butter, Cocoa butter, Argan oil, Aloe Vera,
Olive oil, Sunflower oil, Avocado oil, Butylene glycol, Vegetable glycerin, and
the like.
[00117] In an embodiment, the present invention relates to a waterless surgical
hand-rub composition wherein the preservative can be selected from sorbic acid,
calendula oil, benzoic acid, citric acid, triclosan, triclocarban, phenoxyethanol,
benzyl benzoate, benzyl alcohol, zinc pyrithione, benzalkonium chloride, and the
like.
[00118] In an embodiment, the present invention relates to a waterless surgical
hand-rub composition wherein the natural emollient can be selected from aloe vera,
shea butter, cocoa butter, argan oil, jojoba oil, cucumber extract, olive oil,
sunflower oil, oil of Melaleucae alternifolia (tea tree oil), avocado oil, and the like.
Most preferably tea tree oil.
[00119] In an embodiment, the present invention relates to a waterless surgical
hand-rub composition wherein the thickener can be selected from methyl cellulose
(HPMC), CMC, guar gum, xanthan gum, carbopol, gum arabic, cornstarch, gelatin,
or the combinations thereof.
[00120] In an embodiment, the present invention relates to a waterless surgical
hand-rub composition wherein the pH regulator can be selected from sodium
hydroxide, citric acid, lactic acid, triethanolamine, glacial acetic acid, sodium
carbonate, acetic acid, and the like.
[00121] In an embodiment, the present invention relates to a waterless surgical
hand-rub composition wherein the solvent is purified water.

In an embodiment, the present invention relates to a waterless surgical hand-rub
composition wherein the fragrance is natural fragrance.
[00122] In an embodiment, the present invention relates to a waterless surgical
hand-rub composition wherein the natural fragrance can be selected from lemon,
jasmine, lavender, mint ice, peach, red berry, apple, vanilla, rose, rosemary, mogra,
sandalwood, orange, and the like.
[00123] In an embodiment, the present invention relates to a waterless surgical
hand-rub composition comprises:
a) Ethyl Alcohol;
b) Sophorolipids;
c) Chlorhexidine digluconate;
d) Tea Tree oil;
e) Aloe vera gel;
f) Jojoba oil;
g) Glycerine;
h) Guar gum/Xanthum Gum/HPMC/CMC;
i) Citric acid;
j) Sodium hydroxide;
k) Colour;
1) Fragrance; and
m) Purified water.
[00124] In another embodiment, the present invention provides a waterless
surgical hand-rub composition comprising, by weight:
a) Ethyl Alcohol;
b) Sophorolipids;
c) Chlorhexidine digluconate;
d) Tea Tree oil;
e) Aloe vera gel;
f) Jojoba oil;
g) Glycerine;
h) Guar gum/Xanthum Gum/HPMC/CMC;

i) Citric acid;
j) Sodium hydroxide;
k) Colour: 0.00-1.0%;
1) Fragrance: 0.00-1.0%; and
m) Purified water q.s. to make 100%). [00125] In yet another embodiment, the present invention relates to a process of preparing the waterless surgical hand-rub composition comprising the steps of a) mixing of emulsifier/thickening agent in oil or water by constant stirring at 400 rpm/homogenizing the mixture till uniformity achieved; b) mixing of preservatives, biosurfactants and emollients in pharmaceutical grade water; c) mixing of solutions from steps a) and b) with constant stirring at higher speed ranging from about 1000 rpm to about 2000rpm; and d) adding chlorhexidine digluconate to said solution with gentle stirring and without heating.
[00126] In an embodiment, the waterless surgical hand-rub composition is
provided in the form of a powder or liquid or gel. Most preferably, the waterless surgical hand-rub composition realized in accordance with embodiments of the present disclosure is prepared in liquid form.
[00127] In an embodiment, the waterless surgical hand-rub composition of
the present invention maybe used on the body part in any manner known to a person skilled in the art.
[00128] In an embodiment, the present invention relates to a composition
which is useful as a waterless surgical hand-rub composition by medical care¬
givers. The term 'waterless surgical hand-rub composition' as used herein
throughout the present disclosure denotes the washing compositions that do not
require utilization of water or require minimal amount of water (such as use of wet
cloth or sponge or wipe) to effect removal of dirt or soil along with the composition.
[00129] The present disclosure is further explained in the form of following
examples. However, it is to be understood that the foregoing examples are merely illustrative and are not to be taken as limitations upon the scope of the invention. Various changes and modifications to the disclosed embodiments will be apparent

to those skilled in the art. Such changes and modifications may be made without departing from the scope of the invention.
[00130] Example 1: Preparation of waterless surgical hand-rub composition
Xanthan gum/Methyl Cellulose/CMC/ 1% is mixed in the oil with stirring at 400 rpm/homogenizing the solution mixture. Sorbic acid (2%), Aloe vera gel (0.5%), rhamnolipid (0.015%>), sophorolipid (0.015%>), Sodium hydroxide (1.5%), jojoba oil (2%>) are mixed in the pharmaceutical grade water. Then, both the solutions are mixed together with constant stirring at higher speed (1500 rpm) followed by the addition of Ethyl Alcohol (60%) and Chlorhexidine digluconate (4%) with gentle stirring and without heating.
[00131] Example 2: In-vitro Antimicrobial Activity of the waterless hand-
rub composition
Test Item Name: Waterless Surgical Hand-rub Solution (4% Chlorhexidine, 60% Ethyl Alcohol, 1.0% Sophorolipid, 0.1% Tea Tree Oil) METHOD
Preparation of Stock cultures of test organisms: Bacterial cultures:
S. epidermidis, P. aeruginosa and S. aureus-The working culture of test organism was prepared, sub cultured from the stock culture by streaking on SCDA slants and incubated for 24 hours, a second subculture from first subculture in the same way was prepared and incubate for 24 hours. From the second subculture, a third subculture was produce in the same way. Stock solution of all the test organisms was prepared as to obtain a count of at least 1.5 x 108 - 5.0 x 108 cfu per ml by using densitometer. The individual test organism count was also validated by serial dilution method.
The final test suspension used for inoculation onto the surface was prepared with the help of serial dilution method to a concentration of working suspension >104cfu/mL.
The final test spore suspension used for inoculation onto the surface was prepared with the help of serial dilution method to a concentration of working suspension >104cfu/mL.

TEST PROCEDURE
1. 10 ml of the sample was taken with respect to individual test culture.
2. 100 ul of adjusted test cultures were inoculated in individual sample prepared.
3. A contact time of 3 minute was considered.
4. Using the pour plate technique 1 ml of above was pipetted to triplicated petri dishes for each dilution prepared by serial dilution technique and then 20ml of melted SCDA was added.
5. The Petri dish was incubated at 30-35°C for 72 hours.
6. A positive control experiment was also carried out using purified water in place of disinfectant with all test organisms.
7. The colonies on the petri dishes were counted with the help of colony counter after incubation and the observations was recorded in cfu (colony forming unit).
Note- The petri dish showing a number of colonies included in a 15-300 for
bacterial and fungal of 15-150 range to be used for perform the result
calculation.
LOG REDUCTION CALCULATION
The effectiveness of the disinfection procedure against each challenge organism
will be calculated for each product as a log 10 reduction as follows:
LoglO Reduction per product= LoglO [Positive Control Count] - LoglO
Test Surface Count
Note: The log reduction will be rounded to the nearest 0.1 value
For each product concentration and each experimental condition, calculate and
recorded the decimal log reduction separately.
ACCEPTANCE CRITERIA
In case of surface challenge test positive control should yield 50 to 200% recovery
of the microorganism in comparison to inoculums added.
Agents should demonstrate a 3 log reduction of vegetative test organisms.
RESULTS: The observed results are as in tables:

Table-2: Antimicrobial efficacy of waterless surgical hand-rub

Micro Organism Initial Inoculum cfu Waterless
surgical
hand-rub:
(PPC) cfu Positive Control (PC) cfu % Recovery = (PPC/PC) X
100
Staphylococcus epidermidis 1.2 x 102 89 103 81.65
Pseudomonas aeruginosa 1.2 x 102 85 101 84.15
Staphylococcus aureus 1.3 x 102 89 105 84.76
Table-3: Positive Control recovery

Micro Organism Initial Inoculum cfu Positive
Control (PC)
cfu % Recovery of PC =
(PC/Initial
Inoculum) X 100
Staphylococcus epidermidis 1.2 x 102 103 85.83
Pseudomonas aeruginosa 12 x 102 101 84.16
Staphylococcus aureus 1.2 x 102 105 80.76
5
Table-4: Antimicrobial efficacy of waterless surgical hand-rub: contact time 3 minute-

Micro organism Microbial
Population
Recovered
From Positive
Control Number of Organisms Recovered
After Treatment Log reduction Acceptance criteria
Staphylococcus epidermidis 5.6 X104 NCO 4.75 3 Log reduction
Pseudomonas aeruginosa 5.5 X104 NCO 4.74 3 Log reduction
Staphylococcus aureus 5.0 X104 NCO 4.72 3 Log reduction

Table-5: Observations: Negative Control-

Replicate No. Dilution selected for Negative Control Colony Count (cfu) obtained

lO"1 10"2 10"3 lO"4
1 NCO NCO NCO NCO
2 NCO NCO NCO NCO
3 NCO NCO NCO NCO
Average: NCO (No Colony Observed)
Waterless Surgical Hand-rub composition meets the acceptance criteria and showed more than 3 log reduction at 3 minute contact time using the challenge organisms 5 Staphylococcus epidermidis, Pseudomonas aeruginosa and Staphylococcus aureus.
[00132] Example 3: In-vitro Antimicrobial Activity of the waterless hand-
rub composition Test Item Name: Waterless Surgical Hand-rub Solution (4% Chlorhexidine, 60%
10 Ethyl Alcohol, 1.0% Sophorolipid, 0.1% Tea Tree Oil) METHOD
Preparation of Stock cultures of test organisms: Bacterial cultures: The working culture of test organism was prepared, sub cultured from the stock
15 culture by streaking on SCDA slants and incubated for 24 hours, and further inoculated in SCDM, incubation of 24 hours was carried out for Staphylococcus aureus, Pseudomonas aeruginosa and Staphylococcus epidermidis. Stock solution of the test organism was prepared as to obtain a count of at least 108 cfu per ml by using densitometer. The individual test organism count was also validated by serial
20 dilution method. Fungal cultures:
Candida albicans- The working culture of test organism was prepared, sub cultured from the stock culture by streaking on SCDA slants and incubated for 24 hours, and

further inoculated in SCDM, incubation of 24 hours was carried out. Stock solution of the test organism was prepared as to obtain a count of at least 108 cfu per ml by using densitometer. The individual test organism count was also validated by serial dilution method. TEST PROCEDURE-
1. 10 ml of the sample was taken with respect to individual test culture.
2. 100 ul of adjusted 106 cfu per ml test cultures were inoculated in individual sample prepared.
3. A contact time of 3 minute was considered.
4. Thus a '0' min and '3' was taken. Plates were incubated at 30°C for 48 hrs.
5. The Count was taken and observations recorded.
6. Population quantitation of the control blank: A volume of inoculum suspension was also inoculated into the 10ml of dilution blank (saline).The initial and final count of the population in the blank was done for valid test.
Note- The petri dish showing a number of colonies included in a 15-300 for
bacterial and fungal of 15-150 range to be used for perform the result
calculation.
LOG REDUCTION CALCULATION
The effectiveness of the disinfection procedure against each challenge organism
will be calculated for each product as a loglO reduction as follows:
LoglO Reduction (LR) = mean LoglO (measured initial microbial population) -
mean LoglO (surviving microbial population)
Formula for calculation of Percent Reduction:
% Reduction= 100 x (1-10"LR)
RESULTS: The observed results are as in tables:

Table-6: Antimicrobial efficacy of waterless surgical hand-rub: contact
time 3 minute-

Micro organism Count at 0 min (in cfu) Count after 3 min % reduction
Staphylococcus epidermidis 2.9 X106 No Colony Observed 99.9%
Pseudomonas aeruginosa 3.0 X106 No Colony Observed 99.9%
Staphylococcus aureus 3.5 X106 No Colony Observed 99.9%
Candida albicans 2.3 X106 No Colony Observed 99.9%
The antimicrobial efficacy of Waterless Surgical Hand Rub Solution was found
99.99% effective against all of the above four (Staphylococcus aureus,
Pseudomonas aeruginosa, Staphylococcus epidermidis and Candida albicans) test
organism.
[00133] Example 4: Efficacy of Waterless Surgical Hand-rub Solution
Test Item Name: Waterless Surgical Hand-rub Solution (4% Chlorhexidine, 60%
Ethyl Alcohol, 1.0% Sophorolipid, 0.1% Tea Tree Oil)
METHOD
The test was performed on 20 healthy persons (Male-14: Female-06) who had hands
with healthy skin, no cuts or abrasions were found, nails were clean and short. Prior
to study from one week they were instructed not to use any substances with
antimicrobial activity. All volunteers included in the study were above 18 years of
age.
Procedure of Application
i) The volunteers were randomly divided into two groups. In the first run,
volunteers of group 1 were made to use the reference (60% propanol) and that of
group 2 the test product. After one week, the test was repeated with changed roles
in a second run.

ii) Preparatory Hand wash-Initially the volunteer's hands were washed with 10ml of soft soap solution, then rinsed under running tap water, thoroughly dried with paper towels (standard hand wash/handrub procedure was applied for washing and use of reference/test product application as mentioned in BSEN 12791). iii) Count before treatment-
Immediately after the prewash with soft soap solution, count was taken after incubation and recorded as pre count. 3ml of reference was applied for an application time of 3 minutes. Similarly 3ml of test product was applied for 3 minutes.
iv) Count after disinfection procedure-
Immediately after the disinfection procedure, the count was taken in respect to as mentioned in BSEN 12791. The count was taken after incubation and recorded as post count immediate.
v) Count after 3 hours of disinfection procedure-One hand of respective volunteer was protected by wearing a surgical glove for 3 hours (validated for antimicrobial activity, details mentioned in the report). The glove was removed after 3 hours, the count was taken and recorded as post count 3 hours.
Note- All petri plates were incubated at 37 deg C for 48 hours. RESULTS
Table 7: Evaluation of P (Comparison of the mean log Reduction Factor as
obtained with Pand R)

Assessed effects Mean log Reduction Factor

P R
Immediate effect 2.78 2.22
3-Hour Effect 1.73 1.57
Waterless Surgical Hand-rub Solution when used as a surgical hand antiseptic was found to be effective.

Table-8: Surgical hand disinfection procedure with test product-
experimental result

s.
No Hand
Left or
Right Number of cfu per plate from dilution 10

Pre Count Post Count (Immediate) Post Count (3 Hour)

-1 -2 -3 0 -1 -2 0 -1 -2
1 Left NC NC 91 81 8 0 NC 84 7

Right NC NC 13

2 Left NC 150 14 13 2 0 NC 80 7

Right NC 121 11

3 Left NC NC 28 108 9 0 NC 113 12

Right NC NC 61

4 Left NC NC 124 46 4 0 NC 172 78

Right NC NC 91

5 Left NC 94 9 54 5 0 NC 111 11

Right NC 59 7

6 Left NC 61 6 10 0 0 NC 129 13

Right NC 92 9

7 Left NC 118 10 NC 49 4 NC 139 14

Right NC 88 9

8 Left NC NC 36 110 10 0 NC 38 0

Right NC NC 61

9 Left NC NC 55 40 3 0 NC 73 7

Right NC NC 85

10 Left NC NC 59 58 5 0 121 11 0

Right NC NC 118

11 Left NC NC 101 105 11 0 NC 112 11

Right NC NC 65

12 Left NC NC 112 109 11 0 NC 30 3

Right NC NC 61

13 Left NC NC 102 83 8 0 NC 81 9

Right NC NC 125

14 Left NC NC 119 65 6 0 NC 112 11

Right NC NC 145

15 Left NC 101 11 40 3 0 NC 24 3

Right NC 89 7

16 Left NC 121 12 16 2 0 NC 50 0

Right NC 86 8

17 Left NC NC 65 35 4 0 NC 112 11

Right NC NC 42

18 Left NC NC 179 88 8 0 NC 111 11

Right NC NC 141

19 Left NC 41 2 11 0 0 78 7 0

Right NC 89 9

20 Left NC 30 3 5 0 0 44 4 0

Right NC 89 9

[00134] While the foregoing describes various embodiments of the disclosure, other and further embodiments of the disclosure may be devised without departing from the basic scope thereof. The scope of the invention is determined by the claims that follow. The invention is not limited to the described embodiments, versions or examples, which are included to enable a person having ordinary skill in the art to make and use the invention when combined with information and knowledge available to the person having ordinary skill in the art.

We Claim:

1. A waterless surgical hand-rub composition comprising of a) one or more biosurfactants; b) chlorhexidine digluconate; c) Tea tree oil; and d) alcohol.
2. The composition as claimed in claim 1, wherein the biosurfactant is sophorolipid.
3. The composition as claimed in claim 1, wherein the alcohol is ethyl alcohol orisopropyl alcohol.
4. The composition as claimed in claim 1, wherein the amount of biosurfactant ranges from about 0.001% to about 4.0%, preferably in the amount ranging from about 0.01% to about 3.2% by weight with respect to overall composition.
5. The composition as claimed in claim 1, wherein the amount of Chlorhexidine digluconate ranges from about 0.01% to about 5.0%, preferably in the amount ranging from about 0.12% to about 4.1%> by weight with respect to the overall composition.
6. The composition as claimed in claim 1, wherein the composition further comprises moisturizer, natural gel, natural emulsifier, natural emollient, thickener, solvent, preservative, fragrance and pH regulator.
7. The composition as claimed in claim 1, wherein the pH of the composition ranges from about 6.8 to about 7.5.
8. The composition as claimed in claim 1, wherein the composition is effective against Staphylococcus epidermidis, Pseudomonas aeruginosa, Candida albicans, and Methicillin Resistant Staphylococcus aureus, MRSA.
9. A process for producing waterless surgical hand-rub composition comprising the steps of a) mixing of emulsifier/thickener in oil or water by heating from about 40 to about 60 Degree Celsius, and constant stirring at 400 rpm; b) mixing of preservatives, biosurfactants and emollients in pharmaceutical grade water; c) mixing of solutions from steps a) and b) with constant stirring at higher speed ranging from about 3000 rpm to about

18000 rpm; and d) adding chlorhexidine digluconate and octenidine dihydrochloride to said solution with gentle stirring and without heating.
10. A waterless surgical hand-rub composition comprising,
a) Ethyl Alcohol;
b) Sophorolipids;
c) Chlorhexidine digluconate;
d) Tea Tree oil;
e) Aloe vera gel;
f) Jojoba oil;
g) Glycerine;
h) Guar gum/Xanthum Gum;
i) Citric acid;
j) Sodium hydroxide;
k) Natural colour
1) Natural fragrance; and
m) Pharmaceutical grade water.
11. The composition as claimed in claim 9, wherein the composition comprises,
a) Ethyl Alcohol ranging from about 30 to about 70% of the total composition;
b) Sophorolipids ranging from about 0.01% to about 2.0%> of the total composition;
c) Chlorhexidine digluconate ranging from about 0.1%> to about 3.0%) of the total composition;
d) Tea Tree oil ranging from about 0.01%> to about 0.3% of the total composition;
e) Aloe vera gel ranging from about 0.01%> to about 0.3% of the total composition;
f) Jojoba oil ranging from about 0.01% to about 3.0% of the total composition;
g) Glycerine ranging from about 0.01% to about 3.0%> of the total composition;

h) Guar gum/Xanthum Gum ranging from about 0.01 g to about 3.0
g of the total composition;
i) Citric acid ranging from about 0.01%> to about 2.0%> of the total
composition;
j) Sodium hydroxide ranging from about 0.01%> to about 2.0%> of the
total composition;
k) Natural colour ranging from about 0.01%> to about 1.0%> of the
total composition;
1) Natural fragrance ranging from about 0.01%> to about 1.0%> of the
total composition; and
m) Purified water q.s. to make 100%>.
a) Octenidine Dihydrochloride ranging from about 0.001 to about 2.1%) of the total composition;
b) Rhamnolipid ranging from about 0.01 to about 1.1% of the total composition;
c) Sophorolipids ranging from about 0.01 to about 2.1%> of the total composition;
d) Chlorhexidine digluconate ranging from about 0.12 to about 4.1%> of the total composition;
e) Aloe vera gel ranging from about 0.2 to about 10.0%> of the total composition;
f) Jojoba oil or cucumber extract or combinations thereof ranging from about 0.01 to about 2.0% of the total composition;
g) Sorbic acid ranging from about 0.01 to about 2.0%> of the total composition;
h) Calendula oil ranging from about 0.01 to about 5.0% of the total
composition;
j) Methyl Cellulose or Guar Gum or combinations thereof ranging
from about 0.01 to about 4.0% of the total composition;
k) Sodium hydroxide ranging from about 0.01 to about 2.0%> of the
total composition;

1) Fragrance ranging from about 0.00 to about 1.0% of the total
composition; and
m) Pharmaceutical grade water: q.s. to make 100%.