[0001]The present invention relates to a surgical scrub composition. Specifically, the present invention relates to a waterless surgical scrub composition having antimicrobial, antifungal, and cleansing properties. The present invention further relates to a waterless surgical scrub composition comprising one or more biosurfactants, and chlorhexidine digluconate.

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 scrubbing 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 scrub 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 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 scrub composition comprising Chlorhexidine digluconate (CHG).
[0010] Another object of the present invention is to provide a composition that is a waterless surgical scrub composition having excellent antimicrobial, antifungal, and cleansing activities.
[0011] Another object of the present invention is to provide a composition that is effective even on Methicillin Resistant Staphylococcus Aureus (MRSA).
[0012] Another object of the present invention is to provide an antiseptic and antimicrobial solution which is suitable for all skin types.
[0013] Another object of the present invention is to provide a composition which is suitable for cleaning and disinfecting the whole body and hair instantly.
[0014] Another object of the present invention is to provide a composition that has a mild and gentle action on the hair and skin of the individual.
[0015] 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.
[0016] Another object of the present invention is to provide a single composition for head hygiene and full-body hygiene.
[0017] Another object of the present invention is to provide a composition that can be used during pre-&-post- surgical whole-body disinfection applications.
[0018] Yet another object of the present invention is to provide a composition that can be used in home as well as hospital settings.
[0019] Yet another object of the present invention is to provide a composition that can be used as rubbing composition.
[0020] 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 Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans, Aspergillus brasiliensis spores and 2 log reduction for Bacillus subtilis spores.
[0021] 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.
[0022] 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
[0023] 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.
[0024] The present invention relates to a surgical scrub composition. Specifically, the present invention relates to a waterless surgical scrub composition having antimicrobial, antifungal, and cleansing properties.
[0025] In an aspect, the present invention relates to a waterless surgical scrub composition which is essentially free of alcohol.
[0026] In an aspect, the present invention relates to a waterless surgical scrub composition which is suitable for all skin types.
[0027] In an aspect, the present invention relates to a waterless surgical scrub composition for cleaning and disinfecting the whole body and hair, instantly.
[0028] In an aspect, the present invention provides a waterless surgical scrub composition that has a mild and gentle action on the hair and skin of the individual.
[0029] In an aspect, the present invention provides a waterless surgical scrub composition that maintains the smoothening and soothing effect on the skin while providing protection from germs.
[0030] In an aspect, the present invention provides a single waterless surgical scrub composition for head hygiene and full-body hygiene.
[0031] In an aspect, the present invention provides a waterless surgical scrub composition that can be used during pre-&-post-surgical applications.
[0032] In one aspect, the present invention relates to a waterless surgical scrub composition comprising three active agents and a natural cleansing agent.
[0033] In one aspect, the present invention relates to a waterless surgical scrub composition comprising three active agents and a biosurfactant selected from rhamnolipid or sophorolipid or combinations thereof.
[0034] In one aspect, the present invention relates to a waterless surgical scrub composition comprising a) one or more biosurfactants; b) chlorhexidine digluconate; and c) octenidine dihydrochloride.
[0035] In another aspect, the present invention relates to a waterless surgical scrub composition further comprising moisturizer.
[0036] In another aspect, the present invention relates to a waterless surgical scrub composition further comprising natural gel.
[0037] In another aspect, the present invention relates to a waterless surgical scrub composition further comprising natural emulsifier.
[0038] In another aspect, the present invention relates to a waterless surgical scrub composition further comprising natural emollient.
[0039] In another aspect, the present invention relates to a waterless surgical scrub composition further comprising a thickener.
[0040] In another aspect, the present invention relates to a waterless surgical scrub composition comprising a solvent.
[0041] In another aspect, the present invention relates to a waterless surgical scrub composition comprising a preservative.
[0042] In yet another aspect, the present invention relates to a waterless surgical scrub composition comprising a fragrance.
[0043] In still another aspect, the present invention relates to a waterless surgical scrub composition comprising a pH regulator.
[0044] In an aspect, the present invention relates to a waterless surgical scrub composition wherein the biosurfactant can be selected from glycolipids, lipopeptides, phospholipids, fatty acids, neutral lipids, polymeric and particulate compounds, and the like.
[0045] In another aspect, the present invention relates to a waterless surgical scrub composition wherein the glycolipids can be selected from rhamnolipid, Sophorolipids, Trehalolipids, Mannosylerythritol lipids, and the like.
[0046] In still another aspect, the present invention relates to a waterless surgical scrub composition wherein the bio-surfactant is preferably rhamnolipid or sophorolipid or combinations thereof.
[0047] In yet another aspect, the present invention relates to a waterless surgical scrub composition wherein the bio-surfactant is preferably a combination of rhamnolipid and sophorolipid.
[0048] In an aspect, the present invention relates to a waterless surgical scrub 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.
[0049] In an aspect, the present invention relates to a waterless surgical scrub 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.
[0050] In an aspect, the present invention relates to a waterless surgical scrub 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.
[0051] In an aspect, the present invention relates to a waterless surgical scrub 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, avocado oil, and the like.
[0052] In an aspect, the present invention relates to a waterless surgical scrub composition wherein the natural emulsifier can be selected from lecithin, Coco-glucoside, beeswax, candelilla wax, shea butter, cocoa butter, and the like.
[0053] In an aspect, the present invention relates to a waterless surgical scrub composition wherein the thickener can be selected from methyl cellulose, guar gum, Xanthan gum, Carbopol, Gum Arabic, Cornstarch, Gelatin, and the like.
[0054] In an aspect, the present invention relates to a waterless surgical scrub 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.
[0055] In an aspect, the present invention relates to a waterless surgical scrub composition wherein the solvent is purified water or pharmaceutical grade water.
[0056] In an aspect, the present invention relates to a waterless surgical scrub 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.
[0057] In an aspect, the present invention provides a waterless surgical scrub composition comprising, by weight of the composition:
a) Octenidine Dihydrochloride: 0.001-2.1%;
b) Rhamnolipid: 0.01-1.1%;
c) Sophorolipids: 0.01-2.1%;
d) Chlorhexidine digluconate; 0.12-4.1%;
e) Aloe vera gel: 0.2-10.0%;
f) Jojoba oil/cucumber extract: 0.01-2.0%;
g) Sorbic acid: 0.01-2.0%;
h) Calendula oil: 0.01-5.0%;
j) Methyl Cellulose/Guar Gum/Carbopol/Carbomer/Xanthum Gum: 0.01-4.0%;
k) Sodium hydroxide: 0.01-2.0%;
l) Fragrance: 0.00-1.0%; and
m) Purified water: q.s. to make 100%.
[0058] In another aspect, the present invention also relates to a process of preparing the waterless surgical scrub composition.
[0059] In yet another aspect, the present invention relates to a process of preparing the waterless surgical scrub composition comprising the steps of a) emulsifier/thickening agent is mixed in the oil or water depending on the solubility of the ingredient with heating (40-60 Degree Celsius) and constant stirring at 400 rpm; 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.
[0060] 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
[0061] 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.
[0062] 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.
[0063] 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.
[0064] 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.
[0065] 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.
[0066] 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.
[0067] 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.”
[0068] 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.
[0069] 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.
[0070] 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.
[0071] 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.
[0072] 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.
[0073] The headings and abstract of the invention provided herein are for convenience only and do not interpret the scope or meaning of the embodiments.
[0074] 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.
[0075] 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.
[0076] The present invention relates to a surgical scrub composition. Specifically, the present invention relates to a waterless surgical scrub composition having antimicrobial, antifungal, and cleansing properties.
[0077] In some embodiments, the present invention provides a waterless surgical scrub composition that is effective on Escherichia coli, Pseudomonas aeruginosa, Candida albicans, Aspergillus brasiliensis spores, Bacillus subtilis spores.and even on Methicillin Resistant Staphylococcus Aureus (MRSA).
[0078] In some embodiments, the present invention provides an antiseptic and antimicrobial waterless surgical scrub which is suitable for all skin types, preferably is suitable for cleaning the whole body and hair.
[0079] In some embodiments, the present invention relates to a waterless surgical scrub composition comprising three or four active agents plus natural cleansing agent.
[0080] In some embodiments, the present invention relates to a waterless surgical scrub composition comprising a) one or more biosurfactants, b) chlorhexidine digluconate, and c) octenidine dihydrochloride.
[0081] In some embodiments, the present invention relates to a waterless surgical scrub composition further comprises a moisturizer.
[0082] In some embodiments, the present invention relates to a waterless surgical scrub composition further comprises a natural gel.
[0083] In some embodiments, the present invention relates to a waterless surgical scrub composition further comprises a natural or safe synthetic emulsifier/thickener.
[0084] In some embodiments, the present invention relates to a waterless surgical scrub composition further comprises a natural emollient.
[0085] In some embodiments, the present invention relates to a waterless surgical scrub composition further comprises a thickener.
[0086] In some embodiments, the present invention relates to a waterless surgical scrub composition comprises a solvent.
[0087] In some embodiments, the present invention relates to a waterless surgical scrub composition comprises a preservative.
[0088] In some embodiments, the present invention relates to a waterless surgical scrub composition wherein the composition further comprises an aromatic or fragrance generating agent.
[0089] In some embodiments, the present invention provides a waterless surgical scrub composition optionally including a pH regulator.
[0090] In an embodiment, the present invention provides a waterless surgical scrub composition comprising the following ingredients:
S. No. Name of the ingredients Category
1. Octenidine dihydrochloride Antimicrobial/Active Agent
2. Rhamnolipid Antimicrobial/ Active Cleansing Agent
3. Sophorolipid Antimicrobial/Active Cleansing Agent
4. Chlorhexidine digluconate Antimicrobial/Active Agent
5. Aloe Vera Gel Active Emollient/Preservative
6. Cucumber extract/Jojoba Oil Active Emollient
7. Methyl Cellulose/Guar Gum/Carbomer/Carbopol/Xanthum Gum Thickening agent/Natural Thickener
8. Calendula Oil Preservative
9. Sorbic Acid Preservative
10. Sodium Hydroxide pH stabilizer
11. Natural Fragrance Fragrance

[0091] In an embodiment, the waterless surgical scrub 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.
[0092] In an embodiment, the waterless surgical scrub 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 2.1% by weight with respect to the overall composition.
[0093] In an embodiment, the waterless surgical scrub composition of the present invention comprises octenidine dihydrochloride in an amount ranging from about 0.001% to about 3.0%, preferably in the amount ranging from about 0.001% to about 1.0% by weight with respect to the overall composition.
[0094] In an embodiment, the waterless surgical scrub composition of the present invention comprises Chlorhexidine digluconate in an amount ranging 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.
[0095] In an embodiment, the waterless surgical scrub composition of the present invention comprises the natural gel in an amount ranging from about 0.1% to about 15.0%, preferably in the amount ranging from about 0.2% to about 10.0% by weight with respect to the overall composition.
[0096] In an embodiment, the waterless surgical scrub 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 2.0% by weight with respect to the overall composition.
[0097] In an embodiment, the waterless surgical scrub composition of the present invention comprises the preservative in an amount ranging from about 0.01% to about 27.0% by weight with respect to the overall composition.
[0098] In an embodiment, the waterless surgical scrub composition of the present invention comprises the preservative preferably in an amount ranging from about 1.0% 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.
[0099] In an embodiment, the waterless surgical scrub 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.
[00100] In an embodiment, the waterless surgical scrub composition of the present invention comprises the thickener in an amount ranging from about 0.01% to about 5.0%, preferably in the amount ranging from about 0.01% to about 4.0% by weight with respect to the overall composition.
[00101] In an embodiment, the waterless surgical scrub 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.
[00102] In an embodiment, the waterless surgical scrub composition of the present invention optionally comprises the fragrance in the amount ranging from about 0.0% to about 1.0% by weight with respect to the overall composition.
[00103] In another embodiment, the waterless surgical scrub composition of the present invention comprises the solvent in a quantity sufficient to make up the weight percentage to 100%.
[00104] In an embodiment, the present invention relates to a waterless surgical scrub composition wherein the biosurfactant can be selected from glycolipids, Lipopeptides, phospholipids, fatty acids, neutral lipids, polymeric and particulate compounds, and the like.
[00105] In an embodiment, the present invention relates to a waterless surgical scrub composition wherein the glycolipids can be selected from the group comprising rhamnolipid, sophorolipid, Trehalolipids, Mannosylerythritol lipids, Surfactin, Viscosin, Ornithine, and the like.
[00106] In an embodiment, the present invention relates to a waterless surgical scrub composition wherein the bio-surfactant is preferably rhamnolipid or sophorolipid or combinations thereof.
[00107] In an embodiment, the present invention relates to a waterless surgical scrub composition wherein the bio-surfactant is preferably a combination of rhamnolipid and sophorolipid.
[00108] In an embodiment, the present invention relates to a waterless surgical scrub composition wherein the rhamnolipid is present in the weight ranging from about 0.01% to about 1.1%.
[00109] In an embodiment, the present invention relates to a waterless surgical scrub composition wherein the sophorolipid is present in the weight ranging from about 0.01% to about 2.1%.
[00110] In an embodiment, the present invention relates to a waterless surgical scrub composition wherein the natural gel is aloe vera gel.
[00111] In an embodiment, the present invention relates to a waterless surgical scrub 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.
[00112] In an embodiment, the present invention relates to a waterless surgical scrub 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.
[00113] In an embodiment, the present invention relates to a waterless surgical scrub 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, avocado oil, and the like.
[00114] In an embodiment, the present invention relates to a waterless surgical scrub composition wherein the natural emulsifier can be selected from lecithin, coco-glucoside, beeswax, candelilla wax, shea butter, cocoa butter, and the like.
[00115] In an embodiment, the present invention relates to a waterless surgical scrub composition wherein the thickener can be selected from methyl cellulose, guar gum, xanthan gum, carbopol, gum arabic, cornstarch, gelatin, and the like.
[00116] In an embodiment, the present invention relates to a waterless surgical scrub 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.
[00117] In an embodiment, the present invention relates to a waterless surgical scrub composition wherein the solvent is purified water.
In an embodiment, the present invention relates to a waterless surgical scrub composition wherein the fragrance is natural fragrance.
[00118] In an embodiment, the present invention relates to a waterless surgical scrub 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.
[00119] In an embodiment, the present invention relates to a waterless surgical scrub composition comprises:
a) Octenidine HCl;
b) Rhamnolipid;
c) Sophorolipids;
d) Chlorhexidine digluconate;
e) Aloe vera gel;
f) Jojoba oil/cucumber extract;
g) Sorbic acid;
h) Calendula oil;
i) Lecithin;
j) Methyl Cellulose/Guar Gum;
k) Sodium hydroxide;
l) Fragrance; and
m) Purified water.
[00120] In another embodiment, the present invention provides a waterless surgical scrub composition comprising, by weight:
a) Octenidine HCl: 0.001-1%;
b) Rhamnolipid: 0.01-1.1%;
c) Sophorolipids: 0.01-2.1%;
d) Chlorhexidine digluconate; 0.12-4.1%;
e) Aloe vera gel: 0.2-10.0%;
f) Jojoba oil/cucumber extract: 0.01-2.0%;
g) Sorbic acid: 0.01-2.0%;
h) Calendula oil: 0.01-5.0%;
j) Methyl Cellulose/Guar Gum: 0.01-4.0%;
k) Sodium hydroxide: 0.01-2.0%;
l) Fragrance: 0.00-1.0%; and
m) Purified water: q.s. to make 100%.
[00121] In yet another embodiment, the present invention relates to a process of preparing the waterless surgical scrub composition comprising the steps of a) mixing of emulsifier/thickening agent 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 1000 rpm to about 2000rpm; and d) adding chlorhexidine digluconate and octenidine dihydrochloride to said solution with gentle stirring and without heating.
[00122] In an embodiment, the waterless surgical scrub composition is provided in the form of a powder or liquid or gel. Most preferably, the waterless surgical scrub composition realized in accordance with embodiments of the present disclosure is prepared in liquid form.
[00123] In an embodiment, the waterless surgical scrub composition of the present invention maybe used on the body part in any manner known to a person skilled in the art.
[00124] In an embodiment, the present invention relates to a composition which is useful as a waterless surgical scrub composition by medical care-givers. The term ‘waterless surgical scrub 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.
[00125] 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.
[00126] Example 1: Preparation of waterless surgical scrub composition
Xanthan gum 1% is mixed in the oil with heating (50 Degree Celsius) and constant stirring at 400 rpm. 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 Octenidine dihydrochloride (0.001%) and Chlorhexidine digluconate (4%) with gentle stirring and without heating.
[00127] Example 2: In-vitro Antimicrobial Activity of the waterless scrub composition
Test Item Name: Waterless Surgical Scrub Solution (4% Chlorhexidine, 0.001% Octenidine HCl, 0.5% Aloe vera gel, 0.015% Rhamnolipid & 0.0015% Sophorolipids)
METHOD
Preparation of Stock cultures of test organisms:
Bacterial cultures:
E. coli, 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 >104 cfu/mL.
B. subtilis spores-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 incubation of 7 days was carried out for the formation of B. subtilis spores. Stock solution of the test organism 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 spore count was also validated by serial dilution method.
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 >104 cfu/mL.
Fungal cultures:
Candida albicans- The working culture of Candida albicans was prepared, sub cultured from the stock culture by streaking on MEA slants and incubated for 48 hours, a second subculture from first subculture was prepared in the same way and incubated for 48 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 107 and 5.0 x 108 cfu per ml by using densitometer. The individual test organism count should was also validated by serial dilution method.
Aspergillus brasiliensis spores- The working culture of Aspergillus brasiliensis was prepared, only the first subculture grown on MEA petri dish was used and incubated at 30°C for 14 days for the formations of spores.
Based on stock suspension count, on the day of the test serial dilution were prepared in 0.9% saline with 0.05% w/v Polysorbate 80 from the stock suspension to yield a working suspension solution of >104 cfu/ml. This suspension was used as inoculum for surface challenge test.
TEST PROCEDURE-
1. 10 ml of the sample was taken with respect to individual test culture.
2. 100 µl 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. Simultaneously the similar procedure was carried out for Candida albicans and Aspergillus brasiliensis spores using SDA. C. albicans plates incubated at 20°C for 5 days and A. brasiliensis spores plates for 7 days at 25°C respectively.
7. A positive control experiment was also carried out using purified water in place of disinfectant with all test organisms.
8. 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 log10 reduction as follows:
Log10 Reduction per product= Log10 [Positive Control Count] – Log10
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.
Bactericidal, Fungicidal or Yeasticidal activity on surfaces for general purposes is characterized by the concentration of the tested product.
1) Agents should demonstrate a 3 log reduction of vegetative test organisms and mold spores.
2) Agents should demonstrate sporicidal activity of 2 log reduction for B. subtilis spores and a 3 log reduction for A. brasiliensis spores.
RESULTS: The observed results are as in tables:
Table- 1: Antimicrobial efficacy of Clensta waterless surgical scrub
Micro Organism Initial Inoculum cfu Waterless surgical scrub: (PPC) cfu Positive Control (PC) cfu % Recovery = (PPC/PC) X 100
Escherichia coli 1.3 x 102 89 110 80.90
Pseudomonas aeruginosa 1.3 x 102 85 104 81.73
Staphylococcus aureus 1.2 x 102 91 108 84.25
Bacillus Subtilis spores 1.1 x 102 78 99 78.78
Candida albicans 1.1 x 102 72 89 80.89
Aspergillus brasiliensis spores 1.1 x 102 69 88 77.40

Table-2: Positive Control recovery
Micro Organism Initial Inoculum cfu Positive Control (PC) cfu % Recovery of PC = (PC/Initial Inoculum) X 100
Escherichia coli 1.3 x 102 110 84.61
Pseudomonas aeruginosa 1.3 x 102 104 80
Staphylococcus aureus 1.2 x 102 108 90
Bacillus Subtilis spores 1.1 x 102 99 90
Candida albicans 1.1 x 102 89 80.90
Aspergillus brasiliensis spores 1.1 x 102 88 80
Table-3: Antimicrobial efficacy of Clensta waterless surgical scrub: contact time 3 minute-

Micro organism Microbial
Population Recovered From Positive Control cfu/mL Number of
Organisms Recovered After Treatment cfu/mL
Log reduction
Acceptance criteria
Escherichia coli 5.3 X 104 NCO 4.72 3 Log reduction
Pseudomonas aeruginosa 5.5 X 104 NCO 4.74 3 Log reduction
Staphylococcus aureus 5.0 X 104 NCO 4.70 3 Log reduction
Bacillus subtilis spores 2.6 X 104 NCO 4.41 2 Log reduction
Candida albicans 1.6 X 104 NCO 4.20 3 Log reduction
Aspergillus brasiliensis spores 1.6 X 104 NCO 4.20 3 Log reduction

Table-4: Observations: Negative Control-
Replicate No. Dilution selected for Negative Control Colony Count (cfu) obtained
10-1 10-2 10-3 10-4

1
2
3
NCO
NCO
NCO
NCO
NCO
NCO
NCO
NCO
NCO
NCO
NCO
NCO
Average: NCO (No Colony Observed)

Waterless Surgical Scrub composition meets the acceptance criteria and showed more than 3 log reduction at 3 minute contact time using the challenge organism Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans, Aspergillus brasiliensis spores and 2 log reduction for Bacillus subtilis spores.
[00128] Example 3: Skin Moisturizing / Skin Dryness Test of Waterless Surgical Scrub
Test Item Name: Waterless Surgical Scrub Solution (4% Chlorhexidine, 0.001% Octenidine HCl, 0.5% Aloe vera gel, 0.015% Rhamnolipid & 0.015% Sophorolipids)
METHOD
Preliminary Examination
The subjects were initially examined for the presence of any cuts, bruises or abrasions at the site of test item application, which could impair the integrity of the results.
Procedure of Application
1. The human subjects were briefed by the investigator and a written informed consent form was taken from each subject.
2. In order to obtain accurate results it was made sure that the checking area is not too sweaty, dirty, wet or hairy and the room temperature is maintained at 25-30°C.
3. Human skin types of the volunteers was classified as normal, dry, combination, and oily prior to the conduct of the study by testing the skin type by applying distilled water and taking the reading of moisture oil content by simple instrumental measurement.
4. Different body parts have different moisture levels so we applied on the upper arm of human subjects.
5. 40µl of investigational product Waterless Surgical Scrub Solution was applied on the upper arm of the human subjects and reading was noted at 0 hours and 2 hours after the application of the test item.
6. The sites were marked with a blue/black marker to facilitate evaluation later.
7. After 2 hours of the exposure period the sites were cleared with luke warm water to remove the left over test item.
8. The scoring was done as per the table given in observation of reactions.

OBSERVATION OF REACTIONS
Table-5: The gradation for any reaction (if any) has been performed in accordance to the following table:
Oil Rate Reference: Reading and interpretation of skin type
16%-22% (Partial wet skin)
23%-33% (General Skin)
34%-63% (Oily Skin)

RESULTS
The investigational product was topically applied on the upper arm of Human subject. The test item was rubbed lightly on the area and the moisture content of the skin was measured at 0 hours and 2 hours after application.
It was observed that immediately after application of the test item, the skin moisture level increased to an average percentage change of 15.43% in males and 14.88% in females at 0 hrs. After 2 hours of application of test item, a decrease in skin moisture level was observed at an average percentage change of 12.43% in males and 12.82% in females. Similarly, the reading of oil content in skin was noted immediately after application of the test item and it showed an increase of average percentage change of 6.78% in males and 7.08% in females at 0 hrs and an increase of percentage change of 8.28% in males and 9.05% in females after two hours was observed.
Table-6: Evaluation of moisture content of skin in males
PATIENT ID MOISTURE CONTENT
Male Human subject Before application 0 hrs after application 2hrs after application Change (%) 0 hrs after application Change (%) 2hrs after application
1 17.5 34.5 30.5 17 13
2 16.8 29.2 25.2 12.4 8.4
3 19.1 32.1 29.6 13 10.5
4 17 39.1 34.1 22.1 17.1
5 30 44.5 41.5 14.5 11.5
6 21.5 40.2 40.2 18.7 18.7
7 31.2 48.9 46.9 17.7 15.7
8 38 47.1 45.2 9.1 7.2
9 18 35.1 30.1 17.1 12.1
10 20.4 40.2 40.2 19.8 19.8
11 17.7 30.1 20.5 12.4 2.8
12 18.03 29.4 30.4 11.37 12.37
MEAN 15.43 12.43
SD 3.89 4.93

Table-7: Evaluation of moisture content of skin in females
PATIENT ID MOISTURE CONTENT
Female Human subject Before application 0 hrs after application 2hrs after application Change (%) 0 hrs after application Change (%)
24hrs after application
1 22.5 36.5 30.5 14 8
2 19.8 35.2 30.2 15.4 10.4
3 22.1 39.1 35.1 17 13
4 40 47.1 43.1 7.1 3.1
5 25 40.5 41.5 15.5 16.5
6 26.5 42.2 46.2 15.7 19.7
7 30.2 44.9 46.9 14.7 16.7
8 17.2 33.1 35.8 15.9 18.6
9 19 30.1 30.1 11.1 11.1
10 20.5 41.2 40.2 20.7 19.7
11 16.7 35.1 20.5 18.4 3.8
12 17.2 30.2 30.4 13 13.2
MEAN 14.88 12.82
SD 3.47 5.76

Table-8: Evaluation of oil content of skin in males
PATIENT ID OIL CONTENT
Male Human subject Before application 0 hrs after application 2hrs after application Change (%) 0 hrs after application Change (%)
24hrs after application
1 18.5 24.5 26.5 6 8
2 37.8 39.2 38.1 1.4 0.3
3 28.1 32.1 36.1 4 8
4 30 39.1 40.1 9.1 10.1
5 16 32.5 33.5 16.5 17.5
6 30.5 31.2 35.2 0.7 4.7
7 28.2 38.9 36.9 10.7 8.7
8 28.4 37.1 37.1 8.7 8.7
9 19 25.1 27.1 6.1 8.1
10 30.4 36.2 39.2 5.8 8.8
11 28.7 36.1 38.1 7.4 9.4
12 36.2 41.2 43.2 5 7
MEAN 6.78 8.28
SD 4.24 3.91

Table-9: Evaluation of oil content of skin in females
PATIENT ID OIL CONTENT
Female Human subject Before application 0 hrs after application 2hrs after application Change (%) 0 hrs after application Change (%)
24hrs after application
1 26.5 30.5 31.5 4 5
2 20.8 25.2 29.2 4.4 8.4
3 26.1 28.1 32.2 2 6.1
4 28 32.5 34.5 4.5 6.5
5 30.2 40.5 39.5 10.3 9.3
6 46.3 48.4 49.5 2.1 3.2
7 25.8 34.9 37.2 9.1 11.4
8 20.6 36.3 33.2 15.7 12.6
9 28.2 34.1 38.8 5.9 10.6
10 28.5 35.2 39.4 6.7 10.9
11 25.7 39.1 37.9 13.4 12.2
12 19.2 26.1 31.6 6.9 12.4
MEAN 7.08 9.05
SD 4.31 3.18

The waterless Surgical Scrub composition was found to be: a) Helpful in increasing the moisture and oil content of the skin immediately after its application at 0 hours and up to 8 hours with a negligible change; b) Non-irritant and non-toxic to the skin of human subject for long term use.
[00129] Example 4: Skin Moisturizing / Skin Dryness Test of Waterless Surgical Scrub
Test Item Name: Waterless Surgical Scrub Solution (4% Chlorhexidine, 0.001% Octenidine HCl, 0.5% Aloe vera gel, 0.015% Rhamnolipid & 0.015% Sophorolipids)
METHOD
Preliminary Examination
The subjects were initially examined for the presence of any cuts, bruises or abrasions at the site of test item application, which could impair the integrity of the results.
Patch Test Application
40µl of 8% investigational product ‘Skin Irritation (Patch Test) Study of Waterless Surgical Scrub and Distilled water (negative control) were dispensed in separate Finn chamber using a micropipette and was applied on the skin of the inner aspect of the upper arm of the human subjects for a period of 24 hours at the sites marked as 3 and 1 respectively. Similarly, 40µl of 3% solution of Sodium Lauryl Sulphate (positive control) was dispensed in the Finn chamber and applied on the upper arm and the site was marked as “2”
The patches were held in place by securing it with non-allergic tape. After 24 hrs of the exposure period, the patches were removed gently and the sites were cleared with luke warm water to remove the left over and marked for identification. The reactions were observed at 24 hours, 72 hours, and 7 days after the patch removal.
OBSERVATION OF REACTIONS
The appearance of any erythematous or oedematous reactions was noted at 24 hours, 72 hours and 7 days respectively after the patch removal.
Table-10: The resulting reaction values were evaluated on the basis of the following Draize table:
Score for Erythema

/ Dryness &

wrinkling Reaction Score for Oedema Reaction
0 No Reaction 0 No Reaction
1 Very slight erythema / dryness with shiny appearance 1 Very slight Oedema
2 Slight erythema/dryness/ wrinkles 2 Slight Oedema
3 Moderate erythema/dryness/ wrinkles 3 Moderate Oedema
4 Severe erythema/
wrinkles/ scales 4 Severe Oedema

RESULTS
The reactions observed in the human subjects were found to be statistically non-significant, when compared to the skin reactions with positive control i.e. Sodium Lauryl Sulphate.
The mean score of investigational product was as 0.20.
The reactions of 3% Sodium Lauryl Sulphate (positive control) in all the human subjects subsided within 7 days of the patch removal. The average total score of the reactions in case of human subjects applied with 3% Sodium Lauryl Sulphate (positive control) was found to be 4.73 at 24 hours after the patch removal.
Waterless Surgical Scrub composition did not elicit any skin reactions and was found to be: a) Non-irritant/ Dermatologically safe; and b) Dermatologically tested: safe for human skin for long term use.
[00130] 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 scrub composition comprising of a) one or more biosurfactants; b) chlorhexidine digluconate; and c) octenidine dihydrochloride.
2. The composition as claimed in claim 1, wherein the biosurfactant is rhamnolipid or sophorolipid or combinations thereof.
3. 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.
4. 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.
5. The composition as claimed in claim 1, wherein the amount of octenidine dihydrochloride ranges from about 0.001% to about 3.0%, preferably in the amount ranging from about 0.001% to about 2.1% 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 composition is effective against Escherichia coli, Pseudomonas aeruginosa, Candida albicans, Aspergillus brasiliensis spores, Bacillus subtilis spores and Methicillin Resistant Staphylococcus aureus, MRSA.
8. A process for producing waterless surgical scrub 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.
9. A waterless surgical scrub composition comprising,
a) Octenidine Dihydrochloride;
b) Rhamnolipid;
c) Sophorolipids;
d) Chlorhexidine digluconate;
e) Aloe vera gel;
f) Jojoba oil or cucumber extract or combinations thereof;
g) Sorbic acid;
h) Calendula oil;
i) Lecithin;
j) Methyl Cellulose or Guar Gum or combinations thereof;
k) Sodium hydroxide;
l) Fragrance; and
m) Pharmaceutical grade water.
10. The composition as claimed in claim 9, wherein the composition comprises,
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;
l) Fragrance ranging from about 0.00 to about 1.0% of the total composition; and
m) Pharmaceutical grade water: q.s. to make 100%.