[0001] The present invention relates to intimate wash composition. Specifically, the present invention relates to rinse-free intimate wash composition for women having antimicrobial properties and maintaining the pH and bacterial flora of the vagina. The present invention relates to an intimate wash composition comprising a bio-surfactant, essential oils, natural emollient, natural gel and acidity regulator. The present invention also relates to the process of obtaining the rinse-free intimate wash composition.

BACKGROUND OF 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] The vagina is a muscular canal in the female genitals responsible for childbirth and sexual intercourse. It connects the uterus, which is the organ for childbearing, to the outside world. It also acts as a pathway for the flow of menstrual fluid, mucus, etc., from the body. Considering its extremely important role in the life of a woman, vaginal health is critical for the overall health of a woman. Vaginal health is determined by analysis of multiple factors such as pH, elasticity, vaginal secretions etc.
[0004] The vagina has a lining of epithelial cells and provides an acidic environment with a pH typically in the range of 3.8 to 4.5. However, the pH varies owing to the different stages of the woman’s reproductive cycle, for example, menopause, menstruation, childbirth etc. pH is an important marker for the health of the vagina. Vaginal acidity is caused by the metabolism of glycogen to lactic acid by the bacteria present in the vagina. Lactobacilli is the primary bacteria present in the vagina, known as the good bacteria, responsible for maintaining the pH which further prevents harmful bacteria from entering the vagina. Anything altering the bacterial flora leads to infections symptomized by discomforts like itching, foul-smelling discharge etc. Bacterial infections of the vagina are termed as Bacterial vaginosis, which may be caused by an array of bad bacteria for example, Staphylococcus aureus MRSA strain (communal and hospitals), Aspergillus niger and Pseudomonas aeruginosa. Apart from bacterial infections, the vagina may also be affected by yeast or fungal infections. A typical example of a yeast infection in the vagina is Candidiasis, caused by Candida albicans.
[0005] Owing to the importance of vaginal health, women in recent times have incorporated intimate hygiene as part of their routines. With proper care, vaginal health can be maintained or restored. Vaginal care involves maintaining monogamy, indulging in safe sex, vaginal douching, vaccinations, routine washing, and drying, using breathable fabrics like cotton etc. among other things.
[0006] Multiple compositions have been disclosed in the past that may be used for washing the vagina to maintain the natural bacterial flora of the vagina. However, vaginal pathogens are increasingly becoming immune to available drugs and medicines. The administration of antibiotic drugs is also associated with side effects and indiscriminate attacks on bacteria including good bacteria. There is a dearth of compositions that can act on pathogens and simultaneously provide necessary moisture to the skin. Therefore, there is a need to look for alternative natural compositions for treating vaginal infections, which are effective yet gentle on the skin and are also environmental friendly. The prior composition that exist in this field are generally lacking one of the properties either cleansing or antimicrobial. The present invention provides for a bio-degradable composition that is rinse-free and has antimicrobial properties and maintains the pH and bacterial flora of the vagina. This composition can be used on the go without rinsing off the residues in contrast to the other compositions in the art.

OBJECTS OF THE INVENTION
[0007] An object of the present disclosure is to provide a rinse-free intimate wash composition that can be used on the go without rinsing.
[0008] An object of the present invention is to provide a rinse-free intimate wash composition for women having antimicrobial properties.
[0009] Another object of the present invention is to provide a composition for washing that maintains the pH and good bacterial flora around the vagina.
[0010] Another object of the present invention is to provide a rinse-free biodegradable composition in which the bio-surfactant and the natural antimicrobial agents mutually regulate their activity.
[0011] Another object of the present invention is to provide a composition effective against vaginal yeast and fungal infections like Candidiasis caused by Candida albicans; bacterial infections caused by Staphylococcus aureus MRSA strain (communal and hospitals), Aspergillus niger and Pseudomonas aeruginosa.
[0012] Another object of the invention relates to a process of preparing the rinse-free intimate wash composition.

SUMMARY OF THE INVENTION
[0013] 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.
[0014] The present invention relates to an intimate wash composition. Specifically, the present invention relates to rinse-free intimate wash composition for women.
[0015] In one aspect, the present invention relates to a rinse-free intimate wash composition having antimicrobial properties and maintaining the pH and bacterial flora of the vagina.
[0016] In one aspect, the present invention provides a rinse-free intimate wash composition which is biodegradable.
[0017] In one aspect, the present invention relates to a rinse-free intimate wash composition comprising a bio-surfactant, essential oils, natural emollient, natural gel and acidity regulator.
[0018] In one aspect, the present invention relates to a rinse-free intimate wash composition further comprising water, optionally along with a pH regulator.
[0019] In one aspect, the present invention relates to a rinse-free intimate wash composition wherein the bio-surfactant can be selected from rhamnolipid, sophorolipids, trehalolipids, mannosylerythritol lipids, surfactin, viscosin and ornithine.
[0020] In an aspect, the present invention relates to a rinse-free intimate wash composition wherein the essential oil can be selected from tea tree oil, spearmint oil, peppermint oil, lemon oil, clove oil, oregano oil, thyme oil, cinnamon oil, lemongrass oil or combinations thereof.
[0021] In an aspect, the present invention relates to a rinse-free intimate wash composition wherein 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 hydroxypropyl methyl cellulose.
[0022] In an aspect, the present invention relates to a rinse-free intimate wash composition wherein the natural gel can be selected from aloe vera gel, Stone Aloe/Aloe Petricola, Climbing Aloe/Aloe Ciliaris, Cape Aloe/Aloe Ferox, Coral Aloe/Aloe Striata, Lace Aloe/Aloe Aristata, Candelabra Aloe/Aloe Arborescens, and Spider Aloe/Aloe Humilis.
[0023] In an aspect, the present invention relates to a rinse-free intimate wash composition wherein acidity regulator is selected from lactic acid, acetic acid, citric acid, hydrochloric acid, phosphoric acid and malic acid.
[0024] In an aspect, the present invention relates to a rinse-free intimate wash composition wherein pH regulator can be selected from sodium hydroxide, citric acid, lactic acid, triethanolamine, glacial acetic acid, sodium carbonate and acetic acid.
[0025] In an aspect, the present invention relates to a rinse-free intimate wash composition wherein water is present in a quantity sufficient to bring up the volume of the composition to 100% by weight.
[0026] In another aspect, the present invention relates to a rinse-free intimate wash composition comprising:
a) Rhamnolipid;
b) Peppermint Oil;
c) Tea tree Oil;
d) Spearmint Oil;
e) Lemon Oil;
f) Aloe Vera gel;
g) Hydroxypropyl Methyl cellulose;
h) Lactic acid; and
i) Distilled Water.
[0027] In one aspect, the present invention provides a rinse-free intimate wash composition effective against vaginal yeast and fungal infections like Candidiasis caused by Candida albicans; bacterial infections caused by Staphylococcus aureus MRSA strain (communal and hospitals), Aspergillus niger and Pseudomonas aeruginosa.
[0028] In another aspect, the present invention relates to the process of preparing the rinse-free intimate wash composition.
[0029] 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
[0030] 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 as defined by the appended claims.
[0031] 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.
[0032] 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.
[0033] 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.
[0034] 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.
[0035] 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.
[0036] 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.”
[0037] 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.
[0038] 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.
[0039] 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 thus fulfilling the written description of all Markush groups used in the appended claims.
[0040] 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.
[0041] 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.
[0042] The headings and abstract of the invention provided herein are for convenience only and do not interpret the scope or meaning of the embodiments.
[0043] 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.
[0044] 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 scope of the invention.
[0045] To overcome the existing problems as defined in the background of the invention, the present invention discloses a composition for intimate washing. Specifically, the present invention relates to rinse-free intimate wash composition for women.
[0046] The present invention relates to an intimate wash composition. Specifically, the present invention relates to rinse-free intimate wash composition for women.
[0047] In one embodiment, the present invention relates to a rinse-free intimate wash composition having antimicrobial properties and maintaining the pH and bacterial flora of the vagina.
[0048] In one embodiment, the present invention provides a rinse-free intimate wash composition which is biodegradable.
[0049] In one embodiment, the present invention relates to a rinse-free intimate wash composition comprising a bio-surfactant, essential oils, natural emollient, natural gel and acidity regulator.
[0050] In one embodiment, the present invention relates to rinse-free intimate wash composition further comprising water, optionally along with a pH regulator.
[0051] In an embodiment, the rinse-free intimate wash compostion relates to a composition wherein the bio-surfactant can be selected from glycolipid, lipopeptide, phospholipid, fatty acid, neutral lipid, polymeric and particulate compounds.
[0052] In another embodiment, the bio-surfactant is preferably glycolipid, wherein the glycolipid can be selected from the group comprising rhamnolipid, sophorolipids, trehalolipids and mannosylerythritol lipids.
[0053] In another preferred embodiment, the bio-surfactant is rhamnolipid.
[0054] In one embodiment, the present invention relates to a rinse-free intimate wash composition wherein the bio-surfactant is present in an amount ranging from about 0.001% to about 0.1%, preferably in the amount ranging from about 0.005% to about 0.05%, by weight with respect to the overall composition.
[0055] In an embodiment, the present invention relates to a rinse-free intimate wash composition wherein the essential oil can be selected from tea tree oil, spearmint oil, peppermint oil, lemon oil, clove oil, oregano oil, thyme oil, cinnamon oil, lemongrass oil or combinations thereof.
[0056] In a preferred embodiment, the essential oils are a combination of tea tree oil, spearmint oil, peppermint oil and lemon oil.
[0057] In another embodiment, the present invention relates to a rinse-free intimate wash composition wherein the essential oils are present in an amount ranging from 0.1% to 5% by weight with respect to the overall composition, preferably in the amount ranging from 0.5% to 3% by weight with respect to the overall composition.
[0058] In an embodiment, the present invention relates to a rinse-free intimate wash composition wherein 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 hydroxypropyl methyl cellulose.
[0059] In a preferred embodiment, natural emollient is selected from aloe vera, jojoba oil and hydroxypropyl methyl cellulose.
[0060] In another embodiment, the present invention relates to a rinse-free intimate wash composition wherein the natural emollient is present in an amount ranging from 0.01 to 1% by weight with respect to the overall composition, preferably in the amount ranging from 0.1% to 0.5% by weight with respect to the overall composition.
[0061] In an embodiment, the present invention relates to a rinse-free intimate wash composition wherein the natural gel can be selected from aloe vera gel, Stone Aloe/Aloe Petricola, Climbing Aloe/Aloe Ciliaris, Cape Aloe/Aloe Ferox, Coral Aloe/Aloe Striata, Lace Aloe/Aloe Aristata, Candelabra Aloe/Aloe Arborescens, and Spider Aloe/Aloe Humilis. In a preferred embodiment, the natural gel is aloe vera gel.
[0062] In another embodiment, the present invention relates to a rinse-free intimate wash composition wherein the natural gel is present in an amount ranging from 0.1% to 1% by weight with respect to the overall composition, preferably in the amount ranging from 0.2% to 0.7% by weight with respect to the overall composition.
[0063] In an embodiment, the present invention relates to a rinse-free intimate wash composition wherein acidity regulator is selected from lactic acid, acetic acid, citric acid, hydrochloric acid, phosphoric acid and malic acid. In a preferred embodiment, the acidity regulator is lactic acid.
[0064] In another embodiment, the present invention relates to a rinse-free intimate wash composition wherein acidity regulator is present in an amount ranging from 0.5% to 5% by weight with respect to the overall composition, preferably in the amount ranging from 1% to 3% by weight with respect to the overall composition.
[0065] In an embodiment, the present invention relates to a rinse-free intimate wash composition wherein pH regulator can be selected from sodium hydroxide, citric acid, lactic acid, triethanolamine, glacial acetic acid, sodium carbonate and acetic acid. In a preferred embodiment, the pH regulator is sodium hydroxide.
[0066] In another embodiment, the pH regulator is required to adjust the pH of the final composition in the range of 2-5, preferably 3-4 and most preferably 3.5.
[0067] In an embodiment, the present invention relates to a rinse-free intimate wash composition wherein water is present in a quantity sufficient to bring up the volume of the composition to 100% by weight.
[0068] In another embodiment, the present invention relates to a rinse-free intimate wash composition comprising:
a) Rhamnolipid;
b) Peppermint Oil;
c) Tea tree Oil;
d) Spearmint Oil;
e) Lemon Oil;
f) Aloe Vera gel;
g) Hydroxypropyl Methyl cellulose;
h) Lactic acid; and
i) Distilled Water.
[0069] In another embodiment, the present invention relates to a rinse-free intimate wash composition comprising:
a) Rhamnolipid 0.01%;
b) Peppermint Oil 0.5%;
c) Tea tree Oil 0.03%;
d) Spearmint Oil 0.5%;
e) Lemon Oil 0.4%;
f) Aloe Vera gel 0.5%;
g) Hydroxypropyl Methyl cellulose 0.2%;
h) Lactic acid 2.0%; and
i) Distilled Water q.s.
[0070] According to the embodiments of the present invention, the intimate wash composition comprises bio-surfactant along with natural antimicrobial agents that provide a perfect combination of cleansing and antimicrobial activity. Additionally, this is the first intimate wash composition that has been formulated with bio-surfactant which has multifunctional roles such as cleaning, antimicrobial, anti-fungal, biodegradable, and biocompatible. The use of a bio-surfactant in this composition makes it skin-friendly for all types.
[0071] In one embodiment, the present invention relates to a rinse-free intimate wash composition which has a combination of the bio-surfactant and essential oils not known hitherto. The biosurfactant itself has antimicrobial properties that complement the antimicrobial activity of the essential oils used.
[0072] In another embodiment, the anti-microbial activity of the rinse-free intimate wash composition is imparted by Rhamnolipid, Lactic Acid and Tea tree Oil.
[0073] In another embodiment, the essential oils are incorporated in the rinse-free intimate wash composition to provide the different properties. Tea tree oil is anti-microbial, spearmint oil acts as a skin softner and skin moisturizer whereas peppermint oil has anti-inflammatory properties.
[0074] In one embodiment, the present invention provides a rinse-free intimate wash composition effective against vaginal yeast and fungal infections like Candidiasis caused by Candida albicans; bacterial infections caused by Staphylococcus aureus MRSA strain (communal and hospitals), Aspergillus niger and Pseudomonas aeruginosa.
[0075] In one embodiment, the present invention provides a rinse-free intimate wash composition, wherein the composition exists in the form of a powder, liquid, gel or emulsion. In a preferred embodiment, the composition exists as an emulsion.
[0076] In an embodiment, the rinse-free intimate wash composition of the present invention maybe used on the body part in any manner known to a person skilled in the art.
[0077] In an embodiment, the present invention relates to a composition which is useful as a rinse-free intimate wash composition for woman. The term ‘rinse-free intimate wash 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. The intimate wash composition can be used on the go without rinsing off the residues in contrast to the other compositions in the art.
[0078] In another embodiment, the present invention relates to a rinse-free intimate wash composition in which the bio-surfactant and the natural antimicrobial agent mutually regulate their activity.
[0079] In one embodiment, the present invention provides a rinse-free intimate wash composition which is biodegradable. In another embodiment, the present invention relates to a rinse-free intimate wash composition which is composed of biodegradable and biocompatible ingredients. This composition is composed of natural bio-surfactant, suitable for all skin types and maintains the pH of the vagina on regular use basis.
[0080] In another embodiment, the present invention relates to a rinse-free intimate wash composition which can be used without water on a regular basis without harming the vagina. For a single wash, 2-3 sprays, which is approximately 5 ml of the composition is required. There is no need to rinse with water after using the composition.
[0081] In another embodiment, the present invention relates to the process of preparing the rinse-free intimate wash composition.
[0082] In yet another embodiment, the present invention relates to a process of preparing the rinse-free intimate wash composition comprising the steps of :
a) Dissolving bio-surfactant, natural gel, emollient and acidity regulator in distilled water with constant stirring to give solution A;
b) Mixing essential oils to give solution B;
c) Slowly adding solution B to solution A using an ultrasonic homogenizer; and
d) Adjusting the pH of the solution in the range of 3-4 to obtain the final composition as an emulsion.
[0083] In still another embodiment, the present invention relates to a process of preparing the rinse-free intimate wash composition comprising the steps of :
a) Dissolving bio-surfactant, natural gel, emollient and acidity regulator in distilled water with constant stirring at 1200-1500 rpm, at 30°C to give solution A;
b) Mixing essential oils to give solution B;
c) Slowly adding solution B to solution A using an ultrasonic homogenizer for 20 minutes at 20°C, with work/clearance time of 10.8 second and 1% ultrasonic power; and
d) Adjusting the pH of the solution in the range of 3-4 to obtain the final composition as an emulsion.
[0084] The present invention is further explained in the form of the following examples. However, it is to be understood that the following examples are merely illustrative and are not to be taken as limitations upon the scope of the invention.
[0085] All chemical raw materials were purcahseed from PK scientific, Karan Vihar, Gali No. 1, Kirari Suleman Nagar, Delhi-86, and were industrial grade and IH. The bacterial and fungal strains were either collected from BBIF-FITT incubation center in IIT or were procured for the research purposes from CSIR-National Chemical Laboratory, Dr. Homi Bhabha Road, Pune- 411 008, India.
[0086] Example 1: Composition of the rinse-free intimate wash composition
Table 1
Ingredients Composition (wt/wt%)
Rhamnolipid 0.01%
Peppermint Oil 0.5%
Tea tree Oil 0.03%
Spearmint Oil 0.5%
Lemon Oil 0.4%
Aloe Vera gel 0.5%
Hydroxypropyl Methyl cellulose 0.2%
Lactic acid 2.0%
Distilled Water q.s. to 100%

[0087] Example 2: Preparation of the rinse-free intimate wash composition
[0088] To prepare the “rinse-free intimate wash composition”, the water-soluble ingredients such as 0.01 % (wt/wt) rhamnolipid, lactic acid 2.0 % (wt/wt), aloe vera gel 0.5 % (wt/wt), and 0.2 % (wt/wt) hydroxypropylmethyl cellulose were added to approximately 80 ml of distilled water with constant stirring at 1200-1500 rpm and at 30°C. All essential oils (tea tree oil, spearmint oil, peppermint oil and lemon oil, in weight ratios as per Example 1) were mixed in a separate vessel, followed by slowly adding the oil solution to aqueous solution using ultrasonic homogenizer for 20 minutes at 20°C, with work/clearance time of 10.8 second and 1% ultrasonic power. The pH of the rinse-free intimate wash composition was then adjusted to 3.5 using 10 M sodium hydroxide at room temperature to obtain the rinse free intimate wash composition as an emulsion.
[0089] Example 3: Anti-microbial activity of the intimate wash composition
[0090] The composition of Example 1 was tested for its anti-microbial activity by a time kill assay. The assay notes the changes in the microbial population within a specified time in presence of the composition. The time kill assays were performed on the ready-to-use composition. The assays were performed as per the American Standard for Testing and Material protocol ASTM-E2315-16.

[0091] TEST PROCEDURE: The working cultures of the test organisms were prepared. 10 mL of the sample was taken with respect to individual test culture. 100 µL of adjusted test cultures were inoculated in individual samples prepared. A contact time of 10 seconds was considered. Using the pour plate technique, 1 mL of the intimate wash composition was pipetted to triplicated petri dishes for each dilution prepared by serial dilution technique and then 20mL of melted SCDA was added. The petri dish was incubated at 30-35°C for 72 hours. The colonies on the petri dishes were counted with the help of colony counter after incubation and the observations were recorded in cfu (colony forming unit). The petri dish showing a number of colonies included in a 15-300 for bacterial and fungal of 15-150 range were used to perform the result calculation.
[0092] LOG REDUCTION CALCULATION:The effectiveness of the disinfection procedure against each challenge organism was calculated for each product as a log10 reduction as follows:
Log10 Reduction per product = Log10 [Positive Control Count] – Log10 [Test Surface Count]
(The log reduction was rounded to the nearest 0.1 value)
[0093] For each product concentration and each experimental condition, decimal log reduction was calculated and recorded separately.
[0094] 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. Agents should demonstrate a 3 log reduction of vegetative test organisms and mold spores.
[0095] RESULTS: The results of the anti-microbial tests are provided in Table 2 below:

Table 2: Anti-microbial activity of the composition
S. No. Organism Contact time with the composition
(sec) % reduction
1 Candida Albiacn 10 99.99%
2 Staphylococcus aureus MRSA 30 99.99%
3 Staph. Epidermis 10 99.99%
4 Escherichia coli 10 99.99%
5 Aspergillus niger 10 99.99%
6 Aspergillus brasilensis 10 99.99%
7 Lisleria monocytogenes 10 99.99%

[0096] The above results demonstrate that the composition of the present invention provides quick action as the anti-microbial efficacy was about 99.99% within 10 seconds of use. Additionally, the composition shows broad spectrum activity.
[0097] Example 4: Activity against Gardnerella vaginalis
[0098] Disk-diffusion test was carried out to evaluate the activity against Gardnerella vaginalis. In the well-diffusion method, 100 ?l of intimate wash composition was incubated against the specified microorganisms for 12-14 hours at 37 °C. The working cultures of the test organisms were prepared. 10 mL of the sample was taken with respect to individual test culture. 100 µL of adjusted test cultures were inoculated in individual samples prepared. Using the pour plate technique, 100 ?l of the intimate wash composition was pipetted to triplicated petri dishes for each dilution prepared by serial dilution technique and then 20mL of melted SCDA was added. The petri dish was incubated at 30-35°C for 12-14 hours. Thereafter zone antimicrobial inhibition was analysed.
[0099] It was surprisingly found that the disinfectant activity of rhamnolipid was significantly increased by the addition of lactic acid and tea tree oil in the specific weight percentage ranges. This was demonstrated by the results of a disk diffusion test performed on Gardnerella vaginalis using the composition of Example 1 and some comparative compositions as shown in Table 3.
Table 3: Disk-diffusion tests
S. No Component Antimicrobial Inhibition Zone (cm)
1. Rhamnolipid 0.01% (wt/wt) 2.5
2. Rhamnolipid 0.01 % (wt/wt) +Tea tree oil 0.3 % (wt/wt) 3.3
3. Rhamnolipid 0.01 % (wt/wt) + Lactic Acid 2.0 % (wt/wt) 3.4
4. Rhamnolipid 0.01 % (wt/wt) + Lactic Acid 2.0 % (wt/wt)+ Tea Tree Oil 0.3 % (wt/wt) 4.6
From the results, it was concluded that the combination of rhamnolipid, tea tree oil, and lactic acid mutually regulate the antimicrobial activity and show synergistic activity.
[00100] 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.

ADVANTAGES OF THE PRESENT INVENTION
[00101] The present invention provides a rinse-free intimate wash composition.
[00102] The present invention provides a rinse-free intimate wash composition for women having antimicrobial properties.
[00103] The present invention provides a rinse-free intimate wash composition for washing that maintains the pH and good bacterial flora around the vagina.
[00104] The present invention provides a rinse-free intimate wash composition effective against vaginal yeast and fungal infections like Candidiasis caused by Candida albicans; bacterial infections caused by Staphylococcus aureus MRSA strain (communal and hospitals), Aspergillus niger and Pseudomonas aeruginosa.
[00105] The present invention provides a rinse-free intimate wash composition which is biodegradable.

CLAIMS:1. A rinse-free, antimicrobial intimate wash composition for women that maintains the pH and bacterial flora of the vagina; the composition comprising a bio-surfactant, essential oils, natural emollient, natural gel and acidity regulator, wherein the bio-surfactant is a glycoplipid selected from rhamnolipid, sophorolipids, trehalolipids, mannosylerythritol lipids, surfactin, viscosin and ornithine.
2. The composition as claimed in claim 1, wherein the glycoplipid is selected from rhamnolipid, sophorolipids, trehalolipids, mannosylerythritol lipids, surfactin, viscosin and ornithine; present in an amount ranging from 0.001% to 0.1% by weight with respect to the overall composition.
3. The composition as claimed in claim 1, wherein the essential oil is selected from tea tree oil, spearmint oil, peppermint oil, lemon oil, clove oil, oregano oil, thyme oil, cinnamon oil, lemongrass oil or combinations thereof, present in an amount ranging from 0.1% to 5% by weight with respect to the overall composition.
4. The composition as claimed in claim 1,wherein natural emollient is selected from aloe vera, shea butter, cocoa butter, argan oil, jojoba oil, cucumber extract, olive oil, sunflower oil, avocado oil and hydroxypropyl methyl cellulose, present in an amount ranging from 0.01 to 1% by weight with respect to the overall composition; natural gel is selected from aloe vera gel, Stone Aloe/Aloe Petricola, Climbing Aloe/Aloe Ciliaris, Cape Aloe/Aloe Ferox, Coral Aloe/Aloe Striata, Lace Aloe/Aloe Aristata, Candelabra Aloe/Aloe Arborescens and Spider Aloe/Aloe Humilis, present in an amount ranging from 0.1 to 1% by weight with respect to the overall composition; and acidity regulator is selected from lactic acid, acetic acid, citric acid, hydrochloric acid, phosphoric acid and malic acid, present in an amount ranging from 0.5% to 5% by weight with respect to the overall composition.
5. The composition as claimed in claim 1, further comprising water optionally along with a pH regulator; wherein water is present in a quantity sufficient to bring up the volume of the composition to 100% by weight; and pH regulator is selected from sodium hydroxide, citric acid, lactic acid, triethanolamine, glacial acetic acid, sodium carbonate and acetic acid, present in an amount selected from 0.1% to 5% by weight with respect to the overall composition and is used to adjust the pH of the final composition in the range of 3-4.
6. The composition as claimed in claims 1 to 5, comprising:
a) Rhamnolipid;
b) Peppermint Oil;
c) Tea tree Oil;
d) Spearmint Oil;
e) Lemon Oil;
f) Aloe Vera gel;
g) Hydroxypropyl Methyl cellulose;
h) Lactic acid; and
i) Distilled Water.
7. A rinse-free, antimicrobial intimate wash composition for women that maintains the pH and bacterial flora of the vagina; the composition comprising:
a) Rhamnolipid 0.01%;
b) Peppermint Oil 0.5%;
c) Tea tree Oil 0.03%;
d) Spearmint Oil 0.5%;
e) Lemon Oil 0.4%;
f) Aloe Vera gel 0.5%;
g) Hydroxypropyl Methyl cellulose 0.2%;
h) Lactic acid 2.0%; and
i) Distilled Water q.s to make 100%.
8. The composition as claimed in claims 1 to 7 wherein the composition exists in the form of a powder, liquid, gel or emulsion; preferably as an emulsion.
9. A process for preparing a rinse-free, antimicrobial intimate wash composition for women, the composition comprising a bio-surfactant, essential oils, natural emollient, natural gel and acidity regulator; wherein the process comprises the steps of:
a) Dissolving bio-surfactant, natural gel, emollient and acidity regulator in distilled water with constant stirring at 1200-1500 rpm, at 30°C to give solution A;
b) Mixing essential oils to give solution B;
c) Slowly adding solution B to solution A using an ultrasonic homogenizer for 20 minutes at 20°C, with work/clearance time of 10.8 second and 1% ultrasonic power; and
d) Adjusting the pH of the solution in the range of 3-4 to obtain the final composition as an emulsion.
10. The rinse-free, antimicrobial intimate wash composition prepared by the process as claimed in claim 9.