[0001] The present invention generally relates to a hand sanitizer composition. Specifically, the present invention relates to a non-alcoholic herbal hand sanitizer comprising of mixture of natural oils selected from cinnamon oil, tea tree oil, lemon oil and lavender oil and method of preparation of the hand sanitizer. The hand sanitizer composition of the present invention possesses excellent antimicrobial properties.
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] Hands are the main source of transmission of microbes or germs which may cause infections and diseases to an individual. Hand sterilization is essential in food production, healthcare, homes and day to day life. Also, the rise of hospital-acquired infections has emphasized the need for cleanliness.One of the best and easiest ways of preventing germ and/or disease transmission is by routinely washing one's hands. In particular, effective hand washing is needed for people working in a clinical environment. Recognizing the inconvenience or impossibility of such hand washing under certain circumstances, such as traveling conditions and/or time constraints, a number of manufacturers have introduced hand sanitizing products which sanitize skin surfaces without the need for water and/or drying towels.
[0004] Currently, the alcoholic gel-based hand sanitizers have been successfully commercialized in the health care and consumer markets. These products are convenient to use and effective at killing germs. However, since these products typically contain 60-70% ethanol, they are highly flammable. Therefore, special storage and handling procedures have been developed to store and transport these products. Not only have the flammability of these products increased their storage and distribution costs, but they have foreclosed several markets, such as the airline industry. In addition, alcohol-based sanitizers may cause skin drying and irritation.

[0005] There is, therefore, a need to develop an alcohol-freehand sanitizer which is safe, stable, non-flammable and effective against various infections.
OBJECTS OF THE INVENTION
[0006] An object of the present invention is to provide an antimicrobial hand sanitizer
composition substantially free of alcohol.
[0007] Another object of the present invention is to provide an antimicrobial hand
sanitizer composition comprising of natural herbal oils.
[0008] Another object of the present invention is to provide an antimicrobial hand
sanitizer composition substantially free of alcohol which is stable, safe and economical.
[0009] Another object of the present invention is to provide a simple and economical
method for the preparation of the antimicrobial hand sanitizer composition.
SUMMARY OF THE INVENTION
[0010] The present invention generally relates to a hand sanitizer composition. Specifically, the present invention relates to an antimicrobial hand sanitizer substantially free of alcohol, comprising of mixture of natural oils selected from cinnamon oil, tea tree oil, lemon oil and lavender oil. The hand sanitizer composition of the present invention possesses excellent antimicrobial properties.
[0011] In one aspect, the present invention relates to an antimicrobial hand sanitizer composition comprising of:
(a) mixture of natural oils selected from the group consisting of cinnamon oil, lemon oil, tea tree oil and lavender oil;
(b) one or more thickening agents;
(c) one or more moisturizing agents and
(d) water.
[0012] In another aspect, the thickening agent is selected from the group consisting of
carbomer acrylic polymer, cross-linked sulfonic acid copolymers, triethanolamine and
mixtures thereof.
[0013] In another aspect, the moisturizing agent is selected from the group consisting of
glycerol, honey, lactose, maltose, polyethylene glycol, sorbitol, sodium lactate, PEG-7 olive
oil esters and mixtures thereof.
[0014] In yet another aspect, the present invention relates to an antimicrobial hand
sanitizer composition comprising of:

(a) about 15% to about 50% of mixture of natural oils;
(b) about 5 % to 20% of one or more thickening agents;
(c) about 30%) to 75 % of one or more moisturizing agents; and
(d) water q.s.
[0015] In yet another aspect, the present invention relates to an antimicrobial hand sanitizer composition comprising of:
(a) about 30% of mixture of cinnamon oil, lemon oil, tea tree oil and lavender oil;
(b) about 7% of Carbopol® 940;
(c) about 3%> of triethanolamine;
(d) about 60%) of glycerol; and
(e) water q.s.
[0016] In yet another aspect, the present invention relates to an antimicrobial hand
sanitizer composition having viscosity in the range of 40 cP to 60 cP.
[0017] In another aspect, the antimicrobial hand sanitizer composition is in the form of
gel, solution, lotion, foam or cream.
[0018] In another aspect, the present invention relates to an antimicrobial hand sanitizer
composition having pH in the range of 6.5 to 7.5.
[0019] In yet another aspect of the present invention, provided herein is a process for
preparation of the antimicrobial hand sanitizer.
[0020] In another aspect, the process for preparation of the antimicrobial hand sanitizer
comprising the steps of:
(a) mixing one or more thickening agents and EDTA in de-ionised water under stirring to obtain a mixture;
(b) adding one or more moisturizing agent to the mixture obtained in step (a) under stirring;
(c) adding a mixture of natural oils under uniform stirring to obtain a final mixture;
(d) mixing the final mixture obtained in the step (c) in homogenizer slowly to obtain the hand sanitizer
[0021] In another aspect, the process for preparation of the antimicrobial hand sanitizer comprising the steps of:
(a) mixing Carbopol® 940 and EDTA in de-ionised water under stirring to
obtain a mixture;

(b) adding triethanolamine and glycerol to the mixture obtained in step (a) under
stirring;
(c) adding a mixture of cinnamon oil, lemon oil, tea tree oil and lavender oil
under uniform stirring to obtain a final mixture;
(d) mixing the final mixture obtained in the step (c) in homogenizer slowly to
obtain the hand sanitizer.
[0022] 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
[0023] 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. [0024] 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." [0025] 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.
[0026] As used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. It should also be noted that the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise.
[0027] In some embodiments, the numbers expressing quantities of ingredients, properties such as concentration, reaction conditions, and so forth, used to describe and claim certain embodiments of the invention 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 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
5 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.
[0028] 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.
10 Unless otherwise indicated herein, each individual value is incorporated into the specification
as if it were individually recited herein.
[0029] All processes 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
15 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.
[0030] The headings and abstract of the invention provided herein are for convenience
20 only and do not interpret the scope or meaning of the embodiments.
[0031] 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
25 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.
[0032] 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
30 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.
[0033] 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
6

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
5 written description that follows, and the embodiments described herein, 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.
[0034] It should also be appreciated that the present invention can be implemented in
10 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.
[0035] Various terms as used herein are shown below. To the extent a term used in a
15 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.
[0036] In a general embodiment, the present invention generally relates to a hand
sanitizer composition. Specifically, the present invention relates to a non-alcoholic herbal
20 hand sanitizer comprising of mixture of natural oils selected from cinnamon oil, tea tree oil,
lemon oil and lavender oil. The hand sanitizer composition of the present invention possesses excellent antimicrobial properties.
[0037] The term "about" as used herein refers to a defined range of the value by plus or
minus 10 %.For example, about 2 % means 1.8 % to 2.2 %, about 5 % means 4.5 % to 5.5 %,
25 about 10 % means 9 % to 11 % and about 40 % means 36 % to 44 %.
[0038] The term, "hand sanitizers", as used herein refers to the skin sanitizers, which may
also be used as a topical anti-septic non-human animal skin.
[0039] In an embodiment, the present invention relates a sustained release pharmaceutical
composition comprising of:
30 (a) nanocomposite of glimepiride in soluplus®;
(b) binder selected from natural gum or synthetic gum; and
(c) one or more pharmaceutically acceptable excipients.
[0040] In another embodiment, the present invention relates to a sustained release
pharmaceutical composition comprising of:
7

(a) about 4% of nanocomposite comprising of nanoemulsion of glimepiride and soluplus®;
(b) about 5% of neem gum; and
(c) about 91% of one or more pharmaceutically acceptable excipients.
5 [0041] In another embodiment, the present invention relates to an antimicrobial hand
sanitizer composition comprising of:
(a) mixture of natural oils selected from the group consisting of cinnamon oil, lemon oil, tea tree oil and lavender oil;
(b) one or more thickening agents;
10 (c) one or more moisturizing agents and
(d) water.
[0042] In another embodiment, the mixture of natural oils is present in an amount ranges
from about 15% to about 60% by weight of the composition of the present invention. Preferably, the mixture of natural oils is present in an amount of 15%, 20%, 25%, 30%, 35%,
15 40%, 45%, 50%, 55% and 60% by weight of the composition. More preferably, present in an
amount of 25%, 30%, 35%, 40%, 45% and 50% by weight of the composition.
[0043] In another embodiment, the one or more thickening agentsof the present
invention is present in an amount ranges from about 5% to about 20% by weight of the composition of the present invention. Preferably in an amount of 5%, 8%, 10%, 12%, 15%,
20 18 and 20% by weight of the composition.More preferably in an an amount of 8%, 10%,
12%, 15%and 18% by weight of the composition.
[0044] In another embodiment, the one or more moisturizing agents in the composition of
the present invention is present in an amount ranges from about 30% to about 75% by weight of the composition. Preferably, in an amount of 35%, 40%, 45%, 50%, 55% and 60% by
25 weight of the composition. More preferably, in an amount of 45%, 50%, 55%, 60% and 65%
by weight of the composition.
[0045] The thickening agents of the present invention may also act as a gelling agent.
Examples of the thickening agents include but not limited to carbomeracrylic polymer, cross-linked sulfonic acid copolymers, triethanolamine and mixtures thereof. Preferably, the
30 thickening agent is carbomer acrylic polymer such as Carbopol 934, Carbopol 940, Carbopol
950, Carbopol 980, Carbopol 951, Carbopol 981, CarbopolUltrez 10, Carbopol ETD2020 and mixtures thereof and triethanolamine. Carbopol 940 and triethanolamine are the preferred thickening agents of the present invention.
8

[0046] Another essential ingredient of the present invention is the moisturizing agent.
Moisturizing agent serve to retain water on the skin surface. Examples of moisturizing
agentincludes but not limited to glycerol, honey, lactose, maltose, polyethylene glycol,
sorbitol, sodium lactate, PEG-7 olive oil esters and mixtures thereof. Glycerol is presently
5 preferred.
[0047] In another embodiment of the present invention, the antimicrobial hand sanitizer is
alcohol free sanitizer and comprises:
(a) about 9% of Cinnamon oil;
(b) about 9% of Lavender oil; 10 (c) about 6% of Lemon oil;

(d) about 6% of Tea tree oil;
(e) about 7% of Carbopol 940;
(f) about 3% of triethanolamine;
(g) about 60% of glycerol; and 15 (h) water q.s.
[0048] The present invention provides a simple and cost-effective method for preparation
of an antimicrobial hand sanitizer.
[0049] In an embodiment, the process for preparation of the antimicrobial hand sanitizer
comprises the steps of:
20 (a) mixing one or more thickening agents and EDTA in de-ionised water under
stirring to obtain a mixture;
(b) adding one or more moisturizing agent to the mixture obtained in step (a)
under stirring;
(c) adding a mixture of natural oils under uniform stirring to obtain a final
25 mixture;
(d) mixing the final mixture obtained in the step (c) in homogenizer slowly to
obtain the hand sanitizer.
[0050] In yet another embodiment of the present invention, the antimicrobial hand
sanitizer is prepared in the form of gel, cream, solution and foam. Preferably in the form of
30 gel sanitizer. The person having ordinary skill in the art would easily prepare the various
forms of the hand sanitizer using the common general knowledge and routine experimentation based on the composition of the present invention.
[0051] The hand sanitizer of the present invention possesses excellent antimicrobial
properties when compared with the antibacterial drug available in the market. The hand
9

sanitizer of the present invention was effective against the microbes such as Escherichia coli and Staphylococcus aureus.
[0052] 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
5 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.
[0053] The present invention is further explained in the form of following examples.
10 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.
Example 1: Preparation of GelHand Sanitizer Essential Ingredients:

Sr. No. Name of Ingredients Percentage
1. Carbopol 940 0.25%
2. Tri Ethanol Amine 0.1%
3. Cinnamon oil 0.3%
4. Lemon oil 0.2%
5. Tea tree oil 0.2%
6. Lavender oil 0.3%
7. Glycerol 2%
8. De-ionised water q.s
15 [0054] Firstly, Carbopol 940 (0.25 g) and de-ionised water (q.s (100 ml)) with constant
stirring. After uniform mixing, triethanolamine (0.1 ml)and glycerol (2 ml) were added at slow stirring speed in order to avoid formation of possible air bubbles in the preparation. All the volatile oils were added to this mixture followed by the continuous mixing on homogeniser. Mixed all ingredients at slow stirring to obtain uniform product. The
20 productobtained was stored in high density polyethylene (HDPE) containers for evaluation
and testing. Results:
The test results demonstrated that the gel hand sanitizer as prepared above iseasily spreadable and has no skin irritancy. The gel has good stability after 12 weeks period and the pH of the
10

gel is in the range of 6.5-7. The viscosity of the gel was found to decrease with increase in shear rate, so that the composition was regarded as shear thing or pseudoplastic.
Evaluation of Different Parameters

S. No Parameters Observation
1. pH 6.5-7
2. Viscosity 50c Pascal
3. Stability Stable at different conditions
4. Spread ability Easily spreadable
5. Skin irritancy No irritation
6. Visual inspection No particle observed
5 Example 2: Antimicrobial Activityusing agar well diffusion method
[0055] Theanti-microbial potential of the formulated herbal gel was tested against
different microbes such as Escherichia coli and Staphylococcus aureusby using agar well diffusion method at different concentrations.

S. No Concentration (%) MIC (mm)

E. Coli S. aureus
1. 10 - -
2. 20 - -
3. 50 15 17
4. 100 24 21
5. Antibiotic (Ciprofloxacin 5µg) 32 38
10 Results:
The results suggested that the herbal gel composition of the present invention is significantly better when compared with antibacterial standards drug. Also, the efficiency of the gel hand sanitizer of the present invention was checked on healthy volunteers, the results of which clearly showed that the hand sanitizer gel is very effective in controlling the microbes.
15 [0056] A skilled artisan will appreciate that the quantity and type of each ingredient
including the medicinal plant can be used in different combinations or singly. All such
variations and combinations would be falling within the scope of present disclosure
[0057] 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
11

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.

We Claim:

An antimicrobial hand sanitizer composition comprising of:
(a) mixture of natural oils selected from the group consisting of cinnamon oil, lemon oil, tea tree oil and lavender oil;
(b) one or more thickening agents;
(c) one or more moisturizing agents and
(d) water.
2. The antimicrobial hand sanitizer composition as claimed in claim 1, wherein the thickening
agent is selected from the group consisting of carbomer acrylic polymer, cross-linked
sulfonic acid copolymers, triethanolamine and mixtures thereof.
3. The antimicrobial hand sanitizer composition as claimed in claim 1, wherein the moisturizing agent is selected from the group consisting of glycerol, honey, lactose, maltose, polyethylene glycol, sorbitol, sodium lactate, PEG-7 olive oil esters and mixtures thereof.
4. The antimicrobial hand sanitizer composition as claimed in claim 1, wherein the composition comprises:

(a) about 15% to about 50% of mixture of natural oils;
(b) about 5 % to 20% of one or more thickening agents;
(c) about 30%) to 75 % of one or more moisturizing agents; and
(d) water q.s.
5. The antimicrobial hand sanitizer compositionas claimed in claim 1, wherein the
composition comprises:
(a) about 30% of mixture of cinnamon oil, lemon oil, tea tree oil and lavender oil;
(b) about 7% of Carbopol® 940;
(c) about 3%> of triethanolamine;
(d) about 60%) of glycerol; and
(e) water q.s.

6. The antimicrobial hand sanitizer composition as claimed in claim 1, wherein the composition has viscosity in the range of 40 cP to 60 cP.
7. The antimicrobial hand sanitizer composition as claimed in claim 1, wherein the composition is in the form of gel, solution, lotion, foam or cream.
8. The antimicrobial hand sanitizer composition as claimed in claim 1, wherein the
composition has pH in the range of 6.5 to 7.5.

9. A process for preparation of the antimicrobial hand sanitizer as claimed in claim 1,
comprising the steps of:
(a) mixing one or more thickening agents and EDTA in de-ionised water under stirring to obtain a mixture;
(b) adding one or more moisturizing agent to the mixture obtained in step (a) under stirring;
(c) adding a mixture of natural oils under uniform stirring to obtain a final mixture;
(d) mixing the final mixture obtained in the step (c) in homogenizer slowly to obtain the hand sanitizer.
10. The process for preparation of antimicrobial hand sanitizeras claimed claim 7, comprises
the steps of:
(a) mixing Carbopol® 940 and EDTA in de-ionised water under stirring to obtain a mixture;
(b) adding triethanolamine and glycerol to the mixture obtained in step (a) under stirring;
(c) adding a mixture of cinnamon oil, lemon oil, tea tree oil and lavender oil under uniform stirring to obtain a final mixture;
(d) mixing the final mixture obtained in the step (c) in homogenizer slowly to obtain the hand sanitizer.