Abstract: AN ANTIBACTERIAL COMPOSITION AND IMPLEMENTATIONS THEREOF The present disclosure provides an antibacterial composition comprising: a) lavindin oil; and b) thymol, wherein lavindin oil to thymol weight ratio is the range of 1:0.00625 - 1:84.2. The present disclosure further provides a convenient process for preparing the composition.
TECHNICAL FIELD
[001] The subject matter described herein in general relates to cleansing
compositions, and in particular, relates to the antimicrobial compositions.
5 BACKGROUND OF INVENTION
[002] Microbial contaminations of compositions cause severe problems and commercial losses, for example, personal care products such as shampoos, cosmetics, and soaps; and household products such as laundry detergents, hard surface cleaners, fabric softeners and the like. In order to prevent these
10 compositions from being contaminated by microorganisms, anti-microbial actives, such as preservatives are frequently added to the formula.
[003] Conventionally available preservative compositions that exist involve the use of aggressive chemical agents like for example formaldehyde, alcohols, phenols, sodium azide, sodium hypochloride or strong oxidizing agents like for
15 example hypochloride, bleaching substances, peroxides or mineral acids for killing microorganisms. The major disadvantages associated with the use of these compositions are that they are toxic, not bio-safe, corrosive; and cause irritation on skin and mucous membrane of the user. [004] In the recent years, owing to environmental concerns, compositions derived
20 from natural sources, such as essential oils, are being increasingly used as desirable alternatives in consumer products. For example, tea tree oil (TTO) from Melaleuca alternifolia is one prominent example of essential oils with good biocidal action against bacteria and fungi (Carson, C. F et al., Clinical Microbiology Reviews, Vol. 19, No. 1, 50-62). Further, US6767876B2 discloses a composition comprising
25 surface cleaning composition comprising Mentha Spicata var.viridis oil, citronella oil, 2-ethoxyethanol, sodium hydroxide, benzalkonium chloride, and sodium lauryl sulphate surfactant. Furthermore, U.S. Pat. No. 3,688,985 discloses emulsions of essential oils, such as methyl salicylate, and thymol that are impregnated into water insoluble resins. However, these compositions have met with minimal acceptance
30 in the marketplace owing to poor microbicidal effects and similar
2
instances/symptoms of skin irritancy experienced as with synthetic chemical agents.
[005] Considering the above evidence, there exists a need to develop a herbal cleanser that is devoid of synthetic ingredients, that provides better cleansing 5 properties and proves safe to use. It is therefore an object of the invention to provide antibacterial compositions that overcome the drawbacks as discussed in the prior art.
SUMMARY OF THE INVENTION
[006] In an aspect of the present invention, there is provided an antibacterial
10 composition comprising: a) lavindin oil; and b) thymol, wherein lavindin oil to thymol weight ratio is the range of 1:0.00625 - 1:84.2.
[007] In an aspect of the present invention, there is provided an antibacterial formulation comprising: i) an antibacterial composition comprising: a) lavindin oil; and b) thymol, wherein lavindin oil to thymol weight ratio is the range of
15 1:0.00625 - 1:84.2; and ii) at least one cosmetically suitable carrier.
[008] In another aspect of the present invention, there is provided a process for preparing the antibacterial composition comprising: a) lavindin oil; and b) thymol, wherein lavindin oil to thymol weight ratio is the range of 1:0.00625 - 1:84.2, said process comprising steps of: a) obtaining lavindin oil; b) obtaining thymol; and c)
20 contacting lavindin oil with thymol to obtain the composition.
[009] These and other features, aspects, and advantages of the present subject matter will be better understood with reference to the following description and appended claims. This summary is provided to introduce a selection of concepts in a simplified form. This summary is not intended to identify key features or
25 essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter.
DETAILED DESCRIPTION OF THE INVENTION
[0010] Those skilled in the art will be aware that the present disclosure is subject to
variations and modifications other than those specifically described. It is to be
30 understood that the present disclosure includes all such variations and
3
modifications. The disclosure also includes all such steps, features, compositions,
and compounds referred to or indicated in this specification, individually or
collectively, and any and all combinations of any or more of such steps or features.
Definitions 5 [0011] For convenience, before further description of the present disclosure,
certain terms employed in the specification, and examples are delineated here.
These definitions should be read in the light of the remainder of the disclosure and
understood as by a person of skill in the art. The terms used herein have the
meanings recognized and known to those of skill in the art, however, for 10 convenience and completeness, particular terms and their meanings are set forth
below.
[0012] The articles “a”, “an” and “the” are used to refer to one or to more than one
(i.e., to at least one) of the grammatical object of the article.
[0013] The terms “comprise” and “comprising” are used in the inclusive, open 15 sense, meaning that additional elements may be included. It is not intended to be
construed as “consists of only”.
[0014] Throughout this specification, unless the context requires otherwise the
word “comprise”, and variations such as “comprises” and “comprising”, will be
understood to imply the inclusion of a stated element or step or group of element or 20 steps but not the exclusion of any other element or step or group of element or
steps.
[0015] The term “including” is used to mean “including but not limited to”.
“Including” and “including but not limited to” are used interchangeably.
[0016] The term ‘MIC’ refers to minimum inhibitory concentration. MIC is the 25 lowest concentration of an antimicrobial (like an antifungal, antibiotic or
bacteriostatic) drug that will inhibit the visible growth of a microorganism after
overnight incubation.
[0017] The term “liquid cleansing product” include shower gel, face wash, body
wash, hand wash, and paste. It is apparent that numerous other forms and 30 modifications of the liquid cleansing product will be obvious to those skilled in the
4
art and generally should be construed to cover all such obvious forms and modifications which are within the true spirit and scope of the present disclosure. [0018] The term “solid cleansing products” include cleansing bars, and films. It is apparent that numerous other forms and modifications of the solid cleansing 5 product will be obvious to those skilled in the art and generally should be construed to cover all such obvious forms and modifications which are within the true spirit and scope of the present disclosure.
[0019] Ratios, concentrations, amounts, and other numerical data may be presented herein in a range format. It is to be understood that such range format is used
10 merely for convenience and brevity and should be interpreted flexibly to include not only the numerical values explicitly recited as the limits of the range, but also to include all the individual numerical values or sub-ranges encompassed within that range as if each numerical value and sub-range is explicitly recited. For example, a weight ranges of about 0.0019-0.16 % should be interpreted to include
15 not only the explicitly recited limits of about 0.0019 % to about 0.16 %, but also to include sub-ranges, such as 0.0019-0.12 %, 0.002-0.16 %, and so forth, as well as individual amounts, including fractional amounts, within the specified ranges, such as 0.00193 %, and 0.145 %, for example. [0020] The term “at least one” is used to mean one or more and thus includes
20 individual components as well as mixtures/combinations.
[0021] A composition comprising “synergistic activity” or a “synergistic composition” is a combination of compounds which exhibits increased biological or functional activity as a non-linear multiple of the biological or functional activity of the individual compounds. In other words, the combined biological or
25 functional activity of two or more compounds being tested is significantly greater than the expected result based on independent effects of the compounds when tested separately. Synergy may be apparent only at some ranges or weight percentages. [0022] Carriers are substances that serve as mechanisms to improve the delivery
30 and the effectiveness of drugs
[0023] A diluent (also referred to as filler, diluent or thinner) is a diluting agent.
5
[0024] Diluent is an inactive substance that serves as the vehicle or medium for a drug or other active substance.
[0025] Lavindin oil is oil extracted from plant Lavindin. Lavindin is born as a result of the hybridization of Lavandula angustifolia and Lavandula latifolia. The 5 main components of this oil are lavandulol, linalool, linalyl acetate, camphor, cineole, caryophyllene, camphene, dipentene, limonene, ocimene, and terpinene. Any plant part of lavindin, such as leaves, seed, bark, root, flowers, fruit, or any other plant part can be used to extract lavindin oil. [0026] Thymol (also known as 2-isopropyl-5-methylphenol) is a natural
10 monoterpene derivative of cymene, C10H14O, found in oil of thyme, and can be extracted from plants including, but not limited to, Thymus vulgaris, Euphrasia rostkoviana, Monarda didyma, Monarda fistulosa, Trachyspermum ammi, Origanum compactum, Origanum dictamnus, Origanum onites, Origanum vulgare, Thymus glandulosus, Thymus hyemalis, or Thymus zygis. Any plant part such as
15 leaves, seed, bark, root, flowers, fruit, or any other plant part can be used to extract thymol.
[0027] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs. Although any methods and materials similar or
20 equivalent to those described herein can be used in the practice or testing of the disclosure, the preferred methods, and materials are now described. All publications mentioned herein are incorporated herein by reference. [0028] The present disclosure is not to be limited in scope by the specific embodiments described herein, which are intended for the purposes of
25 exemplification only. Functionally-equivalent products, compositions, and methods are clearly within the scope of the disclosure, as described herein. [0029] As mentioned previously, conventionally used preservative compositions are toxic, not bio-safe, corrosive; and cause irritation on skin and mucous membrane of the user. Although essential oils obtained from natural sources is
30 increasingly used as a desirable alternative, so far, these preservative compositions have met with minimal acceptance in the marketplace owing to poor microbicidal
6
effect and similar instances/symptoms of skin irritancy experienced as with synthetic chemical agents. The present disclosure aims to solve the said problem by using a synergistic combination of lavindin oil and thymol. The applications include, but are not limited to, personal care products such as cosmetics, foodstuffs, 5 pharmaceuticals, paints, cutting oils or fluids, agricultural products, oil drilling fluids, paper industry, embalming solutions, cold sterilization medical and dental equipment, cooling towers, fabric impregnation, latexes, swimming pools, inks, household products, waxes and polishes, toilet bowl cleaners, bathroom cleaners, laundry detergents, soaps, wood preservatives, hospital and medical antiseptics and
10 adhesives.
[0030] In an embodiment of the present invention, there is provided an antibacterial composition comprising: a) lavindin oil; and b) thymol, wherein lavindin oil to thymol weight ratio is the range of 1:0.00625 - 1:84.2. In another embodiment of the present disclosure, lavindin oil to thymol weight ratio is in the
15 range of 1:0.007 – 1:80. In yet another embodiment of the present disclosure lavindin oil to thymol weight ratio is in the range of 1:0.06 - 1:5. [0031] In an embodiment of the present disclosure, there is provided an antibacterial composition described herein comprising: wherein lavindin oil has a weight percentage in range of 0.0019 – 0.16 % with respect to the composition. In
20 another embodiment, the lavindin oil has a weight percentage of 0.0019 - 0.157 % with respect to said composition.
[0032] In an embodiment of the present disclosure, there is provided an antibacterial composition comprising: a) lavindin oil; and b) thymol, wherein lavindin oil to thymol weight ratio is the range of 1:0.00625 - 1:84.2, and wherein
25 lavindin oil has a weight percentage in range of 0.0019 – 0.016 % with respect to the composition.
[0033] In an embodiment of the present disclosure, there is provided an antibacterial composition described herein comprising: wherein thymol has a weight percentage in range of 0.001 – 0.16 % with respect to the composition. In
30 another embodiment, thymol has a weight percentage of 0.001 to 0.157 weight percent in said composition.
7
[0034] In an embodiment of the present disclosure, there is provided an antibacterial composition comprising: a) lavindin oil; and b) thymol, wherein lavindin oil to thymol weight ratio is the range of 1:0.00625 - 1:84.2, and wherein thymol has a weight percentage in range of 0.001 – 0.16 % with respect to the 5 composition.
[0035] In an embodiment of the present disclosure, there is provided an antibacterial composition comprising: a) lavindin oil; and b) thymol, wherein lavindin oil to thymol weight ratio is the range of 1:0.00625 - 1:84.2, and wherein lavindin oil has a weight percentage in range of 0.0019 – 0.16 % with respect to the
10 composition, and wherein thymol has a weight percentage in range of 0.001 – 0.16 % with respect to the composition.
[0036] In an embodiment of the present disclosure, there is provided an antibacterial composition comprising: a) lavindin oil; and b) thymol, wherein lavindin oil to thymol weight ratio is the range of 1:0.00625 - 1:84.2; and ii) at least
15 one cosmetically suitable carrier.
[0037] In an embodiment of the present disclosure, there is provided an antibacterial composition comprising: a) lavindin oil; and b) thymol, wherein lavindin oil to thymol weight ratio is the range of 1:0.00625 - 1:84.2; and wherein lavindin oil has a weight percentage in range of 0.0019 – 0.16 % with respect to the
20 composition; and ii) at least one cosmetically suitable carrier.
[0038] In an embodiment of the present disclosure, there is provided an antibacterial formulation comprising: a) lavindin oil; and b) thymol, wherein lavindin oil to thymol weight ratio is the range of 1:0.00625 - 1:84.2; and wherein lavindin oil has a weight percentage in range of 0.0019 – 0.16 % with respect to the
25 composition; and wherein thymol has a weight percentage in range of 0.009 – 0.15 % with respect to the composition, and ii) at least one cosmetically suitable carrier. [0039] In an embodiment of the present disclosure, there is provided an antibacterial formulation as described herein, wherein the at least one cosmetically suitable carrier comprises additives selected from the group consisting of diluent,
30 anti-caking agent, absorbent, skin protectant, viscosity modifier, opacifying agent, preservative, skin conditioning agent, cooling agent, odour enhancer, hydrophilic
8
polymer, UV stabilizer, pH adjusting agent, chelating agent, deodorant, perfumes, antimicrobial, antioxidant, humectant, conditioning ingredients, propellants, salts, colorants, dyes, and combinations thereof. A list of additives has been provided herein, however the provided list is not to be considered exhaustive and other 5 known additives may be considered to fall within scope of the present disclosure. [0040] In an embodiment of the present disclosure, there is provided an antibacterial composition comprising: a) lavindin oil having a weight percentage in range of 0.019 – 0.15 % with respect to the composition; b) thymol having a weight percentage in range of 0.009 – 0.15 % with respect to the composition, c) anti-10 caking agent having a weight percentage in the range of 60 – 70% with respect to the composition; d) absorbent having a weight percentage in the range of 10 – 15% with respect to the composition; e) skin protectant having a weight percentage in the range of 10 – 15% with respect to the composition; f) viscosity modifiers having a weight percentage in the range of 0 – 20% with respect to the 15 composition; g) opacifying agent having a weight percentage in the range of 0 – 10% with respect to the composition; h) preservative having a weight percentage in the range of 0 – 5% with respect to the composition; i) skin conditioning agent having a weight percentage in the range of 0 – 1.5% with respect to the composition; j) cooling agent having a weight percentage in the range of 0 – 2% 20 with respect to the composition; k) odour enhancer having a weight percentage in the range of 0.5 – 3% with respect to the composition; l) perfume having a weight percentage in the range of 0.5 – 30% with respect to the composition; m) antioxidant having a weight percentage in the range of 0.001 – 5% with respect to the composition; and n) chelating agent having a weight percentage in the range of 25 0.001 – 0.2% with respect to the composition, wherein lavindin oil to thymol weight ratio is the range of 1:0.00625 - 1:84.2.
[0041] In an embodiment of the present disclosure, there is provided an antibacterial composition as described herein, wherein a) anti-caking agent is talc; b) absorbent is starch; c) skin protectant is selected without limitation from the 30 group consisting of zinc oxide, zinc carbonate, and combinations thereof; d) viscosity modifier is selected without limitation from the group consisting of
9
aluminium starch octenylsuccinate, crosslinked polyacrylate polymers, carboxylic acid polymers, polyacrylamide polymers, acrylic acid/ethyl acrylate copolymers, carboxyvinyl polymers, polyalkenyl polyether crosslinked polymer of acrylic acid crosslinked, and mixtures thereof; e) opacifying agent is selected without limitation 5 from the group consisting of titanium dioxide, diatomaceous earth, calcium carbonate, magnesium carbonate, and combinations thereof; f) preservative is selected without limitation from the group consisting of boric acid, capryloyl salicylic acid, and combinations thereof; g) skin conditioning agent is selected without limitation from the group consisting of salicylic acid, allantoin, calcium
10 salicylate, magnesium salicylate, potassium salicylate, sodium salicylate, panthenol, panthetine, pantotheine, panthenyl ethyl ether, and combinations thereof; h) cooling agent is selected without limitation from the group consisting of menthol, trimethyl isopropyl butanamide, peppermint oil, and combinations thereof; i) odour enhancer is selected from known fragrances; j) perfume is selected
15 without limitation from known fragrances; k) hydrophilic polymer is selected from group consisting of polyethylene glycols (PEGs), polyvinylpyrrolidones (PVP), hydroxypropyl methylcellulose (HPMC), poloxamers, and combinations thereof; l) UV stabilizer is selected without limitation from group consisting of benzophenone-3 and other known UV stabilizers in the art; m) antioxidants is
20 selected without limitation from group consisting of tocopheryl acetate, propyl, octyl and dodecyl esters of gallic acid, butylated hydroxyanisole (BHA, usually purchased as a mixture of ortho and meta isomers), butylated hydroxytoluene (BHT) , nordihydroguaiaretic acid, oxynex (Oxynex ST liquid is a mixture of diethylhexyl syringyliden-emalonate and caprylic/capric triglyceride), vitamin A,
25 vitamin E, vitamin C, and other known antioxidants in the art; n) preservative is selected without limitation from group consisting of phenoxyethanol, benzyl alcohol, methyl paraben, propyl paraben, and combinations thereof; o) pH adjusting agent is selected without limitation from group consisting of lactic acid, citric acid, sodium citrate, succinic acid, phosphoric acid, sodium hydroxide,
30 sodium carbonate, and combinations thereof; q) antimicrobial is selected without limitation from group consisting of farnesol, zinc phenolsulphonate,
10
ethylhexylglycerin, and combinations thereof; r) humectant is selected without limitation from group consisting of tribehenin, glycerine, and combinations thereof; s) propellant is selected without limitation from group consisting of propane, isopropane, butane, isobutene, and combinations thereof; t) salt is selected without 5 limitation from group consisting of potassium acetate, sodium chloride, and mixtures thereof; u) colorant and dye are selected from group consisting of known colorants in the art; v) chelating agent is selected without limitation from group consisting of ethylene diaminetetraacetic acid (EDTA) , EDTA disodium, calcium disodium edetate, EDTA trisodium, citric acid, EDTA tetrasodium, EDTA
10 dipotassium, and combinations thereof; and w) diluent is selected from group consisting of water, alcohol, silicone, oil, and combinations thereof. In another embodiment of the present disclosure, the absorbent is a starch selected from corn starch, maize starch, and other known starches. In yet another embodiment of the present disclosure, the viscosity modifier is selected from well-known compounds
15 as mentioned in Amjad et al., Carbomer Resins: Past, Present and Future Cosmetics & Toiletries 107 (1992), pp 81-85. In an alternate embodiment of the present disclosure, the viscosity modifier is selected from resins consisting of a colloidally water-soluble polyalkenyl polyether crosslinked polymer of acrylic acid crosslinked with from 0.75% to 2.00% of a crosslinking agent such as for example
20 polyallyl sucrose or polyallyl pentaerythritol.
[0042] In an embodiment of the present disclosure, there is provided an antibacterial composition comprising: a) lavindin oil; and b) thymol, wherein lavindin oil to thymol weight ratio is the range of 1:0.00625 - 1:84.2; and wherein the said composition inhibits growth of Gram-negative bacteria.
25 [0043] In an embodiment of the present disclosure, there is provided an antibacterial composition comprising: a) lavindin oil; and b) thymol, wherein lavindin oil to thymol weight ratio is the range of 1:0.00625 - 1:84.2; and wherein lavindin oil has a weight percentage in range of 0.0019 – 0.16 % with respect to the composition, and wherein the said composition inhibits growth of Gram-negative
30 bacteria.
11
[0044] In an embodiment of the present disclosure, there is provided an antibacterial composition comprising: a) lavindin oil; and b) thymol, wherein lavindin oil to thymol weight ratio is the range of 1:0.00625 - 1:84.2; and wherein thymol has a weight percentage in range of 0.001 – 0.16 % with respect to the 5 composition; and wherein the said composition inhibits growth of Gram-negative bacteria.
[0045] In an embodiment of the present disclosure, there is provided an antibacterial composition comprising: a) lavindin oil; and b) thymol, wherein lavindin oil to thymol weight ratio is the range of 1:0.00625 - 1:84.2; and wherein
10 lavindin oil has a weight percentage in range of 0.0019 – 0.16 % with respect to the composition, and wherein thymol has a weight percentage in range of 0.001 – 0.16 % with respect to the composition; and wherein the said composition inhibits growth of Gram-negative bacteria. [0046] In an embodiment of the present disclosure, there is provided an
15 antibacterial composition comprising: i) a) lavindin oil; and b) thymol, wherein lavindin oil to thymol weight ratio is the range of 1:0.00625 - 1:84.2; and ii) at least one cosmetically suitable carrier; and wherein the said composition inhibits growth of Gram-negative bacteria. [0047] In an embodiment of the present disclosure, there is provided an
20 antibacterial composition comprising: i) a) lavindin oil; and b) thymol, wherein lavindin oil to thymol weight ratio is the range of 1:0.00625 - 1:84.2; and wherein lavindin oil has a weight percentage in range of 0.0019 – 0.16 % with respect to the composition, and wherein thymol has a weight percentage in range of 0.001 – 0.16 % with respect to the composition, and ii) at least one cosmetically suitable carrier;
25 and wherein the said composition inhibits growth of Gram-negative bacteria.
[0048] In an embodiment of the present disclosure, there is provided an antibacterial composition comprising: a) lavindin oil; and b) thymol, wherein lavindin oil to thymol weight ratio is the range of 1:0.00625 - 1:84.2; and wherein the said composition inhibits growth of gram-positive bacteria.
30 [0049] In an embodiment of the present disclosure, there is provided an antibacterial composition comprising: a) lavindin oil; and b) thymol, wherein
12
lavindin oil to thymol weight ratio is the range of 1:0.00625 - 1:84.2; and wherein lavindin oil has a weight percentage in range of 0.0019 – 0.16 % with respect to the composition, and wherein the said composition inhibits growth of gram-positive bacteria. 5 [0050] In an embodiment of the present disclosure, there is provided an antibacterial composition comprising: a) lavindin oil; and b) thymol, wherein lavindin oil to thymol weight ratio is the range of 1:0.00625 - 1:84.2; and wherein thymol has a weight percentage in range of 0.001 – 0.16 % with respect to the composition; and wherein the said composition inhibits growth of gram-positive
10 bacteria.
[0051] In an embodiment of the present disclosure, there is provided an antibacterial composition comprising: a) lavindin oil; and b) thymol, wherein lavindin oil to thymol weight ratio is the range of 1:0.00625 - 1:84.2; and wherein lavindin oil has a weight percentage in range of 0.0019 – 0.16 % with respect to the
15 composition, and wherein thymol has a weight percentage in range of 0.001 – 0.16 % with respect to the composition; and wherein the said composition inhibits growth of gram-positive bacteria.
[0052] In an embodiment of the present disclosure, there is provided an antibacterial composition comprising: i) a) lavindin oil; and b) thymol, wherein
20 lavindin oil to thymol weight ratio is the range of 1:0.00625 - 1:84.2; and ii) at least one cosmetically suitable carrier; and wherein the said composition inhibits growth of gram-positive bacteria.
[0053] In an embodiment of the present disclosure, there is provided an antibacterial composition comprising: i) a) lavindin oil; and b) thymol, wherein
25 lavindin oil to thymol weight ratio is the range of 1:0.00625 - 1:84.2; and wherein lavindin oil has a weight percentage in range of 0.0019 – 0.16 % with respect to the composition, and wherein thymol has a weight percentage in range of 0.001 – 0.16 % with respect to the composition, and ii) at least one cosmetically suitable carrier; and wherein the said composition inhibits growth of gram-positive bacteria.
30 [0054] In an embodiment of the present disclosure, there is provided a process for preparing the antibacterial composition comprising: a) lavindin oil; and b) thymol,
13
wherein lavindin oil to thymol weight ratio is the range of 1:0.00625 - 1:84.2, said process comprising steps of: a) obtaining lavindin oil; b) obtaining thymol; and c) contacting lavindin oil with thymol to obtain the composition. [0055] In an embodiment of the present disclosure, there is provided a process for 5 preparing the antibacterial composition comprising: a) lavindin oil; and b) thymol, wherein lavindin oil to thymol weight ratio is the range of 1:0.00625 - 1:84.2, and wherein lavindin oil has a weight percentage in range of 0.0019 – 0.16 % with respect to the composition, said process comprising steps of: a) obtaining lavindin oil; b) obtaining thymol; and c) contacting lavindin oil with thymol to obtain the
10 composition.
[0056] In an embodiment of the present disclosure, there is provided a process for preparing the antibacterial composition comprising: a) lavindin oil; and b) thymol, wherein lavindin oil to thymol weight ratio is the range of 1:0.00625 - 1:84.2, and wherein thymol has a weight percentage in range of 0.001 – 0.16 % with respect to
15 the composition, said process comprising steps of: a) obtaining lavindin oil; b) obtaining thymol; and c) contacting lavindin oil with thymol to obtain the composition.
[0057] In an embodiment of the present disclosure, there is provided a process for preparing the antibacterial composition comprising: a) lavindin oil; and b) thymol,
20 wherein lavindin oil to thymol weight ratio is the range of 1:0.00625 - 1:84.2, and wherein lavindin oil has a weight percentage in range of 0.0019 – 0.16 % with respect to the composition, and wherein thymol has a weight percentage in range of 0.001 – 0.16 % with respect to the composition, said process comprising steps of: a) obtaining lavindin oil; b) obtaining thymol; and c) contacting lavindin oil with
25 thymol to obtain the composition.
[0058] In an embodiment of the present disclosure, there is provided a process for preparing the antibacterial composition comprising: i) an antibacterial composition comprising: a) lavindin oil; and b) thymol, wherein lavindin oil to thymol weight ratio is the range of 1:0.00625 - 1:84.2; ii) and at least one cosmetically suitable
30 carrier comprising additives selected from the group consisting of diluent, anti-caking agent, absorbent, skin protectant, viscosity modifier, opacifying agent,
14
preservative, skin conditioning agent, cooling agent, odour enhancer, hydrophilic polymer, UV stabilizer, pH adjusting agent, chelating agent, deodorant, perfumes, antimicrobial, antioxidant, humectant, conditioning ingredients, propellants, salts, colorants, dyes, and combinations thereof, said process comprising the steps of: a) 5 obtaining lavindin oil; b) obtaining thymol; and c) contacting lavindin oil and thymol with at least one cosmetically suitable carrier to obtain the composition. [0059] In an embodiment of the present disclosure, there is provided an antibacterial composition that can be used as antimicrobial in commercially available formulations. The applications include, personal care products such as
10 shampoos, cosmetics, and soaps; and household products such as laundry detergents, hard surface cleaners, fabric softeners and the like. [0060] In an embodiment of the present disclosure, there is provided a process for preparing an antimicrobial composition, said process comprising the steps of i) obtaining a composition comprising a) lavindin oil; and b) thymol, wherein
15 lavindin oil to thymol weight ratio is the range of 1:0.00625 - 1:84.2; ii) contacting the composition with personal care product or a household product, wherein contacting prevents the compositions from being contaminated by microorganisms. [0061] In an embodiment of the present disclosure, there is provided a process for preparing the antimicrobial composition, said process comprising the steps of i)
20 obtaining a composition comprising a) lavindin oil; and b) thymol, wherein lavindin oil to thymol weight ratio is the range of 1:0.00625 - 1:84.2; and wherein lavindin oil has a weight percentage in range of 0.0019 – 0.16 % with respect to the composition; ii) contacting the composition with the personal care product or a household product, wherein contacting prevents the compositions from being
25 contaminated by microorganisms.
[0062] In an embodiment of the present disclosure, there is provided a process for disinfecting a surface, said process comprising the steps of i) obtaining a composition comprising a) lavindin oil; and b) thymol, wherein lavindin oil to thymol weight ratio is the range of 1:0.00625 - 1:84.2; and wherein thymol has a
30 weight percentage in range of 0.001 – 0.16 % with respect to the composition; ii) contacting the composition with the surface, wherein contacting leads to
15
disinfecting of the surface. personal care product or a household product, wherein contacting prevents the compositions from being contaminated by microorganisms. [0063] In an embodiment of the present disclosure, there is provided a process for disinfecting a surface, said process comprising the steps of i) obtaining a 5 composition comprising a) lavindin oil; and b) thymol, wherein lavindin oil to thymol weight ratio is the range of 1:0.00625 - 1:84.2; and wherein lavindin oil has a weight percentage in range of 0.0019 – 0.16 % with respect to the composition; and wherein thymol has a weight percentage in range of 0.001 – 0.16 % with respect to the composition; ii) contacting the composition with the surface, wherein
10 contacting leads to disinfecting of the surface. personal care product or a household product, wherein contacting prevents the compositions from being contaminated by microorganisms.
[0064] In an embodiment of the present disclosure, there is provided a composition as described herein, wherein the composition is dispensed in a form selected from
15 powders, shower gels, sprays, emulsion, solution, antiseptics, patches, face washes, body washes, hand washes, pastes, liquid cleansing products, solid cleansing products, cleansing bars and films. In another embodiment of the present disclosure, the composition is dispensed in the form of powder.
EXAMPLES
20 [0065] The disclosure will now be illustrated with working examples, which is intended to illustrate the working of disclosure and not intended to take restrictively to imply any limitations on the scope of the present disclosure. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood to one of ordinary skill in the art to which this
25 disclosure belongs. Although methods and materials similar or equivalent to those described herein can be used in the practice of the disclosed methods and compositions, the exemplary methods, devices and materials are described herein. It is to be understood that this disclosure is not limited to particular methods, and experimental conditions described, as such methods and conditions may apply.
30 [0066] Conventionally used microbicidal compositions are synthetic biocides that are toxic, not bio-safe, corrosive; and cause irritation on skin and mucous
16
membrane of the user. Although essential oils obtained from natural sources is increasingly used as a desirable alternative, so far, these compositions have met with minimal acceptance in the marketplace owing to poor microbicidal effects and similar instances/symptoms of skin irritancy experienced as with synthetic 5 chemical agents. The present disclosure aims to solve the said problem by using a synergistic combination of lavindin oil and thymol. The composition of the invention thus provides a highly effective means for preserving substances susceptible to microbial contamination by significantly inhibiting growth of bacteria
10 Materials Required
[0067] Sterile Muller Hinton broth media (bacteria), sabouraud dextrose broth (fungi), sterile round bottom 96 wells of the microtitre plate transparent, Microbial Culture, alamar blue dye/ resazurin. Lavindin oil is a value-added essential oil that was procured from well-known commercial sources. Thymol is a synthetic
15 compound procured from well-known commercial sources.
Bacterial Cultivation: -E coli & S. aureus
[0068] E. coli and S. aureus were cultured on sterile Muller Hinton broth media, and the plates were incubated at 37° C for 24 hours under aerobic condition. The inoculum size was adjusted to 0.1 absorbance at 600 nm (corresponding to 20 approximately 108 CFU/mL) using spectrophotometer. The culture was further diluted by 100-fold in Sterile Muller Hinton broth to a concentration of approximately 106 CFU/ml.
Sample/Active Preparation:
[0069] Test Sample A (TSA) i.e., Lavindin oil, was prepared at a concentration 25 128 times greater than the expected Minimum Inhibitory Concentration (MIC) values.
[0070] Test Sample B (TSB) i.e., Thymol, was prepared at a concentration 64 times greater than the expected MIC values.
Example 1 30 Minimum Inhibitory Concentration (MIC) determination
17
[0071] Individual MIC values were determined for each test sample according to the microbroth dilution method as per CLSI M11-A7 Vol. 27 No.2 standard (modified). For this purpose, briefly, serial dilutions of each sample (50 ul) were added to wells in a 96-well plate followed by 50 ul of the prepared E. coli 5 inoculum as described earlier. Media without E. coli and medium with E. coli only were used for negative and positive controls, respectively, and contained the highest concentration of solvent used in each sample analysis. Similar procedure was adopted to determine the MIC values for each test sample against S. aureus. Plates were incubated under 37° C for 24 hours under aerobic conditions. 10 Following incubation, each well was re-suspended by pipetting and the optical density at 600 nm (OD6oo) was determined on a plate reader. The MIC value was defined as the first well showing > 95% reduction in bacterial growth compared to controls. The MIC values for both lavindin oil and thymol against E. coli and S. aureus are herewith presented below in Table 1.
[0072] Further to MIC observations, the starting concentration of two actives was
selected for the checkerboard assay.
Checkerboard Assay as per Micro-Broth Dilution. As the invention is directed
20 towards the substitution of prevalently used natural antibacterial agents, appraising
the synergistic effect of combination of phytochemicals (Lavindin oil and
thymol) is essential. Thus, two-dimensional checkerboard assay was employed to assess the in vitro interactions between lavindin oil and thymol using 96 well microliter plate in 8 (rows) X 12 (columns) grid. 50ul of the nutrient broth was
25 added to all the wells. lOOul of the broth was added in the 12th column which acts as a sterility control. Further, 50 ul of lavindin oil was added at 8x the desired final concentration was added in the first column (Al to HI) and serially diluted on the
18
x-axis till the 10th column (A10 to H10) where 50μl of the solution was discarded to maintain same volume of the solution in all wells. Similarly, 50 μl of thymol was added, at 4x the desired final concentration, in the row (A1 to A10), in which each row contains the same amount of thymol being diluted on column (A to H). The 5 result is that each well in the checkerboard contains a unique combination of lavindin oil and thymol being tested where that the highest concentration of lavindin oil and the highest concentration of thymol were in the same well at one corner of the 10 x 8 grid, and similarly, the lowest concentration of thymol and lavindin oil was present at another corner of the plate. 100 μl microbial suspension
10 (106 CFU/ml) of E. coli was further added to all the wells. Similar procedure is subsequently repeated to determine the effect of the combination against S. aureus. A sterility control (A12 to H12), growth control (100 μl media + 100 μl bacterial cell suspension from A11 to H11) was set-up. The plates were incubated at 25°C for 24hours under aerobic conditions. Based on the growth/inhibition of the
15 microbial cultures, the MIC at various concentrations was determined. The MICs determined was used for calculating the synergistic/indifferent/ antagonistic effects. MIC of the combination was compared with the MIC of the actives alone and the fractional inhibitory concentration values (FIC index) was determined as follows:
FIC of Lavindin oil = MIC of lavindin oil in combination with thymol
20 MIC of lavindin oil alone
FIC of Thymol = MIC of thymol in combination with lavindin oil
MIC of thymol alone
FIC index = FIC of lavindin oil + FIC of thymol
The FIC index was interpreted to infer the effect of various combinations of active:
25 • A concentration of combination of actives is inferred as synergistic if FIC
index < 0.5
• A concentration of combination of actives is inferred as indifferent if 2 >
FIC index > 0.5
• A concentration of combination of actives is inferred as antagonistic if FIC
30 index > 2
19
[0073] The effect of various combinations of lavindin oil and thymol against E. coli is herewith presented below in Table 2.
[0074] The effect of various combinations of lavindin oil and thymol against S. aureus is herewith presented below in Table 3. Table 3
[0075] The varying concentrations of lavindin oil and thymol may be noted from the values listed under MIC (L:T) and MIC (T:L), respectively. From a combined reading of Table 2 and Table 3, it can be inferred that lavindin oil at a 5 concentration range of 0.0019 - 0.16 wt.% in combination with thymol at a concentration range of 0.001 - 0.16 wt.% was found to exhibit synergistic antimicrobial efficacy. Furthermore, it may be noted the minimum inhibitory concentration of each of the actives present in the combination varies as per the micro-organism acted upon. This is evident from a working synergistic example 10 reproduced from the Tables 2 and 3, in the Table 4 below.
[0076] A formulation comprising of lavindin oil and thymol, suitable carriers, diluents, and excipients was further prepared for inhibition of bacterial growth as detailed below in Table 5.
The formulation as seen above in Table 5 was prepared by a process comprising the steps of a) mixing deionized water and glycerine in a first vessel to obtain a first mixture at 27°C; (b) adding acrylates/C10-30 alkyl acrylate cross-polymer to the first mixture and mixed under vigorous agitation to obtain a uniformly
23
dispersed second mixture; (c) adding lavindin oil and thymol to the second mixture and mixed until a uniform third mixture is obtained; (d) adding a pH stabilizer, triethanolamine, to the third mixture to neutralize the pH to 6.5-7; (e) mixing mineral oil, cetyl alcohol, glycol distearate, dimethicone, and allantoin in a second 5 vessel to obtain an uniform primary mixture; (f) mixing the primary mixture with the mixture from (e) under rapid mixing conditions till a uniform mixture is obtained; (g) adding phenoxyethanol, and perfume to the uniform mixture of step in a serial manner to obtain said formulation.
Negative data 10 Example 2
[0077] It was observed that if thymol is replaced with other known antimicrobial agents, synergistic antimicrobial effect may or may not be achieved. For example, it was observed that a combination of dehydro-acetic acid (D) and lavindin oil (L) does not provide a synergistic antimicrobial activity. The results are herewith 15 presented in Table 6.
Negative data 2 Example 3
20 [0078] It is observed that if lavindin oil is replaced with other known antimicrobial agents, synergistic antimicrobial effect may or may not be achieved. For example, it was observed that a combination of Thymol (T) and tea tree oil (TTO) does not provide a synergistic antimicrobial activity. The results are herewith presented in Table 6. Hence, from Tables 6 and 7 it may be noted that the choice of essential oil
25 (lavindin oil) and the herbal additive (thymol) was non-obvious. Furthermore, it
24
may be appreciated that the working weight percentage ranges mentioned herein, provided surprising synergistic ability against pathogenic bacteria.
5 Advantages of the present disclosure;
[0079] The present disclosure reveals a composition comprising herbal ingredients that is effective against gram-positive and gram-negative bacteria, particularly against S. aureus and E. coli. The composition comprising lavindin oil to thymol weight ratio is the range of 1:0.00625 - 1:84.2 was found to synergistically inhibit 10 said bacteria. The combination was found to be more effective than commercially available synthetic biocides. The composition can be easily adapted to obtain useful commercial compositions such as powders.
25
I/We Claim:
1. An antibacterial composition comprising:
a) lavindin oil; and
5 b) thymol,
wherein lavindin oil to thymol weight ratio is the range of 1:0.00625 -1:84.2.
2. The anti-bacterial composition as claimed in claim 1, wherein lavindin oil
has a weight percentage in range of 0.0019 – 0.16 % with respect to the
10 composition.
3. The anti-bacterial composition as claimed in claim 1, wherein thymol has a weight percentage in range of 0.001 – 0.16 % with respect to the composition.
4. A formulation comprising:
15 a) the composition as claimed in any of the claims 1-3; and
b) at least one cosmetically suitable carrier.
5. The antibacterial formulation as claimed in claim 4, wherein the at least one
cosmetically suitable carrier comprises additives selected from the group
consisting of diluent, anti-caking agent, absorbent, skin protectant, viscosity
20 modifier, opacifying agent, preservative, skin conditioning agent, cooling
agent, odour enhancer, hydrophilic polymer, UV stabilizer, pH adjusting agent, chelating agent, deodorant, perfumes, antimicrobial, antioxidant, humectant, conditioning ingredients, propellants, salts, colorants, dyes, and combinations thereof.
25 6. The anti-bacterial composition as claimed in any of the claims 1-3, wherein
said composition inhibits growth of Gram-negative bacteria.
7. The anti-bacterial composition as claimed in any of the claims 1-3, wherein
said composition inhibits growth of Gram-positive bacteria.
8. A process for preparing the composition as claimed in claim 1, said process
30 comprising the steps of: a) obtaining lavindin oil; b) obtaining thymol; and
c) contacting lavindin oil with thymol to obtain the composition.
26
9. A process for preparing the formulation as claimed in claim 4, said process comprising the steps of: a) obtaining lavindin oil; b) obtaining thymol; and c) contacting lavindin oil and thymol with at least one cosmetically suitable carrier to obtain the composition.
10. The formulation as claimed in any one of the claims 4-5, is dispensed in a form selected from powders, sprays, emulsion, solution, antiseptics, patches, face washes, body washes, hand washes, pastes, liquid cleansing product, solid cleansing products, cleansing bars and films.
| # | Name | Date |
|---|---|---|
| 1 | 201841010071-STATEMENT OF UNDERTAKING (FORM 3) [19-03-2018(online)].pdf | 2018-03-19 |
| 2 | 201841010071-FORM 1 [19-03-2018(online)].pdf | 2018-03-19 |
| 3 | 201841010071-DECLARATION OF INVENTORSHIP (FORM 5) [19-03-2018(online)].pdf | 2018-03-19 |
| 4 | 201841010071-COMPLETE SPECIFICATION [19-03-2018(online)].pdf | 2018-03-19 |
| 5 | 201841010071-Proof of Right (MANDATORY) [06-06-2018(online)].pdf | 2018-06-06 |
| 6 | 201841010071-FORM-26 [06-06-2018(online)].pdf | 2018-06-06 |
| 7 | Correspondence by Agent _Power Of Attorney_Form 1_07-06-2018.pdf | 2018-06-07 |