DESC:FIELD OF THE INVENTION
The present invention relates to formulation for head lice control. More particularly this invention relates to composition comprising wild basil oil synergized with other plant extracts and essential oils for repelling head lice and treatment of pediculosis capitis.

BACKGROUND OF THE INVENTION
Head lice infestation (pediculosis capitis) is a major problem all over the world. Head lice are small insects that live on people’s heads and feed on human blood. Head lice may be found anywhere on the head, but are usually found on the scalp, along the neckline and behind the ears. They are small (adult lice are the size of a sesame seed) grey-brown insects that live only on human scalps. They cannot fly or jump; neither can they burrow into the scalp. They can affect anyone, with long or short hair, no matter how clean the hair is.

Head lice are usually picked up by head-to-head contact; it takes about 30 seconds for a single louse to transfer from one scalp to another. Less often, sharing hats, combs or pillows can spread them. Head lice live only on humans and die in a day or two away from the human scalp. They cannot be caught from animals. Head lice can affect anyone, but are: Most common in children between the ages of 4 and 11, more common in girls than boys and most often found at the start of the school year.

Female lice live for up to 40 days, during which time they can lay more than 100 eggs. The eggs hatch in seven to nine days into the first nymph stage, which looks like a miniature adult. They nymph takes a blood meal by biting the scalp soon after hatching and will feed every three to six hours. In about nine days, the louse will have passed through two more nymphal stages and reach the adult stage. The adult will stay on the head for its entire life. Adult head lice are about the size of a sesame seed. They have six legs and are usually tan, grayish white or brown in colour. Head lice can crawl quickly through the hair and are difficult to spot. They do not have wings and cannot fly or jump. Head lice lay their eggs on the hair shaft very close to the scalp with waterproof “glue.” This makes it difficult to wash them off or brush them out like dandruff. When the eggs hatch, the empty eggshell is left. This is called a “nit.” The nit remains stuck to the hair shaft. It is hard to tell the difference between an egg and a nit. Eggs that have hatched (nits) are sometimes easier to see than unhatched eggs because they appear white in color against dark hair. Dandruff, scabs and other hair debris are sometimes mistaken for lice, eggs or nits.

Head lice have to feed on human blood several times a day to survive, and their bites, saliva and faeces often make the scalp itchy. Some people may be unaware they have head lice as they do not experience the itch and other symptoms. This lack of itching does not mean that lice are not present, and the only way to be sure is by taking a careful look at the scalp. If the skin becomes infected with the bacteria that cause impetigo, the scalp may become sore and children may have a raised temperature and feel unwell.

Head lice do not cause or carry disease. Scratching an itchy scalp may break the skin and cause infection but this does not happen often. Head lice are not a health hazard.

Traditionally, head lice infestations have been treated by applying kerosene on the infected hair, but this practice is painful and potentially very dangerous. Another method of prevention, especially among children, includes shaving the hair or cutting it very short, however, this method is not recommended nowadays due to possible psychological damage to the child.

Combing and Heat treatments are the other traditional physical methods which are time heavy commitments and does not offer any repelling effect.

Several products for treating pediculosis capitis are available over the counter. They are mostly shampoos or lotions containing synthetic insecticides like Malathion, permethrin, phenothryn, benzyl benzoate etc. The general drawback of these synthetic insecticides are the developing resistance to several of the insecticides in use hence the therapeutic treatment regime decrease over time, carcinogenicity to humans and detrimental side effects etc.

Various formulation disclosed in the prior art make use of compositions of essential oils for lice treatment.

Many herbal products are based on essential oils and the modest capacity of essential-oils and certain terpenes of the oils to kill insects are known from numerous studies. Several patent applications claim the use of essential oils and terpenes as lice treatments, e.g. Limonene (KR 20000022375 and US 2009/176890) or a mixture of essential oils (WO 2008/101131). Also combinations of neem oil and essential oils, e.g. those from anise, tea tree and other eucalyptus oils and lavender oils have been proposed to treat lice (AU 2008101219). Essential oils, however, have the serious disadvantage of being skin irritating and sensitizing.

US20130252911 discloses compositions comprising flavonoid-containing extracts from plants of the genus citrus and/or isolated citrus flavonoids and specific cationic surface active agents, and said composition for use as an agent for treating infestations with head lice.

US 6342253 disclose natural compositions and using essential oils like anise oil, tea-tree-oil used for head lice repellant and treatment of Pediculosis capitis.

WO 2014146058 discloses using plant essential oils mixed with tea tree oil and basil oil to treat head lice and scalp problems.

WO2010145655 discloses use of Ocimum basilicum species along with herbal/plant extract & essential oils used for repelling insects/ head-lice control.

Such formulations disclosed in prior arts comprise of different individual or blend of essential oils such as teatree oil, neem oil, citronella oil, catnip oil, geranium oil, lavender oil, lime oil, pennyroyal, lemon grass oil, fennal oil, cedar oil, clove oil, sandal wood oil, peppermint oil. All oils in combination with one another show good repellent character to some insects and even some are effective in killing by its chemo-receptor binding property. Some other formulations disclosed in the prior art make use of natural pyrethrum to repel head lice. However, these oils and natural pyrethrum lack in efficacy and stability to show the knock down of insects at lower concentration.
There remains the need for an effective method and composition for controlling, killing and repelling head lice that does not carry the disadvantages of the previously stated chemical, biological, and physical methods.

OBJECTIVES OF THE INVENTION
An object of the present invention is to provide new synergistic compositions comprising basil oil synergized with other plant extracts and essential oils for controlling and/or treatment of head lice.

A preferred object of the present invention is to provide new synergistic compositions comprising wild basil oil synergized with other plant extracts and essential oils.
Another object of the present invention is to provide synergistic composition comprising wild basil oil synergized with other plant extracts and essential oils, wherein the ingredients are derived from natural sources.

Another object of the present invention is to provide synergistic composition comprising wild basil oil synergized with other plant extracts and essential oils, wherein the composition kills all stages of head lice and repels adult head lice.

Still another object of the present invention is to provide synergistic composition comprising wild basil oil synergized with other plant extracts and essential oils, which minimizes the need for repeated application by maintaining its effectiveness over a period of time beyond the initial application.

Further, another object of the present invention is to provide synergistic composition comprising wild basil oil synergized with other plant extracts and essential oils wherein the active synergistic composition of the present invention can be employed in a reduced amount and still achieves the desired control over the target organisms.

Still another object of the present invention is to provide process of preparing synergistic composition comprising basil oil synergized with other plant extracts and essential oils.

Another preferred object of the present invention is to provide process of preparing synergistic composition comprising wild basil oil synergized with other plant extracts and essential oils.

Yet another object of the invention is to provide a process of applying the prepared synergistic composition comprising basil oil synergized with other plant extracts and essential oils for controlling or treatment of head lice.

Yet another object of the invention is to provide synergistic composition comprising wild basil oil synergized with other plant extracts and essential oils that is safe and non-toxic to human beings and other non-target organisms.

DESCRIPTION OF THE INVENTION
The present invention relates to novel synergistic composition comprising basil oil synergized with other plant extracts and essential oils for controlling all stages of head lice, while being eco-friendly. In particular, the present invention provides compositions/formulations for controlling head lice or treatment of pediculosis capitis, comprising naturally occurring ingredients.

In a preferred embodiment, the present invention provides novel synergistic composition comprising wild basil oil synergized with other plant extracts and essential oils that controls all stages of head lice, while being eco-friendly. In particular, the present invention relates to formulations comprising naturally occurring ingredients.

The present invention provides synergistic composition/formulation comprising wild basil oil and naturally occurring ingredients.

In another embodiment of the invention, the naturally occurring agents are the essential oils and plant extracts.

In preferred embodiment of the invention the formulation comprises essential oils and plant extracts wherein the essential oils are selected from coconut oil, lemon eucalyptus oil, spearmint oil, cedar wood oil, neem oil, cinnamon bark oil, orange oil, geranium oil, tea tree oil and lilac oil.

In another preferred embodiment of the invention the formulation comprises essential and plant extracts wherein the plant extracts are soap coconut extract, aloe-vera extract and celery extract.

In yet another embodiment the formulation comprises wild basil oil in an amount of 0.5-70% by volume.

In still another embodiment the essential oils in said formulation is a combination of two or more essential oils and plant extracts.

In another embodiment amount of said combination of essential oil and plant extracts is 0.5-49.5% by volume.

In another embodiment the formulation comprises a surface active agent/surfactant.

In another embodiment the surface active agent is a natural surfactant. In preferred embodiment said surface active agent is castor oil. In still another preferred embodiment castor oil is activated preferably hydrogenated. In still another preferred embodiment SLS is the said surface active agent.
In another embodiment the natural surfactant in said formulation is present at a concentration of 1-60% by volume.

In a specific embodiment of the invention said formulation is provided in a concentrate form, comprising (1) approximately 0.5-49.5 percent by volume of one or more essential oils and plant extracts; (2) approximately 0.5 to 70 percent by volume of wild basil oil; and (3) approximately 1-60 percent by volume of the natural surface acting agent/surfactant. The concentrate may be diluted from between 1:50 to 1:500, and preferably from about 1:10 to about 1:50, with water to yield a ready-to-use formulation.

In another embodiment of the invention the formulation is in oil form.

In another embodiment of the invention the formulation is in aqueous form.

In yet another embodiment the formulation is in the form of water emulsion and water is present in an amount of 90-99% by volume.

In yet another embodiment said formulation is provided in concentrated form that can be diluted with water at the time of use.

In yet another embodiment said formulation is provided in concentrated form that can be diluted with shampoo base at the time of use.

In yet another embodiment said formulation is provided in concentrated form that can be diluted with carrier oil at the time of use.

In still another embodiment the formulation is effective against all stages of head lice.

In still another embodiment the formulation is effective repellent against head lice.

In still another embodiment the said synergistic composition comprising wild basil oil synergized with other plant extracts and essential oils is target specific and is safe and non-toxic to human beings and other non-target organisms.

In yet another aspect, the present invention provides a process for making synergistic composition comprising basil oil synergized with other plant extracts and essential oils. In a preferred embodiment, the present invention provides a process for making synergistic composition comprising wild basil oil synergized with other plant extracts and essential oils.

The wild basil oil is extracted from the leaves of Ocimum grattissimum L. (also known as clove basil, Africa basil and wild basil). For this invention, Ocimum grattissimum L. was procured from a vendor called “Kanha Nature Oils” situated at M.I.E, Part-1, Bahadurgarh, Haryana. It is believed that the origin of said plant is the state of Uttar Pradesh.

Steam distillation method was used to extract the wild basil oil.

Steam distillation is a special type of distillation or a separation process for temperature sensitive materials like oils, resins, hydrocarbons, etc. which are insoluble in water and may decompose at their boiling point. The fundamental nature of steam distillation is that it enables a compound or mixture of compounds to be distilled at a temperature substantially below that of the boiling point(s) of the individual constituent(s). Essential 15 oils contain substances with boiling points up to 200°C or higher temperatures. In the presence of steam or boiling water, however, these substances are volatilized at a temperature close to 100°C, at atmospheric pressure. Fresh, or sometimes dried, botanical material is placed in the plant chamber of the still and the steam is allows to pass through the herb material under pressure which softens the cells and allows the Essential Oil to escape in vapor form. The temperature of the steam must be high enough to vaporize the oil present, yet not so high that it destroys the plants or burns the Essential-Oils. Besides the steam tiny droplets of Essential Oil evaporates and travel through a tube into the still's condensation chamber. Here Essential Oil vapors condense with the steam. The essential oil forms a film on the surface of the water. To separate the Essential Oil from the water, the film is then decanted or skimmed off the top. The remaining water, a byproduct of distillation, is called floral water, distillate, or hydrosol. It retains many of the therapeutic properties of the plant, making it valuable in skin care for facial mists and toners (A solution containing chemicals that can change the color of a photographic print). In certain situations, floral water may be preferable to be pure essential oil, such as when treating a sensitive individual or a child, or when a more diluted treatment is required. Rose hydrosol, for example, is commonly used for its mild antiseptic and soothing properties, as well as its pleasing floral aroma. A number of factors determine the final quality of a steam distilled essential oil. Apart from the plant material, most important are time, temperature and pressure, and the quality of the distillation equipment. Essential oils are very complex products. Each is made up of many, sometimes hundreds, of distinct molecules which come together to form the oil's aroma and therapeutic properties. Some of these molecules are fairly delicate structures which can be altered or destroyed by adverse environmental conditions. So, much like a fine meal is more flavorful when made with patience, most oils benefit from a long, slow 'cooking' process. It is possible that longer distillation times may give more complete oil. It is also possible however, that longer distillation time may lead to the accumulation of more artifacts than normal. This may have a curious effect of appearing to improving the odor, as sometimes when materials that have a larger number of components are sniffed, the perception is often of slightly increased sophistication, added fullness and character, and possibly, and extra pleasantness.

The major components in wild basil oil are a-Pinene, ß-Pinene, 1,8-Cineole, (Z)-Ocimene, a-Terpineole, Eugenol, (E)-ß-Caryophyllene, a-Humulene, ?-Muurolene, ß-Selinene and a-Selinene.

The other essential oils used in the invention, lemon eucalyptus oil, spearmint oil, cedar wood oil, neem oil, cinnamon bark oil, orange oil, geranium oil, tea tree Oil and lilac oil, are also extracted by steam distillation method.

Plant extracts used in the invention are soap nut extract, aloe-vera extract and celery extract. Soap nut and celery extracts are extracted using solvent extraction method. Where the aloe vera extract was produced by commonly used gel extraction from the aloe vera leaves (O’brien, 2005).

The present invention is described with reference to the following examples, which are given by way of illustration and should not be construed to limit the scope of the present invention.
Exemplary formulations are given below:

Example 1
Formulation (A): Ready to mix with water Formulation
Components (%) v/v
Wild basil oil
Lilac oil
Cedar wood oil
Geranium oil
Ethoxylated Castor oil 29
10.5
6
4.5
49

All the essential oils are blended first in a container, using a stirrer for 10 mins, and then added the ethoxylated castor oil in to it. It is blended again for 15 more minutes. This ready to mix with water formulation can be diluted with water and spray directly to hair for lice control.

Example 2
Formulation (B): Ready to mix with water Formulation
Components (%)v/v
Wild basil oil
Tea Tree oil
Cinnamon bark oil
Neem oil
Orange oil
Ethoxylated Castor oil 24
13
8
3
2
50

All the essential oils are blended first in a container, using a stirrer for 10 mins, then added the ethoxylated castor oil in to it. It is blended again for 15 more minutes. This ready to mix with water formulation can be diluted with water and spray directly to hair for lice control.

Example 3
Formulation (C): Ready to mix with water Formulation
Components (%)v/v
Wild basil oil
Lemon Eucalyptus oil
Spearmint oil
Ethoxylated Castor oil 21
17
12
50

All the essential oils are blended first in a container, using a stirrer for 10 mins, then added the ethoxylated castor oil in to it. It is blended again for 15 more minutes. This ready to mix with water formulation can be diluted with water and spray directly to hair for lice control.

Example 4
Formulation (D): Ready to mix with water Formulation

Components (%) v/v
Wild basil oil
Cedarwood oil
Spearmint oil
Lilac oil
Soapnut Extract
Ethoxylated castor oil 27
9
7
7
40
10

All the essential oils are blended first in a container, using a stirrer for 10 mins, then added the ethoxylated castor oil in to it. It is blended again for 10 more minutes. Added Soapnut extract in to this blend and stirred again for 10 mins. This ready to mix with water formulation can be diluted with water and spray directly to hair for lice control.

Example 5
Formulation (E): Ready to mix with water Formulation
Components (%) v/v
Wild basil oil
Teatree oil
Geranium oil
Cinnamon bark oil
Lemon Eucalyptus oil
Orange oil
Sodium lauryl Sulphate 16
10
7.5
6.5
5
5
50

All the essential oils are blended first in a container, using a stirrer for 10 mins, then added SLS in to it. It is blended again for 15 more minutes. This ready to mix with water formulation can be diluted with water and spray directly to hair for lice control.

Example 6
Formulation (F): Ready to mix with Shampoo and lotions Formulation
Components (%) v/v
Wild basil oil
Geranium oil
Cedar wood oil
Teatree oil
Spearmint oil
Neem Oil 60
16
11
6
4
3

All the essential oils are blended first in a container, using a stirrer for 15 mins. This ready to mix with shampoo formulation can be diluted with shampoo base or lotion base and wash the hair for lice control.

Example 7
Formulation (G): Ready to mix with Shampoo and lotions Formulation
Components (%) v/v
Wild basil oil
LemonEucalyptus
Cinnamon bark oil
Spearmint oil
Cedarwood oil 69
14
8
5
4

All the essential oils are blended first in a container, using a stirrer for 15 mins. This ready to mix with shampoo formulation can be diluted with shampoo base or lotion base and wash the hair for lice control.

Example 8
Formulation (H): Ready to mix with Shampoo and lotions Formulation
Components (%) v/v
Wild basil oil
Lilac oil
geranium oil
Tea Tree Oil
Cedar wood oil
Lemon Eucalyptus oil
Cinnamon bark oil
Neem oil
Orange oil
Spearmint oil 34
14
9
9
7
6
6
6
5
4

All the essential oils are blended first in a container, using a stirrer for 15 mins. This ready to mix with shampoo formulation can be diluted with shampoo base or lotion base and wash the hair for lice control.

Example 9
Formulation (I): Ready to use formulation.
Components (%)v/v
Wild basil oil
Lemon eucalyptus oil
Cedarwood oil
Orange oil
Coconut Oil 4.3
2.1
1.4
1.2
91

All the essential oils are blended first in a container, using a stirrer for 10 mins, then added the coconut oil in to it. It is blended again for 10 more minutes. This ready to use formulation can apply to hair for lice repellency.

Example 10
Formulation (J): Ready to use formulation.
Components (%) v/v
Wild basil oil
Geranium oil
Cinnamon bark oil
Tea Tree oil
Spearmint oil
Celery Extracts
Aloevera Extracts
Coconut Oil 3.2
2.2
2
1.6
1
10
40
40

All the essential oils are blended first in a container, using a stirrer for 10 mins, and then added the coconut oil, celery extracts and Aloevera extracts, one by one, in to it. It is blended again for 10 more minutes. This ready to use formulation can apply to treat Pediculosis capitis.

The present invention also comprises a process for preparing a synergistic composition for controlling and repelling head lice, comprising of ,
a) blending essential oil to obtain a blended mixture of oils, b) stirring the blended mixture of oils for 10-20 mins, then adding the stirred oil with a surfactant for about 10-15 min. to form a ready to mix with water formulation.

Advantages
The synergistic composition is effective for controlling and repelling head lice wherein the formulation is diluted with shampoo base or carrier oil.
The synergistic composition for controlling and repelling head lice can be diluted with water and is sprayed directly to hair for lice control.
The synergistic composition for controlling and repelling head lice is effective against all stages of head lice.
The synergistic composition for controlling and repelling head lice is used for treatment of pediculosis capitis; wherein the synergistic composition is target specific, safe and non-toxic to human beings.

CLAIMS:

1. A synergistic composition for controlling and repelling head lice, comprising :
a) wild basil oil,
b) a plant extract; and
c) essential oil.

2. The synergistic composition as claimed in claim 1, wherein the wild basil oil is extracted from the leaves of Ocimum grattissimum L.

3. The synergistic composition as claimed in claim 1, wherein the wild basil oil comprises a-Pinene, ß-Pinene, 1,8-Cineole, (Z)-Ocimene, a-Terpineole, Eugenol, (E)-ß-Caryophyllene, a-Humulene, ?-Muurolene, ß-Selinene and a-Selinene.

4. The synergistic composition as claimed in claim 1 or 2, wherein the wild basil oil is present in an amount ranging from 0.5-70%.

5. The synergistic composition as claimed in claim 1, wherein plant extract is selected from the group consisting of soap nut extract, aloe-vera extract and celery extract and combination thereof and essential oil is selected from the group consisting of lemon eucalyptus oil, spearmint oil, cedar wood oil, neem oil, cinnamon bark oil, orange oil, geranium oil, tea tree Oil, lilac oil and combination thereof.

6. The synergistic composition as claimed in claim 1, wherein the essential oil and other plant extract is present in an amount ranging from 0.5-49.5%.

7. The synergistic composition as claimed in claim 1 further comprises of surface active agent or surfactant selected from the group consisting of castor oil or sodium lauryl sulphate in an amount ranging from 1-60%.

8. The synergistic composition as claimed in claim 1 is in the form of formulation; wherein the formulation is in a concentrate form, comprising
a) one or more essential oils and plant extracts falling in the range of about 0.5-49.5 percent by volume;
(b) wild basil oil ranging from 0.5 to 70 percent by volume and
(c) natural surface acting agent/surfactant ranges from 1-60 percent by volume;
wherein the formulation is in oil or in aqueous or in water emulsion form.

9. A process for preparing a synergistic composition for controlling and repelling head lice as claimed in claim 1, comprising of;
a) blending essential oil to obtain a blended mixture of oils,
b) stirring the blended mixture of oils for 10-20 mins, then adding the stirred oil with a surfactant for about 10-15 min. to form a ready to mix with water formulation.

10. The synergistic composition for controlling and repelling head lice as claimed in claim 1 and 9; wherein the said formulation is diluted with water and is sprayed directly to hair for lice control; or wherein the formulation is diluted with shampoo base or carrier oil, and wherein the formulation is effective against all stages of head lice; and used for treatment of pediculosis capitis; wherein the synergistic composition is target specific, safe and non-toxic to human beings.