FORM 2


THE PATENTS ACT, 1970 (39 of 1970)
& THE PATENTS RULES, 2003
COMPLETE SPECIFICATION
[See section 10, Rule 13]
WATER-BASED ANTI-LICE
PHARMACEUTICAL COMPOSITIONS AND THE PROCESS FOR PREPARING THE SAME;
MARICO LTD, A COMPANY
INCORPORATED UNDER THE
COMPANIES ACT, 1956, WHOSE ADDRESS IS RANGSHARDA, KC MARG, BANDRA RECLAMATION, BANDRA (W) MUMBAI 400050, MAHARASHTRA, INDIA
THE FOLLOWING SPECIFICATION PARTICULARLY DESCRIBES THE INVENTION AND THE MANNER IN WHICH IT IS TO BE PERFORMED.


FIELD OF THE INVENTION
The present invention relates to a water based ant-lice compositions and the process for preparing the same.
BACKGROUND OF THE INVENTION
Lice are a problem faced by children across the world. Surveys conducted by WHO show that more than half of the school children in India are lice infested. A large chunk of Indian women are also infested with lice. Lice belong to blood sucking ectoparasite category and feed on human blood. They generally spread through contact and cause allergic reactions such as itching and inflammation of the scalp. It also causes severe mental trauma and affects the quality of life. There are several mechanisms of dealing with lice infection. Mechanical removal, use of insecticides, and natural actives are the most common modes of treatment of lice. The infestation is more commons amongst the lower socio economic classes and there is an affordability issue amongst this class for the use of anti lice products. Hence they prefer manual removal which is not very efficient.
WO20070858992 provides a composition for treating a subject infested with a parasite or preventing infestation by a parasite. The insecticide composition is a foamable composition, that comprises of : (1) a first insecticide; (2) at least one organic carrier selected from a hydrophobic organic carrier, a polar solvent, an

emollient and mixtures thereof, at a concentration of about 2 % to about 5 %, or about 5% to about 10 %;or about 10% to about 20%; or about 20 % to about 50 % by weight; (3) a surface-active agent; (4) about 0.01 % to about 5 % by weight of at least one polymeric agent selected from a bioadhesive agent, a gelling agent, a film forming agent and a phase change agent; and (5) a liquefied or compressed gas propellant at a concentration of about 3 % to about 25 % by weight of the total composition. In another aspect of the invention, an insecticide composition includes: (i) a first insecticide; (N) an organic carrier, at a concentration of about 5 % to about 50 %, said organic carrier containing at least one member selected from the group of (1) a second insecticide comprising a plant-derived oil having the ability to kill or prevent the growth of parasite arthropods or to repel or prevent infestation by parasite arthropods, and (2) a potent solvent; and (iii) a surface-active agent.
However, the above composition is highly complex, requiring more than one insecticide for killing the ectoparasites.
A very cheap but efficacious product is a much desired need gap for this socioeconomic class in order to eradicate lice and prevent cross contamination. The present invention fulfills the much needed gap for the socioeconomic class of individuals where lice infestation is more common for eradication of lice and preventing cross contamination.
SUMMARY OF THE INVENTION
In an embodiment of the present invention is provided simple water based pharmaceutical anti-lice compositions.

In another embodiment of the present invention is provided the process of preparing the water based pharmaceutical compositions for the treatment of lice among the children and Indian women.
The embodiment of the present invention provides water-based ant-lice pharmaceutical compositions comprising of a synthetic pyrethroid compound such as permethrin, emulsifier(s), fragrance and surfactant(s).
DESCRIPTION OF THE INVENTION
The present invention encompasses water-based ant-lice pharmaceutical compositions.
The compositions and method of this invention are safer and more effective than those presently available. A particular benefit of the compositions is their effectiveness against louse species that have become resistant to currently used products. The anti-lice compositions of this invention may be formulated in a number of ways. Particularly useful formulations are shampoos, conditioners, and lotions.
The water-based composition of this invention comprise of a synthetic pyrethroid
compound such as permethrin or its physiologically acceptable salt thereof, together
with emulsifier(s), water, surfactant(s), fragrance, and other cosmetically acceptable
components.
When used in this formulation, the pyrethroid component is generally present at a
level of from about 0.1 % to about 5 %.

In one embodiment, non-limiting examples of suitable surfactants include anionic agents, cationic agents, amphoteric agents, zwitterionic agents, nonionic agents and mixtures thereof. Non-limiting examples of such agents include sodium lauryl sulfate, sorbitan tristearate, sorbitan monostearate, sorbitan monopalmitate, and butylene glycol distearate or mixtures thereof.
Examples of suitable emulsifiers include, without limitation, PEG-40 castor oil (Cresmor), stearic acid, cetyl alcohol, stearate and glyceryl stearate, cetearyl glucoside, polysorbate 20, ceteareth-20, cetyl alcohol, cetearyl alcohol, self-emulsifying wax, isopropyl palmitate, cetyl palmitate, stearyl alcohol, lecithin, hydrogenated lecithin, steareth- 2, steareth-20, and polyglyceryl-2 stearate or mixtures thereof.
It may also be desirable to add ingredients such as fragrances to make the pediculicidal compound or composition more pleasing to the senses. It is preferred that such fragrances be natural in derivation, although it is not believed to be critical to the effectiveness of the present invention. An example of such a desired ingredient would be perfume.
The following example illustrate the invention, but are not limiting thereof.
EXAMPLE-1
The formulation of the present invention has the following composition:

s.
No. Ingredients % range Function

1 Cresmor RH 40 1 - 20% Emulsifier
2 Permethrin 0.1-5% Active
3 Perfume 0.1- 5% Fragrance
4 SLES 1 - 20% Surfactant
5 Water 80 - 95%

The above composition was prepared as per the following process disclosed below:
A) Oil phase:
Cresmor RH 40 was weighed in a beaker and heated to about 50 °C. Permethrin was then added to it and stirred, followed by addition of perfume at around 45 °C and again stirred.
B) Water phase:
SLES & water was mixed together in a beaker & heated to around 50 °C.
This aqueous phase (B) was then added to the above oil phase (A) at around 50 °C
and the whole mixture is stirred till the temperature of the mixture comes down to
room temperature.
The above formulation so prepared was subjected to biological activity for
demonstrating its ant-lice activity.
Biological activity of water-based ant-lice formulations: A) In-vitro study:
For this study, Petri plate Method: Laboratory in-Vitro study Protocol was
designed as follows:
The filter paper was placed on a Petri dish (3.5"diameters). The filter paper was
soaked with the test sample of 1.5 ml, as prepared according to the formula and
process disclosed in Example 1. Around 20 lices were placed over the soaked
filter paper and the mortality of the lice were checked at different intervals i.e. at
the end of 1 hour and at the end of 2 hours.
Results: At the end of 1 hour, the mortality rate was found to be 100 %.

B) In-vivo activity:
Consumers (school going girls in the age limit of 7-15 yrs) with medium to heavy infestation of lice were selected for the test. Around 15-20 ml of the product was applied thoroughly to the scalp of medium shoulder length hair. Itching was observed post application which also implies the efficacy of the product & thereby the repellant effect of lice. After 1 hour, the hair was first combed with a normal comb & then with a lice comb.
Results: Heavy dislodge of lice was observed. The dislodged lice were found to be in a morbid state. The hairs were then washed with any normal shampoo.
The above water-based anti-lice formulations prepared according to the present invention have the following advantages:
1. The formulations are aqueous based, which includes around 90-95 % water.
2. Cost of the formulation is low as involves very few ingredients.
3. The efficacy of the product is at par with the market sample containing the same active.
4. Simplified processing & manufacturing cost is less and needs no sophisticated facilities.

We Claim:
1. An aqueous-based anti-lice pharmaceutical composition characterized in that composition comprising of:
a) a synthetic pyrethroid, permethrin or its physiologically acceptable salt thereof,
b) emulsifier(s),
c) surfactants), and
d) fragrance(s)

2. An aqueous-based pharmaceutical composition as claimed in claim 1 characterized in that permethrin or its physiologically acceptable derivative or salt thereof is present in the range from about 0.1 % to about 5 %.
3. An aqueous-based pharmaceutical composition as claimed in claim 1 or 2 characterized in that the suitable emulsifiers is selected from, without limited to, PEG-40 castor oil (Cresmor), stearic acid, cetyl alcohol, stearate and glyceryl stearate, cetearyl glucoside, polysorbate 20, ceteareth-20, cetyl alcohol, cetearyl alcohol, self-emulsifying wax, isopropyl palmitate, cetyl palmitate, stearyl alcohol, lecithin, hydrogenated lecithin, polyglyceryl-2 stearate or mixtures thereof, preferably PEG-40 castor oil (Cresmor).
4. An aqueous-based pharmaceutical composition of claims 1 to 3 characterized in that PEG-40 castor oil (Cresmor) is in the range from about 1 % to about 20 %.
5. An aqueous-based pharmaceutical composition as claimed in claim 1 characterized in that suitable surfactants include, but not limited to sodium lauryl sulfate, sorbitan tristearate, sorbitan monostearate, sorbitan

monopalmitate, butylene glycol distearate or mixtures thereof, preferably sodium lauryl sulfate, which is in the range from of 1 % to about 20 %.
6. An aqueous-based pharmaceutical composition as claimed in claim 1 characterized in that the fragrance is perfume, present in the range from about 0.1 % to about 5 %.
7. The process of preparing aqueous-based anti-lice pharmaceutical composition as claimed in claim 1 or 2 which comprises the steps of:

a) Heating the emulsifier(s) to about 50 °C, followed by addition of permethrin or its pharmaceutically acceptable salt, stirred and addition of fragrance at around 45 °C and again stirred.
b) Mixing surfactant(s) & water & heating the mixture to around 50 °C.
c) Adding aqueous phase (step b) to the oil phase (step a) at around 50 °C and the whole mixture stirred till temperature of mixture comes down to room temperature.

8. An aqueous-based ant-lice pharmaceutical composition as claimed in any of the preceding claims wherein the compositions are administered in the form of shampoos, conditioners, and lotions.
9. An aqueous-based anti-lice pharmaceutical composition as claimed in any of the preceding claims and exemplified in the examples.

FOR MARICO LTD By their Agent
(SAIMA SAGHIR ANSARI) KRISHNA & SAURASTRI ASSOCIATES