FIELD OF INVENTION
This invention relates to an anti-fertility composition for preventing fertility in mammals, particularly in such mammals wherein fertility is initiated and characterized by deposit of semen in the vaginal cavity with subsequent transport into the genital tract. Specifically but without implying any limitation thereto, the composition is useful for prevention of fertilization in human females after deposit of semen in the vaginal cavity after coitus.
PRIOR ART
Currently methods of fertility prevention rely mostly on birth control pills, contraceptive devices etc. Most of these systems are used prior to coitus and only few are capable of being used after coitus. Contraceptive devices are at times difficult to operate and uncomfortable to use. Birth control systems such as medical preparations are generally based upon systemic absorption of the fertility control agent. The drawback of such medical preparations is that they are often required to be taken in single doses or large cumulative amounts. This results sometimes in serous adverse side-effects on the body of the person relying on such medicinal preparations for birth control. Another drawback of contraceptive devices or medicinal preparations is that these do not find favour with rural females, particularly in India.
An allopathic medical preparation which is often used is Nonoxynil-9 under the trade name "TODAY".
A drawback of the above medical preparation is that it has to be inserted into the vaginal cavity at least 15-20 minutes before coitus.
Another drawback of the above medical preparation is that it has to be inserted deep into the vagina with a finger.
Still another drawback of the above allopathic preparation is that it may melt on exposure to sunlight thereby becoming unfit for use.
A herb known in the art which is used for anit-fertility effect is Wild Yam, often called Dioscoria, which is a source of steroidal compound and is used in the manufacture of anti-fertility pills.
A drawback of Wild Yam as contraceptive pill is that it has to be taken twice daily, for about two months, in order that it may be effective.
Still another drawback of the above herb based pill is that as it requires to be taken at least for two months before it becomes effective, for birth control during this period, it has to be combined with use of condomn by male.
Further drawback of the above herb is that above herbal pill is usefiil for females and cannot be used by males since the herbal tablets control the eggs of females (and not kill the spermatozoa) by either making the eggs sterile or by thickening the outer covering on the eggs shell so that sperm are unable to penetrate.
Yet further drawback of the above herb is that the use of anti-biotic may negate the effect of Wild Yam.

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Still further drawback of wild yam is that it has still not been tested by FDA, USA for use as contraceptive.
Another herbal contraceptive known in the art is oral tablets based on neem leaves or capsules containing oil of neem seed.
A drawback of the above is that it takes about 6 weeks to become 100% effective.
Another drawback of the above is that the herb takes effect when 2 neem leaf capsules are taken 3 times a day before meals, for period of 6 weeks.
OBJECTS OF THE PRESENT INVENTION
An object of the present invention is to provide an anti-fertility composition based on herbal and natural constituents.
Another object of the present invention is to provide an anti-fertility composition, which has no adverse side effects.
Still another object of the present invention is to provide an anti-fertility composition, which is for local application.
Further object of the present invention is to provide an anti-fertility composition, which has a herbal oil as one of its constituent due to which the composition acts both as a lubricant as well as an anti-fertility agent.
Still farther object of the present invention is to provide an anti-fertility composition, which can be used for local application both by a male as well as a female, however it is more effective for local application by females.
Even further object of the present invention is to provide an anti-fertility composition which can be instantly used before coitus, as compared to some of compositions known in the art, which require waiting time of 15-20 minutes for coitus, after application of an anti-fertility composition, in order that the composition may be effective for birth control.
STATEMENT OF INVENTION
According to this invention there is provided an anti-fertility composition comprising of 80 to 90% by weight of at least one oil, 10 to 15% by weight of finely grinded and sieved iodised sodium chloride and 0.5 to 0.8% by weight of camphor (Cavacrol) wherein oil is selected from mustard oil (chemical name- AUylisothio cynate), groundnut oil( chemical name- Aracnis hypogaea), castor oil (chemical name- Ricinus Communis), almond oil (Fry primus amy gladus), Babassu oil (chemical name - Orbighya wartiha), coconut oil (chemical name -Cocos nucifera), corn oil (chemical name -Zea mayst), cotton seed oil (chemical name -Gossypiume spt), Jojoba oil, linseed oil (chemical name -Linume usitatissimum), olive oil (chemical name -Olea europea), palm oil(chemical name- Elaeis guineen sis), peanut oil (chemical name -Arachin hypogea), safflower oil (chemical name -Catharan thus tictorius, Sesame oil (chemical name -Seasamum indicam-Gingelly oil), soyabean oil (chemical name -Glycine max), sunflower-seed oil (chemical name -Helianthus ahhus) and wheat germ oil (chemical name -Triticum aestivum).
DESCRIPTION OF THE PROCESS OF THE PRESENT INVENTION
According to this invention, the anti-fertility composition of the present invention comprises 80-90% preferably 85-87% of at least one vegetable oil, 0.5 to 0.8% preferably 0.5 to 0.7% camphor (Carvacrol) and 10 to 15% preferably 13 to 15% of finely grinded and sieved sodium chloride (iodised). The mixture is exposed to heating under sunlight when ambient temperature is between 35 to 45°C, for a period of 2 to 3 hours, with frequent stirring to form a homogenous mixture. The solution is filtered and the filtrate obtained is then stored in shade for 1-2 days preferably 3-4 days to obtain the composition of the present invention. The composition thus obtained has viscosity in the range of 210 to 230 cps, generally 220cps.. The composition obtained has a shelf life upto one year.
The oil is selected from mustard oil (chemical name- Allylisothio cynate), groundnut oil( chemical name- Arachis hypogaea), castor oil (chemical name- Ricinus Communis), almond oil (Fry prunus amy gladus), Babassu oil (chemical name - Orbighya wartiha), coconut oil (chemical name -Cocos nucifera), corn oil (chemical name -Zea mayst), cotton seed oil (chemical name -Gossypiume spt), Jojoba oil, linseed oil (chemical name--Linume usitatissimum), olive oil (chemical name -Olea europea), palm oil(chemical name- Elaeis guineen sis), peanut oil (chemical name -Arachin hypogea), safflower oil (chemical name -Catharan thus tictorius, Sesame oil (chemical name -Seasamum indicam-Gingelly oil), soyabean oil (chemical name -Glycine max), sunflower-seed oil (chemical name -Helianthus ahhus) and wheat germ oil (chemical name -Triticum aestivum). However mustard oil are alone are a combination of coconut oil and soyabean oil is preferred wherein coconut oil is taken in amount 10 to 90% by weight and correspondingly soyabean oil is taken in quantity 90 to 10% by weight.
EXAMPLES
The invention will now be illustrated with working examples which are intended to be illustrative examples to illustrate the working of invention and are not intended to be taken restrictively to imply any limitation on the scope of the present invention.
Example-1
Seeds of mustard (Brassicas napus) were ground finely to powder form and then submitted to conventional extraction methods to extract about 100 gm oil from the seeds. Clear oil obtained was weighed and used for further processing. 14gms of sodium chloride was first grinded to a fine powder and sieved. Such finely grinded sodium chloride was taken together with 0.7gm camphor and mixed with mustard oil to form a uniform and homogenous solution. The solution was exposed to an ambient temperature of 35 to 45°C by heating under sun for a period of 2 to 3 hours, with frequent strring, so as to form a homogenous mixture. The mixture thus obtained was filtered and the filtrate obtained was kept in the shade for about 1-2 days preferably 3-4 days. The composition thus obtained was then ready for use.
Examole-2
Castor seeds were ground finely to powder form and then submitted to conventional extraction methods to extract about 100 gm oil from the seeds. Clear oil obtained was weighed and used for further processing. 13gms of sodium chloride was first grinded to a fine powder and sieved. Such finely grinded sodium chloride sodium chloride was mixed with 0.6g camphor and then with castor oil. The mixture was exposed to an ambient temperature of 35 to 45°C for a period of 2 to 3 hours and frequently stirred to form a homogenous mixture. . The mixture thus obtained was filtered and the filtrate was kept
in the shade for 1-2 days preferably 3-4days. The composition thus obtained was then ready for use.
Example-3
Seeds of soyabean were ground finely to powder form and then submitted to conventional extraction methods to extract about 100 gm oil from the seeds. Clear oil obtained was weighed and used for further processing. 12gms of sodium chloride was first grinded to a fine powder and sieved. Such finely grinded sodium chloride sodium chloride was mixed with 0.5g camphor and with the soya bean oil. The mixture was exposed to an ambient temperature of 35 to 45°C by exposing under sun, for a period of 2 to 3 hours and frequently stirred so as to form a homogenous mixture. The mixture was then filtered and the filtrate was kept under shade for 1-2 days preferably 3-4 days and the composition thus obtained was ready for use.
Example-4
Groundnut seeds were ground finely to powder form and then submitted to conventional extraction methods to extract about 100 gm oil from the seeds. Clear oil obtained was weighed and used for further processing. 14gms of sodium chloride was first grinded to a fine powder and sieved. Such finely grinded sodium chloride sodium chloride was mixed with 0.6g camphor was mixed with the groundnut oil. The mixture was heated under sunlight when the ambient temperature was 35 to 45 °C , for a period of 2 to 3 hours, with frequent stirring to form a homogenous mixture. The mixture thus obtained was filtered and the filtrate was kept in the shade for 1-2 days preferably 3-4days. The composition was then ready for use.
Method of use
The composition is used for direct application prior to coitus, in the form of an ointment gel cream, etc or may be used with any known drug delivery device such as through applicap. The composition may be locally applied by a females on the vaginal cavity or by a male on the male organ immediately prior to coitus. The composition being a natural product based on herbs, has no side effect on the human body. The composition which in the form of suspension, should be thoroughly mixed prior to application. Generally 0.5 to 0.8ml, preferably 0.6ml of the composition is used at a time. There is a synergistic effect among the different ingredients. By itself none of the ingredients namely sodium chloride or camphor or vegetable, exhibit any spermicidal activity. However when combined together and exposed to heating under sunlight under ambient temperature between 35 to 45°C for 2-3 hours, the composition, unexpectedly, exhibits spermicidal activity.
Evaluation
Spermatozoa were collected from over 50 volunteers and stored under hygienic and aseptic conditions. The spermatozoa of each volunteer was kept in a pertidish in the presence of the composition of the invention. Sperm count was taken at the beginning and at the end of the study to determine the effect of the composition. Sperm mortality was observed in most cases, within 10-12 seconds of contact with the composition of the invention. Table-I below sets out the results of the in vitro studies.

TABLE-1 INVITRO STUDIES(Table Removed)
TABLE -II INVIVO STUDIES(Table Removed)The volunteer was a 36 year old male. The person already had 2 children and did not want to have any more children. The volunteer was advised to use the composition of he invention before coitus and report the results. The volunteer used the composition as lubricating jelly. The volunteer reported use of the composition three times a week for about a month. The volunteer did not report conception. The volunteer did not report any side effects. These findings are considered to show that the formulation of this invention is an effective birth control tool and also has a beneficial effect on the person. The composition has no adverse side effects on the user.
It is to be noted that the present invention is susceptible to modifications, changes and adaptations by those skilled in the art. Such variant embodiments incorporating the concepts and features of the present invention, are intended to be within the scope of the present invention, which is further set forth under the following claims:-

WE CLAIM:
1. An anti-fertility composition comprising of 80 to 90% by weight of an oil, 10 to 15% by weight of finely grinded and sieved iodised sodium chloride and 0.5 to 0.8% by weight of camphor wherein oil is selected from mustard oil, groundnut oil, castor oil, almond oil, babassu oil, coconut oil, corn oil, cotton seed oil, Jojoba oil, linseed oil, olive oil, palm oil, peanut oil, safflower oil, sesame oil, soyabean oil, sunflower-seed oil and wheat germ oil.
2. An anti-fertility composition as claimed in claim 1, wherein oil is preferably 84-87% by weight.
3. An anti-fertility composition as claimed in claim 1 or 2, wherein camphor (Carvacrol) is preferably 0.5 to 0.7% by weight.
4. An anti-fertility composition as claimed in any of the preceding claims, wherein sodium chloride is preferably 13 to 15% by weight.
5. An anti-fertility composition as claimed in any of the preceding claims, wherein the oil is preferably mustard oil or a mixture of coconut oil and soyabean oil prepared by taking coconut oil in quantity of 10 to 90% by weight and correspondingly soyabean oil in quantity of 90 to 10% by weight.
6. An anti-fertility composition substantially as herein described and illustrated.