FIELD OF THE INVENTION
The present invention relates to an oral composition for enhancing female sex ratio in Bovines.

BACKGROUND OF THE INVENTION
The global dairy industry is worth around USD 350 billion and plays a crucial role in national economies and in feeding the world, both in terms of creating food sufficiency and in improving health and wellbeing. However, to continue to feed a growing population with essential fats and protein while reducing hunger the industry faces two inherent growth problems; a) poor cow fertility, and b) birth of unproductive male calves.

At a primary level the economics are simple - to produce milk cows must give birth to a calf each year. Poor fertility means longer periods to calving, less annual milk production. While high numbers of male calves, with little or no re-sale value, means slower genetic improvement, less replacement calves for herd expansion, and significant loss in revenue from livestock sales thus overall presenting a massive roadblock to revenue growth and production efficiencies.

This problem is no more so than in India - a 5.3 trillion-rupee dairy industry wherein the Government has stated its goals of doubling by 2022. While India is the world’s biggest dairy market per-cow milk yield is significantly behind other large dairy producing nations while prohibitions on cattle slaughter means millions of abandoned (male) cows, billions of lost revenues for farmers and a major roadblock in production cycles. This phenomenon takes away the ability and incentive to build better and bigger herds.

Based on the problems of the industry as illustrated herein and the prevailing issue of the birth of unwanted male calves the need was to develop/improve the technologies to produce a greater number of female calves without disturbing the genetic profile of the off springs.

Sex determination has been a favorite subject for reproductive physiologists since long. Sex determination is a process whereby the sex of the offspring is decided by sex chromosomes in Mammals and by factors such as temperature in certain chordates such as reptiles. Sex assignment and determination in Mammals is a method whereby the sex of the offspring is decided even before actual formation of the zygote by the fusion of an ovum with a spermatozoa bearing the sex chromosome of a particular sex and conditions are created such that the combination of chromosomes leading to the formation of a fetus of desired sex. Sex ratio is an indicator/measure devised to ascertain the proportion of males and females in a given population. There have been several attempts in the prior art to alter the sex ratio in Mammals and more particularly in Bovines.

Some chordate species are known to be temperature dependent for sexual determination (TSD). In case of such animals, the sex of the offspring instead of being determined by sex chromosomes is determined by the temperature at which egg is incubated. Further, there are certain species where application of certain hormones alters the sex of the offspring. Such species include certain reptiles and ratites. Such attempts to alter the sex are discussed and disclosed in U.S. Pat. Nos. 5,201,280 and 5,377,618.

However, in case of Bovines, sex of the offspring is determined by random combinations of X- or Y-chromosome bearing sperms with an ovum always containing the X-chromosome and giving rise to a sex ratio of almost 50:50. In case of Bovines also, some workers have tried to manipulate sex ratios. Manipulation of sex ratio gains prominence with the fact that Bovines are an important family and success in altering the sex ratio in Bovines, especially to the female side, has advantages in milk and meat producing species and in evolving livestock of better quality. This becomes doubly important in crossbreeding programs where 50% of the offsprings turn out to be of female sex and remaining 50% of male sex. The offsprings of the male sex are not generally favoured in the livestock industry. Altering the sex ratio, thereby leading to preferential production of females may make such crossbreeding programs a tremendous success. This also keeps the proportion of male populations of these species to the minimum extent as required for insemination purposes only.
Presently there are certain techniques available for sex determination to produce a greater number of females including Sexed Semen Technology. An article by Seidel et al, summarises, the technology and more importantly lists the disadvantages of this technology (Seidel GE, Jr.Animal 2014 May;8 Suppl 1:160-4). This article discloses that at the speed in which the technology is operated it is not economical and that there is a damage to sperm during sorting, and that the fertility is improved only about 4 and 6 percentage points, or about 10%.

United States Patent 5,110,592, titled ‘Composition and method of increasing live births to female animals and animal feed blend suitable for same’. This invention describes a method for increasing the number of live births to a female animal by feeding the mother, an edible flaxseed composition comprising ground flaxseed at least one week before the expected time of birth. The invention further discloses that a ground flaxseed composition can be admixed with a suitable animal feed. Zinc and/or vitamin B-6 can be included in the composition. However, there is no evidence of the utility and industrial application of the sample.

United States Patent 5,439,362, titled ‘Sex-associated membrane proteins and methods for increasing the probability that offspring will be of a desired sex discloses a method of sorting living cells based on DNA content and for increasing the probability that offspring will be male or female comprising the step of allowing as sperm from an enriched semen sample to fertilize an ovum. US’362 discloses a method of sorting the semen samples so as to enrich them with X chromosome, so that on conception, it leads to predominantly female population. US’362 also discloses a step of immunizing a female with X- or Y-SAM proteins and methods of decreasing fertility comprising the step of immunizing a female with both X- and Y-sperm along with methods of increasing the probability that mammalian offspring will carry a gene for a particular sex-chromosome linked trait. However, it has been reported that such methods lead to poor conception, cannot be carried out widely across different species and/or genus of Bovines and leads to several genetic disorders. Furthermore, it is an expensive technology and requires highly specialised instruments. (Proceedings in Applied Reproductive Strategies in Beef Cattle, Aug. 29-30, 2017)

U.S. patent No. 7351581 titled “In vivo method for producing female off springs in bovines” discloses an in vivo method whereby female offspring can be produced in bovines, said method comprising the step of administering a composition comprising acetic acid (approximately 8-16% dilute acetic acid), or its pharmaceutically acceptable derivatives to female bovines just after or before insemination in the range of 250 to 400mL. The composition also appears to comprise vinegar, sodium acetate and/or their natural or synthetic derivatives. US’581 proposes that the effect is due to the blocking of the “Y” sperm specific sites on the Ovum, who such a hypothesis is not proven and does not yield consistent results on industrial usage. Furthermore, the storage temperature of the composition is 8-20 degrees centigrade, and hence difficult to store and transport across the globe. The composition is highly volatile and is also found to be an irritant on the muzzle and the buckle and coupled with its very short half-life period, is not a suitable composition for its use in the market.

United States Patent 9,107,402, titled ‘Composition and method to modify sperm fertility and female gender ratio in Bovines’. US’402 discloses a composition and method to modify sperm fertility and sex ratio of mammalian offspring. The composition includes an amount of a class of compounds of phenoxazine or phenothiazine derivatives in addition with an electron transfer agent capable of oxidizing a reduced cofactor (NADPH or NADH) an amount of a hexose sugar and/or the phosphorylated esters of such sugars. When mixed with living sperm prior to or at the time of insemination, it is purported that the composition results in modified rates of conception and an alteration of birth sex ratio in mammal species. However, the composition has to be stabilised by lyophilization (freeze-drying) and requires a temperature of 00C, to -150C for stabilization, which is expensive and not industrially viable.

Hence, there is a need to have a simple method to enhance the sex ratio of Bovines, in a convenient and economic manner.

OBJECT OF THE INVENTION
The object of the invention is to provide an economic, synergistic, stable oral composition for enhancing female sex ratio in Bovines.

SUMMARY OF THE INVENTION:
The Present invention provides a synergistic, stable composition for enhancing the female sex ratio in bovines. The present invention also provides a process for preparing the composition, its dose, dosing regimen and its use. The synergistic composition of the present invention comprises a polyhydric alcohol, combination of amino acid and a buffer, along with acceptable excipients.

DETAILED DESCRIPTION OF THE INVENTION
The embodiments of this invention, illustrating its features, will now be described in detail. The words "comprising," having, "containing," and "including," and other forms thereof, are intended to be equivalent in meaning and be open ended in that an item or items following any one of these words is not meant to be an exhaustive listing such item or items, or meant to be limited to only the listed item or items.

The present invention discloses an oral composition for enhancing the female sex ratio in Bovines.

The term “Bovines” as described herein includes members of the class Mammalia, any member of the group of vertebrate animals in which the young are nourished with milk from special mammary glands of the mother. In particular, the Bovines of the present invention pertain to bovine animals.

The present invention discloses an oral composition for enhancing the female sex ratio in Bovines comprising a polyhydric alcohol, an amino acid, a buffer, along with acceptable excipients.

The polyhydric alcohol of the present invention is selected from the group comprising pentaerythritol, xylitol, adonitol, arabitol, mannitol, sorbitol, dulcitol preferably the polyhydric alcohol of the present invention is sorbitol.

The oral composition of the present invention comprises the polyhydric alcohol in the range from 70% to 80%, preferably, it comprises sorbitol in the range of 60-67%.

The amino acid of the present invention is selected from the group comprising alanine, arginine, asparagine, aspartic acid, cysteine, glutamic acid, glutamine, glycine, proline, serine, tyrosin or mixtures thereof. Preferably the amino acid of the present invention is aspartic acid or glutamic acid or mixtures thereof.
The oral composition of the present invention comprises the amino acid in a range from 0.5% to 4%, preferably, it comprises in the range of 1-2%.

The oral composition of the present invention comprises of a buffer. The buffer may be any buffer of acidic pH. Preferably the buffer may be acetate buffer.

The oral composition of the present invention comprises a buffer in the range from 3-5%, preferably, in the ratio of 3.8% to 4.2%.

The acceptable excipients of the present invention may be selected from the group comprising a carbohydrate, a colouring agent, a flavouring agent.

The carbohydrate of the present invention is selected from the group comprising Maltose, dextrose, xanthan gum, or mixtures thereof, preferably the carbohydrate is maltose. The carbohydrate of the present invention may be present in the range of 10-40%, preferably 15-25%.

The colouring and the flavouring agent may be added as per quantity required. The composition of the present invention is stable a temperature range of 6-25 degree Celsius.

The oral composition of the present invention, is stable at a temperature range of 6-25 degree Celsius and increases the flow rate of saliva 10-12 times after 2 -3 minutes (0.47ml/minute) of gurgitation and remains higher 2.7 times more than control group and pH of saliva dropped to 4.7 from 7.2, and remains for more than 96 hours.

The composition of the present invention is effective across various types of Bovines, especially bovines, and equally effective in Heifers and the subsequent parturitions.

The composition of the present invention is safe efficacious and does not lead to any Genetic disorder. The composition of the present invention is synergistic with improved stability, provides balanced pH and works in varied temperature conditions.

In an embodiment, the present invention discloses a process for preparing the composition of the present invention comprising the following steps:

(i) mixing the amino acid and the excipient to obtain a mixture;
(ii) mixing the polyhydric alcohol and buffer to obtain a second mixture;
(iii) adding the mixtures of step (i) and step (ii) to arrive at the composition of the present invention.

In another embodiment, the composition of the present invention also discloses a dosage form comprising the composition as disclosed herein selected from the group consisting of oral dosage forms such as powder, cachets, tablets, dispersible tablets, liquids etc. The route of administration of the material primarily depends on the subject. Hence, if the subject is bovine species, then oral route may be adopted. Familiar methods of oral administration routes include sublingual, nasal, buccal. Other routes of administration, such as cutaneous, sub-cutaneous, parenteral, vaginal, intra-urethral, anal routes, etc. may also be adopted.

The material may be administered as such or may be formulated in various physical forms such as solution, syrup, elixir, mixture, emulsion, suspension, tablet, capsule, pessary, suppository, aerosol or a parental preparation, etc. The dosage form may accordingly be varied. As such, there is no intention to limit the scope of the invention to any particular physical form. In yet another embodiment, the composition of the present invention also discloses a dose of the administering the composition of the present invention. The composition can be dosed to the mammal in the range of 0.2 to 1 grams/Kg body weight. The dosage to be adjusted based on the weight of the animal. A therapeutic amount of the composition may be administered. By “therapeutically effective amount”, the applicants imply an amount that will enable production of female offsprings. Again, the dosage or the amount of material to be administered will vary from animal to animal and can be readily determined by a person skilled in the art on the basis of body weight of the subject to which the material is to be administered. For instance, in case of cows and buffaloes, the amount may be about 250 grams 350 grams of formulated composition for the body weight from 400 kgs to 600 Kgs. Preferably, 320 grams of the material may be administered to the animal (600 kgs). In short, the amount administered should be safe, efficacious and nontoxic.

Without being limited to theory, it is submitted that the presence of Sorbitol ensures the enhanced salivation and maintains the desired pH, the role of amino acids (Aspartic and Glutamic acid) is provides stability to the composition. The acetates and acetic acids provide the desired pH (4.11-4.19) at the site of reproduction to provide higher chance of XX zygote formation. Hence, the composition acts in a synergistic manner.

The insemination of the mammal may be affected naturally or by adoption of artificial methods as known in the art. In an embodiment, this material is administered to the animal as early as possible before insemination and preferably at the first signal/sight of heat symptoms (Estrous). The step of administration of the material to the animal may even precede the process of insemination as an alternate embodiment and at least between two hours to half an hour before insemination. In case of animals where repeated insemination occurs, such as in cows if need occurs may have to repeat administration of the material before two hours of second insemination if repeated after 24 hours. It must also be ensured that the insemination is not subjected to prolonged or extended periods of time so that the peak levels for maximum effects of the material during the process of fertilization are realized.

The time period for the administration of the material to the animal is quite critical. The period may of course vary from one animal to the other, but the general thumb rule is administration of the material 30 minutes before insemination. The reason is that the material must be administered to the animal before ovulation. In any case, the material should be administered at least within one hour after insemination. After administering the material as a single dose, the foetus develops normally and the animal goes through, completes pregnancy and gives birth to totally normal and viable female offspring/s. It is found that the offsprings produced according to the method of the invention lead a normal life. The applicants have observed that administration of the material to the animal does not evoke any adverse reactions or side-effects like fever, skin reactions, behavioural changes etc. Hence the material of the invention can be readily and safely administered to the animals.
In another embodiment, the composition of the present invention is administered in the dose of 320 grams as a single dose, preferably at the onset of heat symptoms (Oestrus Cycle).The does may administered directly into the mouth of the animal to allow it to be retained in the mouth to enhance salivation thus increasing the results of the product.

Other parameters that may considered during the insemination include
• Semen: Sperm motility more than 55-60%, Defective sperm less than 5% and Sperm count per insemination minimum: 20 million - 40 million.
• Hygiene: The maintenance of hygiene is of paramount consideration during the artificial inseminate.
• Lower Urea/degradable protein in diet during breeding phase - affects 40% reduction due to detrimental effect of reduced Uterine pH 6.66-6.86 from normal pH 7.16 -7.20
• Discontinue feeding of sugarcane 6 days prior to expected breeding.
• Vaginal Temperature between 40-41 °C at Insemination

Without being limited by theory, it is submitted that the composition of the present invention ensures enhanced female sex ratio in the Bovines by providing the right pH environment at the conception site through metabolism. Most Bovines comprise of a reproductive system that involves a male and female involving fertilisation of the ovum by sperms and where Oviduct (tube that links ovary to the uterus, also fallopian tubes) is the established site of zygote (fertilized egg cell) formation. The ovum comprises a “X” chromosome and fertilisation of the ovum by a sperm carrying an “X” chromosome leads to female zygote and by a “Y” chromosome carrying sperm leads to a male zygote. “Y” chromosomes bearing sperms are negatively charged and smaller in size and density, where as the “X” bearing chromosomes are positively charged particles and relatively bigger in size.

It is an established fact that Sorbitol has a large impact on the salivary flow rate due to its mastication (chewing) in the buccal cavity. Sorbitol increases the flow rate of saliva 10-12 times after 2 -3 minutes (0.47ml/minute) of gurgitation and remains higher 2.7 times more than control group and pH of saliva dropped to 4.7 from 7.2, and remains for more than 96 hours.

In bovine reproduction, fertilization is the process of transmitting genetic character from one generation to next generation. The fertilization involves union of two gametes i.e. ovum and sperm. The sex of conceptus depends upon type of fertilization of X or Y sperm bearing sperm participated in the union process. When “Y” chromosome bearing sperm involves in Zygote formation then conceptus is male while if “X” chromosome bearing sperm then conceptus is Female. “Y” sperm is positively charged while “X” sperm is negatively charged as explained above. The sequence of Y sperm specific amino acid sequence is (*Serine + Proline + Serine + Valine + Aspertine + Lysine + Alanine + Arginine+ Alanaine + Glutamic acid + Leucine) resulting in relatively a net positive charge. While the amino sequence of X sperm (Serine + Proline + alanine + valine + Aspertine is lysine + Alanine + Glutamic + alanine + Glutamic acid + Leucine) and thus the relatively net charge is negative.

Sperm heads carry different carbohydrates, Sialic acid, Galactose, Glucose, N-glycolyneuramic acid, n-acetylneuramic acids, Mannose, Xylose, Fucose, Glucosamine, Glucouronic acid, Iduronic acid, polypeptides, phospholipids, glycosphinngolipid, phospatidylinositol and cholesterol etc. in Glycocalyx of sperm head. The electrical charge on ovum post ovulation varies with change the pH of oviduct and time span. The progress post ovulation from positively charge in early ovulation in alkaline phase of oestrous cycle and gradually changes to negatively charge in Acidic phase as stage of oestrous cycle advances.

Sialic acid plays very important role in union of zona-pelucida of ovum and sperm head after capacitation. The chemical analysis of bovine zona-pelucida is glycoprotein n acetylneuramic acid (Neu5Ac) 85% and N-glycolyl neuramic acid (Neu5Gc) 15%. The use of neuraminidase inhibitor resulted in increased number of sperm bound zona-pelucida and penetrating Oocyte. Sialic acids are in abundance in bovine saliva and composition and pH of saliva varies with type of feeding practices adopted in bovine.

Neuraminidase is released from cortical granules of ovum which prevents the polyspermy union by removing the Sialic acid from Zona-pelucida. Binding sites of enzyme Neuraminidase consists of 18 amino acids residues of which 12 have direct contact with bound Sialic acid and out of 12, four are positively charged Argenine, while another four are negatively charged Glutamic acid and Aspartic acid residues. Remaining four is neutral that is tyrosine, asparagines, Isoleucine and Tryptophan.

All sperm cell surfaces in nature are covered by Glycocalyx which dense sugar coat formed by a complex array of Glycans, Oligosaccharides and Polysaccharides are attached with Glycoprotein and Glycolipids. Sperm coat is thick rich in Sialic acids which are 9 carbon backbones amino-sugars abundantly found on cell surfaces. These acidic sugars serves a wide variety of biological roles ranging from structural roles based on their negatively charge to involvement in molecular reorganization during fertilization. Sialic acid is synthesized by Glucosamine 6 phosphate and Acety-CoA and provides negatively charged molecules which are abundantly found in Bovine saliva.

The composition of the present invention regulates the pH in the reproductive tract enabling faster travel of the “X” sperms, to obtain better changes of a “XX-Zygote” and therefore a female offspring. In most species, once formed in the testis, spermatozoa are bathed in a fluid where they remained immobile and with a very low level of metabolism. This immotile status is understandable in view of the need to preserve the sperm energy reserve and to decrease the risk of alteration to membranes, internal structures and biochemical compounds by endogenous oxidizing agents produced by mitochondrial activity. This quiescent phase can be of different lengths and finishes when the semen is released into the external environment where the spermatozoa become motile and metabolically active. For invertebrates, and some fish, sexual activity is generally seasonal and fertilization is external. The activation of sperm motility occurs in response to changes in the external medium. Among the external factors, ions and particularly internal pH (pHj) seem to play a pivotal role in sperm physiology in Bovines. The charge of the Ovum membrane is not fixed but alters from positive to neutral to negative and this phenomenon is called the “Polarity”. The time taken for this alteration is not established and varies animal to animal.

In most bovine animals post ovulation the pH of the ovum (Follicular fluid) is more likely to be alkaline (pH 7.6 to 7.9), where as the uterine pH is 6.7 to 7.2 and the pH of frozen semen is 7.2 to 7.4. Whereas the semen stored at cauda epidydemis pH is 6.0 to 6.5 i.e. acidic. This means that the Ovum and the oviducts are having a positive charge, thus increasing the chances of accepting/attracting the “Y” chromosome bearing sperm fundamentally due to negatively charged body and more agile sperm and the first opportunity to produce a XY Zygote i.e. Male. The composition of the present invention creates an environment that will create negatively charged Ovum and the surroundings of the Oviducts, then the chances of deposition/attracting positively charged “X” chromosome bearing sperms increases, thus producing XX Zygote i.e. a female.

Advantages of the invention:
• Provides balanced pH and stability for enhancing female ratio in Bovines.
• Better stability in varied conditions of temperature variation.
• the timing of the product administration is not an issue as it can be administered just on the onset of the heat of the animal
• highly palatable product with soothing flavor
• metabolic product, hence no chance of Genetic disorder.
• performs at all temperature conditions
• no side effects have been reported.

The foregoing descriptions of specific embodiments of the present invention have been presented for purposes of illustration and description. They are not intended to be exhaustive or to limit the present invention to the precise forms disclosed, and obviously many modifications and variations are possible in light of the above teaching. The embodiments were chosen and described in order to best explain the principles of the present invention and its practical application, to thereby enable others skilled in the art to best utilize the present invention and various embodiments with various modifications as are suited to the particular use contemplated. It is understood that various omission and substitutions of equivalents are contemplated as circumstance may suggest or render expedient, but such are intended to cover the application or implementation without departing from the spirit or scope of the present invention.

EXAMPLE 1.: Composition of the present invention
Various compositions within the scope of the present invention are tabulated here below at Table 1:
Table 1: Exemplary compositions of the present invention
Ingredient C1 C2 C3 C4 C5
Sorbitol 67 70 74 70 77
Aspartic acid 1 2 1 2 0
Glutamic acid 1 2 2 1 0
Acetate buffer 4
Maltose 20 20 20 20 20
Others & Water 17 6 3 7 3
Total 100 100 100 100 100

Other compositions of the present invention were also tried. The same are illustrated at Table 2.
Table 2: Compositions within the scope of the present invention
Ingredient C1 in% C2
in% C3
in% C4
in% C5
in%
Sorbitol 60 62 64 66 67
Aspartic acid 2 1.5 0.5 0 1
Glutamic acid 0 0.5 1.5 2 1
Acetate buffer 3.8 4.0 4.0 4.2 3.8
Maltose 25 20 15 18 20
Others & Water 9.2 12 15 9.8 7.2
Total 100 100 100 100 100

The composition of the present invention may be diluted to arrive at the appropriate dose. Also, the concentration of the components of the composition may be kept same and the water or any other liquid feed may be added to reach a volume of 320 mL. The compositions of the present invention in its various forms were tested for their stability and were found to be stable during the shelf life.

Example 2: Preparation of the composition of the present invention
The composition of the present invention may be obtained by mixing the amino acids and excipients such as maltose. Separately, sorbitol is mixed with the buffer. Then both mixtures are added to obtain the final material. The process may be carried out in aseptic environment. The pH of the material is 3.1- 3.6 and the material is in viscous form

Example 3: Physicochemical properties of composition of the present invention (pH, stability data)
The material produced out the formulations was essentially acidic in nature with the pH ranging between 3.1 and 3.6. The material is semi viscous in nature which should allow the animal to retain it for chewing in the buccal cavity for at least two to three minutes.

Example 4: Synergy of the composition of the present invention
The composition of the present invention was tested for its activity in increasing the motility of the sperms and the formation of the XX zygote.
Semen samples were analysed for their volume, pH, colour and viscosity were determined for each sample. Sperm counts and percentage motility were first determined manually, then measured by computer-aided sperm analysis (CASA). Grades of progressive motility were tested for this study population. Data on rapid and linear motile sperm (%), velocity of average path (µm/s), amplitude of lateral head displacement (µm), linearity and other sperm movement characteristics were analysed morphologically using a microscope. Imaging and nuclei scoring and FISH was carried out for chromosomes X, Y and 18 using Vysis probes (Vysis, Downers Grove, IL, USA). Chromosome 18 was used as an autosomal control. The effect of the individual components of the assay in influencing the sperm motility between X and Y sperms were examined the percentage increase in the motility of the X sperms is tabulated herein below at table

Table 3: Effect of the individual components and the composition of the present invention in increasing sperm motility

Ingredient Activity
Sorbitol 10%
Aspartic acid NIL
Glutamic acid NIL
Acetic acid 23%
Acetate buffer 21%
Maltose NIL
Composition of the present invention 88%

From Table 3, above, it can be clearly seen that the composition of the present invention is synergistic in comparison to the individual components of the assay. It is postulated that since the X chromosomes carry positively charged particles and are relatively bigger in size and the charge of the Ovum membrane is not fixed but alters from positive to neutral to negative and post ovulation the pH of the ovum is more likely to be alkaline (pH7.6 to 7.9) and uterine pH is 6.7 to 7.2. The composition provides/increases the chances of having negatively charged environment and providing higher possibility of XX zygote formation.

EXAMPLE 4: Activity of the composition of the present invention
The objective of the initial trial was to examine the efficacy and toxicity of the composition of the present invention. The composition was prepared as described about at example 1 and 2 and had physicochemical properties as described in example 3. The effect was tested in Dairy Bovines, under the supervision of qualified Veterinarians, Breeders & Applicators. The product was administered as per the standard protocol. The results are elaborated at Table 4.

Table 4: Effect of the composition of the present invention.
Total AI Outcome
AI 32 Female
Pregnancy 22 Male
Percentage Female 87.5%
Male 12.5%
Conception Ratio 69%

From the table above, it is evident that the composition of the present invention was found to be quite effective in enhancing the chances of producing sexed off-springs of female type in the Dairy animals. The percentage delivery of female calves has ranged from more than 80% to absolute 100% in some farms, cumulatively it was 87.5%. The conception rate has also been found to be increasing with the standard application of the product. No side effects of the product as increase in body temperature, uneasiness, skin rashes, GIT disorder etc. came to be noticed.

EXAMPLE 5: Testing of the composition of the present invention in mammals
The composition of the present invention as illustrated hereinabove was tested for its efficacy in cows (Table 5) and in Buffaloes (Table 6) after obtaining necessary ethical clearances. The composition was administered at a dose of 320 grams per animal single dose of the composition at the on-set of heat symptoms, i.e. at the onset of oestrous cycle.

Table 5: Effect of the composition of the present invention on cows
Sr. No.
Group No.
Number of animals in group Number of animals with Confirmed pregnant Calving occurred
Sex of new-born calf
Female Male
1 Group -1 40 24 21 17 4
Percentage 60 88 81 19
2 Group -2 40 27 25 20 5
percentage 68 93 80 20
3 Group -3 40 20 19 17 2
Percentage 50 95 89 11
4 Group-4 40 18 15 14 1
percentage 45 83 93 7
5 Group-5 40 21 19 15 4
percentage 53 90 79 21
6 Group-6 40 31 26 22 4
Percentage 78 84 85 15

Table 6: Effect of the composition of the present invention on Buffaloes
Group No. Number of animals number of animals confirmed Calving occurred sex of new-born calf
Pregnancy Female Male
Group -1 40 20 19 17 2
Percentage 50 95 89 11
Group -2 40 23 23 19 4
percentage 58 100 83 17
Group -3 40 15 15 13 2
percentage 38 100 87 13
Group-4 40 21 19 17 2
percentage 53 90 89 11
Group-5 40 15 14 13 1
percentage 38 93 93 7
Group-6 40 19 18 16 2
percentage 48 95 89 11
From tables 5 and 6 as above, it can be seen that the Composition in both Cows and Buffaloes demonstrates enhanced conception and an increased female ratio of 77% on various parameters with the ratio of the female calves as high as 83%.

We Claim:

1. An oral composition for enhancing the female sex ratio in Bovines comprising a polyhydric alcohol, an amino acid, a buffer, along with acceptable excipients.

2. The polyhydric alcohol as claimed in claim 1, is selected from the group comprising pentaerythritol, xylitol, adonitol, arabitol, mannitol, sorbitol, dulcitol preferably sorbitol and is in the range of 70% to 80%, preferably, 60-67%.

3. The amino acid as claimed in claim 1, is selected from the group comprising alanine, arginine, asparagine, aspartic acid, cysteine, glutamic acid, glutamine, glycine, proline, serine, tyrosin or mixtures thereof, preferably the amino acid is aspartic acid or glutamic acid or mixtures thereof and is in the range of 0.5% to 4%, preferably, in the range of 1-2%.

4. The buffer as claimed in claim 1, is a buffer of acidic pH, preferably acetate buffer and is in the range of 3-5%, preferably, 3.8% to 4.2%.

5. The acceptable excipients as claimed in claim 1, is selected from the group comprising a carbohydrate, a colouring agent, a flavouring agent.

6. The carbohydrate as claimed in claim 5, is selected from the group comprising Maltose, dextrose, xanthan gum, or mixtures thereof, preferably maltose and is in the range of 10-40%, preferably 15-25%.

7. The oral composition as claimed in claim 1, when administered as oral dosage form, selected from the group consisting of powder, cachets, tablets, dispersible tablets, solution, syrup, elixir, mixture, emulsion, suspension.

8. The oral composition as claimed in claim 1, the composition is administered to the bovines at the dose of 320 grams as a single dose.

9. The oral composition as claimed in claim 1, is stable a temperature range of 6-25 degree Celsius, increases the flow rate of saliva 10-12 times after 2 -3 minutes (0.47ml/minute) of gurgitation by 2.7 times, decreases pH of saliva to near neutral pH and maintains neutral PH for more than 96 hours.

10. A process for preparing the composition as claimed in claim 1, comprising the following steps:
i. mixing the amino acid and the excipient to obtain a mixture;
ii. mixing the polyhydric alcohol and buffer to obtain a second mixture;
iii. adding the mixtures of step (i) and step (ii) to arrive at the composition of the present invention.

11. Use of the composition as claimed in claim1, for enhancing the female sex ratio in Bovines.