FORM 2
THE PATENTS ACT, 1970 (39 of 1970)
COMPLETE SPECIFICATION
(See section 10 and rule 13)
1. TITLE OF THE INVENTION
"A PROCESSED DRY POWDER OF COW URINE AND PROCESS OF PREPARATION FOR THE SAME"
2. APPLICANT
NAME : PITAMBARI PRODUCTS PVT.LTD
NATIONALITY : INDIAN
ADDRESS : HEMENDRA CO.HSG.SOC, 3RD FLOOR, GOKHALE ROAD,
THANE -400602,MAHARASHTRA
The following specification particularly describes the invention and manner in which it is to be
performed.

FIELD OF THE INVENTION:
The present invention relates to the dry cow urine powder,processed by spray drying of cow urine at controlled temperature and pressure. The prepared cow urine powder has various uses, of which it is preferably used for the preparation of pharmaceutical formulation for the treatment of anemia, worm infection, cough, itching, ascites, obesity, piles,skin diseasesand cancer diseases.
BACKGROUND OF THE INVENTION:
Ayurveda recommends the use of cow urine for different purposes in their daily and ceremonial activities due to its therapeutic value. As perAyurveda literatures fresh cow urine (Gomutra)has various uses, some of which are use of the same in treating diseases particularly in anemia, worm infection, cough, itching, ascites, obesity, piles,skin diseases,cancer etc.Chemo profiling of fresh cow urine confirms the presence of protein, urea,uric acid, creatinine, phenol, aromatic acids, enzymes likeacid phosphates, alkaline phosphatase, amylase andvitamins as a bioactive components of cow urine.
Therefore, presence of phenols in cow urine may beinstrumental for its potent antimicrobial nature likewise uric acid helps to control cancer, vitamins increases potency.US6,410,059 disclose the use of cow urine to enhance the anti-microbial effects of antibiotic and antifungal agents.

In current scenario Gomutra either converted to ark or ghanvati as a pharmaceutical formulation. Gomutra ark is concentrated distillate of cow urine prepared by distillating the cow urine. Ghanvati is solid form of cow urine prepared by drying the urine at high temperature in iron pan. Further this ghanvati can be converted into tablets, capsules or ointment. These formulations are useful as it solved the stability problem of cow urine.
US6,896,907 disclose the use of bioactive fraction (distillate) from cow urineas a bio-enhancer of anti-infective, anti-cancer agents and nutrient. Wherein, the cow urine distillate is lyophilized. Lyophilization technique requires expensive equipment, takes days to complete and takes up a great deal of space within a production facility.
US 7, 718,360 disclose method of removing ammonia by re-distilling cow urine distillate (Gomutra ark) using orthophosphoric acid.
WO2002096440 Al (IN203973) discloses the process of manufacturing herbal medicinal composition by incorporating cow urine concentrated residue in tablets, capsules, ointments.
Cow's urine (Sanskrit: Gomutra) is being used as an effective medicine. Ancient literature in Ayurveda states that cow's urine is one of the best natural remedies to cure many bacterial and fungal diseases, especially skin diseases. Recent researches prove that cow's urine therapy is capable of curing several diseases, including certain types of cancer. The breed selected are from Asian breedpreferably Gir, khilar, Sindhi, Ongole, Jersey Cows.

The chemical constituents of cow's urine includes nitrogen, sulphur, phosphate, sodium, manganese, carbolic acid, iron, silicon, chlorine, magnesium, citric, titric, succenic, calcium salts, Vitamins A, B, C, D and E, minerals, lactose, enzymes, creatinine, hormones, urea and
gold acids.
Urea, a key chemical in urine, is known to kill fungi and bacteria. This is the principle behind Gomutra being an effective fungicide as well as antibacterial agent; Current researches even exploit the enzymatic activity of the same, indicating that this natural source of enzymes and Following chemical content of cow urine and cure of diseases accordingly; Nitrogen, N2, NH2 helps to removes blood abnormalities and toxins, natural stimulant of urinary track, activates kidneys and it is diuretic. Sulphur (S) helps supports motion in large intestines and cleanses blood. Ammonia, NH3helps stabilizes bile, mucous and air of body and stabilizes blood formation. Copper (Cu) helps controls built up of unwanted fats. Iron (Fe) maintains balance and helps in production of red blood cells & hemoglobin and stabilizes working power. Urea CO (NIT2)2 affects urine formation and removal. Germicidal Uric Acid, C5H4N403 helps removes heart swelling or inflammation. It is diuretic therefore destroys toxins. Phosphate helps in removing stones from urinary track. Sodium, Na purifies blood and also has properties of antacid. Potassium, K helps cures hereditary rheumatism. Increases appetite it also removes muscular weakness and laziness. Manganese (Mn) shows germicidal, stops growth of germs, protects decay due to gangrene. Carbolic acid, HCOOH shows germicidal, stops growth of germs and decay due to gangrene. Calcium,Caact as blood purifier, bone strengthener, germicidal. Salt NaCl Decreases acidic contents of blood, germicidal. Vitamins specifically Vitamin B is active ingredient for energetic life and saves from nervousness and thirst, strengthens bones and

reproductive power. Minerals Increase immunity. Lactose, C6H1206Gives satisfaction, strengths heart, removes thirst and nervousness. Enzymesmake healthy digestive juices, increase immunity. Hipuric acid,C9N9NO10 helps Removes toxins through urine. Creatinin C4HgN2O2 exhibits Germicidal activity, Aurum Hydroxide AuOH shows germicidal activity and increases immunity power. AuOH is highly antibiotic and anti-toxic.
The 95% of cow urine content being water, 2.5% of urea, and the remaining 2.5% a mixture of minerals, salts, hormones and enzymes. Cow urine has some volatile as well as nonvolatile components as mentioned above.
Conventional method like Gomutra ark (distillate) contains only volatile constituents and ghanvati contains only non-volatile constituents of cow urine. Thus, it is very important to have volatile and non- volatile constituent in the processed cow urine to be effective against several diseases with enhanced bioavailability as well as stability.
As evident from the prior art, it becomes challenging to produce a dry powder form of cows urine retaining maximum important constituents of fresh cows urine, conventional method like Gomutra ark (distillate) contains only volatile constituents and ghanvati contains only nonvolatile constituents of cow urine. Thus, the present invention holds an advantage of yielding cows urine in dry powder form retaining volatile and non- volatile constituent, as well as high percentages of bio-active components withenhanced bioavailability as well as stability. The present invention provides the method for preparation of cow urine powder which is less time consuming and more economic.

The discussion of documents, acts, materials, devices, articles and the like is included in this specification solely for the purpose of providing a context for the present invention. It is not suggested or represented that any or all of these matters formed part of the prior art base or were common general knowledge in the field relevant to the present invention as it existed before the priority date of each claim of this application.
OBJECTIVES OF THE INVENTION
• A primary objective of the present invention is to prepare a cow urine powderthat has as high percentages of bio-active components.
• Another objective of the present invention is to prepare a cow urine powder that has good stability
• Another objective of the present invention is to prepare a cow urine powder comprising of both volatile and non-volatile bio-active components.
• Another objective of the present invention is to provide the method for preparation of cow urine powder which is less time consuming and more economic.
• Another objective of present innovation is to convert Gomutra in such form that it can be Capsulated in capsules; and is made palatable by masking its undesired taste.

SUMMARY OF INVENTION
The present invention relates to a preparation of cow urine powder comprising spray drying of
fresh cow urine at controlled temperature and pressure. More specifically the invention is related
to preparation of gomutra powder with increased stability and high percentage of bio-active
components.
In an embodiment of the present invention the process for preparation of gomutra powder
comprising collection of fresh cow urine from healthy cows and filtration to remove the foreign
matters. This collection process utilizes appropriate mean to collect cow's urine in sterile
conditions.
This Urine is collected, not limited to any specific species of bovine; the preferred are healthy
Indian breed. Urine is collected in sterile condition. Further to the collectedurine preservative are
added to the same and is stored at controlled temperature and pressure. Bulking agents are added
to same and mixture is homogenized. Homogenous mixture is subjected to controlled drying
under regulated pressure. The powder form is then subjected to formulation as required and
irradiation with Gamma Rays.
STATEMENT OF INVENTION
The present invention relates to pharmaceutical formulation comprising of spray dried cow urine powder prepared from fresh cow urine at controlled temperature and pressure wherein percentage of bio-active components is high and stable. The cow urine is fresh cow urine having the presence of protein, urea, uric acid, creatinine, phenol, aromatic acids, enzymes like acid

phosphatase, alkaline phosphatase, amylase and vitamins as bioactive components of cow urine.
The dried cow urine powder has high percentage of total bio-active constituents as that of fresh
cow urine, the percentages of bio-active components are about 0.1 to 99% and the percentage of
volatile bio-active component is about 0.5 to 10 % and Non- Volatile bio-active component are
about 85 to 90%. The fresh cow urine is subjected to physical purification and adding
preservatives, Urine is collected, not limited to any specific species of bovine; the preferred are
healthy Indian breed.
The purified cow urine is stored at controlled temperature preferably from 20° C to 42 C
temperature and for 1 Hr to 168 Hr, preferably for lHr to 48 Hr.
Process for preparation of spray dried cow urine powder for Pharmaceutical formulation
comprising steps of
(a) collecting cow urine in sterile condition early in the morning ;
(b) Filter cow urine to remove physical impurities.
(c) adding preservative to processed cow urine;
(d) storing at controlled temperature and pressure;
(e) adding Excipients to cow urine mixture and subjecting to homogenization;
(f) Spray drying of Homogenous mixture at temperature 100-180 ° C under low pressure -90 to -200 mm.
(g) Irradiation of Gomutra powder to reduce bio-burden without affecting bioactive components
(h) Subjecting dried cow urine powder form to formulation as required.

Spray dried cow urine powder is capsulated or loose packed or nitrogen packed and gamma irradiation is in range of about 2.5 KGy to 10 KGy, collection of Cow urine belongs to Indian breed cow belongs to Geer, khillar, etc Indian breed .
Spray dried cow urine powder is used in Obesity, Cancer, Rheumatoid arthritis, Osteoarthritis, Skin Disorders.
DESCRIPTION OF THE INVENTION:
While the making and using of various embodiments of the present invention are discussed in detail below, it should be appreciated that the present invention provides many applicable inventive concepts that can be embodied in a wide variety of specific contexts. The specific embodiments discussed herein are merely illustrative of specific ways to make and use the invention and do not delimit the scope of the invention.
To facilitate the understanding of this invention, a number of terms are defined below. Terms defined herein have meanings as commonly understood by a person of ordinary skill in the areas relevant to the present invention. Terms such as "a", "an" and "the" are not intended to refer to only a singular entity, but include the general class of which a specific example may be used for illustration. The terminology herein is used to describe specific embodiments of the invention, but their usage does not delimit the invention, except as outlined in the claims.
In an embodiment of the present invention the process for preparation of gomutra powder comprises:

Collection of Urine: Collection of fresh cow urine from healthy cow.This collection process utilizes appropriate mean to collect cow's urine in sterile conditions. This Urine is collected form cow not limited to any specific species of bovine; the preferred are healthy Indian breed. Purified: The collected urine solution is then subjected to clarification to remove the foreign matters.This clarification is carried out by a filtration technique. This can also be done by centrifugation. The Purified urine is optionally subjected to sterilizationtechnique such as micro-filtration to minimize the microbial load.
Addition of Preservative: Preservatives are added to Purified urine.The preservatives are selected fromSodium Benzoate, Potassium Benzoate, Sodium propionate, Bromopronol, Ascorbic Acid within the range of about 0.1% to 0.5%
Most preferably selected preservativeis sodium benzoate and the concentration of preservative is selected from 0.1 % to 0.3%. The urine solution is then stored for 1 hr. to 168 hr. at controlled temperatureof about 20 C to 42°C and pressure. The urine solution is preferably stored for 1 hr. to 48 hr. at controlled temperature.
Addition of bulking agent: The bulking agents selected from Nachani powder, Gum acacia or Maltodextrine is added to above solution.The concentration of bulking agent are selected from group of Nachani powder (Eleusinecoracana), Gum Acacia,Maltodextrine, Cyprodextrine, Lactose in the range of 5% to 50% wt/wt, Starch. Then mixture is homogenized uniformly. Drying: Homogenous mixture is then subjected to spray drying at controlled temperature of about 100° C -180 ° C underlowpressure -90 to -200 mm (-900 to -2000 pascal) to form a powder.

Irradiation: Irradiation of powder to reduce bio-burden without affecting bioactive components
with gamma irradiation technique inthe rangeof about 2.5 KGy to 10 KGy
In another embodiment of the present invention the spry dried urine powder comprising of 0.1
%to 0.3 % of preservatives and 5% to50 wt. % of bulking agent.
In another embodiment of the present invention the spry dried urine powder comprising of 0.5 %
to 10 % of volatile bioactive components and 85 % to 90% of non-volatile bioactive
components.
The powder form is then subjected to formulation as required such as tablets, capsules, granules,
candy, effervescent granules, bar or combination thereof optionally after addition of
pharmaceutical acceptable excipients such as diluents, disintegrates, lubricants, and flow aids.
Accordingly one more embodiment, thegomutra powder ofthe present invention containshigh percentages of bio-active components and comprising of both volatile as well as non-volatile bio-active components.

The table 1 provides the percentage of bio-active components present in cow urine powder prepared according to present invention:

Sr. No. Name of Component Concentration Range
1 Protein 3-6 %
2 Uric acid 3-6 ppm
Total Phenol 0.5- 4 %
4 Vitamin C 200-400 ppm
5 Alkaline Phosphatase as PO4 0.1-0.5 ppm
6 Calcium 2000-7000 ppm
7 Phosphorus 300- 500 ppm
Table: 1 Percentage of Bio-active components in Cow urine powder
The Table 2 provides the percentage of bio-active components present in different cow urine
formulations.

Sr No. Name of components Gomutra powder Gomutra (Urine) GomutraArka Method used for analysis
1 Total Phenol 0.90 % 0.09% 0.05 % Folin-Ciocalteu's Method
2 Uric acid 5.4 ppm 3.3 ppm 0.2 ppm DGHS Manual
3 Protein 4.2 % 1.1% 2.7 % IS 7219-1973 RA: 2012
4 Vitamin C < 20 ppm < 20 ppm < 20 ppm AOAC 967.21
5 Alkaline Phosphate as PO4 <0.50 ppm <0.50 ppm <0.50 ppm APHA 4500P C
6 Calcium 2207 ppm 207ppm 39 ppm AOAC 985.35
7 Phosphorus as P 483 ppm <0.50 ppm <0.50 ppm APHA 4500P C
Table: 2 Percentage of Bio-active components in different cow urine formulations

The present invention is further described with the help of the following examples, which are given by way of illustration all the parts, percent's and ratios are by weight unless otherwise indicated and therefore should not be construed to limit the scope of the invention in any manner.
EXAMPLES:
Ingredients of composition in weight percentage range or in other unit in following conditions:
EXAMPLE 1:
The fresh cow urine (100 kg) was collected in the early morning from healthy cow. The collected urine solution was then filtered to remove the foreign matters. Then in purified urine Sodium benzoate (0.1kg) was added and mixed well. The urine solution is then stored for 48 Hr at controlled temperatureof about 25°C. Nachanipowder (8 kg),Gum acacia (1 kg) was added to above solution. Then mixture is homogenized uniformly.Homogenous mixture was then subjected to spray drying at controlled temperature of about 180 C under low pressure -2000pascal to form a powder. The powder was filled in size 0 capsules and Irradiated with gammairradiation inthe rangeof about2.5 to 10 KGy.
EXAMPLE 2: Stability Testing
The capsules prepared as per the examples lwere kept for stability testing under conditions given
as below:
Temperature condition: Room Temperature, 40°C/75% relative humidity and Refrigeration
Duration: 9 months
Products were tested for microbiological testing and total phenol content in products

At initial stage,

At completion of 3 month, At completion of 6 months, and \t completion of 9 months. The results of the study are represented in Table 3 and Table

Sr. Conditio Gomutra capsules Gomutra capsules at Gomutra capsules at
No. n → at Room Temperature 45°C/75%RH Refrigeration

Microbiological testing
1 Initial TBC-<101cfu/g TBC-< 101cfu/g TBC-< 101cfu/g
Y&M-<101cfu/g Y&M-<101cfu/g Y&M-<101cfu/g
Coliform-Absent Coliform-Absent Coliform-Absent
E. coli-Absent E. coli-Absent E. coli-Absent
Ps. aeruginosa- Ps. aeruginosa-Absent Ps. aeruginosa-
Absent S. aureus-Absent Absent
S. aureus-Absent Salmonella-Absent Salmonella-Absent S. aureus-Absznt Salmonella-Absent
2 3 Month TBC-<101cfu/g TBC-<10lcfu/g TBC-<101cfu/g
Y&M-<101cfu/g Y&M-<101cfu/g Y&M-< 101cfu/g
Co liform-Absent Coliform-Absent Coliform-Absent
E. coli-Absent E. coli-Absent E. coli-Absent
Ps. aeruginosa- Ps. aeruginosa-Absent Ps. aeruginosa-
Absent S. aureus-Absent Absent
S. aureus-Absent Salmonella-Absent Salmonella-Absent S. aureus-Absent Salmonella-Absent

3 6 Month TBC-< 101cfu/g TBC-< 10'cfu/g TBC-<10'cfu/g
Y&M-<101cfu/g Y&M-<10'cfu/g Y&M-<10'cfu/g
Coliform-Absent Coliform-Absent Coliform-Absent
E. coli-Absent E. coli-Absent E. coli-Absent
Ps. aeruginosa- Ps. aeruginosa-Absent Ps. aeruginosa-
Absent S. aureus-Absent Absent
S. aureus-Absent Salmonella-Absent Salmonella-Absent S. aureus-Absent Salmonella-Absent
4 9 Month TBC-<101cfu/g TBC-<101cfu/g TBC-<101cfu/g
Y&M-<101cfu/g Y&M-<101cfu/g Y&M-<101cfu/g
Coliform-Absent Coliform-Absent Coliform-Absent
E. coli-Absent E. coli-Absent E. coli-Absent
Ps. aeruginosa- Ps. aeruginosa-Absent Ps. aeruginosa-
Absent S. aureus-Absent Absent
S. aureus-Absent Salmonella-Absent Salmonella-Absent S. aureus-Absent Salmonella-Absent
Table: 3Microbiological results of stability studies

Sr.N
0 Conditio
n -^ Gomutra capsules at Room Temperature Gomutra capsules at 45°C/75% RH Gomutra capsules Refrigeration at

Total phenol content in %
1 Initial 1.69 1.69 1.69
2 3 Month 1.75 1.79 1.70
6 Month 1.48 1.30 1.51
4 9 Month 1.09 1.12 1.28
Table: 4 Total Phenol Content found in formulation kept for stability studies

All of the compositions and/or methods disclosed and claimed herein can be made and executed without undue experimentation in light of the present disclosure. While the compositions and methods of this invention have been described in terms of preferred embodiments, it will be apparent to those of skill in the art that variations may be applied to the compositions and/or methods and in the steps or in the sequence of steps of the method described herein without departing from the concept, spirit and scope of the invention. All such similar substitutes and modifications apparent to those skilled in the art are deemed to be within the spirit, scope and concept of the invention as defined by the appended claims.

CLAIMS We Claim,
1) Pharmaceutical formulation comprising of spray dried cow urine powder prepared from fresh cow urine at controlled temperature and pressure wherein percentage of bio-active components is high and stable.
2) Pharmaceutical formulation claimed in claim 1 wherein cow urine is fresh cow urine having the presence of protein, urea, uric acid, creatinine, phenol, aromatic acids, enzymes like acid phosphatase, alkaline phosphatase, amylase and vitamins as bioactive components of cow urine.
3) Pharmaceutical formulation as claimed in claim 1 wherein dried cow urine powder has high percentage of total bio-active constituents as that of fresh cow urine.
4) Pharmaceutical formulation as claimed in claim 1 wherein percentages of bio-active components are about 0.1 to 99%.
5) Pharmaceutical formulation as claimed in claim 1 wherein percentage of Volatile bioactive component is about 0.5 to 10 % and Non-Volatile bio-active component are about 85 to 90%.

6) Pharmaceutical formulation as claimed in claim 1 wherein cow urine powder that has improved stability.
7) Pharmaceutical formulation as claimed in claim 1 wherein Urine is collected, not limited to any specific species of bovine; the preferred are healthy Indian breed.
8) Pharmaceutical formulation as claimed in claim 1 wherein fresh cow urine is subjected to physical purification and adding preservatives.
9) Pharmaceutical formulation as claimed in claim 1 wherein purified cow urine is stored at controlled temperature preferably from 20° C to 42° C temperature and for 1 Hr to 168 Hr, preferably for lHr to 48 Hr.
10) Process for preparation of spray dried cow urine powder for Pharmaceutical formulation As claim 1 comprising steps of
(i) collecting cow urine in sterile condition early in the morning ; (j) Filter cow urine to remove physical impurities, (k) adding preservative to processed cow urine; (1) storing at controlled temperature and pressure;
(m)adding Excipients to cow urine mixture and subjecting to homogenization; (n) Spray drying of Homogenous mixture at temperature 100-180 °C underlowpressure -90 to -200 mm.

(o) Irradiation of Gomutra powder to reduce bio-burden without affecting bioactive
components (p) Subjecting dried cow urine powder form to formulation as required.
11) Spray dried cow urine powder as claimed in claim 1 wherein powder is capsulated or loose packed or nitrogen packed.
12) Spray dried cow urine powder as claimed in claim 1 wherein gamma irradiation is in range of about 2.5 KGy to 10 KGy.
13) Process for preparation of Spray dried cow urine powder as claimed I claim 10, wherein collection of cow urine is done from Indian cow breed belongs to Geer, khillar, Indian breed .
14) Spray dried cow urine powder is useful intreatment of Obesity, Cancer, Rheumatoid arthritis, Osteoarthritis, Skin Disorders.