FORM 2
THE PATENTS ACT, 1970
(39 of 1970)
&
The Patents Rules, 2003
COMPLETE SPECIFICATION
(See section 10 and rule 13)
1. TITLE OF THE INVENTION
"A novel herbal composition to supercharged the manly power in natural way and a process for preparation thereof
2. APPLICANT
(a) NAME ; ARKA BIOLOGICS PVT LTD
(b) NATIONALITY : A company registered in India under The Companies Registration act -1956
(c) ADDRESS : Celler, Kalash Appartment-2, B/H.Teiephone Exchange,
C.G.Road, Ahmedabad-3 80009
3. PREAMBLE TO THE DESCRIPTION
COMPLETE SPECIFICATION
The following specification particularly describes the invention and the manner in which it is to be performed and processed.

4. DESCRIPTION
FIELD OF INVENTION
A potent & novel herbal combination to supercharge the manly power in natural way and a process for preparation thereof
PRIOR ART
Today's life style is comprises of intense competition, work or life stress, poor dieting habits, consumption of chemicals and pesticides in diet, smoking, consumption of alcohol, drug abuse which results into Testosterone deficiency in men.
Due to Testosterone deficiency, people are experiencing decrease in energy, decrease in stamina, less or no motivation, decrease in sexual desire, frequent mood swings, poor concentration, loss of memory, obesity, increase body fat and mental fatigue.
At market, there are alternative compositions which elevate the level of Testosterone, but they offer nasty side effects on once life & hence there is genuine need of herbal solutions which help them to perform fullest both in personal and professional life.
Other category of available alternatives to increase in energy, sexual power & vitality are as below.

1, Revital -Vitamins & Minerals (Normal combination) and Ginseng

REVITAL
Vitamin A 2000 I.U
Vitamin B2 1.5 mg
Vitamin B5 5mg
Vitamin B12 1 meg
Vitamin D3 200 I.U
Folic Acid 0.12 mg
Ferrous Fumarate 17 mg
Magnesium 3mg
Calcium 75 mg
Vitamin Bl lmg
Vitamin B3 10 mg
Vitamin B6 1 mg
Vitamin C 40 mg
Vitamin E 5 mg
Zinc 10 mg
Iodine 0.1 mg
Manganese 0.5 mg
Copper 0.5 mg
Ginseng extract powder (Highly concentrated, standardized Ginseng extract corresponding to 212.5 mg of root of Panax Ginseng) 42.5 mg

2. Stay on: Ayurvedic ingredients + Ginseng

STAY ON
Laung 4%
Taalamkhaana 5%
Beejbank 4%
Salampanja 4%
VidarikandSatva 4%
Jaaypatti 6%
Akarkara 6%
Pipal 5%
Kaunch 6%
Shatawari 5%
Utigan 4%
Shilajit 3%
BangBhasam 0%
Makardwaj 2%
Ginseng 10%
Safed Musli 8%
Jaiphal 7%
Ashwagandha Satva 6%
Gokhru Satva 5%

3. Shilajit Gold: Ayurvedic ingredients + Tribulus terrestris

SHILAJIT GOLD
Kewanch extract 90 mg
Gokshur extract 90 mg
Ashwagandha extract 75 mg
Shudha Shilajit 50 mg
Safed Mushali 50 mg
Barahikand 45 mg
Bedarikand 45 mg
Yasad Bhasma 15 mg
Dalchini 10 mg
Akarkara 10 mg
Lavang 10 mg
Kesar 10 mg
Kapoor 9mg
Rajat Bhasma 5mg
Nutmeg Oil 3mg
Swama Bhasma 1 mg

4. Vigorex -: Ayurvedic ingredients + Tribulus terrestris

VIGOREX
Mucuna pruriens Sd 125 m
Asparagus adscendens Rt 100 mg
Tribulus terrestris Frt 75 mg
Withania somnifera Rt 50 mg
Black asphaltum 50 mg
Myristica fragrans Sd 25 mg
Yasad Bhasma 25 mg
Abhrak Bhasma 25 mg
Praval Bhasma 25 mg
Svarna Bhasma 0.5 mg
Suddha Karpur Excipients 5mg

DRAWBACKS OF PRIOR ART
Limitations of aforesaid combinations
1. No role in increasing immune system
2. External source of energy & not natural source of energy
3. In-adequate role in Testosterone elevation
4. Limited benefits in sexual health or sexual activities however no role in overall wellbeing of health.
OBJECTIVE OF INVENTION:
The primary objective of the present invention is to propose a novel & potent herbal composition and process for preparation thereof effective in


Increase in blood circulation Increase in energy and stamina Increase in male function Increase in sperm count Increase in sexual desire, endurance Increase in overall performance Normalizing growth hormones


Activates body's ability to produce it's natural testosterone and other vital hormones
Improving overall quality of life, well-being & behaviour
Improving mental fatigue, exhaustion and slow the aging process
Improves Erectile Dysfunction and semen volume
Bodybuilders to increase muscle mass and strength
It motivates naturally
It has already been proposed for "anti-aging" remedy and modern supplements are to improve libido, energy, sports performance and weight loss.
The principle object of this invention is to stimulate release of free testosterone, improve sex drive, reduce fatigue, and improve well-being.
Another object of this invented composition is to provide significantly effective and safe alternative to treat Testosterone Deficiency Syndrome (TDS) which is characterized by numerous symptoms, including low libido, increased fat mass, mental fatigue, erectile dysfunction, osteoporosis and decrease in energy.
Another object of this invented composition is to control the testosterone levels which is closely associated with major disease and medical conditions such as obesity, metabolic syndrome, diabetes or hypertension.
The further object of this novel composition is to increases fat free mass, muscle strength, and muscle mass, which are important for physical function and athletic performance.
The further object of this novel composition is to control the progressive bone loss and to have significant positive effects on bone health.

STATEMENT OF INVENTION:
According to this invention there is provided a novel herbal composition effective in increasing natural energy level comprises of 100 mg of Tongkat Ali (Eurycoma Longifolia Jack), 50 mg of Tribulus Terrestris (Gokshura/ Sarrata, Caltrop, Puncture Vine), 10 mg-Epimedium or Homy Goat Weed, 50 mg of Pananax Ginsang, 15 mg of Zinc & other ingredients such as Starch, Magnesium Steatrate, Di calcium Phosphate, Talc, Polyvinyl Pyrolidone.
Further there is provided a novel herbal composition effective in increasing energy, stamina, endurance & performance, where in the process of preparation of a novel herbal composition comprising of:
• Sizing, grinding, drying, extraction with solvent deionised water, filtration & product concentrate separately each for Tongkat Ali, Panax Ginseng
• Pulverization, potentiating, decotion separately followed by Sorted, dedusted, washed & rewashed in DM water, shadow dried for Tribulus Terrestris
• Extraction of Horny goat weed / Epimedium subjected to concentration
• Mixing of extracts or powder form thus obtained followed by drying

DETAIL DESCRIPTION OF THE INVENTION
The herbal composition of the present invention comprises of the following ingredients with specified amounts, which may be taken as an example without restricting the scope of the invention to the same.

Tongkat Ali (Eurycoma Longifolia Jack) 100 mg -200 mg
Tribulus Terrestris (Gokshura/ Serrata) 50mg-100mg
Horny Goat Weed (Epimedium) 10mg-20mg
Panax Ginseng 50mg-100mg
Zinc 15mg-30mg
The process for preparation of the herbal composition comprising Process, Modelling, Optimisation, Scale Up
PROCESS DESCRIPTION
The aforesaid novel herbal composition is contains extracted herbal content mainly of Tongkat All also known as "Eurycoma Longifolia Jack", Tribulus Terrestris also known as "Gokshura/ Serrata", Horny Goat Weed also known as "Epimedium", "Panax Ginseng".
The aforesaid herbal contents are extracted using any of below alternative processes.
EXTRACTING TONGKAT ALI
Extracting a herb called "TONGKAT ALI" using any of below methods.

METHOD-1:
Tongkat AH root dried, extraction is been carried out by using aqueous alcohol, followed by filtration & Concentration of extract This process is continued with Spray Drying, Powdering, Sieving, Blending and again Sieving.
METHOD - 2:
a. Chipping: Chipped Tongkat Ali root sent to the extraction vessel maintaining
solvent of boiled water, ratio 6 L: 1 kg.
b. Extraction: Tongkat Ali roots then boiled with water at 110-1208°C. for 2 hours,
followed by second extraction.
c. Extract from the first extraction stage is sent to the spray dryer operated at 1708 °C.
to produce Tongkat Ali extract powder.
METHOD-3:
a. This includes the Tongkat Ali root chips, fibre, residue and extract. After Heating,
extraction & product discharge, extraction solvent charging is the subsequent
operation
b. Extract-water and solid mixture was sent to the centrifugation procedure and finally
spray drying procedure (P-6/SDR-101) at a flow rate of 0.12 L min21 (with ambient
air at l708°C.)

EXTRACTING TRIBULUS TERRESTRIS
Extraction of "TRIBULUS TERRESTRIS" fruit, Stem, Root & Leaves any or all.using any of below methods.
METHOD-1:
Tribulus terristris fruit, Stem, Root & Leaves are dried, Repeated Extraction is been carried out by using Water, followed by Filtration & Concentration of extract This process is continued with Spray drying, Powdering, Sieving, Blending, Heat sterilizing and again Sieving.
METHOD-2:
a. Samples to air dried at 250°C. The materials were triturated in an electrical grinder
to obtain a fine powder & passed through a stainless-steel sieve.
b. Reagents to use: Chloroform, Methanol & Ethanol. Extraction solution, Ethanol
(30%, 50%, 70% and 100%), methanol & pure water were tested under the same
microwave parameter.
c. Under the optimum FMAE conditions, the filtrated extracts were collected in a
graduated cuvette and then distilled under vacuum. Aq. hydrochloric acid (2 mol/L,
15 mL) was added.
d. Hydrolysis temp, maintained at 90 C for 1 hour by using a water bath mixtures of
steroidal sapogenins were obtained on acid hydrolysis of the saponins. Then the
extracts were distilled under vacuum again. The residue was dissolved with 5 mL

METHOD-3:
a. Exhaustive Soxhlet extraction was performed using a classical Soxhlet
apparatus with an accurate measure of l.0g of Tribuius Terrestris fruit, Stem,
Root & Leaves powder for 24 hours.
b. Extraction was performed with ethanol as the extracting solvent. The extraction
was conducted for 8h/time for 3 times. Every time, the previous extract was
removed, and then 50mL fresh ethanol was added.
EXTRACTING HORNEY GOAT WEED OR EPIMEDIUM
Extracting "HORNEY GOAT WEED" also known as "EPIMEDIUM HERB" using any of below methods.
METHOD-1:
The Horny goat weed is dried, repeated extraction is been carried out by using water, followed by filtration & concentration of extract. This process is continued with spray drying & powdering, Sieving, Blending; Heat sterilizing & again Sieving
METHOD -2:
Extraction is done by using ultrasonic probe system, extraction temperature of 50°C, methanol concentration 60% (v/v), ratio of liquor to solid 30 mL g_1, and ultrasonication time 15 min, ultrasound enhanced the mass transfer of the solvents into the leaf materials and the soluble constituents into the solvents.

EXTRACTING PANAX GINSENG
Extracting "PANAX GINSENG" using any of below methods.
METHOD-1:
In the first step mature Panax Ginseng roots to select, cut them into small sizes. Further extraction to done by using water/alcohol- This process to continue with filtration, concentration, spray drying & finally grind into powder.
METHOD-2:
a. The extraction is performed by percolation with aqueous alcohol solution (60%) and
then concentration under vacuum to dryness or percolation with propylene glycol followed by concentration under vacuum.
b. The solvent for the root extract propylene glycol, propylene glycol + water, propylene
glycol + dicaprylate/dicaprate + butylene glycol + ethanol, ethanol + water, glycerin + water, caprylic/capric + triglyceride, or helianthus annuus (sunflower) seed oil.
At the end of the process, the powders and extracts obtained using any of above method are mixed together with suitable preservative and diluents.

WE CLAIM
(1) A novel and potent herbal composition is effectively useful for
- Increasing the blood circulation.
- Boost sexual power
- Increases overall energy, stamina, endurance & performance
- Increases the duration of intercourse and pleasure
- Facilitates muscle growth, fat free mass and enlargement of penis
- Enhancing the natural defence system of the body
- Improves sex drive and performance during intercourse
- Improvement in fertility by improving quality of semen, promote lean muscle growth and stimulate sexual desire.
- Helping body to make its own testosterone and thereby reduce the effects of andropause.
- Increasing the sperm growth in men's body and thus helps men to treat the problems of infertility.
- Significantly gaining in libido, erectile function and semen volume.
- Helps to regulate chronic stress and reduces tension, anger and confiision.
- Helps in decreasing mental fatigue and exhaustion.
- Maintaining bone health by controlling a progressive bone loss.
- Help against malaria and fevers, soothe lower back pain
- Normalize the growth hormone levels
Significantly performing as a sexual stimulant for women both as a libido and pleasure enhance

Comprising of Tongkat Ali (Eurycoma Longifolia Jack) Root extracts.
(2) A novel and potent herbal composition significantly effective and useful in various ways as claimed in claim-1 and having content ratio Comprising of Tongkat Alt (Eurycoma Longifolia Jack) Root extracts 100 mg - 200 mg, Tribulus Terrestris (Gokshura / Serrata) 50 mg -100 mg, Epimedium or Homy Goat Weed 10 mg - 20 mg, Panax Ginseng 50 mg -100 mg, Zinc 15 mg - 30 mg, Starch, Dicalcium phosphate, Magnesium stearate, Polyvinylpyrrolidone, Talc
(3) A novel and potent herbal composition which is effectively useful as mentioned in claim-1 whereas the ratio of comprising contents are more or less than mentioned in claim-2.
(4) A novel and potent herbal composition significantly effective and useful in various ways as claimed in claim-1 and having content ratio as mentioned in claim-1,2,3 wherein the process of preparation of a novel herbal composition comprising extracting method as below :
a. Extracting "TONGKAT ALI" whereas Tongkat Ali root dried, extraction is carried out by using aqueous alcohol, followed by filtration & Concentration of extract. This process is continued with Spray Drying, Powdering, Sieving, Blending, again Sieving.
b. Extracting "TRIBULUS TERRESTRIS" whereas Tribulus terristris fruit, Stem, Root & Leaves any or all are dried, Repeated Extraction is been carried out by using Water, followed by Filtration & Concentration of

extract. This process is continued with Spray drying, Powdering, Sieving, Blending, Heat sterilizing, and again Sieving.
c. Extracting "HORNEY GOAT WEED" or "EPIMEDIUM" whereas the Homy goat weed is dried, repeated extraction is been carried out by using water, followed by filtration & concentration of extract. This process is continued with spray drying & powdering, Sieving, Blending; Heat sterilizing, again Sieving.
d. In the first step mature Panax Ginseng roots to select, cut them into small size, followed by extraction with water/alcohol, filtration, concentration & spray drying & finally grind into powder.
(5) A process of preparation of a novel and potent herbal composition as claimed in claim-4 wherein the "TONGKAT ALT' is extracted in following steps:
a. Tongkat Ali root chips are sent to the extraction vessel maintaining solvent of
boiled water, ratio 6 L: 1 kg.
b. Tongkat Ali roots are boiled with water at 110 - 1208°C for 2 hours, followed by
second extraction.
c. Extract from the first extraction stage is sent to the spray dryer operated at 1708°C
to produce Tongkat Ali extract powder.

(6) A process of preparation of a novel and potent herbal composition as claimed in claim-4
wherein the 'TONGKAT ALI" is processed in following steps:
a. The Tongkat Ali root chips, fibre, residue and extract. After Heating, extraction & product discharge, extraction solvent charging is the subsequent operation
b. Extract-water and solid mixture was sent to the centrifugation procedure and finally spray drying procedure (P-6/SDR-101) at a flow rate of 0.12 L min21 (with ambient air at 1708°C)
(7) A process of preparation of a novel and potent herbal composition as claimed in claim-4
wherein the "TRIBULUS TERRESTRIS" fruit, Stem, Root & Leaves any or all are
processed in following steps:
a. Tribulus terrestris fruit, Stem, Root & Leaves any or all are air dried at 250°C. The
materials were triturated in an electrical grinder to obtain a fine powder & passed
through a stainless-steel sieve.
b. Reagents to use: chloroform, methanol & ethanol. Extraction solution, Ethanol
(30%, 50%, 70% and 100%), methanol & pure water were tested under the same
microwave parameter.
c. Under the optimum FMAE conditions, the filtrated extracts were collected in a
graduated cuvette and then distilled under vacuum. Aq. hydrochloric acid (2 mol/L,
15 mL) was added.

d. Hydrolysis temp, maintained at 90°C. for 1 hr by using a water bath. Mixtures of steroidal sapogenins were obtained on acid hydrolysis of the saponins. Then the extracts were distilled under vacuum again. The residue was dissolved with 5 mL
(8) A process of preparation of a novel and potent herbal composition as claimed in claim-
4 wherein the "TRIBULUS TERRESTRIS" fruit, Stem, Root & Leaves any or all are
processed in following steps:
a. Exhaustive Soxhlet extraction was performed using a classical Soxhlet
apparatus with an accurate measure of 1 .Og of Tribulus Terrestris fruit, Stem,
Root & Leaves powder for 24 hours.
b. Extraction was performed with ethanol as the extracting solvent. The
extraction was conducted for 8h/time for 3 times. Every time, the
previous extract was removed, and then 50mL fresh ethanol was added.
(9) A process of preparation of a novel and potent herbal composition as claimed in
claim-4 wherein the "HORNEY GOAT WEED" is extracted by using ultrasonic probe
system, extraction temperature of 50°C, methanol concentration 60% (v/v), ratio of
liquor to solid 30 mL g-1, and ultrasonication time 15 min, ultrasound enhanced the
mass transfer of the solvents into the leaf materials and the soluble constituents into the
solvents.

(10) A process of preparation of a novel and potent herbal composition as claimed in claim-4 wherein the "PANAX GINSENG" is extracted by percolation with aqueous alcohol solution (60%) and then concentration under vacuum to dryness or percolation with propylene glycol followed by concentration under vacuum. Then the solvent for the root extract propylene glycol, propylene glycol + water, propylene glycol dicaprylate/dicaprate, butylene glycol, ethanol, ethanol + water, glycerin + water, caprylic/capric triglyceride, or helianthus annuus (sunflower) seed oil.
(11) A process of preparation of a novel and potent herbal composition as claimed in any of claims 3-8, wherein the powders and extracts thus obtained are mixed together with suitable preservative and diluents.