FORM 2
THE PATENTS ACT, 1970
(39 OF 1970)
&
THE PATENTS RULES, 2003
COMPLETE SPECIFICATION
(See Section 10 and rule 13)
"STABLE SYNERGISTIC AYURVEDIC COMPOSITION FOR HIGHER
ENERGY AND ALERTNESS"
TRIQUETRUS ESSENTIALS PVT. LTD.
An Indian Company
523, Shri Saisadan, Road No. 12, Chembur East, Mumbai, Maharashtra, India-
400071
The following specification particularly describes the invention and the manner in
which it is to be performed

FIELD OF THE INVENTION
The present invention relates to a stable synergistic ayurvedic composition of herbal extracts of green tea, amla, ashwagandha, kaucha and safed musli and its method of preparation.
BACKGROUND OF THE INVENTION
Green tea is made from Camellia sinensis which is a shrub or small tree whose leaves and leaf buds are used to prepare tea. This plant is cultivated in many parts of world. According to literature survey, it is used in cardiovascular diseases, improving physical performance, glycemic control, hyperlipidemia, inflammation, weight loss and as an antioxidant. Chemically it contains phytochemicals such as polyphenols, caffeine and flavanols.
Amla also known as Phyllanthus emblica is a fruit used in traditional Indian medicine. It helps in reducing blood sugar, improving immunity unity and has anti¬inflammatory properties. It is used in dried or fresh fruit form. Amla is sour and astringent in taste. It is mostly used in digestive preparations. The fruits contain high amounts of ascorbic acid (Vitamin C).
Ashwagandha also known as Withania somnifera is a plant used as a medicinal herb in ayurvedic medicine. Chemically it contains alkaloids and steroidal lactones. It helps in reducing the stress, anxiety, and depression.
Kaucha also known as Mucunapruriens is a legume, annual climbing shrub. The seeds of the plant contains L-DOPA, serotonin and bufotenin.
Chlorophytum borivilianum commonly known as Musli or safed musli is a herb with lanceolate leaves, found mostly in tropical wet forests from peninsular India. Chemically it contains saponins and alkaloids which are responsible for its aphrodisiac properties which helps in mind calming.
Although all the above components are used individually or in combination with other ayurvedic medicines, there is still need to prepare a composition which can be administered orally with better human compliance. The present invention provides a composition which can be given orally with better human compliance.

The composition of the present invention is found to improve energy and alertness in human. Composition comprises herbal extracts such as green tea, amla, ashwagandha, kaucha and safed musli. Composition of the present invention is prepared in the form of syrup, chewing gum
OBJECTIVE OF THE INVENTION
An objective of the present invention is to provide a stable synergistic ayurvedic composition comprising herbal extracts of green tea, amla, ashwagandha, kaucha and musli.
Another objective of the present invention is to provide a stable synergistic liquid ayurvedic composition comprising herbal extracts of green tea, amla, ashwagandha, kaucha and musli.
Another objective of the present invention is to provide a stable synergistic solid ayurvedic composition comprising herbal extracts of green tea, amla, ashwagandha, kaucha and musli.
Another objective of the present invention is to provide a stable synergistic ayurvedic composition comprising herbal extracts of green tea, amla, ashwagandha, kaucha and musli in the form of gel.
Another objective of the present invention is to provide a stable synergistic ayurvedic composition comprising herbal extracts of green tea, amla, ashwagandha, kaucha, musli and excipients acceptable in foods or pharmaceuticals.
Another objective of the present invention is to provide a process for the preparation of a stable synergistic ayurvedic composition comprising herbal extracts of green tea, amla, ashwagandha, kaucha and musli.
Further objective of the present invention is to provide a stable synergistic ayurvedic composition which provides higher energy and alertness in humans.

DETAILED DESCRIPTION OF THE INVENTION
Accordingly, the present invention relates to the stable synergistic ayurvedic composition comprising herbal extracts of green tea, amla, ashwagandha, kaucha, musli and other excipients.
The extracts according to the present invention were prepared by decoction method. Green tea (10 kg), amla (7.5 kg), ashwagandha (5 kg), kaucha (10 kg) and safed musli (3.5 kg) subjected to pulverization. The coarse powder obtained after pulverization is subjected to decoction with 200 liters of water as a solvent. The process is carried out for 4 hours to get 100 liters of decoction liquid. This decoction liquid is then subjected to sedimentation for 15 hours to get solid extracts. The extracts obtained are used in the preparation of the compositions of the present invention.
Ayurvedic composition of the present invention is in the form of liquid, preferably in the form of syrup. Further ayurvedic composition of the present invention is in solid form, preferably in the form of chewing gum. Further ayurvedic composition of the present invention is in gel form. Further ayurvedic composition of the present invention is with or without sugar. The composition according to the present invention is administered through oral route.
The composition of the present invention comprises herbal extracts of green tea, amla, ashwagandha, kaucha, musli and excipients acceptable in foods or pharmaceuticals. The term excipients comprises pharmaceutically acceptable or food grade excipients such as sweetener, flavoring agents and preservatives.
As per one embodiment of the present invention, suitable sweetener used in the syrup composition is selected from, but not limited to one or more monosaccharides, disaccharides and polysaccharides, eg. glucose, mannose, galactose, fructose, sucrose, maltose, invert sugar, mannitol, xylitol, sorbitol, steviosides or glycyrrhizin; saccharin in free acid form, soluble saccharin salts, eg. sodium or calcium saccharin salts; acesulfame; dipeptide based sweeteners, such as L-aspartic acid derived sweeteners, eg. aspartame; water soluble sweeteners derived from naturally occurring water soluble sweeteners, e.g. sucralose or mixtures thereof.

As per one embodiment of the present invention, suitable flavoring agent used in the syrup composition is selected from, but not limited to citric acid or its salts, menthol, banana, strawberry, peppermint and spearmint or mixtures thereof.
As per one embodiment of the present invention, suitable preservative used in the syrup composition is selected from, but not limited to sodium sorbate, sodium benzoate, sodium ascorbate, lactic acid or mixtures thereof.
For the purpose of the present invention the solvents to dissolve or disperse the active ingredients or excipients is water.
The syrup composition according to the present invention can be administered once, twice or thrice daily. Preferably the composition of the present invention can be administered twice daily. Preferably the composition of the present invention can be administered when humans are low with energy and alertness. The amount of syrup administered as per the present invention varies from 10ml to 30ml. The amount of herbal extracts present in the 10ml syrup composition include 0.20mg Green tea extract, 0.15mg amla extract, 0.10mg ashwagandha extract, 0.20mg kaucha extract and 0.07mg safed musli extract. The amount of herbal extracts present in the 30ml syrup composition include 0.60mg green tea extract, 0.45mg amla extract, 0.30mg ashwagandha extract, 0.60mg kaucha extract and 0.21mg safed musli extract.
In one of the embodiment of the present invention the composition prepared is in the form of chewing gum. The gum base used in the chewing gum of the present invention may comprise any suitable gum base known in the prior art, including natural gum bases, such as chicle, jelutong, gutta percha and crown gum or synthetic gum materials such as butadiene-styrene rubber, isobutylene isoprene copolymer, paraffin, petroleum waxes, polyethylene, polyisobutylene polyvinyl acetate, or blends thereof. In a preferred embodiment, the gum base used in the present invention is synthetic gum base.
The chewing gum composition comprises gum base in the concentration from about 5 to 50%, preferably from about 10 to 40%. The chewing gum according to the present invention can also contain additives such as sweeteners, flavours,

dehydration agents, pH stabilizers, inclusion agents, lubricants and compression adjuvants.
As per one embodiment of the present invention, suitable sweetener used in the chewing gum composition is selected from, but not limited to one or more monosaccharides, disaccharides and polysaccharides, eg. glucose, mannose, galactose, fructose, sucrose, maltose, invert sugar, mannitol, xylitol, sorbitol, steviosides or glycyrrhizin; saccharin in free acid form, soluble saccharin salts, eg. sodium or calcium saccharin salts; acesulfame; dipeptide based sweeteners, such as L-aspartic acid derived sweeteners, eg. aspartame; water soluble sweeteners derived from naturally occurring water soluble sweeteners, e.g. sucralose or mixtures thereof.
As per one embodiment of the present invention, suitable flavoring agent used in the chewing gum composition is selected from, but not limited to citric acid or its salts, menthol, banana, strawberry, peppermint and spearmint or mixtures thereof.
As per one embodiment of the present invention, suitable preservative used in the chewing gum composition is selected from, but not limited to sodium sorbate, sodium benzoate, sodium ascorbate, lactic acid or mixtures thereof.
As per one embodiment of the present invention, suitable compression adjuvants which facilitate the compression of chewing gum include silicon dioxide, magnesium stearate, behenic acid and talc or mixtures thereof.
The chewing gum composition according to the present invention can be administered once, twice or thrice daily. Preferably the composition of the present invention can be administered twice daily. Preferably the composition of the present invention can be administered when humans are low with energy and alertness. The amount of herbal extracts present in the chewing gum composition include 0.60 mg green tea extract, 0.45 mg amla extract, 0.30 mg ashwagandha extract, 0.60 mg kaucha extract and 0.21 mg musli extract.
In one of the embodiment of the present invention the composition prepared is in the form of gel. The gel according to the present invention can also contain

additives such as sweeteners, flavors, dehydration agents, pH stabilizers, inclusion agents and preservatives.
As per one embodiment of the present invention, suitable sweetener used in the gel composition is selected from, but not limited to one or more monosaccharides, disaccharides and polysaccharides, eg. Glucose, mannose, galactose, fructose, sucrose, maltose, invert sugar, mannitol, xylitol, sorbitol, maltitol, erythritol, steviosides or glycyrrhizin; saccharin in free acid form, soluble saccharin salts, eg. sodium or calcium saccharin salts; acesulfame; dipeptide based sweeteners such as L-aspartic acid derived sweeteners, eg. aspartame; water soluble sweeteners derived from naturally occurring water soluble sweeteners, e.g. sucralose or mixtures thereof.
As per one embodiment of the present invention, suitable flavoring agent used in the gel composition is selected from, but not limited to citric acid or its salts, menthol, banana, strawberry, honey, peppermint and spearmint or mixtures thereof.
As per one embodiment of the present invention, suitable preservative used in the gel composition is selected from, but not limited to sodium sorbate, sodium benzoate, sodium ascorbate, lactic acid or mixtures thereof.
The geJ composition according to the present invention can be administered once, twice or thrice daily. Preferably the composition of the present invention can be administered twice daily. Preferably the composition of the present invention can be administered when humans are low with energy and alertness. The amount of gel composition administered as per the present invention varies from 10ml to 30ml. The amount of herbal extracts present in the 10ml gel composition include 0.20mg Green tea extract, 0.15mg amla extract, 0.10mg ashwagandha extract, 0.20mg kaucha extract and 0.07mg musli extract. The amount of herbal extracts present in the 30ml gel composition include 0.60mg green tea extract, 0.45mg amla extract, 0.30mg ashwagandha extract, 0.60mg kaucha extract and 0.21mg musli extract.
Further the composition of the present invention provides higher energy and alertness in the humans.

The following examples are intended to be illustrative and non-limiting, and represent specific embodiment of the present invention
Example 1
Ayurvedic syrup composition according to the present invention is disclosed in Table 1 Table 1

Name of the ingredient Quantity required per 10 ml Quantity required per 30 ml
Green tea extract 0.20 gm 0.60 gm
Amla extract 0.15 gm 0.45 gm
Ashwagandha extract 0.10 gm 0.30 gm
Kaucha extract 0.20 gm 0.60 gm
Safed Musli extract 0.07 gm 0.21 gm
Citric acid 1.70 gm 5.10gm
Sorbitol 2.20 gm 6.60 gm
Sodium Benzoate 0.02 gm 0.06 gm
Sugar 2.80 gm 8.40 gm
Sodium Citrate 0.48 gm 1.44 gm
Salt 0.10 gm 0.30 gm
Flavor 0.12 ml 0.36 ml
Water 6.66 ml 19.98 ml
Process for the preparation of ayurvedic syrup composition:
Weigh sugar and sorbitol and mix them in water with stirring in step 1. Weigh all the herbal extracts in proper proportion in step 2. Mix and heat the components of step 1 and 2 in the reactor at 85°C. Add sufficient water to get proper homogenization in the reactor. Add salt, sodium citrate, and citric acid to the reactor. Add sodium benzoate to the reactor. Add flavors and homogenize the formulation.

Example 2
Sugar free ayurvedic syrup composition according to the present invention is
disclosed in Table 2
Table 2

Name of the ingredient Quantity required per 10 mi Quantity required per 30 ml
Green tea extract 200 mg 600 mg
Amla extract 150 mg 450 mg
Ashwagandha extract 100 mg 300 mg
Kaucha extract 200 mg 600 mg
Safed musli extract 70 mg 210 mg
Citric acid monohydrate l00mg 300 mg
Sodium citrate 28 mg 84 mg
Sodium benzoate 20 mg 60 mg
Maltitol 0.75 g 2.25 g
Erythritol 0.75 g 2.25 g
Sucralose 7.5 mg 22.5 mg
Sodium saccharin 3mg 9mg
Acesulfame Potassium 3mg 9mg
Flavour 0.075 ml 0.225 ml
Water 8 ml 24 ml
Process for the preparation of sugar free ayurvedic syrup composition:
Weigh maltitol, erythritol, sucralose and mix them in water with stirring in step 1. Weigh all the herbal extracts in proper proportion in step 2. Mix and heat the components of step 1 and 2 in the reactor at 85°C. Add sufficient water to get proper homogenization in the reactor. Add sodium saccharin, acesulfame potassium, citric acid monohydrate, sodium citrate, and citric acid to the reactor. Add sodium benzoate to the reactor. Add flavors and homogenize the formulation.

Example 3
Ayurvedic chewing gum composition according to the present invention is disclosed in Table 3 Table 3

Name of the ingredient Quantity for 10 Quantity for 30 g
Green tea extract 0.20 g 0.60 g
Amla extract 0.15 g 0.45 g
Ashwagandha extract 0.10g 0.30 g
Kaucha extract 0.20 g 0.60 g
Safed Musli extract 0.07 g 0.21 g
Citric acid 0.10 g 0.30 g
Sodium benzoate 0.02 g 0.06 g
Sugar 3.50 g 10.50 g
Sodium citrate 0.01 g 0.03 g
Sucralose 6mg 18 mg
Acesulfame Potassium 4mg 12 mg
Flavor 0.02 ml 0.06 ml
Gum base 4.50 g 13.50 g
Magnesium stearate 0.84 g 2.51 g
Talc 0.042 g 1.25 g
Process for the preparation of ayurvedic chewing gum:
Weigh all the ingredients properly. Herbal extracts were mixed for 15 minutes with citric acid, sorbitol, sodium benzoate, sugar, sodium citrate, salt, flavor and gum base. To this mixture magnesium stearate and talc were added and mixed for 2 minutes. The mixture was further compressed into tablets.

Example 4
Ayurvedic sugar free chewing gum composition according to the present invention is disclosed in Table 4 Table 4

Name of the ingredient Quantity for 10 Quantity for 30 g
Green tea extract 0.20 g 0.60 g
Amla extract 0.15 g 0.45 g
Ashwagandha extract 0.10 g 0.30 g
Kaucha extract 0.20 g 0.60 g
Musli extract 0.07 g 0.21 g
Citric acid 0.10g 0.30 g
Sodium benzoate 0.02 g 0.06 g
Erythritol 1.00 g 3.00 g
Maltitol 1.00 g 3.00 g
Sodium citrate 0.01 g 0.03 g
Sucralose 6mg 18 mg
Sodium Saccharine 4mg 12 mg
Acesulfame Potassium 4mg 12 mg
Flavor 0.02 ml 0.06 ml
Gum base 4.50 g 13.50 g
Magnesium stearate 1.50 g 4.50 g
Talc 0.50 g 1.50 g
Process for the preparation of ayurvedic chewing gum:
Weigh all the ingredients properly. Herbal extracts were mixed for 15 minutes with citric acid, sorbitol, sodium benzoate, sugar, sodium citrate, salt, flavor and gum base. To this mixture magnesium stearate and talc were added and mixed for 2 minutes. The mixture was further compressed into tablets.

Example 5
Ayurvedic gel composition according to the present invention is disclosed in Table 4 Table 5

Name of the ingredient Quantity required per 10 ml Quantity required per 30 ml
Green tea extract 200 mg 600 mg
Amla extract 150 mg 450 mg
Ashwagandha extract 100 mg 300 mg
Kaucha extract 200 mg 600 mg
Safed musli extract 70 mg 210 mg
Citric acid monohydrate 100 mg 300 mg
Sodium citrate 28 mg 84 mg
Sodium benzoate 20 mg 60 mg
Sugar 6g 18g
Carboxymethyl cellulose 30 mg 90 mg
Flavour 0.075 ml 0.225 ml
Sodium saccharin 6 mg 18 mg
Acesulfame K 6mg 18mg
Water 5 ml 15 ml
Process for the preparation of ayurvedic gel composition:
Weigh sugar, sorbitol and mix them in water with stirring in step 1. Weigh all the herbal extracts in proper proportion in step 2. Mix and heat the components of step 1 and 2 in the reactor at 85°C. Add sufficient water to get proper homogenization in the reactor. Add sodium saccharin, acesulfame K, sodium citrate, and citric acid to the reactor. Add sodium benzoate to the reactor. Add carboxymethyl cellulose to the reactor. Add flavors and homogenize the formulation.

Example 6:
Sugar free ayurvedic gel composition according to the present invention is disclosed in Table 6 Table 6

Name of the ingredient Quantity required for 10 ml Quantity required for 30 ml
Green tea extract 200 mg 600 mg
Amla extract 150 mg 450 mg
Ashwagandha extract 100 mg 300 mg
Kaucha extract 200 mg 600 mg
Safed musli extract 70 mg 210 mg
Citric acid monohydrate 100 mg 300 mg
Sodium citrate 28 mg 84 mg
Sodium benzoate 20 mg 60 mg
Maltitol 0.75 g 2.25 g
Erythritol 0.75 g 2.25 g
Carboxymethyl cellulose 50 mg 150 mg
Flavour 0.075 ml 0.225 ml
Sucralose 7.5 mg 22.5 mg
Sodium saccharin 3 mg 9mg
Acesulfame K 3mg 9mg
Water 7.5 ml 22.5 ml
Process for the preparation of ayurvedic gel composition:
Weigh maltitol, erythritol and sucralose and mix them in water with stirring in step 1. Weigh all the herbal extracts in proper proportion in step 2. Mix and heat the components of step 1 and 2 in the reactor at 85°C. Add sufficient water to get proper homogenization in the reactor. Add sodium saccharin, acesulfame K, citric acid monohydrate, sodium citrate, and citric acid to the reactor. Add sodium benzoate to the reactor. Add flavors and homogenize the formulation.
Formulations prepared according to present invention were found to be stable for 9 months at 37°C and 90% RH.

Animal toxicity study
Toxicity study was conducted to establish the toxicity of the composition disclosed in example 1, when administered by oral route to the albino rats. The study was performed in two different groups of three female rats. Dose of 2000 mg/kg body weight was administered to the rats deprived of food overnight before and 2 hours after dosing. All the animals were observed for 14 days after dosing. The composition caused no mortality in the treated female rats at the dose of 2000mg/kg. All the animals showed no signs of intoxication after dosing till the end of the study. The body weight gain by all the rats treated was not found to be adversely affected during 14 days observation period. The composition did not induce any gross pathological alteration in any of the rat, as evident during necropsy.

Claims
I/We claim
1. An ayurvedic composition comprising herbal extracts of green tea, amla,
ashwagandha, kaucha, musli and excipients acceptable in food or pharmaceuticals.
2. An ayurvedic composition according to claim 1, wherein the composition is in liquid form.
3. An ayurvedic composition according to claim 2, wherein the composition is in the form of syrup.
4. An ayurvedic syrup composition according to claim 3, wherein the composition is with or without sugar.
5. An ayurvedic composition according to claim 1, wherein the composition is in solid form.
6. An ayurvedic solid composition according to claim 5, wherein the composition is in the form of chewing gum.
7. An ayurvedic composition according to claim 1, wherein the composition is in gel form.
8. An ayurvedic gel composition according to claim 7, wherein the composition is with or without sugar.
9. An ayurvedic chewing gum composition according to claim 6, wherein the composition is with or without sugar.
10. An ayurvedic composition according to claim 1, wherein the excipients
acceptable in food or pharmaceuticals are selected form sweetener, flavoring agents
and preservatives.