FORM 2
THE PATENTS ACT, 1970
(39 of 1970)
& The Patents Rules, 2003
PROVISIONAL SPECIFICATION
(See section 10 and rule 13)
ORAL HERBAL COMPOSITION WITH NOVEL ACTION MECHANISM


PRADIP RAVAL
VIPUL PATEL
DINESHCHANDRA JOSHI
VAN VET PVT. LTD.
Plot No. 303, 1st Floor,
Shalin Complex, Sector - 22,
Gandhinagar-382022 (Gujarat)
INDIA
Email : info@vanvet.co.in

The following specification describes the invention:


FIELD OF INVENTION
The invention pertains to the field of herbal preparations. More specifically it deals with a novel oral herba! preparation which has a unique biological action mechanism. The mechanism involves promoting excessive salivation thereby facilitating release of the active ingredients from the remaining herbs in the mixture, resulting in faster therapeutic action, especially in case of digestive disorders.
BACKGROUND OF THE INVENTION (PRIOR ART)
Digestive disorders in humans or animals are one of the most common disorders. Digestion being the fundamental process involved in energy release and a host of other physiological functions, any formulation which provides therapeutic relief in case of digestive disorders, obviously has considerable clinical and commercial importance.
The present invention describes a novel, oral formulation comprising a unique combination of EIGHT herbs viz. viz.
1 .Zingiber Officinal (Ginger),
2. Piper Nigrum (Black Pepper),
3.Piper Longum (Piper)
4.Unakya Sodiai Cloredam,
5.Zanthoxylun Alatum,
6.Kerat Coptikam (Bishops weed),
7.Cuminam Cyminum(Cumin),
8. Ferula Narthex (Asafetida).
Additionally, sweeteners e.g. Sugar, Honey are also added along with Sodiai Cloridam (Sodium Chloride) and preservatives. The composition has a unique mechanism of action in that it promotes excessive salivation which in turn promotes extraction of the active ingredients present in the herbal mixture, leading to faster therapeutic action. It can be used for humans as well as animals.
2

Formulations for humans:
Formulations for providing relief in case of digestive disorders in humans are well-documented in Ayurvedic Texts. However, none of the prior art documents discloses the formulation of the present invention which comprises a unique combination of ingredients which has been arrived at by the present inventors after a considerable degree of research and development effort. Moreover, the oral formulation of the present invention comprises ingredients with the specific aim of promoting excessive salivation, which has not been disclosed in the prior art.
Some of the natural herbal formulations described in the prior art are powders (churnas) viz. Hmgvastak Churna, Lavanbhaskar Churna, Talisadi Churna, Vyosadi Vati, Pachan Churna and also tablets viz. Hamitone Tablets, Digomap, Hajmola and Zanduzyme Tablet. The same are being manufactured by a number of generic manufacturers under different brand names, but composition is same. Composition of the existing herbal powders and tablets of the prior art is disclosed below. These are well-documented in standard ayurvedic texts such as Charak Samhita, AYRABHISHHEK Compositions of the powders (churnas) and tablets is given below: Powders (Churnas)
1.Hingvastak Churna
2.Lavanbhaskar Churna,
3.Talisadi Churna,
4. Vyosadi Vati (This appears to be a tablet, not a churna)
5. Pachan Churna
SEPARATELY.
1. Hingvastak Churna : It comprises eight active herbs listed below:
1. Zingiber Officinale
2. Piper Nigrum
3. Piper Longum
4. Kerat Coptikam
5. Cuminam Cyminum
6. Unakya Sodiai Cloredam
7. Ferula Narthex
8. Carum carvi
3

Lavanbhaskar Churna: It comprises fourteen active herbs listed below:
1. Zingiber Officinale
2. Piper Nigrum
3. Kerat Coptikam
4. Punica granatum
5. Eletteria cardamamum
6. Piper longam
7. Sodium muras
8. Plumbago zeylnica
9. Mesua ferra
10. Unakya sodiai cloredam
11. Taxus buccata
12. Bidlavan
13. Garcinia pedenculata
14. Coriandrum sativum
Talisadi Churna: It comprises Seven active herbs listed below:
1. Zingiber Officinale
2. Piper Nigrum
3. Piper Longum
4. Eletteria cardamamum
5. Cinnamamum zeylnicum
6. Taxus buccata
7. Lembhuza arandinasia
Vyosadi Vati: It comprises twelve active herbs listed below:
1. Zingiber Officinale
2. Piper Nigrum
3. Piper Longum
4. Plumbago zeylnica
5. Taxus buccata
6. Garcinia pedenculata
7. Piper retrofractum
8. Cuminam Cyminum
9. Eletteria cardamamum
10. Cinnamomum cardamom urn
11. Tamrindus indica
12. Cinnamamum tamal

5. Pachan Churna: It comprises fourteen active herbs listed below:
1. Eletteria cardamomum
2. Terminalia chebula
3. Terminalia balerica
4. Phyilanthus emblica
5. Zingiber Officinale
6. Piper Nigrum
7. Piper Longum
8. Plumbago zeylnica
9. Ferula Narthex
10. Cuminam cyminum
11. Foeniculum vulgare
12. Embelia ribs
13. Unakya sodiai cloredam
14. Caryophyllus aromaticus
Tablets
Oral herbal tablets for promoting digestion as disclosed in the prior art are as follows:
1. Hamitone Tablet
2. Digomap
3. Hajmola
4. Zanduzyme Tablet
1. Hamitone Tablet manufactured by Herbal Laboratoires, Pharmaceutical Division,Bharthana-
2062242 (India) comprises the following SIX herbs.
1. Zingiber officinale
2. Embelia ribs
3. Piper nigrum
4. Piper longum
5. Cuminam cyminum
6. Trachyspermum ammi
2. Digomap (Digestive Tablet), manufactured by Maharshi Ayurved corporation ltd.,A-34
Mohan Industrial state, Mathura road, New Delhi-110044 (India) comprises the following 4 active herbs.
1. Foeniculum valgare
2. Zingiber officinale
3. Terminalia chebula
4. Cassia angustifolia leaf
5

3. Hajmola manufactured by Dabur India Ltd., post box Dabar Gram, PIN-814132 Bihar (India) comprises the following Six herbs.
1. Zingiber officinale
2. Cuminam cyminum
3. Nimbu sar
4. Kshudhavardhak Churna
5. Krishnalavan
6. Samudralavan
4. Zanduzyme Tablet manufactured by Zandu Pharmaceuticals Ltd. Gokhale road South Dadar, Mumbai-400025 (India) comprises the following fifteen herbs.

1. Sajikshar
2. Yavkshar
3. Aconite
4. Ajwayan
5. Asfoetida
6. Dantimool
7. Gulvel
8. Kajjali
9. Trikatu
10. Pippalimool
11. Temaria bark
12. Chitrak
13. Carraca papaya
14. Sankha Bhasma
15. Trikatu
Thus, none of the above compositions of the prior art anticipates the composition of the present invention which includes as one of the components Zanthoxylun Alatum which is not present in compositions of the prior art.

6

Formulations for animals:
Some of the existing commercially available oral herbal formulations for digestive disorders in animals are as follows:
1. APPETONIC (Bolus / Powder)
2. RUMIGEST
3. Natural Batisa
4. Ruchamax
1. APPETONIC (Bolus / Powder) manufactured by The Himalaya Drug Company, Makali,
Bangalore 562123 (INDIA) comprises the following herbs.
1. Shunthi
2. Arjuna
3. Lasuna
4. Maricha
5. Vidanga
6. Guduchi
2. RUMIGEST manufactured by Alembic Chemical Works Co. Ltd, Alembic Road Vadodara-
390003 (India) comprises the following herbs.

1.
2. 3. 4. Sindhuj Karshaphal Raktapushpak Karvi
5. 6. 7. Manthapak
Keshraj
Avartini
8. Kuruvinda
9. 10. Kharmanjari
Subhra
11. 12. Abhaya Ikshurassar
13. Plihari
14. 15. 16. Sriphal
Rasayani
Karak
7

3. NATURAL BATISA: Manufactured by Natural Remedies Pvt Ltd, 5-B Veerasandra
Industrial Area, Bangalore (India) comprises the following herbs.
1. Terminalia Chebula
2. Curcuma Longa
3. Bacopa Monnieri
4. Terminalia Belerica
5. Apium Graveolens
4. RUCHAMAX: Manufactured by Ayurvet Limited, 6th Floor, Sagar Piazza Distt. Centre,
Laxminagar, Vikas Marg, Delhi-110092 (India) comprises the following herbs.

I. Sunthi
2. Samundra Lavan
3. Amritphal
4. Inguda
5. Markav
6. Yavani
1, Somraji
8. Nimba
9. Methika
10. Lahsun
11. Bhunimba
12. Haritaki
13. Kiratikt
14. Dhataki
15. Katurohini
16. Nadhingu
17. Bach
18. Gugglu
19. Navsadar
20. Puspakasish
21. Vidang
22. Haridra
23. Marich
24. Guduchi
25. Pippali
26. Aakpusp
27. Mayurak
28. Agnik
29. Excipients
8

From the above it is clear that none of the existing compositions of the prior art discloses the composition of the present invention. In fact, in the present invention, one of the key ingredients is Zanthoxylun Alatum which is not present in the compositions of the prior art, at all. Also, none of the compositions or formulations of the prior art discloses a composition of the type disclosed in the present invention.
Though various therapeutic uses of the plants and their respective parts, present in the formulation have been described in the prior art, such a herbal composition which comprises a specific component which promotes excessive salivation, resulting in faster release digestion and 'extraction' of the active ingredients from the remaining herbs, resulting in faster and more efficacious therapeutic effect, especially in case of digestive disorders, has not been described in the prior art.
3. OBJECTS OF THE INVENTION
It is an object of the invention to provide a novel, oral herbal preparation useful for therapeutic applications, especially in the area of digestive disorders.
One more object of the invention is to disclose a novel oral herbal preparation with a unique biological action mechanism, which comprises inclusion in the herbal formulation of a specific component which promotes excessive salivation, resulting in faster 'extraction' of the active ingredients from the remaining herbs, leading to faster and more efficacious therapeutic effects.
Yet another object of the invention is to disclose a novel, oral herbal formulation which is effective in providing relief in digestive disorders in humans or animals or both.
One more object of the invention is to disclose a novel, oral herbal formulation which is particularly suitable for providing relief in case of digestive disorders in children.
Still another object of the invention is to disclose a novel, oral herbal formulation which is effective in providing relief from tympany (excessive gas) in case of ruminants.
Another object of the invention is to disclose a novel, oral herbal formulation which enhances absorption of minerals in animals.
A further object of the invention is to disclose a novel, oral herbal formulation which enhances milk production in animals.
Still one more object is to disclose a method of preparation of the above composition.
9

4. DETAILED DESCRIPTION OF THE INVENTION
The present invention relates to a herbal formulation for oral administration in animals or humans or both comprising a number of herbs in defined ratios, resulting in synergistic effects. The novelty of the herbal formulation of the present invention lies in the unique biological action mechanism, which comprises inclusion in the herbal formulation of a specific component which promotes excessive salivation, resulting in faster 'extraction' of the active ingredients from the remaining herbs, leading to faster and more efficacious therapeutic effects. The formulation has been tested and found to be quite efficacious in treating disorders related to digestive disorders. The formulation is particularly effective in treating digestive disorders in children, especially those related to indigestion of food. The formulation has also been found to be quite effective in enhancing appetite and as a carminative (gas removal from stomach). In animals, it is quite effective in enhancing mineral absorption, in tympany (relief from excessive gas formation) and also enhancing milk production, possibly by promoting better digestion of the roughages ingested. Table 1 below gives the detailed composition of the herbal formulation and Table 2 gives dosage.
10

Table 1

Latin Name English Name % Composition
Active Herbs
Zingiber Officinale Ginger 3.75%
Piper Nigrum Black Pepper 3.75%
Piper Longum Piper 3.75%
Sodiai Cloridam Sodium Cloride 4.25%
Unakya Sodiai Cloredam 4.25%
Zanthoxylun Alatum 4.50%
Kerat Coptikam Bishopos weed 2.75%
Cuminam Cyminum Cumin 2.75%
Ferula Narthex Asfoetida 3.25%

Excipients
Sugar 50.00%
Honey Q.S
Preservatives Q.S
Table 2 Dosages (humans as well as Animal)
50 mg per kg body weight ONCE DAILY
The herbal preparation as such has no bitter or unpleasant taste, which might hinder oral intake. However, to facilitate intake especially in children (5-12 years) and even adults, the preparation can be conveniently taken with suitable quantity of table sugar or honey.
Thus, in accordance with the present invention, is presented a novel herbal formulation that is effective in various digestive disorders. The invention also provides a method for preparation of this formulation, according to the composition listed in Table 1.
The invention is now illustrated by the following examples, which are not meant to limit the scope of the invention in any manner but are meant for illustrative purposes so as to promoted better understanding of the invention.
11

Example 1: Preparation of the herbal formulation
Check all ingredients by Quality control department.
After approval of Q.C. department herbal ingredients are weighed according to batch size
Each ingredient is finely powdered by pulveriser.
Proper shifting of material made by s.s.shifter machine.
After powdering each powder ingredient checked by Q.C. department for uniformity of Product.
Powder materials are weighed according to Batch size.
[A] Mixing of powdered material in ascending order of weight in s.s. mass mixer.
Simultaneously Sugar syrup is prepared, cool it at room temperature. [B]Honey & syrup mixed together, add required quantity of Q.C. approved
Preservative in it. [C] Above mixture A & B are mixed according to recipe quantity in cool stage. Above [C] mass is finished product. It is checked by Q.C. Department. After approval of Q.C.Department fill in pouch. Example 2: Use of the herbal preparation in Humans
Appropriate quantity of the herbal preparation as described in Table 2 is simply swallowed in dry powder form, either as such or by mixing with a teaspoon of table sugar, followed by intake of one glass of water to wash down the contents. Alternatively, the preparation can be taken by mixing with an equal quantity of natural honey.
Example 3: Use of the herbal preparation in Animals
Appropriate quantity of the herbal preparation as described in Table 2 is given to the animal in bolus form.
Positive effects obtained by using the herbal formulation
The preparation when taken regularly over a period of time, ranging from 6-8 weeks significantly provided a number of beneficial effects in animals as well as humans, thus pointing to a fundamental mechanism of action which results in beneficial physiological effects, applicable in case of humans as well as animals.
In addition, the present invention offers a host of commercial advantages not offered by any of the existing formulation, particularly with respect to the unique mechanism of action involving promoting of excessive salivation. Some of the commercial advantages of the product of the present invention are listed below:
12

Commercial advantages of the present formulation:
1. Low-cost: Compared to existing formulations for the same purpose, the cost of the present formulation is 50%.
2. Enhanced efficacy: Product acts in mouth itself so salivation start within 5 to 10 minutes only. Formulation has duly evaluated at field level and found to be highly effective.
3. Stability: The formulation is highly stable, enabling easy storage, marketing and commercialization efforts. It is stable for four years
4. Simple formulation process: Formulation process is simple and involves mainly mixing of the 10 herbs along with excipients. No expensive equipment or machinery is required.
5. Easy availability of the active ingredients: The active ingredients used in the formulation are readily available, thus facilitating commercial application of the invention.
6. Unique delivery mechanism: The formulation has a unique delivery mechanism involving promotion of excessive salivation as a tool for delivery of the active ingredients through the oral route.
13