FORM 2
THE PATENTS ACT, 1970
(39 of 1970)
&
THE PATENTS RULES, 2003
COMPLETE SPECIFICATION (See section 10, rule 13)
HERBAL FORMULATION FOR RESPIRATORY WELLNESS Inmart Commerce Private Limited
An Indian Private Limited Company
of 4 th floor, B-2/405 DSK Madhuban, Andheri Kurla Road Saki Naka, Andheri East, Mumbai 400 072, INDIA
The following specification particularly describes and ascertains the invention and the manner in which it is to be performed:

FIELD OF INVENTION
[0001] The present invention relates to the field of herbal formulation. Particularly, the invention relates to a herbal formulation and process of preparation thereof, which is effective in protecting respiratory systems from ailments. More particularly, the invention relates to the herbal formulation to mitigate both bacterial and viral infections, among other respiratory ailments.
BACKGROUND OF INVENTION
[0002] The respiratory diseases are on the rise with pollution. Asthma and chronic obstructive pulmonary disease are two major respiratory diseases which result in death of millions of patients per year in India and world over. Other respiratory diseases include idiopathic pulmonary fibrosis, sarcoidosis, respiratory distress syndromes, and upper airway conditions such as rhinitis and chronic sinusitis.
[0003] Asthma is not just a public health problem for developed countries. In the developing countries, the incidence of the disease varies greatly. The human and economic burden associated with this condition is severe. The cost of asthma to society can be reduced to a large extent through concerted international and national efforts. In the US for example, the annual care expenditures for asthma alone are estimated at $20.7 billion.

[0004] Among lung diseases, asthma is a reversible obstructive airway disease which is histologically characterized by inflammatory changes. The symptoms of asthma are caused by reversible bronchoconstriction, which are exemplified by spasmodic dyspnea, cough, and sputum, etc. The development mechanism of asthma can be described by contraction or convulsion of tracheal smooth muscle, edema in bronchial mucosa, and the increase of mucus secretion, and particularly contraction of tracheal smooth muscle is most responsible for the development of asthma.
[0005] The most convincing theory to explain the reason of bronchoconstriction known so far is that when an antigen is inhaled or taken, airway hypersensitivity is induced, resulting in the broad contraction of the airway. In addition, other acceptable reasons are respiratory infection, inhalation of pungent gas or air polluted by SO2, heavy metal, asbestos, dust, etc., sudden change of weather, psychological stimulus, endocrine disorder, autonomic neuropathy, physical activities, and β-receptor blockade, etc. Chronic asthma and allergic asthma are well known to be the ones that can recur easily. These diseases have high risk of recurrence by cytokines of immune cells, and are known to be developed by autoimmunity.
[0006] There are several drugs to enhance respiratory immunity but they have side effects. The regular use of bronchodilators has a deleterious effect on the functioning of the heart. Over and above, they are known to cause drug resistance rapidly.

Frequent use of glucocorticoids cause generalized fluid retention and also weaken the bone mineral mass. Further, they are known to weaken the immune system causing a risk of frequent infections. On the other hand, natural products are being evaluated to evolve multiple responses in order to control the risk of frequent attacks of breathlessness. Many herbal drugs are reported to cause selective immune suppression and cause mast cell stability.
[0007] In Ayurveda, there are several herbs available for use in respiratory problems. The known anti-inflammatory and anti-asthma extracts or fractions include those derived from but not limited to Achyranthes aspera, Annoa squamosa, Anogeissus latifolia, Bauhinia purpurea Boerhaavia diffusa, Calotropis gigantean, Cassia fistula, Chloroxylon swietenia, Cressa cretica, Curculigo orchioides, Cynodon doctylon, Datura metel, Euphorbia hirta, Evolvulus alsinoides, Ficus religiosa, Garuga pinnata, Justicia adhatoda, Madhuca latifolia, Morinda pubescens, Moringa oleifera, Ocimum basilicum, Ocimum tenuiflorum, Pegularia daemia, Phyllanthus emblica, Piper longum, Piper nigrum, Pistacia integerrima, Prosopis julifera, Quercus infectoria, Randia dumetorum, Solanum surattense, Terminalia chebula, Tinospora malabarica, Trianthema portulacastrum, Tribulus terrestris, Tylophora Indica, Vitex negundo and Wrightia tinctoria.

[0008] U. S. Patent Application No 15/343,022 discloses therapeutic compositions comprising herbal extracts and essential oils for smoking and vaporization useful in the treatment of various symptoms and diseases. More particularly the invention relates to compositions comprising herbal extracts and essential oils capable of providing therapeutic benefits, which helps to improve conditions like cough, cold, pain, energy, relaxation, calmness, digestion, immune system disorders and neurological disorders etc. The invention further relates to methods for treating the same using the compositions of the invention. The invention also discloses a method of formulating a blend of herbal CO2 extracts and essential oils without the use of any type of synthetic carriers or residual solvent or synthetic chemicals, thus improving quality, safety and efficacy.
[0009] U.S. Patent publication No. US20030228383A1 teaches about a herbal composition for the treatment of chronic respiratory disorders such as cold, cough, allergic asthma, seasonal allergic rhinitis, pharyngitis, laryngitis and the like and a process for preparing the same. The composition comprises extracts derived from Ayurvedic plants selected from the following group: Botanical name Quantity in % Ocimum sanctum 10-40% Glycyrrhiza glabra 10-25% Curcuma longa  2-20% Zingiber officinale  1-10% Adhatoda vasica 10-25% Solanum indicum  1-10% Saussurea lappa 1-5% Piper cubeba 1-5% Terminalia belerica  1-10% Aloe

barbadensis 10-30% Inula racemosa  2-10% Clerodendrum serratum 1-5% Solanum xanthocarpum 1-5% Piper longum 1-5% Alpinia galanga 1-5% Terminalia chebula  5-15% Emblica officinalis  5-15%.
[0010] Several chemical and herbal formulations have been tested for their action in controlling respiratory illness and enhancing the immunity against respiratory diseases, but they have either been not providing adequate relief or have undesirable side effects. Many patent applications and granted patent teaches use of the herbal compositions for the treatment of respiratory diseases.
[0011] Additionally, in spite of the above, the prior art generally does not reveal a herbal formulation which has the desired combination of safety, effectiveness and low cost which is needed for treating a large number of patients who have very different medical conditions and socio-economic backgrounds.
[0012] Accordingly, there is a continuous search in the art for a medicine or herbal formulation that is safe, useful and inexpensive for enhancing respiratory wellness. Surprisingly, the present invention has shown that the combination of the Adusa, Mulethi, Punarnava, Mahua, Asthamabuti, Choti Kateli, Tulsi and Shirish provides a synergistic effect in enhancing respiratory wellness and and preventing secondary complications arising out of respiratory tract problems. The inventors with careful

experimentation have prepared a synergistic herbal composition for enhancing respiratory wellness.
SUMMARY OF INVENTION
[0013] The present invention discloses a herbal formulation for regulating respiratory wellness. The formulation comprises of Adusa (Adhatoda vasica) Mulethi (Glycyrrhiza glabra) Punarnava (Boerhaavia diffusa) Mahua (Madhuca indica) Choti Kateli / kanthkari (Solanum surattense) Asthmabooti (Tylophora Indica) Tulsi (Ocimum sanctum) and Shirish (Albizzia lebbeck). Further, the herbal formulation helps promote immunity of the respiratory system and help in curing diseases like Allergic rhinitis, Bronchial Asthma, Chronic cold, Balances Tridosha, flu, relieves cough Bronchitis and Asthma.
[0014] In one aspect of the invention discloses the process of preparation of the herbal formulation. The raw ingredients Adusa, Mulethi, Punarnava, Mahua, Asthamabuti, Choti Kateli, Tulsi and Shirish in original dry herbal form are procured, got together and mixed (in respective ratios) for further process of grinding through pulverization Further, the mixture is grinded through pulveriser wherein the mixed formulation (i.e the dry herbal raw ingredients mixed together in respective ratios) is then put through the pulveriser for grinding. The grinding process leads to a loss of ~10% of the weighted formulation in this step. Furthermore, the grinded mixture is

processed by sifting, wherein the matter is passed through the sift for gaining even more fine powder, where there might be a loss of ~1% of the net weight and it removes any granules or larger particles. Moreover, post sifting the entire mixture is even further mixed, to ensure thorough mixing of the ingredients and to gain uniformity.
[0015] In another aspect of the invention discloses the process of preparation of capsule of the herbal formulation. Wherein the Ingredients in the form of dry herbal extracts are procured. The dry extract is made via a standard extraction process using a “Clavenger Apparatus” are process; then a quath (“boiled syrup formulation”) is formed; the quath is dried and converted to dry extract which is a concentrated dry fine powder of the herb. Further, the dry extracts of the ingredients are then mixed as per respective ratios, the mixed formulated ingredients are then undergo sifting to remove larger particles and achieve more fineness, which also removes any contaminants. The mixture is then further mixed to achieve uniformity and then excipients are added in respective ratios (for better adsorption within the body). Moreover, the final mixture is then filled in the capsules through standard encapsulation process using capsules of either gelatin or veg. (rice) based.
[0016] In general, in another aspect of the invention, the herbal formulation helps in diseases like Allergic rhinitis, Bronchial Asthma, Chronic cold, Balances Tridosha, flu, relieves cough Bronchitis and Asthma.

[0017] In another aspect of the present invention, the prescribed dosage of 2 capsules after breakfast must be taken for 3 months for visible effects namely, reduction in cough & cold severity and frequency, better breathing, feeling of lightness in chest.
[0018] In yet another aspect of the present invention, the herbal formulation can be administered orally in the form of a tablet, capsule, powder or liquid or in the form of nutritional supplement.
DETAILED DESCRIPTION OF INVENTION
[0019] The following description is full and informative description of the best method presently contemplated for carrying out the present invention which is known to the inventors at the time of filing the patent application. Of course, many modifications and adaptations will be apparent to those skilled in the relevant arts in view of the following description in view of the accompanying drawings and the appended claims. While the system and method described herein are provided with a certain degree of specificity, the present technique may be implemented with either greater or lesser specificity, depending on the needs of the user. Further, some of the features of the present technique may be used to advantage without the corresponding use of other features described in the following paragraphs. As such, the present description should be considered as merely illustrative of the principles of the present

technique and not in limitation thereof, since the present technique is defined solely by the claims.
[0020] The present invention relates to the field of herbal formulation. Particularly, the invention relates to a herbal formulation and process of preparation thereof, which are effective in protecting respiratory systems from ailments. More particularly, the invention relates to the herbal formulation to mitigate both bacterial and viral infections, among other respiratory ailments.
[0021] In one embodiment of the invention discloses a herbal formulation for regulating respiratory wellness. The formulation comprises of Adusa (Adhatoda vasica), Mulethi (Glycyrrhiza glabra), Punarnava (Boerhaavia diffusa), Mahua (Madhuca indica), Choti Kateli / kanthkari (Solanum surattense), Asthmabooti (Tylophora Indica), Tulsi (Ocimum sanctum) and Shirish (Albizzia lebbeck). Further, the herbal formulation helps promote immunity of the respiratory system and help in curing diseases like Allergic rhinitis, Bronchial Asthma, Chronic cold, Balances Tridosha, flu, relieves cough Bronchitis and Asthma. Additionally, pharmaceutically acceptable excipients can be added in the formulation.
[0022] In another embodiment of the invention leaves of Adusa, stem bark of Mulethi, whole plant of Punarnava, flower of Mahua, leaf of Asthamabuti, root of

Choti Kateli, leaves of Tulsi and bark fo Shirish are used to prepare the herbal formulation.
[0023] In still another embodiment of the invention the ingredients have many known medicinal properties individually. Adusa (Adhatoda vasica) is useful in treating bronchitis, colds, whooping cough, asthma, tuberculosis, sore throat, other lung and bronchial disorders, bleeding disorders, allergic conditions, upper respiratory infections, excessive uterine bleeding, heavy menstruation, and epistaxis (nosebleed). Further, Mulethi (Glycyrrhiza glabra) is useful in cough, weakness, Itchy and inflamed skin, dyspepsia, recovery after surgery, canker sores, dental plaque, dry mouth, hepatitis, high cholesterol, lichen planus, stomach ulcers. Furthermore, Punarnava (Boerhaavia diffusa) is useful in curing disorders like intestinal colic, kidney disorders, cough, hemorrhoids, skin diseases, alcoholism, insomnia, eye diseases, asthma and jaundice. Mulethi helps curing dyspnoea and other breathing problems as it helps in the removal of mucus from the bronchial tubes.
[0024] In still another embodiment of the invention, Mahua (Madhuca indica) is used for treating cold, cough, bronchitis and other respiratory disorders, pneumonia, skin diseases, and piles, tonsillitis, gum troubles, diabetes and ulcers. However, Asthamabuti (Tylophora indica) Increase airflow and reduce allergic reactions, helps in allergy, asthma, congestion, cough. Further, Choti Kateli / kanthkari (Solanum

surattense) is used for treating dysuria, cough, respiratory diseases, anorexia, fever, pruritis (excessive itching), cardiac disorders, worn infection, skin diseases. Furthermore, Tulsi (Ocimum sanctum) is used for anxiety, dental plaque, diabetes, obesity, stress, common cold, influenza, asthma, bronchitis, earache, gingivitis, headache, stomach upset, heart disease, fever, insomnia, viral hepatitis, malaria, tuberculosis. Moreover, Shirish (Albizzia lebbeck) is used for anxiety, cancer, depression, sleep problems (insomnia), and sore throat; to improve mood; and to reduce swelling associated with trauma. Albizzia is applied to the skin to treat insect bites, skin infections (boils and abscesses), ulcers, fractures, and sprains.
[0025] In another embodiment of the invention the herbal formulation prepared through the disclosed process having Adusa, Mulethi, Punarnava, Mahua, Asthamabuti, Choti Kateli, Tulsi and Shirish in dry herbal form provides an effective boost in immunity of the respiratory system. The combination is effective in promoting immunity and also supplements in curing diseases like Allergic rhinitis, Bronchial Asthma, Chronic cold, Balances Tridosha, flu, and cough Bronchitis and Asthma. The effectiveness of the formulation depends on the ratio of the ingredients in the mixture, as the disclosed ingredients are having therapeutic effect, while the combination of all ingredients, is having superior efficacy compared to individual ingredients. Furthermore, there are plenty of other herbs having medicinal effect in relation to ayurvedic treatment of respiratory diseases and improving immunity

against them, while the herbal formulation of Adusa, Mulethi, Punarnava, Mahua, Asthamabuti, Choti Kateli, Tulsi and Shirish is having superior therapeutic effect in promoting immunity against respiratory diseases.
[0026] Further, the composition of the invention is a synergistic composition in that it is not a mere admixture of various herbs. The composition of the invention represents a delicate balance of herbs blended in a specific concentration so as to achieve specific results such as being suitable for respiratory disease. When all the herbs of the composition are combined, they exhibit surprising and unexpected properties.
[0027] In another embodiment of the invention the process of preparation of the herbal formulation is disclosed. The raw ingredients Adhatoda vasica, Glycyrrhiza glabra, Boerhavia diffusa, Madhuca Indica, Tylophora Indica, Solanum surattense, Ocimum sanctum and Albizia lebbeck in original dry herbal form are procured, got together and mixed (in respective ratios) for further process of grinding through pulverization Further, the mixture is grinded through pulveriser wherein the mixed formulation (i.e the dry herbal raw ingredients mixed together in respective ratios) is then put through the pulveriser for grinding. The grinding process leads to a loss of ~10% of the weighted formulation in this step. Further, the grinded mixture is processed by sifting, wherein the matter is passed through the sift for gaining even more fine powder, where there might be a loss of ~1% of the net weight and it

removes any granules or larger particles. Moreover, post sifting the entire mixture is even further mixed, to ensure thorough mixing of the ingredients and to gain uniformity.
[0028] In another embodiment of the invention the process of preparation of capsule of the herbal formulation is disclosed. Wherein the Ingredients in the form of dry herbal extracts are procured. The dry extract is made via a standard extraction process using a “Clavenger Apparatus” are process; then a quath (“boiled syrup formulation”) is formed; the quath is dried and converted to dry extract which is a concentrated dry fine powder of the herb. Further, the dry extracts of the ingredients are then mixed as per respective ratios, the mixed formulated ingredients are then undergo sifting to remove larger particles and achieve more fineness, which also removes any contaminants. The mixture is then further mixed to achieve uniformity and then excipients are added in respective ratios (for better adsorption within the body). Moreover, the final mixture is then filled in the capsules through standard encapsulation process using capsules of either gelatin or veg. (rice) based.
[0029] In general, in another embodiment of the invention, the prescribed dosage of 2 capsules after breakfast must be taken for 3 months for visible effects namely, reduction in cough & cold severity and frequency, better breathing, feeling of lightness in chest.

[0030] In yet another aspect of the present invention, the herbal formulation can be administered orally in the form of a tablet, capsule, powder or liquid or in the form of nutritional supplement.
[0031] In another aspect of the present invention, in the case of chronic or severe conditions, the dosage may be increased for the few days to obtain best results and the dosages may be taken in morning after breakfast for best effect. The powder form may be taken with lukewarm water.
[0032] In yet another aspect of the present invention, the herbal formulation for treatment of regulating blood sugar level is disclosed. The formulation comprises Adusa, Mulethi, Punarnava, Mahua, Asthamabuti, Choti Kateli, Tulsi, Shirish and pharmaceutically acceptable excipients. The formulation can be administered orally in the form of a tablet, capsule, powder or liquid.
[0033] In an exemplary embodiment of the invention the formulation comprises of Adusa, Mulethi, Punarnava, Mahua, Asthamabuti, Choti Kateli, Tulsi and Shirish are in the ratio of 10:6:4:3:6:8:4:3.
[0034] In still another embodiment of the invention, preparation of the herbal formulation for regulating blood sugar level and digestive system, the preparation comprises steps of : mixing of Adhatoda vasica, Glycyrrhiza glabra, Boerhavia diffusa, Madhuca Indica, Tylophora Indica, Solanum surattense, Ocimum sanctum

and Albizia lebbeck; grinding the mixed formulation through pulverization; sifting the grinded formulation for gaining more fine powder; and further mixing the grinded formulation to obtain a uniform herbal formulation.
[0035] In still another aspect of the invention, the invention provides advantages in respect of following diseases:
• Allergic rhinitis
• Bronchial Asthma
• Chronic cold
• Balances Tridosha
• Treats flu, relieves cough
• Bronchitis
• Asthma
• Anti-inflammatory
• Anti-microbial
• Rejuvenates liver and digestive system

• Tonic for general debility
• Reduces edema and
• The formulation can be used to prevent, control or treat any conditions arising out of a weak respiratory system by using the herbal formulation prepared with different ratio of ingredients.
[0036] The foregoing description of the embodiments of the invention has been presented for the purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise form disclosed. Many modifications and variations are possible in light of the above teaching. It is intended that the scope of the invention be limited not by this detailed description, but rather by the claims appended hereto.
[0037] While, the following description is presented to enable a person of ordinary skill in the art to make and use the invention and is provided in the context of the requirement for obtaining a patent. The present description is the best presently-contemplated method for carrying out the present invention. Various modifications to the preferred embodiment will be readily apparent to those skilled in the art and the generic principles of the present invention may be applied to other embodiments, and some features of the present invention may be used without the corresponding use of other features. Accordingly, the present invention is not

intended to be limited to the embodiment shown but is to be accorded the widest cope consistent with the principles and features described herein.
[0038] Many modifications of the present invention will be apparent to those skilled in the arts to which the present invention applies. Further, it may be desirable to use some of the features of the present invention without the corresponding use of other features.
[0039] Accordingly, the foregoing description of the present invention should be considered as merely illustrative of the principles of the present invention and not in limitation thereof.

CLAIMS What is Claimed is:
1. A herbal formulation for enhancing wellness of respiratory system of human body, the formulation comprises of Adhatoda vasica, Glycyrrhiza glabra, Boerhavia diffusa, Madhuca Indica, Tylophora Indica, Solanum surattense, Ocimum sanctum and Albizia lebbeck.
2. The Herbal formulation as claimed in claim 1, wherein the formulation comprises of Adhatoda vasica, Glycyrrhiza glabra, Boerhavia diffusa, Madhuca Indica, Tylophora Indica, Solanum surattense, Ocimum sanctum and Albizia lebbeck in the ratio of 10:6:4:3:6:8:4:3.
3. The herbal formulation as claimed in claim 1, wherein the formulation is in the form of power or capsule and optionally comprises pharmaceutical excipients.
4. A method of preparation of herbal formulation for enhancing respiratory wellness, the preparation comprises steps of :
mixing of Adhatoda vasica, Glycyrrhiza glabra, Boerhavia diffusa, Madhuca Indica, Tylophora Indica, Solanum surattense, Ocimum sanctum and Albizia lebbeck;
grinding the mixed formulation through pulverization;
sifting the grinded formulation for gaining more fine powder; and
further mixing the grinded formulation to obtain a uniform herbal formulation.

5. The method as claimed in claim 4, wherein the preparation comprises of Adhatoda vasica, Glycyrrhiza glabra, Boerhavia diffusa, Madhuca Indica, Tylophora Indica, Solanum surattense, Ocimum sanctum and Albizia lebbeck in the ratio of 10:6:4:3:6:8:4:3.
6. The method as claimed in claim 4, wherein the formulation is prepared in the form of power or capsule and optionally comprises pharmaceutical excipients.