This invention relates to A NOVEL POTENT PREPARATION OF "POLYHERBAL TX GEL, (LOBODIL TX) FOR RESPIRATORY DISEASES & DISORDERS, AND ASTHMA."
2.) FIELD OF INVENTION ::
"AN UNIQUE AND NOVEL POTENT PREPARATION OF "POLYHERBAL TX GEL,
(LOBODIL TX) FOR RESPIRATORY DISEASES & DISORDERS, AND ASTHMA."
3.) BACKGROUND OF INVENTION WITH REGARD TO DRAWBACK
ASSOCIATED WITHPRIOR ART:-The lungs of human beings, have a combined surface area greater than 500 Mt2, are directly open to the external environment. Thus structural, functional or microbiological changes within the lungs can be closely related to Epidemiological, environmental, occupational, personal and social factor. Primarily respiratory disease area, are responsible for, a major burden of morbidity and untimely deaths, and the lungs are often affected in multi-system diseases.
Respiratory symptoms are the most common cause of presentation to the family practitioner. Asthma occurs in more than 10% of British Children; Bronchial Carcinoma is the most common fatal malignancy in the; Lung is the major site of opportunistic infection in those Immunocompromised by the Acquired Immune Deficiency (AIDS) or by Anti-allograft and Anti-cancer Chemotherapeutic regimens; and the spectra of Tuberculosis; particularly, the emergence of multiple drug - resistant strins, is back with us.
A number of Research Advances have occurred in the recent years. The discovery of the GENETIC MECHANISM OF CYSTIC FIBROSIS, PROVIDES A NOVEL OPPORTUNITY TO DEVELOP GENETHERAPYSTRA TEGIES TO REPLACE THE DEFECTIVE GENE. The lung is especially favored for the Gene therapy, since its airway Epithelial Cells are accessible to mobilized particles and the pulmonary capillary endothelium is available to intravenously delivered agents. Finally, recent advances in our understanding of the Cellular and Molecular Mechanisms underlying diseases such as Asthma and the acute (formerly adult) distress syndrome (ARDS) are likely to lead to rational, mechanism based therapy, within the foreseeable future.
Respiratory distress including, Chronic Asthma are Life-style disease make a major part of disease in the growing population. Many chemicals entities are recommended for the management of asthma (EPR - 3,2007, Section 3, Component 4 : Medication ; (http://www.nhlbi.nih.sov/suidelines/asthma/asth2din.htm)) with their potential side effects as mentioned below:
CORTISONE DRUGS (Steroids): As prescribed by Doctors for reducing Inflammation by minimizing swelling of Airways. However, steroids are associated with side-effects including Acne, Hairiness, Stunted Growth, Increased appetite, Weight gain, Round Face, Abdominal Pain, Increased Blood Pressure, Cataracts, Dry Mouth, Bruising, Fatigue, Leg Cramps and increased duration of prescribed drugs.
BRONCHODILATORS: Bronchodilators such as Beta-agonists, Theophylline & Ant cholinergic
are used for reliving coughing, wheezing, shortness of breath and in difficulty in breathing. However, potential side effects include nausea, vomiting, headaches, nervousness, restlessness, insomnia.
CORTICOSTEROIDS: These are recommended for the most severe, difficult to control asthma. Oral Systemic corticosteroids suppress, control, and reverse airway inflammation However, it may be potential life threatening if switched over from Oral to Inhaled form. They also reduce ability to cope up with Trauma, Surgery, and Infection. Other side effects include Candidates (Thrush), Dysphonia, Hoarseness, Dry Mouth, Coughing, Increased Appetite, Stunted Growth, Osteoporosis, Dermal Thinning, Diabetes, and Muscle Weakness.
SYSTEMIC CORTICOSTEROIDS: These drugs minimize exacerbation and reverses inflammation. However, they are associated with potential side effects viz: growth suppression, osteoporosis, dermal thinning, increased cholesterol, diabetes, cataracts, muscle weakness, increased appetite, fluid retention, weight gain, mood alteration.
AERESOL DRUGS: These are used and prescribed for Asthma relief. Chemical Propellant(s)
used in aerosols can be an irritant for eyes, skin, or Respiratory System. They can also enter the Bloodstream and dull Nervous System,
ANTIHISTAMINES: helps in reliving allergy attacks, which are major a major cause of Asthma. The potential side effects with Antihistamines include drowsiness, dry mouth, constipation, confusion, nightmares, nervousness, restlessness, irritability.
DECONGESTANTS are used to treat Nasal Congestion. These have potential side effects like Nervousness, Sleeplessness, Increased Blood Pressure, even more Nasal Congestion, if used too long.
MAST CELL STABILIZERS :( Cromolyn Sodium & Nedocromil) are used as preventive treatment before exercise or exposure to Allergens. Potential side effects includes: Throat irritation, Dryness, Bad Taste, and Coughing.
METHYLXANTHINES: These can help, in controlling Night Time Asthma Symptoms. Potential side effects of methylxanthines include: Insomnia, Abdominal Pain, Aggravation of Ulcers or Reflux, Urination, Difficulty in Males with Prostration, Hematemesis, Hyperglycemia, Hypokalemia and Tachycardia.
LEUKOTRIENE ANT A GONISTS are alternative to low-dosage inhaled corticosteroid therapy. Potential side effects include: increase in Liver Enzymes, Reversible Hepatitis, and Hyperbilirubinemia.
Although numerous molecules are available, as mentioned above, to treat the Asthma, the search for a better system of medication are still undergoing: for example: BUDESON1DE in the form of finely divided particles (US Patent 6986904% containing 4-(l-methvl-4- piperidvlidene)-4H-benzo 4.5 cvclohepta 1.2-b thiophen-10(9H)-one (US Patent 4073915), p-hydroxvl-N-d - methvl-3-phenvlpropvlVnor-ephedrine (US Patent 4086363), surface Active phospholipids (SAPL) composition as dry powder (US PATENT Application : 20050063910), and Arvl sulfonamides (US Patent Application: 20080214672),, Tolterodine(US Patent Appl: 200020161054).
Knowing the side effects of organic remedies and increasing public dissatisfaction with the
cost of prescription of the medications, patients are in search of alternative therapies that are free from the side effects, associated with the single chemical medication. Recently the World Health Organisation (WHO) estimated that 80% of people worldwide rely on Herbal Medicines for some aspect of their Primary Health Care. In Germany, roughly 600 to 700 plants - based medicines are available and are prescribed by approximately 70 % of German Physicians.
"MINISTRY OF AYUSH" of the Government of INDIA, CSIR-Laboratories, CIMAP-GOI, and various concerned departments of GOI, are actively giving support for research and development in the Pharmaceuticals Sector including Herbal Medicines for the development of drugs, to treat the chronic diseases like Respiratory Problems and Asthma. As a result, a number of projects has been launched which are related to research and developments of drugs for chronic diseases. As of now, many drugs are available in the market and few new molecules has been developed and are undergoing Phase - I, Clinical Trials. However, the Research concentrated on any molecule which is aimed at solving a particular problem or symptom.
Treatments involving use of Active Molecules(s) is known to cause drug addicted side effects. When the side effects are non-tolerable, it is very common to search for other systems of treatment that can overcome the side effects of the associated with the specific chemical entity, as well as patient''s non-compliance.
In Traditional system, multiple drugs in their crude form are believed to show remarkable therapeutic effect with no common side effects. Medications with Herbal Drugs, at present, using the concepts of drug delivery systems such as Herbal Suppositories (US Patent: Appl. 20020031559) and Herbal Lozenges composition (US Patent Appl. 20060251791) are reported.
4) OBJECT OF INVENTION:
Since, as per our Invention of Polyherbal TX Gel (Lobodil TX) can overcome problems, associated with the conventional drug delivery system as the drug is readily available to the target areas, the onset of the action is rapid and bio- availability of the drug is much better, etc. Therefore, in the present invention, the preparation of Polyherbal TX Gel (Lobodil TX.) with a specific proportionate ad-mixtures of Herbal Drugs, is intended for the treatment of various Respiratory Distress, by applying the unique and thereby a novel concept of drug delivery is provided.
HERBAL REMEDIES FOR ASTHMA AND RESPIRATORY DISTRESSES:-
Due to the severity and complexity, the treatment of ASTHMA, is often frustrating for
patients,, families and clinicians, out of depression, many patients and families turn to
alternative therapies, such as nutrition, herbs, balms, and Chinese medicines. Whether they
are purified or raw, synthetic or natural, modern or ancient, the herbs and supplement
works Bio-chemically -just as the standard medications do.
Herbal remedies are a mainstay of Ethanobotanical Medication Worldwide. Cultural
remedies that are a part of AYURVEDIC MEDICINE (the Traditional Medicine of India)
and other healing systems rely heavily on herbs.
(It may be highlighted that, 5500 to 5000 Years ago, during, the Vedic era, the then
Ayurvedic Sages & Doctors had the knowledge on, and categorized 7000 - 8000 Herbal
Species, available in the Himalayan Range & Kerala, including other States of India, the knowledge was passed on to their disciples in vocabulary form ~ parampara, most of them, quite unfortunately, were lost due to passage of time, and, out of which few documentation were made by Ayurvedic Clinicians / Practioners, in l9th& 20th Century, are now available, for only 700 to 800 Herbal Species, which are now being used for Ayurvedic Formulary).
Whereas, around 290 - 300 species are now declared as HIGHLY ENDANGERED SPECIES by GOI, (and quite a number of the herbs faced extinction due to various factors earlier), are being encouraged to rehabilitate them because of their highly medicinal potent value.
Whole herbs contains many ingredients of potent medicinal-value, and it is likely that they work together to produce the desired medicinal effect. Medications using herbs use whole plants / parts of plants, rather than extracting, a single component from them. Whole plant extracts have many components'' comprising of many organic-molecular-chain compounds. These components work together to produce desired, therapeutic effects and also to lessen the chances of side effects from any one component Hence, several Herbs, are often used tosether to enhance the effectiveness and synergistic actions to reduce toxicity and non-formation of antibodies and immune syndromes ~ at a greater extent, when applied to human physiological systems, since the herbs originate from NATURE.
Like Active Molecules(s), Herbs are scientifically believed to work through a variety of mechanisms. Some decrease inflammation, and act as Pharyngeal Demulcent, viz. by, (JASTIMADHU, Glycyrrhiza Glabra), while other herbs acts as Bronchodilator, Mucolytic Expectorant, Anti-allergic, viz by (BASAK, Adhatoda Vasica), Smoothening Agent for Mucous,( SWET VERANDA, Ricinus Communis), Mucolytic, for Bronchitis (Kasa) and Bronchial Asthma (Shwasa) viz by (SUNTHI, Zinziber Officinale), Astringent, Carminative, and Anti-spasmodic viz by (TALIS PATRA, Abies Webbiana), and to clean up the Respiratory Tract viz by (KAKRASINGHI, Pistacia integerrima Stewart), Antispasmodic, Expectorant in Bronchitis, for Cold Congestion viz by (DARUCHINI, Cinnamonium Zeylancium) and MUCOLYTIC, ANTI-ASTHMATIC viz by PIPUL,(Piper longum).
Therefore, in the present invention, concept of Multi-Herbs is used to treat most of the respiratory, related distress / problems using a Poly-herbal TX Gel.
5) SUMMARY OF THE INVENTION:
This invention provides a n unique Polyherbal TX Gel, for the treatment of various Respiratory Diseases / Distresses, by the application of modern concept called as "TX GEL". In the GEL, Herbs, in their dry powder and extract form, as actives, are incorporated. The Gel was manufactured using basic concepts of TX with suitable modifications in the steps, to give inter and intra spaces / rooms, to herbal drugs. Gels are also added with ingredients that come into contact with mouth and provide organoleptic acceptance. The Tablets were subjected to various Q.C. (Quality Control) Tests, to assess the compliance, with respect to PHARMACOPEIAL LIMITS (USP AND BSP).
6) DETAILED STATEMENT OF INVENTION:-
A novel potent composition of polyherbal TX GEL (LOBODIL TX ) for respiratory diseases and disorders and asthma comprisingT alispatra (Abies Webbiara ) 4 % to 7%w/w, Basak(AdhotaVasica)l% to 7.5% w/w Jastinadhu (Glycyrrhiza Gabrate) 4% to 7.5%w/w, kakrasinghi ( Pistacia Integerrima) 1% to 3.5% w/w,Swet
. Verenda (Ricinus Communis) 1% to 7.5% w/w Sunithi ( ziriziber offrcenale) 0.75% to 4.5% w/w, Daruchini (Cinnamon Zeylancium) 0.75% to 4.5% w/w, pipul(pipeci Orgum)0.75% to 7.5% w/w,Nishadal 0.75% to 2%, Metyl PparabeasadiumO.05% tO 0.35%, propyl paraben sodium 0.05% to 0.35%, sugar (Surcorse AP grade) 13.5% to
•30%
1 The process of manufacturing comprises the following steps wherein drying of herbs and all ingredients as here in described in flow sheet diagram, dry blending of dried ingredientsas herein described in flow sheet diagram blending ofdried powder kneaded with know binder solution preferably with k-30 aqesous solution for atleast 8 to 10 minutes and then sieved to particle size of 0,991mm diameter, drying of wet mass at least 55 degree centigrade , then dry mass isfor size reduction and sieveing preferably to 1.65mm diameter,mixing with item no. 16 to 19 items as here in defined in flow seet diagram finaly powder coating granuals with adjuvants and compression to tablets form
Polyherbal TX Gel for various respiratory distresses is provided in the invention. The Gel
provide various Herbs in their, both, Powder and Extract forms. All herbs were selected after exhaustive Literature Survey and Works, and known administration in other form as Fine Powder. The quantity of the individual ingredient, incorporated is also based on the Ayurvedic Medication System. The proportion of the constituents used, in Polyherbal TX Gel, as invented, for the treatment of Respiratory Distresses, is the novelty of this invention. All the herbs are of Indian Origin
In the composition of Tablet, TALIS PATRA, (Abies Webbiana) is used as an Astringent, Carminative, and Antispasmodic for Asthma and Bronchitis.
In the composition of Tablet, BASAK (Adhatoda Vasica), is used as, Bronchodilator, Mucolytic, Expectorant, and Anti-allergic.
In the composition of Gel, JASTIMADHU, (Glycyrrhizin Glabra) is used as an, Antiinflammatory and Pharyngeal Demulcent
In the composition of Gel, KAKRASINGHI, (Pistacia Intergerrima), is used to clean up the Respiratory tract, as it expels the extra mucous.
In the composition of Gel, SWET VERANDA, (Ricinus Communis), is used as smoothening agent for mucous.
In the composition of Gel, SUNTHI, (Zinziber Officinale) is used as Mucolytic, for Bronchitis,(Kasa) and Bronchial Asthma (Shwasa).
In the composition of Gel, DARUCHINI, (Cinnamonium Zeylancium) is used for Antispasmodic, Expectorant in Bronchitis, Cold and Congestion.
In the composition of Gel, PIPUL, (Piper longum), is used for Mucolytic, Anti-tissusive and Anti-asthmatic.
In the composition of Gel, Nishadal is used as an Expectorant, being Mucokinetic.
In the composition of Gel, Sugar (Sucrose), is added as sweetening agent.
As the composition of Herbal Active(s) are incorporated in different forms (powder and extract), the composition and the method of manufacturing Tablets comprises the main part of the Invention.
Since, the two forms (powder and extract), of each Active Herb, are incorporated, in the Tablet, the STEPS INVOLVEDIN MANUFACTURING ofthese tablets, is unique, compared to manufacturing of other conventional tablets. Hence, these STEPS also, comprise the part of this INVENTION.
Since the present invention, seeks to provide a mouth-dissolving tablet, without disintegration of its ingredients, different ingredients of Pharmaceutical Grade are incorporated at various LEVELS and various STEPS.
6.1) The Present Invention provides a Polvherbal mouth-dissolving tablet for the treatment of Respiratory Distress & Asthma, the manufacturing method, which, comprises of the following STEPS & as detailed below:-
A) Drying of the Ingredients.
B) Dry Blending of Different Dried Ingredients, as obtained from STEP- A.
C) Blending of Dry Mix with suitable Binder.
D) Drying of fVet Mass.
E) Size Reduction of Granules.
F) Mixing of Fine Granules and Super disintegrates with Flow Enhancers.
G) Compression to Tablet using a Tablet Compression Machine.
Purpose of Drying and Methods involved in drying of the ingredients (STEP - A), are well known in the Ayurvedic Science audit''s State of Art and Practice, and hence, do not comprise the part of this Invention.
Dry Blending of Dried Ingredients (STEP - B), involves 2 (Two) kinds of Active Herbs (i.e. in both, Powder and Extract Form) and other pharmaceuticallv suitable ingredients. Quantities of each Active Herb have both dry Powder and Extract form of the herb, in definite proportion. While other ingredients are added to aid mouth dissolving properties, were selected from a well known category of Superdisintegrants at a later STEP - F. The Superdisintegrants used, were Sodium-Starch-glvcol ate. Crosscarmellose Sodium and Crosspovidone. in definite ratios.
All the Dry Ingredients were Mixed (STEP - C). with a "Tablet Binder Solution" prepared, in purified water, in a MASS MULLER MIXER & BLENDER (Rotating Pan Mutter Mixture with Offset Rollers and Pan Rotating in counter paths, driven by 2 Motors with 2 Axial Gear Boxes),or, Twin Sigma (Σ) S.S.304L Blade Mixer, for up to 10 Minute to obtain WET MASS.
The WET MASS was DRIED (STEP - D) in a Hot Air Tray Drver at 55°C. For Continuous Drying of Wet Mass, Vacuum cum Oven Dryer, or, by Rotary (Cross Current Flow) Hot Air in Tube or Coil Drver, or Continuous Steam in Coil Rotary Drver. ~ with S.S.304L ~ Involutes or Spiral Spikes, mounted on S.S.410 shaft, which moves in close tolerance of the inner shell of the Rotary Drver ~ in both the types of Rotary Dryers, are required. The 8 to 10 mm dia. NB, Tube or Coils should be ofS.S. 410 Grade. as to avoid contamination by Iron particles / Fe-oxides due to abrasion, caused during the flow of wet particles bv involutes /spiral spikes and the Coil (carrying steam or hot air), being located inside, the wall, of the Rotary Dryer Shell.
The Dried Granules were Size Reduced (STEP - E) in MULTI-MILLS and thereafter specifically by a Ball Mill with S.S. Balls of both, 3 & 4 mm diameter, for 5 to 10 Minutes per Batch and then duly Sieved using Tyler Series Mesh # 10 having clear opening of 1 65 mm 0. Over sized particles, are to be recycled to the Ball mill. The Dried Granules are of 1.65mm Φ
The Dried Fine Granules are mixed with Superdisintegrants, and were then, mixed with Flow Enhancers like Magnesium Stearate, (as per STEP - F). in which (Magnesium Stearate). was previously. Ground in S.S. Ball Mill with S.S. Balls of both, 3 to 4 mm diameter for 5 to 10 Minutes per Batch, and then, duly Sieved using Tyler Series Mesh # 16 havins clear openine of 0.991 mm Φ ≈1.0 mm Φ (dia.) to remove lumps of Flow Enhancer. The Mixing of this ingredient (Magnesium Stearate) with Dried Fine Granules, mixed with Superdisintegrants can be carried out in S.S.304, Double Cone Blender to give an average diameter of Fine Granules ≈ 1.25 mm Φ i.e. the, bottoms of Tyler Series Mesh # 12. having clear opening = 1.397 mm 0.

The Fine Granules ofi.25 mm Φ . thus obtained from STEP - F. are ready to compress & were Compressed (STEP - G,), in, Tablet Compression Machine, to form, the Polyherbal TX GEL. The Gel was systematically subjected to all the Quality Control Tests (O.C.) as, defined in various Pharmacopeias CUSP and BSP).
The Gel was analyzed using standard O.C. CHARTS.
6.2) EXAMPLE -I:: This example describes the manufacturine of Polyherbal TX Gel
(Table removed):-

All the ingredients as mentioned in TABLE 1 above were blended in double cone blender for 5 minutes. The blended powder was charged in a MASS MULLER MIXER, PVP-K30 aqueous solution was added as Binder, and KNEADED for 8 to 10 Minutes. The wet granules were dried at 55°C. The Mass was then unloaded and passed through 0.991mm Φ Screen {Tyler Mesh No: 16) in a Multi-Mill. The Dried Granules were then passed through a 1.651 mm Φ Screen (Tyler Mesh No: 10.) in Multi Mill. The Dried Granules were then Blended with CROSSCARMELLOSE SODIUM, POLYPLASDONE XL -10, POLYETHYLENE GLYCOL and MAGNESIUM STEARATE in a DOUBLE CONE BLENDER / Twin Sigma (E) S.S.304L Blade Mixer and then, Compressed in a TABLET COMPREEION MACHINE/PRESS with 16 mm Concave Punch Se, by WET GRANULATION METHOD.
The TABLE L cites the primary or basic ingredients weighs 705.20 ms/tablet balance 494.80 ms/tablet is attributed to other items, such as, binders.. blenders, Pharmacopoeial adjuvant and excipients, tablet coatins powders etc. to give the Total Mass of 1.20 Gm / Tablet of Poly herbal TX Gel and as such the final ranee of ratio Wt/Wt %, will thus vary accordingly.
7.) "MANUFACTURING FLOW SHEET OF "THE INVENTION OF POLYHERBAL TX GEL (LOBODIL TXT IS FURNISHED, under PAGE NO: 12 OF 13 (for the PRODUCTION of 1 Million Tablets per 24 Hours, or. on 3 Shifts Basis / Day.)
8.) As mentioned under PARA 6.1 .A) ~DETAILED STEPS OF INVENTION -
(STEP-A). i.e., DRYING OF THE INGRADIENTS. is also given for "(THE SAKE OF CLARITY, AFTER SOURCING THE STOCK, OR. IF MAINTAINED AS BUFFER A STOCK. IN CASE OF DEARTH IN THE MARKET OR. FLUCTUATION IN MARKET PRICE AND PROCESSING THEREOF)" as under: ~
"A FLOWSHEET OF STEP - A IS FURNISHED herein, vide. PAGE NO: 13 OF 13".
. An unique and novel Polyherbal Mouth dissolving Tablet composition for curing or treatment of Respiratory Distress and diseases.
The herbs used in the form of the dry powder and extracts comprising of the following items:

(Table removed):-
.The , Talis patra (Abies Webbiana) in the form at a level of 5% to 6% w/w
The, Basak(Adhota Vasica) is at a level of
2% w/w to 6.50% w/w. The Jastimadhu (Glycyrrhiza Glabrate) is at
a level of 5% w/w to 6% w/w.
The Kakrasinghi (Pistacia Interrima) is at a level of 1.8% w/w to 3% w/w. The Swet Verenda (Ricinus Communis) is at
a kevel of 1.5% w/w to 6 % w/w. The Sunithi (Zinziber Officinale) is at a level
of 1.3% w/w to 3% w/w. Daruchini (Cinnamon Zeylancium) is at a level of 1.3% w/w to 3% w/w.
The Pipul (Piper Longum) is at a level of
1.3% w/w to 3% w/w. Nishadal ia at a level of o.5% w/w to
1.3% w/w. The Sugar ( Sucrose A.P. Grade) is at a
level of 15% w/w to 25% w/w. Metyl paraben Sodium is at a level of
0.1% w/w to 0.25% w/w. Propyl paraben Sodium is at level of
0.1% w/w to 0.25% w/w. The Talis patra (Abies Webbiana) is obtained from Talis patra (Abies
Webbiana) LEAVES. The Basak (Adhota Vasica) is obtained from Basak (Adhota Vasica)
LEAVES. The Jastimadhu (Glycyrrhiza Glabra) is obtained from Jastimadhu
(Glycyrrhiza Glabrate) ROOTS. The Kakrasinghi (Pistacia Interrima) is obtained from Kakrasinghi
(Pistacia Integerrima) LEAVES. The Swet Verenda (Ricinus Communis) is obtained from Swet Verenda
(Ricinus Communis) ROOTS. The Sunithi (Zinziber Officinale) is obtained from Sunithi (Zinziber
Officinale) RHIZOME. The Daruchini (Cinnamon Zeylancium) is obtained from Daruchini
(Cinnamon Zeylancium) STEM BARK. The Pipul (Piper Longum) as claimed 3, is obtained from Pipul (Piper longum) FRUIT.
The method of preparation of Tablet comprises of the following steps:
i) Dry mixing of different kinds (dry powder and extracts) of the Herbs as Active Ingredients with Silicone dioxide (R2SiO)n .
ii) Blending of dry mix with other adjuvant of the Tablet composition.
iii)The Blend was compressed to TABLETS by Wet Granulation Method.
Tablet is used TWICE DAILY FOR RESPIRATORY DISTRESS AND ASTHMA
Tablet DISSOLVES SLOWLY IN MOUTH WITOUTISINTEGRATION.
10.) Abstract of the Invention:
The present invention provides an unique and novel Poly herbal Mouth Dissolving Tablet for respiratory distress cum disorders, including Asthma. The Composition that can provide relief from any respiratory diseases including allergic and for Asthmatic Symptoms, is incorporated with suitable pharmaceutical excipients in a mouth dissolving dosage form that dissolves slowly in mouth without disintegration (of its constituents or molecules).
1.) BIBLIOGRPHY, REFERENCES, PATENT SEARCH & PATENT OBTAINED WITH RESPECT TO ABOVE RESPIRATORY DISRESS & ASTHMA.
11.1) BIBLIOGRAPHY:
As cited above in paragraph 4, under OBJECT OF INVENTION, various Literature Survey were made and research works consulted, including the texts as on date, available under, Traditional System of Medication in India, namely AYURVEDIC SCIENCE and STATE of ART, which are presently being, prescribed, or, are available in the market (in both Antibiotic & Ayurvedic forms) in India and in abroad, were studied in depth, in order to conceptualize the root cause and thus, Formulate the invention of Polyherbal TX Gel (LOBODIL TX GEL), without any side effects.
As stated, the Herbs, for herbal remedies were selected from an array of, potential considering, their, high medicinal potency value, and which follows the principle of effectiveness with the dosage prescribed for Human Physiology and severity of disease or distress, in case of Asthma or Respiratory Disorders /Distress.
Various Institutes / Universities, Research Institutes, MNC''s, are in the quest of finding out the solution to Asthma & Respiratory Disorders/ Distress, but yet the solution, remains Jo be illusive, because of its tendency to relapse, once the Symptomatic Conventional Drugs are withdrawn, which happens, in case of Asthma and acute (formerly adult) distress syndrome (ARDS) - in which case the administered drugs fails to respond for curing the patients, by and large.
11.2) REFERENCES:
1 > AYURVEDSANGRAHA.
2 > S. K Bhattachariee: (2001) Handbook of Medicinal Plants, #rd Edition, Pointer
Publishers, Jaipur, India. 3> CArias- Castro. A.H. Scragg. M Rodreuez: (1993) : "The effect of Cultural
Condition on accumulation of formulation of Suspension Cultures of Glycyrrhiza Glabra" ~Plant Cell Tissues & Organic Culture - Vol. - 34, pp 63 to 70. 4> S.KJain : (1963) Medicinal Plants.: NATIONAL BOOK TRUST, NEW DELHI 5> M.Karki ((1998) "A review of Medicinal Plant Sector in India, IDRC, CANADA.
6> J.Srivatava, J. Lambert N. Vietmever : ((1995) "MedicinalPIants : A Growing Role
in Development,. Washington D.C., U.S.A., Agricultural 7 Natural Resources
Development, WORLD BANK. 7> D.Tavlor ((1997) '' Herbal Medicine: " Environmental Health Perspective - Vol:
105,No:ll. 8> M. Grieve.i 1989) A Modern Herbal Vol -1 & II, Hafner Publishing Co. N.Y.
U.S.A. 9> NR.Fransworth . R. W. Morris (1976) : Higher Plant: THE SLEEPING GIANT OF
DRUG DEVELOPMENT. Am. J. Pharm. Edu. Vol: 148, pp 46 to 52. 10>.B.D. Basu, K.R. Kirtikar (1975) Indian Medicinal Plants Vol I to IV, Allahabad,
India. 11> U.Singh, P Maheswari : ''Dictionary of Economic Plants in India" - ICAR, New
Delhi.
Page 10 of 13
12> ANON: (1945- 11976) : Wealth of INDIA, Raw Material Vol: I to XI: Publivcation
and Information Directorate , CSIR, New Delhi, INDIA. 13> ANON (1986) The useful plants of INDIA, Publication and Information
Directorate , CSIR, New Delhi, INDIA. 14> Dr. Ravindra Sharma: Medicinal Plants of India - An Encyclopedia, Daya
Publishers, New Delhi. 15. Avurvedacharvva (Prof.) Sivhakali Bh attach aryya : "Ayurvedic Oushudhi Vigyan"
, Kolkata.
11.3) PATENT SEARCH:
i) http:// www.bing.com/search
ii) http:// www.patentstorm.us/search
iii) http://www.nhlbi.nih.gov/guidelines/asthma/asthgdin.htm
iv) http://www.brevets-patents.ic.gc.ca/opic-cipo/cpd
v) http://www.freepatentsonline.com
vi) http://www.patentstorm.com.us/search/asthma/herbal
1L4) PATENT OBTAINED (as on date) for (ARDS): ANTIBIOTIC / HERBAL DRUGS.
As on date " NO PATENT HAS BEEN AWARDED ~ bv ANY COUNTRY INCLUDING WIPO .for, the treatment curing of above mentioned "ARDS". as per SPECIFIED Herbal Composition in the form of POLYHERBAL TX GEL. AS INVENTED BY US.

We claim,
1 A novel potent composition of polyherbal TX GEL (LOBODIL TX ) for respiratory diseases and disorders and asthma comprisingT alispatra (Abies Webbiara) 4 % to 7%w/w, Basak(AdhotaVasica)l% to 7.5% w/w Jastinadhu (Glycyrrhiza Gabrate) 4% to 7.5%w/w, kakrasinghi (Pistacia Integerrima) 1% to 3.5% w/w,Swet Verenda (Ricinus Communis) 1% to 7.5% w/w Sunithi (ziriziber offrcenale) 0.75% to 4.5% w/w, Daruchini (Cinnamon Zeylancium) 0.75% to 4.5% w/w, pipul(pipeci Orgum)0.75% to 7.5% w/w,Nishadal 0.75% to 2%, Metyl PparabeasadiumO.05% tO 0.35%, propyl paraben sodium 0.05% to 0.35%, sugar (Surcorse AP grade) 13.5% to 30%
2 The composition as claimed in Claim 1, wherein Talis patra (Abies Webbiana) in the form at a level of 5% to 6% w/w.
3 The composition as claimed in Claim 1, wherein Basak(Adhota Vasica) is at a level of 2% w/w to 6.50% w/w.
4 The composition as claimed in Claim 1, wherein Jastimadhu (Glycyrrhiza Glabrate) is at a level of 5% w/w to 6% w/w.
5 The composition as claimed in Claim 1, wherein, Kakrasinghi (Pistacia Interrima) is at a level of 1.8% w/w to 3% w/w.
6 The composition as claimed in Claim 1, wherein, Swet Verenda (Ricinus Communis) is at a Level of 1.5% w/w to 6 % w/w.
7 The composition as claimed in Claim 1, wherein, Sunithi (Zinziber Officinale) is at a level of 1.3% w/w to 3% w/w.
8 The composition as claimed in Claim 1, wherein, Daruchini (Cinnamon Zeylancium) is at a level of 1.3% w/w to 3% w/w.
9 The composition as claimed in Claim 1, wherein, Pipul (Piper Longum) is at a level of 13% w/w to 3% w/w.
10 The composition as claimed in Claim 1, wherein, Nishadal ia at a level of o.5% w/w to 1.3% w/w.
11 The composition as claimed in Claim 1, wherein, Sugar ( Sucrose A.P. Grade) is at a level of 15% w/w to 25% w/w.
12 The composition as claimed in Claim 1, wherein, Metyl paraben Sodium is at a level of 0.1 % w/w to 0.25% w/w.
13 The composition as claimed in Claim 1, wherein, Propyl paraben Sodium is at level of 0.1% w/w to 0.25% w/w.
14 The composition as claimed in claim 2, wherein, Talis patra (Abies Webbiana), is obtained from Talis patra (Abies Webbiana) LEAVES.
15 The composition as claimed in Claim 3, wherein, Basak (Adhota Vasica), is obtained from Basak (Adhota Vasica) LEAVES.
16 The composition as claimed in Claim 4, wherein, Jastimadhu (Glycyrrhiza Glabra), is obtained from Jastimadhu (Glycyrrhiza Glabrate) ROOTS.
17 The composition as claimed in Claim 5,wherein, Kakrasinghi (Pistacia Interrima), is obtained from Kakrasinghi (Pistacia Integerrima) LEAVES.
18 The composition as claimed in Claim 6,wherein, Swet Verenda (Ricinus Communis), is obtained from Swet Verenda (Ricinus Communis) ROOTS.
19 The composition as claimed in Claim 7,wherein, Sunithi (Zinziber Officinale), is
obtained from Sunithi (Zinziber Officinale) RHIZOME.
20 The composition as claimed in Claim 8,wherein, Daruchini (Cinnamon
Zeylancium), is obtained from Daruchini (Cinnamon Zeylancium) STEM BARK.
21 The composition as claimed in Claim 9,wherein, Pipul (Piper Longum), is obtained from Pipul (Piper longum) FRUIT.
22 The process of manufacturing comprises the following steps wherein drying of herbs and all ingredients as here in described in flow sheet diagram, dry blending of dried ingredientsas herein described in flow sheet diagram blending ofdried powder kneaded with know binder solution preferably with k-30 aqesous solution for atleast 8 to 10 minutes and then sieved to particle size of 0,991mm diameter, drying of wet mass at least 55 degree centigrade , then dry mass isfor size reduction and sieveing preferably to 1.65mm diameter,mixing with item no. 16 to 19 items as here in defined in flow seet diagram finaly powder coating granuals with adjuvants and compression to tablets form
23 A novel potent composition of polyherbal TX GEL (LOBODIL TX) for respiratory diseases and disorders and asthma substantially as herin described in description and flow sheet diagrams
24 A process for manufacturing of polyherbal TX GEL (LOBODIL TX ) for respiratory diseases and disorders and asthma substaintially as herin described in description and flow sheet diagrams