DESC:FILED OF INVENTION:
The present invention relates to synergistic Phytoconstituent blend of sugar free Dry syrup for Cough & Cold and processes for the same. In particular, the present disclosure relates to the polyherbal composition comprising of Trachyspermum Ammi extract, Glycyrrhiza Glabera extract, Ocimum Sanctum extract, Piper longum extract, Iris Germanica extract, Zingiber Officinale extract, Solanum Nigrum extract, Piper betle extract, Piper nirgum extract, Syzygium aromaticum extract, Cinnamomum verum extract, Curcuma Longa extract, Adhatoda vasaca extract to form sugar free dry syrup. The present disclosure further relates to the method of preparing the said polyherbal mixture.

BACKGROUND OF INVENTION:
Herbal ingredients play an important role in respiratory disease. Stability is main drawback in herbal syrup and hence high concentration of antioxidant and preservative should be added and it is not safe for longer period of time. To overcome this problem, present invention compliance with synergy phytoconstituents based Dry Syrup formulation and a method for preparation thereof for providing treatment in chronic respiratory disorders such as cold, cough, allergic, asthma, seasonal allergic rhinitis, pharyngitis, laryngitis, bronchitis and the like and which is nonalcoholic, non-sedating and chemical free in nature.

Phytochemical investigation of the herbal drugs or their extracts reveals the presence of several chemical compounds. Through all the ingredients do not possess specific therapeutic activity, it is believed that the different chemical compounds present in the plant or its extract act in harmonious manner and possibly due to synergistic effect of the compounds, some ingredients potentiate the therapeutic activity of the main active ingredient or even retard the undesirable actions of the main compound because individual compounds may not be as effective as that of the mixture of compounds present in the plant. Multi-ingredient therapy is preferred over single drug therapy since the therapy is more effective also.

WO2024003946A1 discloses Disclosed herein is a poly-herbal composition/formulation for the treatment of respiratory ailments or illnesses associated with inflammation, impaired lung function and fatigue and to the process of preparation thereof. The present invention provides a safe and effective solution to the limitations of the marketed synthetic drugs used for respiratory ailments or illnesses.

WO2020208659A1 discloses an Anti-Viral Anti-Bacterial Immunoboosting single composition consisting of standardized alcoholic extracts of seven specific herbs, combined together in specific synergistic ratios as - Curcuma longa (95% Curcumim) 26-31%; Boswellia serrata resin (65% Boswellic acid)- 22-27%; Moringa pterygosperma (leaves) - 18-23%; Ocimum sanctum (leaves) -7-12%; Tinospora cordifolia (stem) - 7-12%; Withania somnifera (leaves)- 5-7%; Piper nigrum fruit (95% Piperine)- 1-2%. The invention addresses the problem of internal and external infections caused by a wide variety of viruses and bacteria in humans as well as livestock, in a holistic manner and eliminates the need for separate antivirals and antibiotics. It has both prophylactic and therapeutic applications and offers quick, effective treatment without side-effects. Owing to its unique three pronged action – anti-viral, anti-bacterial and immunoboosting, the composition offers a convenient and standardized therapy for mass use during epidemics and pandemics caused due to respiratory tract infections.

Therapeutic Use of Medicinal Plants and their Extracts: (Volume 2 Phytochemistry and Bioactive Compounds) A. N. M. Alamgir discloses Therapeutic use of Medicinal Plants and their Extracts, has been written to meet the needs of undergraduate and postgraduate students, who are pursuing education in the Department of Pharmacognosy and Pharmacy, Botany, and Plant Biochemistry of different universities as well as Ayurvedic and Unani colleges. Natural drugs including botanicals are gaining increasing momentum in popularity and use all over the world for their diversity and less toxic side effects. Complementary and alternative medicine botanicals are equally important in the developing and developed countries, and the uses of more and more herbs are now found as monographs in the national and international pharmacopeia. The knowledge about the nature and properties of phytochemicals and bioactive compounds present in the crude drugs as fundamental constituents and their mechanism of work is important for their optimum utilization. The present book “Phytochemistry and bioactive compounds” may fulfill the purpose of the knowledge hunters in natural resource arena, who take care about the quality, standard, and efficacy of herbal drugs.

The Natural Products Journal (Volume 14, Number 2) A Comprehensive Study on Natural Products and their Bioactive Constituents to Cure Respiratory Diseases (Biharee, Avadh, et al.) discloses In terms of death rates, occurrence, costs, and prevalence, respiratory tract diseases, which include minor issues like the common cold and life-threatening ones like bacterial pneumonia, lung cancers, and tuberculosis, are extremely significant. People have been worried about their health for a long time because of respiratory diseases. Old-style medication has tended to these diseases; however, the accumulation of information produced by elective methodologies, among which medication assumes a significant role, is insignificant. Phytotherapy has consistently given proficient solutions for constant and moderate wellbeing inconveniences and, occasionally, for intense and serious problems. Alleviating the aggravated nasal sections and aviation routes was a shared need in antiquated societies. In this study, we conducted a systematic literature review to gain evidence about herbal products and their phytoconstituents that play a role in respiratory illness. We also predicted the physicochemical properties of various phytoconstituents from therapeutic plants employed to cure respiratory ailments (such as asthma, COPD, cough, tuberculosis, etc.).

OBJECTIVE OF INVENTION
The present invention relates to synergy phytoconstituent based composition which is non-alcoholic, non-sedating and non-freezing, high soluble, non-palatable, excipient less, preservative free with no artificial flavor dry syrup in the treatment of chronic respiratory disorders such as cold, cough, allergic asthma, seasonal allergic rhinitis, pharyngitis, laryngitis, bronchitis and the like and a process for preparing the same.

In conventional marketed syrup, Sugar as a base is drawback of syrup especially in cough cold, and respiratory disease and all. Artificial sweetener and flavor also cause dryness of mouth and throat allergy. Active constituent concentration may not target due to high concentration of additives and hence effectiveness is poor. Keep that in mind, we innovate super-soluble excipient less dry syrup blend with multiple phytoconstituents synergistic effect to solve multiple health benefits in respiratory condition.

SUMMERY OF THE INVENTION
The present invention relates to synergistic Phytoconstituent blend of sugar free Dry syrup for Cough & Cold and processes for the same.

In particular, the present disclosure relates to the polyherbal composition comprising of Trachyspermum Ammi extract, Glycyrrhiza Glabera extract, Ocimum Sanctum extract, Piper longum extract, Iris Germanica extract, Zingiber Officinale extract, Solanum Nigrum extract, Piper betle extract, Piper nirgum extract, Syzygium aromaticum extract, Cinnamomum verum extract, Curcuma Longa extract, Adhatoda vasaca extract to form sugar free dry syrup.

The present disclosure further relates to the method of preparing the said polyherbal mixture. The present invention is Taste masked, Stable, Fast dissolving, Excipient less, Sugar free, Preservative free, compatible Dry syrup made up with Phytoconstituents and its blend.

Adding raw extract of Trachyspermum Ammi extract, Glycyrrhiza Glabera extract, Ocimum Sanctum extract, Piper longum extract, Iris Germanica extract, Zingiber Officinale extract, Solanum Nigrum extract, Piper betle extract, Piper nirgum extract, Syzygium aromaticum extract, Cinnamomum verum extract, Curcuma Longa extract, Adhatoda vasaca extract in a beaker and mixing them well and converting the same into syrup. Dry all blend of Phytoconstituents at 40-55°C in tray dryer or fluidized bed dryer for 30-60 min. Pulverized it in sieve number 80-100. Check flowability of individual as per free flow compliance and mixed all in synergy form. Continue mixing of all improvised granules for 30-45 min and then add natural blend of Mentha Spicata extract 4-8% and again mix for 20-30 minutes. At last mixed Glycyrrhiza Glabera with optimized concentration in above blend and mixed it for 15-20 min. Viscosity adjusted with Natural gum of Phytoconstituents blend.

DETAILED DESCRIPTION OF INVENTION:
Detailed Description of the Invention While this specification concludes with claims particularly pointing out and distinctly claiming that, which is regarded as the invention, it is anticipated that the invention can be more readily understood through reading the following detailed description of the invention and study of the included examples.
The following is a detailed description of embodiments of the present disclosure. The embodiments are in such detail as to clearly communicate the disclosure. However, the amount of detail offered is not intended to limit the anticipated variations of embodiments; on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure as defined by the appended claims.

Unless the context requires otherwise, throughout the specification which follow, the word “comprise” and variations thereof, such as, “comprises” and “comprising” are to be construed in an open, inclusive sense that is as “including, but not limited to.”

Reference throughout this specification to “one embodiment” or “an embodiment” means that a particular feature, structure or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, the appearances of the phrases “in one embodiment” or “in an embodiment” in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.

The headings and abstract of the invention provided herein are for convenience only and do not interpret the scope or meaning of the embodiments.
Various terms are used herein. To the extent a term used in a claim is not defined below, it should be given the broadest definition persons in the pertinent art have given that term as reflected in printed publications and issued patents at the time of.
In pharmaceutical industry, cough syrup is widely used in respiratory disease especially in allergic cough and cold, bronchitis, Pneumonia, asthma and like that. Active pharmaceutical ingredients contain poor characteristics like unpleasant taste, odour, solubility problem and many more. To improve its poor characteristics excipients to be added either equal or more proportional. Additionally base is sugar, sucrose, sucralose set with artificial sweeteners, flavors and for stability, number of preservatives are incorporate. In ayurvedic syrup, stability, fermentation, microbial growth, palatability and sedimentation is key drawback in number of marketed syrups. In allopathy, Palatability and incompatibility is key issue and to overcome limitation, excipients either in form of additives or preservatives should be incorporate. It’s all about present scenario.
Common colds are among the most common infectious diseases, causing millions of doctor visits at a cost of billions of dollars each year. As used in the present disclosure, these symptoms are collectively referred to as “cold symptoms” or the “inflammatory response.” Typically, cold symptoms are caused by some type of picornavirus (usually a rhinovirus), coronavirus, or respiratory syncytial virus. The chronic inflammation causes an associated increase in airway hyper responsiveness that leads to recurrent episodes of wheezing, breathlessness, chest tightness, and coughing, especially at night or in the early morning. These episodes are usually associated with wide spread but variable airflow obstruction that is often reversible either spontaneously or with treatment. Pharmaceutical compositions and methods of using same comprising a non-steroidal anti-inflammatory Phytoconstituents combination and synergy active component selected from an antihistamine, decongestant, cough suppressant (antitussive), expectorant is provided for the relief of cough, cold and cold-like symptoms. The present invention relates to a Phyto Pharmaceutical formulation containing a mixture of specified herbal phytoconstituents and a method for preparation thereof for providing treatment in chronic respiratory disorders such as cold, cough, allergic asthma, seasonal allergic rhinitis, pharyngitis, laryngitis, Bronchitis and the like and which is non-alcoholic, non-sedating and non-freezing and super soluble in nature. Further the process for the preparation of Phyto Synergy composition of the present invention does not involve use of pharmaceutically unacceptable and hazardous organic solvents. The process for preparing this composition of the present invention comprises procuring, cleaning, grading of specified herbal extraction as per the standard specification, and design granulation to improve poor palatability and micromeritics property for high disintegrating power and pulverizing separately to form the fine free flow powder. Colds are minor infections of the nose and throat caused by more than 200 different viruses. Rhinovirus is the most common cause, accounting for 10 to 40 percent of colds. Other common cold viruses include coronavirus. A cold may last for about one week, but some colds last longer, especially in children, the elderly and those in poor health. In the United States, colds account for more visits to the doctor than any other condition. Adults get an average of two to four colds per year, mostly between September and May. Young children suffer from an average of six to eight colds per year. Colds are highly contagious. They most often spread when droplets of fluid that contain a cold virus are transferred by touch. These droplets may also be inhaled.
As per case study, Animal toxicity report and human clinical trials, it is proven safe, and therapeutically proven for cough cold, allergy, bronchitis, asthma, Pneumonia and in viral disease. As per Invitro Sars Cov-2 Antiviral study, Anti- Sars Cov-2 activity found 75% in 24 hrs in VERO E-6 infected cell with more than 95 % cell viability as per Department of Biotechnology report.
The process of manufacturing of herbal extracts is as follows:
1. Individual Phytoconstituent as per mentioned specification cross check by suitable analytical technique.
2. Except Glycyrrhiza Glabera Individual extract reprocesses with granulation to improve palatability and micromeritics property. Granulation blend process are as follow.
(a) Synergy form of Curcumin mixed with Black piper, Lavang and Saponin blend of Liquorice for Anti-inflammatory effect by improve its poor characteristics.
(b) Synergy form of Ajwain, Ginger, Cinnamon mixed for synergy bronchodilation and Antihistaminic effect.
(c) Synergy form of Betel leaf, Kakamachi and Lindipiper mixed for cough, cold and expectorant
(d) Synergy blend of Puskarmool, Tulsi and Vasaka mixed for its Antiviral, Anti-bacterial activity
3. Dry all blend of Phytoconstituents at 40-55 0C in tray dryer or fluidized bed dryer for 30-60 min.
4. Pulverized it in sieve number 80-100.
5. Check flowability of individual as per free flow compliance and mixed all in synergy form.
6. Continue mixing of all improvised granules for 30-45 min and then add natural blend of Mentha Spicata extract 4-8% and again mix for 20-30 minutes.
7. At last mixed Glycyrrhiza Glabera with optimized concentration in above blend and mixed it for 15-20 min.
8. Viscosity adjusted with Natural gum of Phytoconstituents blend.
For the purpose of this invention the Ayurvedic plants constituents are selected from the following group:
Table 1: polyherbal blend of sugar free dry syrup composition
Botanical name of Plant Therapeutic Properties Concentration (%)
Trachyspermum Ammi extract It has an anti-inflammatory antibacterial and stimulating expectorant action. 15-20
Glycyrrhiza Glabera extract It has an Anti-inflammatory, demulcent and expectorant action. 15-20
Ocimum Sanctum extract It has an Anti-inflammatory, spasmolytic action and anti- bacterial action. 8-16
Piper longum extract It has an Expectorant, bronchodilator action. 6-10
Iris Germanica extract It has an Expectorant, spasmolytic, bronchodilator action. 4.5-9
Zingiber Officinale extract It has an Antipyretic action, 4-9
Solanum Nigrum extract It has an Anti-inflammatory, expectorant and antitussive action. 3.5-9
Piper betle extract It has an Anti-asthmatic and antibacterial action. 3-6
Piper nirgum extract It has an Antibacterial action. 3-6
Syzygium aromaticum ext It has an analgesic, anti-inflammatory, and anti-bacterial action. 2-6
Cinnamomum verum extract It has an Anti-inflammatory, Anti-Viral and antihistaminic action. 2-6
Curcuma Longa extract It has an Anti-inflammatory, Anti-Viral, and Anti-Sars-CO2 activity 1-4
Adhatoda vasaca ext It has an antitubercular action. 1-4

Examples and Evaluation parameters

a) Preparation of polyherbal composition:
Preparation of Herbal mixture
Adding raw extract of Trachyspermum Ammi extract, Glycyrrhiza Glabera extract, Ocimum Sanctum extract, Piper longum extract, Iris Germanica extract, Zingiber Officinale extract, Solanum Nigrum extract, Piper betle extract, Piper nirgum extract, Syzygium aromaticum extract, Cinnamomum verum extract, Curcuma Longa extract, Adhatoda vasaca extract in a beaker and mixing them well and converting the same into syrup. Dry all blend of Phytoconstituents at 40-55°C in tray dryer or fluidized bed dryer for 30-60 min. Pulverized it in sieve number 80-100. Check flowability of individual as per free flow compliance and mixed all in synergy form. Continue mixing of all improvised granules for 30-45 min and then add natural blend of Mentha Spicata extract 4-8% and again mix for 20-30 minutes. At last mixed Glycyrrhiza Glabera with optimized concentration in above blend and mixed it for 15-20 min. Viscosity adjusted with Natural gum of Phytoconstituents blend. The procedure is depicted in Table 1 below.
Table 2: polyherbal blend of sugar free dry syrup composition
Ingredients Concentration (%)
F1 F2 F3
Trachyspermum Ammi extract 15 17 20
Glycyrrhiza Glabera ext
16 18 19
Ocimum Sanctum extract 9 12 15
Piper longum extract 6 8 9
Iris Germanica extract 5 6 9
Zingiber Officinale extract 4 7 8
Solanum Nigrum extract 6 7 9
Piper betle extract 3 5 6
Piper nirgum extract 3 4 5
Syzygium aromaticum ext 2 5 6
Curcuma Longa extract 1 3 5
Adhatoda vasaca ext 2 3 4
fluidized bed dryer time - 30-60 min, Pulverize # 80-100 mesh

b) Evaluation of the polyherbal sugar free dry syrup composition
Colour
5 ml of final syrup is taken in a watch glasses and placed under light, and colour is observed by naked eye.
Odour
2 ml of final syrup is smelled individually and then the odour can be detected.
Taste
A pinch of final syrup is placed on the taste bud of tongue to identify the taste.
Determination of pH
Take 5 ml of final syrup in the volumetric flask and make the volume up to 50ml with purified water. The pH can be determined by using digital pH meter.
Determination of viscosity
Viscosity of herbal syrup can be determined by using an Ostwald viscometer. Ostwald viscometer is thoroughly cleaned with chromic acid or acetone. Viscometer should be placed in a vertical position in a suitable stand. Fill the water up to the mark in dried viscometer. Now note the time required for water to flow from mark A to mark Repeat the process for 3 times, to obtain accurate reading. Now ish the viscometer and fill it with herbal syrup, and then note the time required for syrup to flow from mark A to mark B.
Determination of density
The density of syrup can be determined by using a pyncometer. Clean the pyncometer (specific gravity bottle) with chromic acid and nitric acid, and rinse with purified water. Note the weight of empty dry bottle (w1). Fill the pyncometer with 10 ml of water and weigh it (w2). Finally note the weight of bottle with 10 ml of syrup (w3).
Table 3: Evaluation parameter polyherbal blend of sugar free dry syrup composition
SR. No Evaluation Parameters Syrup formulation
1 Colour Reddish Brown
2 Odour Aromatic
3 Taste Lightly bitter
4 pH 6.2
5 Viscosity 1.05
6 Density 1.01
,CLAIMS:1. A polyherbal blend of sugar free dry syrup composition for treating cough & cold.
2. The polyherbal blend of sugar free dry syrup composition as claimed in claim 1, wherein the polyherbal composition comprising of Trachyspermum Ammi extract, Glycyrrhiza Glabera extract, Ocimum Sanctum extract, Piper longum extract, Iris Germanica extract, Zingiber Officinale extract, Solanum Nigrum extract, Piper betle extract, Piper nirgum extract, Syzygium aromaticum extract, Cinnamomum verum extract, Curcuma Longa extract, Adhatoda vasaca extract to form sugar free dry syrup.
3. The polyherbal blend of sugar free dry syrup composition as claimed in claim 1, wherein the polyherbal composition which is non-alcoholic, non-sedating and non-freezing, high soluble, non-palatable, excipient less, preservative free with no artificial flavor dry syrup in the treatment of chronic respiratory disorders such as cold, cough.
4. A method of preparation of polyherbal blend of sugar free dry syrup composition comprises of;
a. Synergy form of Curcumin mixed with Black piper, Lavang and Saponin blend of Liquorice for Anti-inflammatory effect by improve its poor characteristics.
b. Synergy form of Ajwain, Ginger, and Cinnamon mixed for synergy bronchodilation and Antihistaminic effect.
c. Synergy form of Betel leaf, Kakamachi and Lindipiper mixed for cough, cold and expectorant.
d. Synergy blend of Puskarmool, Tulsi and Vasaka mixed for its Antiviral, Anti-bacterial activity.
e. Dry all blend of Phytoconstituents at 40-55 0C in tray dryer or fluidized bed dryer for 30-60 min.
f. Pulverized it in sieve number 80-100.
g. Check flowability of individual as per free flow compliance and mixed all in synergy form.
h. Continue mixing of all improvised granules for 30-45 min and then add natural blend of Mentha Spicata extract 4-8% and again mix for 20-30 minutes.
i. At last mixed Glycyrrhiza Glabera with optimized concentration in above blend and mixed it for 15-20 min.
j. Viscosity adjusted with Natural gum of Phytoconstituents blend.
5. The polyherbal composition as claimed in claim 1, wherein the said polyherbal composition in the form of sugar free dry syrup can be used for treating cough & cold.