DESC:FORM 2
THE PATENTS ACT, 1970
(39 of 1970)
&
THE PATENTS RULE, 2003
(SECTION 10 and RULE 13)

COMPLETE SPECIFICATION

READY TO USE STABLE LIQUID HERBAL COMPOSITION

AMERISE PHARMACEUTICALS PVT LTD.
B1/13-14, 2ND FLOOR, GALAXY SIGNATURE, OPPOSITE SUKAN BUNGALOW, SCIENCE CITY ROAD, SOLA. AHMEDABAD- 380060

THE FOLLOWING SPECIFICATION PARTICULARLY DESCRIBES THE INVENTION AND THE MANNER IN WHICH IT IS TO BE PERFORMED
READY TO USE STABLE LIQUID HERBAL COMPOSITION

FIELD OF THE INVENTION

The present invention relates to herbal composition in the form of ready to use and administer liquid dosage form. More particularly, the present invention relates to oral herbal composition with enhanced efficacy and stability. The formulation is a strong antioxidant and naturally helps to boost the immune system.

BACKGROUND OF THE INVENTION
An oral syringe is used to dispense liquid solutions and suspensions, and can be used to give many medications available as a capsule or tablet as an oral liquid. Oral syringes are also useful for gradually increasing or decreasing the dose of your medication, also called a taper.
Benefits of using an oral syringe to dispense your medication: 1. Provides precise and accurate measurement of medications allowing for flexibility of dosing to meet your individual needs. 2. Liquid medications are easier to administer and can be helpful in small children, pets, and people who have trouble swallowing capsules or pills.
Presently, there is increased interest, awareness and preference amongst individuals towards herbal medicines for enhancement of immunity towards various diseases. Various part of plant or herb like root, flower, leaf, seed etc can be used for medicinal purpose.
Ginger also known as Zingiber officinale is a flowering plant whose rhizome, ginger root or ginger, is widely used. Ginger is in the Zingiberaceae family. Ginger mainly contains volatile oils which give characteristic fragrance and flavor to ginger. Main ingredient of ginger is zingerone, shogaols, and gingerols with [6]-gingerol (1-[4'-hydroxy-3'-methoxyphenyl]-5-hydroxy-3-decanone) as the major pungent compound. Zingerone is produced from gingerols during drying. Shogaols are more pungent and have higher antioxidant activity. It is formed from gingerols during heating and storage. Ginger has variety of medicinal uses. It is used in treatment of nausea, especially morning sickness, infections, reduce muscle pain, chronic indigestion, menstrual pain. It has anti-inflammatory activity, cholesterol-lowering activity. It improve brain function and protect against alzheimer’s disease.
Black pepper known as Piper nigrum is a flowering vine in the family Piperaceae. It is cultivated for its fruit, known as a peppercorn, which is usually dried and used as spices. There are various variety like white pepper, green pepper, red peppercorns and pink pepper. It mainly contains piperine which is responsible for spiciness of black pepper. Black pepper contains between 4.6 and 9.7% piperine by mass. It also contains terpenes, including germacrene (11%), limonene (10%), pinene (10%), alpha-phellandrene (9%), and beta-caryophyllene (7%). Traditionally, black pepper was believed to cure several illnesses, such as constipation, insomnia, oral abscesses, sunburn, and . toothaches. It has anti-inflammatory properties and improves brain function.
Bay leaves come from several plants, linke Bay laurel (Laurus nobilis, Lauraceae family), California bay leaf – the leaf of the California bay tree (Umbellularia californica, Lauraceae), Indian bay leaf or malabathrum (Cinnamomum tamala, Lauraceae), Indonesian bay leaf or Indonesian laurel (Syzygium polyanthum, Myrtaceae), West Indian bay leaf, the leaf of the West Indian bay tree (Pimenta racemosa, Myrtaceae) and Mexican bay leaf (Litsea glaucescens, Lauraceae). The leaves contain about 1.3% essential oils consisting of 45% eucalyptol, 12% other terpenes, 8-12% terpinyl acetate, 3–4% sesquiterpenes, 3% methyleugenol, and other a- and ß-pinenes, phellandrene, linalool, geraniol, terpineol, and contain lauric acid also. It is commonly used in cooking.
Cardamom, also known as cardamon or cardamom, is a spice made from the seeds of several plants in the genera Elettaria and Amomum in the family Zingiberaceae. The two main types of cardamom are, True or green cardamom and Black cardamom, Its main content is essential oils, which is mainly present in seed portion. It contains a-terpineol, myrcene, limonene, menthone, ß-phellandrene, 1,8-cineol, sabinene and heptane. Cardamom are used as flavourings and cooking spices in both food and drink. Its antioxidant and diuretic properties may lower blood pressure. It has anti-inflammatory and antibacterial effects. It is used to treat bad breath and prevent cavities.
IN202021010871A patent application disclose the Trikatu Churna which includes “Piper Nigrum” (black pepper), Piper Longum” (long pepper) and “Zingiber Officinale” (dried ginger), all in powdered form Ayurvedic medicinal composition covered under this patent application is used for treating asthma, includes herbal bio-availability enhancer formulation, and herbal antiinflammatory formulation.
WO2009020902A1 invention discloses beverage composition includes water, milk solids, a tea material, and a pH buffer that itself includes a lactate salt and a carbonate salt. The pH buffer reduces or eliminates precipitation of milk protein when dissolved milk solids are mixed with acidic tea components. Methods of preparing the composition, and packaged beverages are also described. Composition also includes ginger and black pepper.
US20140271923A1 patent application covers composition for reducing polypharmacy or for preventing or ameliorating e.g. chronic diseases that cluster in patients, comprises non-Food and Drug Administration (FDA) approved agent, e.g. sesquiterpenoid, sesquiterpene, and zerumbone. The composition further includes ginger and black pepper as well, Claimed composition is used in treatment of hypertension, obesity, hyperglycemia, hyperlipidemia, atherosclerosis, or cancer or chemotherapeutic resistance.
The marketed formulations are supplied in vial as a solution, suspension or powder form but this formulation has single shot supplied in BD syringe which gives ease of administration with single use. There is no marketed herbal formulation like currently invented compositions of particular concentration of ingredients. This formulation has potential benefit for patient comfort with unique economic way, which kills the cold virus, detoxes the system by relaxing the intestinal tract and naturally helps to boost the immune system. The present inventors has addressed this need and found surprising synergy between ingredients used and manufacturing process as described in the present invention and ease of administration method. These herbal ingredients are optimised to obtain stable formulation, which has maximum therapeutic efficacy and stability. However, herbal ingredient has stability issue on long term storage which ultimately decreases its efficacy.
Hence, there is strong need to formulate a composition, which can be stored at for long term and maintain its efficacy without side effects.

SUMMARY OF THE INVENTION
The present invention related to a stable, ready to use herbal composition comprising ginger, black piper, bay leaf powder and one or more pharmaceutical acceptable excipients. Further, the present invention provides process for the preparation of the said composition and its use for the enhancement of immunity.
One aspect of the present invention is to provide a stable, ready to use herbal composition comprising Ginger, Black piper, Bay leaf powder, one or more flavouring agent and one or more diluent.
One aspect of the present invention is to provide a stable, ready to use herbal composition comprising Ginger, Black piper, Bay leaf powder, Cardamom and one or more pharmaceutical acceptable excipients.
Another aspect of the present invention is to provide a stable, ready to use herbal composition comprising Ginger, Black piper, Bay leaf powder and one or more pharmaceutical acceptable excipients wherein the said composition can be administered orally.
Another aspect of the present invention is an oral pharmaceutical composition consisting of: ginger; bay leaf; black piper; cardamom, honey and water.
Another aspect of the present invention is to provide a stable, ready to use herbal composition comprising Ginger, Black piper, Bay leaf powder and one or more pharmaceutical acceptable excipients wherein the said composition can be administered using oral syringe with single shot.
Another aspect of the present invention is to provide a stable, ready to use herbal composition comprising Ginger, Black piper, Bay leaf powder and one or more pharmaceutical acceptable excipients wherein Ginger, Black piper and Bay leaf powder present in the ration of 1:0.5:0.5.
Another aspect of the present invention is to provide a stable, ready to use herbal composition comprising Ginger, Black piper, Bay leaf powder, Cardamom and one or more pharmaceutical acceptable excipients wherein Ginger, Black piper and Bay leaf powder present in the ration of 1:0.5:0.5:0.1.
Another aspect of the present invention is an oral pharmaceutical composition comprising: a) ginger; b) bay leaf; c) black piper; and d) cardamom and one or more pharmaceutical excipient, wherein the said ginger, bay leaf, black piper, cardamom is present in ration of 1:0.5:0.5:0.2.
Another aspect of the present invention is to provide a stable, ready to use herbal composition comprising Ginger, Black piper, Bay leaf powder, flavouring agent and one or more pharmaceutical acceptable excipients wherein said composition is free of additional specific preservatives and anti-oxidants.
Another aspect of the present invention is to provide a process for preparation of stable, ready to use herbal composition comprising Ginger, Black piper, Bay leaf powder and one or more pharmaceutical acceptable excipients comprises the step of: Wetting, Mixing, Homogenization and filling.
Another aspect of the present invention is to provide a stable, ready to use herbal composition comprising Ginger, Black piper, Bay leaf powder and one or more pharmaceutical acceptable excipients wherein said composition remains stable at Room Temperature for at least 2 months or more.
Another aspect of the present invention is to provide a stable, ready to use herbal composition comprising Ginger, Black piper, Bay leaf powder and one or more pharmaceutical acceptable excipients wherein said composition remains stable at 40°C ± 2° /75% RH ± 5 % for at least 6 months or more.
Another aspect of the present invention is to provide a stable, ready to use herbal composition comprising Ginger, Black piper, Bay leaf powder and one or more pharmaceutical acceptable excipients wherein said composition remains stable at 30° C ± 2°/ 65 % RH ± 5 % for at least 12 month or more.
Another aspect of the present invention is to provide a stable, ready to use herbal composition comprising Ginger, Black piper, Bay leaf powder, Cardamom and one or more pharmaceutical acceptable excipients wherein said composition remains stable at 30° C ± 2°/ 65 % RH ± 5 % for at least 6 months or more.
Another aspect of the present invention is to provide a stable, ready to use herbal composition comprising Ginger, Black piper, Bay leaf powder, flavouring agent and one or more pharmaceutical acceptable excipients wherein said composition is used to enhance immunity and to prevent virus locally in throat and give symptomatic relief.
Another aspect of the present invention is to provide a stable, ready to use herbal composition comprising Ginger, Black piper, Bay leaf powder, flavouring agent and one or more pharmaceutical acceptable excipients wherein said composition is administered to adult as well as pediatric population above 5 years old.
Another aspect of the present invention is to provide a stable, ready to use herbal composition comprising Ginger, Black piper, Bay leaf powder, flavouring agent and one or more pharmaceutical acceptable excipients wherein said composition is in the form of ready to use and ready to shot or administer by oral syringe.

DETAILED DESCRIPTION
Unless otherwise indicated, terms in this specification are intended to have their ordinary meaning in the relevant art.
The present invention relates to a stable, ready to use herbal composition comprising ginger, black piper, bay leaf powder and one or more pharmaceutical acceptable excipients. Further, the present invention provides process for the preparation of the said composition and its use for the enhancement of immunity.
The term “ginger” used throughout the specification refers to Ginger (Zingiber officinale) is a flowering plant whose rhizome, ginger root or ginger, is widely used as a spice and a folk medicine. It is a herbaceous perennial which grows annual pseudostems (false stems made of the rolled bases of leaves) about one meter tall bearing narrow leaf blades. The inflorescences bear flowers having pale yellow petals with purple edges, and arise directly from the rhizome on separate shoots.
The term “black piper” used throughout the specification refers to Black pepper (Piper nigrum) is a flowering vine in the family Piperaceae, cultivated for its fruit, known as a peppercorn, which is usually dried and used as a spice and seasoning. When fresh and fully mature, the fruit is about 5 mm (0.20 in) in diameter and dark red, and contains a single seed, like all drupes. Peppercorns and the ground pepper derived from them may be described simply as pepper, or more precisely as black pepper (cooked and dried unripe fruit), green pepper (dried unripe fruit), or white pepper (ripe fruit seeds).
The term “bay leaf” used throughout the specification refers to Bay laurel (Laurus nobilis, Lauraceae). Fresh or dried bay leaves are used in cooking for their distinctive flavour and fragrance. The leaves should be removed from the cooked food before eating (see Safety section below). The leaves are often used to flavour soups, stews, braises and pâtés in many countries. The fresh leaves are very mild and do not develop their full flavour until several weeks after picking and drying.
The term “pharmaceutically acceptable” means salt, carriers, excipients, and other formulation ingredients that are compatible with all other pharmaceutical ingredients of a composition and are not deleterious to an individual treated with composition.
The term “stable” as used throughout the specification, refers to herbal composition in which the ginger, black piper, bay leaf powder is present in an amount of at least 90% of the original label specified amount for each such ingredient during specific storage conditions 30° C ± 2°/ 65 % RH ± 5 % for at least 12 month and 40°C ± 2° /75% RH ± 5 % for at least 6 month.
In one of the embodiment, the present invention is to provide a stable, ready to use herbal composition comprising ginger, black piper, bay leaf powder and one or more pharmaceutical acceptable excipients wherein the ration of ginger, black piper and bay leaf powder in said herbal composition is about 1:1:1 to 1:0.1:0.1. Preferred ratio for ginger, black piper and bay leaf powder in said herbal composition is 1:0.5:0.5.
In one of the embodiment, the present invention is to provide a stable, ready to use herbal composition comprising ginger, black piper, bay leaf powder and one or more pharmaceutical acceptable excipients wherein the said ginger, black piper and bay leaf should be in powder form.
The term “Flavouring agent” refers to excipient, which is used to give flavour to stable, ready to use herbal composition of ginger, black piper, bay leaf powder or its pharmaceutical acceptable salt thereof.
In one of the embodiments, flavouring agent used according to the present invention is selected from the group comprising but not limited to, eucalytus, orange, peppermint, spearmint, lime, apple, pear, peach, raspberry, plum, cardamom, pineapple flavour and the like or combination thereof. Preferred flavouring agent for present invention is cardamom. The concentration of flavouring agent used may be in the range of between 0.1 and 2 mg/mL and preferably between 0.1 and 3 mg/mL The concentration of flavouring agent used is between 0.1% to 10%.
The term “diluent” refers to excipient, which is used to dilute a stable, ready to use herbal composition of ginger, black piper, bay leaf powder or its pharmaceutical acceptable salt thereof.
In one of the embodiment, the diluent includes glycols, propylene glycol, ethyl alcohol, cetyl alcohol, glyceryl stearate, isopropyl alcohol, diethylamine, glyceryl oleate, myristyl alcohol, simple syrup, glycerin, propylene glycol, ethanol, maltitol, xylitol, inositol, mannitol, invert sugars, sorbitol and the like or combination thereof. Said diluent is preferably selected from the group comprising glycerin, propylene glycol, sorbitol, water, ethanol or combination thereof.
The term “Sweetening agent” refers to excipient, which is used to enhances the taste of a stable, ready to use herbal composition of ginger, black piper, bay leaf powder or its pharmaceutical acceptable salt thereof.
In one of the embodiment, sweetening agent used is selected from the group comprising, but not limited to, saccharine, saccharine sodium, sucralose, sorbitol, acesulfame potassium, aspartame, a fluorinated sucrose derivative, dextrose, corn syrup, alitame, cyclamic acid, thaumatin, monellin, mono-ammonium glycyrrhizinate and the like or combination therof. The most preferred sweetening agent of the present invention can be sorbitol, mono-ammonium glycyrrhizinate, sucralose or combination thereof.
The term “Honey” refers to madhu in ayurvedic scriptures is one of the most important medicines used in ayurveda. In ayurveda, honey is used for both internal and external applications. It is mainly used for the treatment of eye diseases, cough, thirst, phlegm, hiccups, blood in vomit, leprosy, diabetes, obesity, worm infestation, vomiting, asthma, diarrhoea and healing wounds. It is also used as a natural preservative and sweetener in many ayurvedic preparations. It is also used as a vehicle along with some medicines to improve its efficacy or to mitigate the side effects of the other medicines it is mixed with. It is also known to mitigate the increased kapha dosha. (Kapha dosha is the ayurvedic category for body constitutions- those with kapha dosha are of larger proportions with robust frame.)
The term "room temperature" For the purpose of this invention, refers to pharmaceuticals composition of present invention stored at 20-25?C and 50 ± 10 % RH.
In one of the embodiments of the present invention is to provide a stable, ready to use herbal composition comprising Ginger, Black piper, Bay leaf powder and one or more pharmaceutical acceptable excipients wherein said composition is free of additional specific preservatives and anti-oxidants.
In one of the embodiments, process for preparation of stable, ready to use herbal composition comprising Ginger, Black piper, Bay leaf powder and one or more pharmaceutical acceptable excipients comprises the aqueous phase, where in the step for preparation of aqueous phase is:
1. Measuring Ginger powder, Black piper powder and Bay leaf powders accurately.
2. Dissolving weighted amount obtained in step 1 in water.
3. Mixing the solution obtained in step 2 for 30-60 min.
In one of the embodiments, process for preparation of stable, ready to use herbal composition comprising Ginger, Black piper, Bay leaf powder, Cardamom and one or more pharmaceutical acceptable excipients comprises the honey phase, where in the step for preparation of honey phase is:
1. Measuring Honey and cardamom powder accurately.
2. Dissolving cardamom powder to honey.
3. Homogenizing the mixture obtained in step 2 for 30 min
In one of the embodiments, process for preparation of stable, ready to use herbal composition comprising Ginger, Black piper, Bay leaf powder, Cardamom and one or more pharmaceutical acceptable excipients is:
1. Measuring Ginger powder, Black piper powder and Bay leaf powders accurately.
2. Dissolving weighted amount obtained in step 1 in water.
3. Mixing the solution obtained in step 2 for 30-60 min.
4. Measuring Honey and cardamom powder accurately.
5. Dissolving cardamom powder to honey.
6. Homogenizing the mixture obtained in step 2 for 30 min
7. Mixing the solution obtain in step 3 into the mixture obtained in step 6.
8. Filling the solution obtained in step 6 in 1 ml or 2 ml oral syringe
In one of the embodiments, a stable, ready to use herbal composition comprising ginger, black piper, bay leaf powder and one or more pharmaceutical acceptable excipients wherein the composition is stable for a period of six months.
In one of the embodiments, a stable, ready to use herbal composition comprising ginger, black piper, bay leaf powder and one or more pharmaceutical acceptable excipients wherein the composition can be administered orally.
In one of the embodiments, a stable, ready to use herbal composition comprising ginger, black piper, bay leaf powder and one or more pharmaceutical acceptable excipients wherein the composition is in the form of solution or suspension dosage form.
In one of the embodiments, composition comprising 1-10 % Ginger powder, 0.5-5% Black piper powder, 0.5-5% Bay leaf powder, 5-25% Water, quantity sufficient to 100% honey and pharmaceutically acceptable excipients.
In one of the embodiments, composition comprising 1-10 % Ginger powder, 0.5-5% Black piper powder, 0.5-5% Bay leaf powder, 0.1-1% Cardamom powder 5-25% Water and quantity sufficient to 100% honey and pharmaceutically acceptable excipients.
In one of the embodiments, composition comprising of 1 % Ginger powder, 0.5-1% Black piper powder, 0.5% Bay leaf powder, 5% Water and quantity sufficient to 100% honey.
In one of the embodiments, composition consisting of 5 % Ginger powder, 2.5% Black piper powder, 2.5% Bay leaf powder, 1% Cardamom powder, 25% Water and quantity sufficient to 100% honey.
In one of the embodiments, is to provide a stable, ready to use herbal composition comprising Ginger, Black piper, Bay leaf powder, Cardamom and one or more pharmaceutical acceptable excipients wherein Ginger, Black piper and Bay leaf powder present in the ration of 1:0.5:0.5:0.1.
In one of the embodiments, is an oral pharmaceutical composition comprising: a) ginger; b) bay leaf; c) black piper; d) cardamom and one or more pharmaceutical excipient, wherein the said ginger, bay leaf, black piper, cardamom is present in ration of 1:0.5:0.5:0.2.
In one of the embodiments, composition consisting of 5 % Ginger powder, 2.5% Black piper powder, 2.5% Bay leaf powder, 1% Cardamom powder, 25% Water , quantity sufficient to 100% honey and pharmaceutically acceptable excipients, wherein the said ginger, bay leaf, black piper, cardamom is present in ration of 1:0.5:0:0.2, wherein said composition has pH 4 to 5; pH 4.2 to 4.8; pH 4.4 to 4.6; pH 4.5, wherein the composition is ready to use and administered using oral syringe with single shot.
In one of the embodiments, a stable, ready to use herbal composition comprising Ginger, Black piper, Bay leaf powder and one or more pharmaceutical acceptable excipients wherein said composition remains stable at 40°C ± 2° /75% RH ± 5 % for at least 6 months or more.
In one of the embodiments, a stable, ready to use herbal composition comprising Ginger, Black piper, Bay leaf powder and one or more pharmaceutical acceptable excipients wherein said composition remains stable at 30°C ± 2°/ 65 % RH ± 5 % for at least 12 month or more.
In one of the embodiments, a stable, ready to use herbal composition comprising Ginger, Black piper, Bay leaf powder and one or more pharmaceutical acceptable excipients wherein said composition has no microbial growth at 40°C ± 2° /75% RH ± 5 % for at least 6 months or more.
In one of the embodiments, a stable, ready to use herbal composition comprising Ginger, Black piper, Bay leaf powder and one or more pharmaceutical acceptable excipients wherein said composition has no microbial growth at 30°C ± 2°/ 65 % RH ± 5 % for at least 12 month or more.
In one of the embodiments, a stable, ready to use herbal composition comprising Ginger, Black piper, Bay leaf, cardamom powder and one or more pharmaceutical acceptable excipients wherein said composition remains stable at 40°C ± 2° /75% RH ± 5 % for at least 6 months or more.
In one of the embodiments, a stable, ready to use herbal composition comprising Ginger, Black piper, Bay leaf powder, cardamom and one or more pharmaceutical acceptable excipients wherein said composition remains stable at 30°C ± 2°/ 65 % RH ± 5 % for at least 12 month or more.
In one of the embodiments, a stable, ready to use herbal composition comprising Ginger, Black piper, Bay leaf, Cardamom powder and one or more pharmaceutical acceptable excipients wherein said composition has no microbial growth at 40°C ± 2° /75% RH ± 5 % for at least 6 months or more.
In one of the embodiments, a stable, ready to use herbal composition comprising Ginger, Black piper, Bay leaf and Cardamom powder and pharmaceutical acceptable excipients wherein said composition has no microbial growth at 30°C ± 2°/ 65 % RH ± 5 % for at least 12 month or more.
In one of the embodiments, a stable, ready to use herbal composition comprising Ginger, Black piper, Bay leaf powder and one or more pharmaceutical acceptable excipients wherein said composition has pH 4 to 5; pH 4.2 to 4.8; pH 4.4 to 4.6; pH 4.5.
In one of the embodiments, a stable, ready to use herbal composition comprising Ginger, Black piper, Bay leaf powder and cardamom, wherein said composition has pH 4 to 5; pH 4.2 to 4.8; pH 4.4 to 4.6; pH 4.5.
In one of the embodiments, a stable, ready to use herbal composition comprising ginger, black piper, bay leaf powder and one or more pharmaceutical acceptable excipients wherein the composition can fill in to oral syringe which can be administered directly to buccal cavity.
In one of the embodiments, a stable, ready to use herbal composition comprising ginger, black piper, bay leaf powder and one or more pharmaceutical acceptable excipients wherein the composition issued after filling in to oral syringe which can be administered at least one time a day.
In one of the embodiments, a stable, ready to use herbal composition comprising ginger, black piper, bay leaf powder and one or more pharmaceutical acceptable excipients wherein the composition is supplied in 1 to 5 mL syringe; 2 to 4 mL syringe; 2 to 3 mL syringe; 2 to 2.5 mL syringe. Preferably, a stable, ready to use herbal composition comprising ginger, black piper, bay leaf powder and one or more pharmaceutical acceptable excipients wherein the composition is supplied in 2 mL syringe.
In one of the preferred embodiments, a stable, ready to use herbal composition comprising ginger, black piper, bay leaf powder and one or more pharmaceutical acceptable excipients wherein the composition can fill in to oral syringe which can administered two time a day.
In one of the preferred embodiments, a stable, ready to use herbal composition comprising ginger, black piper, bay leaf powder and one or more pharmaceutical acceptable excipients wherein the composition shows anti-viral activity, anti-oxidant activity, anti-microbial activity, apoptotic activity, anti-inflammatory and immunomodulatory activities, anti- diabetes activity, anti-cancer activity.
In one of the preferred embodiments, a stable, ready to use herbal composition comprising ginger, black piper, bay leaf powder and one or more pharmaceutical acceptable excipients wherein the composition shows a strong antioxidant property and naturally helps boosting immune system, kills the cold virus, and detoxes the system by relaxing the intestinal tract.
In one of the preferred embodiments, a stable, ready to use herbal composition comprising ginger, black piper, bay leaf powder and one or more pharmaceutical acceptable excipients wherein the composition is used in treatment of wound healing, gastrointestinal diseases, neurological diseases, cardiovascular diseases or asthma.
In one of the preferred embodiments, a stable, ready to use herbal composition comprising ginger, black piper, bay leaf powder and one or more pharmaceutical acceptable excipients wherein the ready to use composition improved patient compliance.
Palatability study of composition is carried out. Organoleptic evaluation of composition is scaled from range of 0 to 10. scale 0 to 2 indicates composition is scaled as not sweet, not bitter, not pungent, not sour, not spicy, very less Post swallow residue in mouth, and unpleasant post swallow feel in mouth. Scale 3 to 4 indicates composition is scaled as less sweet, less bitter, less Pungent, less sour, less spicy, less Post swallow residue in mouth, and moderate post swallow feel in mouth. Scale 5 to 6 indicates composition is scaled as moderate sweet, moderate bitter, moderate pungent, moderate sour, moderate spicy, moderate post swallow residue in mouth, and pleasant post swallow feel in mouth. Scale 7 to 8 indicates composition is scaled as optimum sweet, optimum bitter, optimum pungent, optimum sour, optimum spicy, optimum post swallow residue in mouth, and excellent post swallow feel in mouth. Scale 9 to 10 indicates composition is scaled as more sweet, more bitter, more pungent, more sour, spicier, more post swallow residue in mouth and extraordinary post swallow feel in mouth.

EXAMPLES:
The present invention has been described by way of example only. It is to be recognized that modifications falling within the scope and spirit of the claims, which would be obvious to a person skilled in the art based upon the disclosure herein, are also considered to be included within the scope of this invention. The scope of the invention is in no manner limited by the disclosed example.

Example 1: Formulation of ready to use solution.
Table 1:
Sr. No Ingredients Quantity (in %)
1 Ginger Powder 1
2 Black piper Powder 1
3 Bay leaf Powder 0.5
4 Water 5
5 Honey q.s. to 100%

Manufacturing process:
1. Ginger powder, Black piper powder and Bay leaf powder were weighed accurately.
2. Powders of step 1 were added in to water.
3. The mixture of step 2 was mixed with heating.
4. Honey was added to the mixture obtained in step 3.
5. The solution obtained in step 4 was mixed.

Table 2: Stability study of ready to use solution
Parameter Initial 30°C ± 2°/ 65 % RH ± 5 % 40°C ± 2° /75% RH ± 5 %
6M 12M 3M 6M
Description
(Light to Dark brown colour liquid) Complies Complies Complies Complies Complies
Odour (Pungent sweet) Complies Complies Complies Complies Complies
Visual phase separation
(No separation) Complies Complies Complies Complies Complies
Pourability
(Easily Pourable) Complies Complies Complies Complies Complies

Example 2: Formulation of ready to use solution
Table 3:
Sr. No Ingredients Quantity (% w/w)
1 Ginger Powder 5
2 Black piper Powder 2.5
3 Bay leaf Powder 2.5
4 Cardamom Powder 1
5 Honey q.s.
6 Water 25
7 Syringe – 1 mL or 2 mL

Manufacturing Process:
1. Ginger powder, Black piper powder and Bay leaf powder were weighed accurately.
2. Powders of step 1 were added in to water.
3. The mixture of step 2 was mixed for 30-60 min with heating to 60 °C for 2 hr.
4. Cardamom powder was added to the honey.
5. The solution obtained in step 4 was mixed for 30 min.
6. The mixture of step 5 was added to the mixture of step 3.
7. The mixture of step 6 was mixed for 30 min.
8. The solution of step 7 was filled to 1 mL or 2 mL syringe.

Table 4: Stability study of ready to use solution
Parameter Initial 30°C ± 2°/ 65 % RH ± 5 % 40°C ± 2° /75% RH ± 5 %
6M 12M 3M 6M
Description
(Light to Dark brown colour liquid) Complies Complies Complies Complies Complies
Odour (Pungent sweet) Complies Complies Complies Complies Complies
Visual phase separation
(No separation) Complies Complies Complies Complies Complies
Pourability
(Easily Pourable) Complies Complies Complies Complies Complies

Clinical studies:
Oral palatability and organoleptic evaluation test study performed for 12 individual with single 2 ml shot inside the mouth over period of 7 days as and results are as acceptable .As study results of table 5 clearly shows that composition is acceptable and palatable
Table 5: Organoleptic evaluation
Sweet Biiter Punjunt Sour Post swallow residue in mouth Post swallow feel in mouth
Person 1 7 2 3 0 3 8
Person 2 8 1 4 0 4 8
Person 3 6 0 5 1 4 7
Person 4 7 1 4 0 3 9
Person 5 7 1 5 0 2 8
Person 6 8 2 6 0 1 7
Person 7 9 0 5 1 3 8
Person 8 8 1 5 0 4 7
Person 9 8 1 4 1 2 9
Person 10 7 0 4 0 2 9
Person 11 6 0 5 0 4 10
Person 12 9 0 6 0 4 7

Example 3: Formulation of ready to use solution.
Table 6:
Sr. No Ingredients Quantity
(in %w/w)
1 Ginger Powder 1
2 Black piper Powder 0.5
3 Bay leaf Powder 0.5
4 Water 5
5 Honey q.s. to 100%

Manufacturing process:
1. Ginger powder, Black piper powder and Bay leaf powder were weighed accurately.
2. Powders of step 1 were added in to water.
3. The mixture of step 2 was mixed for 30-60 min with heating to 60 °C for 2 hr.
4. Honey was added to the mixture obtained in step 3 at 25 C° Tempurature.
5. The solution obtain in step 4 was mixed.
6. The solution of step 5 was filled to 1 mL or 2 mL syringe.

Table 7: Stability study of ready to use solution
Parameter Initial 30°C ± 2°/ 65 % RH ± 5 % 40°C ± 2° /75% RH ± 5 %
3M 6M 9 M 1 M 3M 6M
Description (Light to Dark brown color liquid) Complies Complies Complies Complies Complies Complies Complies
Odor and taste (Pungent- Sweet) Complies Complies Complies Complies Complies Complies Complies
Viscosity (Centipoise) 3200 cp 3150 cp 3210 cp 3230 cp 3220 cp 3250 cp 3300 cp
pH 4.50 4.52 4.45 4.52 4.48 4.53 4.52
Identification by TLC Complies Complies Complies Complies Complies Complies Complies
Visual phase separation
(No separation) Complies Complies Complies Complies Complies Complies Complies
Pourability
(Easily Pourable) Complies Complies Complies Complies Complies Complies Complies
Total solids (%w/v) 20.0 % 20.1% 19.9% 20.0 % 20.2% 20.1% 20.3%
Specific gravity at 25 C 1.46 1.47 1.47 1.46 1.47 1.46 1.45
TLC (Complies with Rf value) Complies Complies Complies Complies Complies Complies Complies
Test for heavy/toxic metals Complies Complies Complies Complies Complies Complies Complies
Pesticide residue Complies Complies Complies Complies Complies Complies Complies
Microbial contamination
Staphylococcus
aureus/g.- absent,
Salmonella sp./g.- absent, Pseudomonas aeruginosa/%- absent,
Escherichia coli- absent, Total Microbial plate count (TPC)-105/g, Total Yeast & Mould- 103/g Complies Complies Complies Complies Complies Complies Complies
Aflatoxins (B, +B2 +G, +G2 <5 ppb) Complies Complies Complies Complies Complies Complies Complies

Clinical studies:
Oral palatability study was performed for 5-15 individual over period of 7 days as and results are as acceptable.

Example 4: Formulation of ready to use composition
Tablet 8:
Sr. No Ingredients Quantity (% w/w)
1 Ginger 10.0
2 Black piper 5.0
3 Bay leaf 5.0
4 Cardamom 1
5 Honey q.s.
6 Water 25
7 Syringe – 1 mL or 2 mL

Manufacturing Process:
1. Ginger powder, Black piper powder and Bay leaf powder were weighed accurately.
2. Powders of step 1 were added in to water.
3. The mixture of step 2 was mixed for 30-60 min with heating to 60 °C for 2 hr.
4. Cardamom powder was added to the honey.
5. The solution obtained in step 4 was mixed for 30 min.
6. The mixture of step 5 was added to the mixture of step 3.
7. The mixture of step 6 was mixed for 30 min.
8. The solution of step 7 was filed to 1 mL or 2 mL syringe

Table 9: Stability study of ready to use composition
Parameter Initial 30°C ± 2°/ 65 % RH ± 5 % 40°C ± 2° /75% RH ± 5 %
3M 6M 9 M 1 M 3M 6M
Description (Light to Dark brown color liquid) Complies Complies Complies Complies Complies Complies Complies
Odor and taste (Pungent- Sweet) Complies Complies Complies Complies Complies Complies Complies
Viscosity (Centipoise) 2500 cp 2510 cp 2530 cp 2533 cp 2550 cp 2580 cp 2585 cp
pH 4.50 4.52 4.45 4.52 4.48 4.53 4.52
Identification by TLC Complies Complies Complies Complies Complies Complies Complies
Visual phase separation
(No separation) Complies Complies Complies Complies Complies Complies Complies
Pourability
(Easily Pourable) Complies Complies Complies Complies Complies Complies Complies
Total solids (%w/v) 27.0 % 27.5% 27.6% 27.8 % 27.2% 27.9% 27.5%
Specific gravity at 25 C 1.15 1.13 1.14 1.14 1.13 1.15 1.14
TLC (Complies with Rf value) Complies Complies Complies Complies Complies Complies Complies
Test for heavy/toxic metals Complies Complies Complies Complies Complies Complies Complies
Pesticide residue Complies Complies Complies Complies Complies Complies Complies
Microbial contamination
Staphylococcus
aureus/g.- absent,
Salmonella sp./g.- absent, Pseudomonas aeruginosa/%- absent,
Escherichia coli- absent, Total Microbial plate count (TPC)-105/g, Total Yeast & Mould- 103/g Complies Complies Complies Complies Complies Complies Complies
Aflatoxins (B, +B2 +G, +G2 <5 ppb) Complies Complies Complies Complies Complies Complies Complies

Clinical studies:
Oral palatability study performed for 5-15 individual over period of 7 days as and results are as acceptable.

Example 5: Formulation of ready to use solution
Tablet 10:
Sr. No Ingredients Quantity (% w/w)
1 Ginger 10.0
2 Black piper 5.0
3 Bay leaf 5.0
4 Cardamom 1
5 Honey q.s.
6 Water 10
7 Syringe – 1 mL or 2 mL

Manufacturing Process:
1. Ginger powder, Black piper powder and Bay leaf powder were weighed accurately.
2. Powders of step 1 were added in to water.
3. The mixture of step 2 was mixed for 30-60 min with heating to 60 °C for 2 hr.
4. Cardamom powder was added to the honey.
5. The solution obtain in step 4 was mixed for 30 min.
6. The mixture of step 5 was added to the mixture of step 3.
7. The mixture of step 6 was mixed for 30 min.
8. The solution of step 7 was filed to 1 mL or 2 mL syringe.
Table 11: Stability study of ready to use solution
Parameter Initial 30°C ± 2°/ 65 % RH ± 5 % 40°C ± 2° /75% RH ± 5 %
3M 6M 9 M 1 M 3M 6M
Description (Light to Dark brown color liquid) Complies Complies Complies Complies Complies Complies Complies
Odor and taste (Pungent- Sweet) Complies Complies Complies Complies Complies Complies Complies
Viscosity (Centipoise) 3500 cp 3550 cp 3560 cp 3580 cp 3490 cp 3540 cp 3590 cp
pH 4.50 4.52 4.45 4.52 4.48 4.53 4.52
Identification by TLC Complies Complies Complies Complies Complies Complies Complies
Visual phase separation
(No separation) Complies Complies Complies Complies Complies Complies Complies
Pourability
(Easily Pourable) Complies Complies Complies Complies Complies Complies Complies
Total solids (%w/v) 27.5% 27.5% 27.3% 27.9 % 27.4% 27.7% 27.9%
Specific gravity at 25 C 1.45 1.46 1.45 1.48 1.43 1.46 1.47
TLC (Complies with Rf value) Complies Complies Complies Complies Complies Complies Complies
Test for heavy/toxic metals Complies Complies Complies Complies Complies Complies Complies
Pesticide residue Complies Complies Complies Complies Complies Complies Complies
Microbial contamination
Staphylococcus
aureus/g.- absent,
Salmonella sp./g.- absent, Pseudomonas aeruginosa/%- absent,
Escherichia coli- absent, Total Microbial plate count (TPC)-105/g, Total Yeast & Mould- 103/g Complies Complies Complies Complies Complies Complies Complies
Aflatoxins (B, +B2 +G, +G2 <5 ppb) Complies Complies Complies Complies Complies Complies Complies

Clinical studies:
Oral palatability study performed for 5-15 individual over period of 7 days as and results are as acceptable.
Stability data mentioned above indicate that herbal composition is in the form of ready to use dosage form is stable over the period of time.


Dated this 30th day of September 2021
Digitally signed by
Name: Kirti Kathiriya
1. IN/PA 3421

I/We claim,
1. An oral pharmaceutical composition comprising: a) ginger powder; b) bay leaf powder; c) black piper powder and one or more pharmaceutical excipient, wherein the said ginger powder, bay leaf powder, and black piper powder, is present in ration of 1:0.5:0.5.
2. The pharmaceutical composition as claimed in claim 1, wherein one or more pharmaceutical excipients consisting of flavoring agent, diluent, Sweetening agent or mixture thereof.
3. The pharmaceutical composition as claimed in claim 1, wherein the composition is free of preservative and antioxidant.
4. The pharmaceutical composition as claimed in claim 1, wherein the composition is prepared by wetting, mixing, and homogenization.
5. The pharmaceutical composition as claimed in claim 3, wherein the composition remains stable at 40°C ± 2° /75% RH ± 5 for at least 6 months.
6. The pharmaceutical composition as claimed in claim 3, wherein the composition remains stable at 30°C ± 2°/ 65 % RH ± 5 % for at least 12 months.
7. The pharmaceutical composition as claimed in claim 1, wherein the composition is in the solution form.
8. The pharmaceutical composition as claimed in claim 7, wherein the composition is filled into syringe, wherein said syringe is 1 to 5 mL syringe.
9. The pharmaceutical composition as claimed in claim 1, wherein the composition is ready to use and administered using oral syringe with single shot.
10. The pharmaceutical composition as claimed in claim 1, wherein the composition has pH of 4 to 5.
11. The pharmaceutical composition as claimed in claim 1, wherein the composition is palatable.
Dated this 30th day of September 2021
Digitally signed by
Name: Kirti Kathiriya
IN/PA 3421

ABSTRACT
READY TO USE STABLE LIQUID HERBAL COMPOSITION
The present invention relates to herbal composition in the form of ready to use and administer liquid dosage form. The present invention related to a stable, ready to use herbal composition comprising ginger, black piper, bay leaf powder and one or more pharmaceutical acceptable excipients. Further, the present invention provides process for the preparation of the said composition and its use for the enhancement of immunity.

,CLAIMS:I/We claim,
1. An oral pharmaceutical composition comprising: a) ginger powder; b) bay leaf powder; c) black piper powder and one or more pharmaceutical excipient, wherein the said ginger powder, bay leaf powder, and black piper powder, is present in ration of 1:0.5:0.5.
2. The pharmaceutical composition as claimed in claim 1, wherein one or more pharmaceutical excipients consisting of flavoring agent, diluent, Sweetening agent or mixture thereof.
3. The pharmaceutical composition as claimed in claim 1, wherein the composition is free of preservative and antioxidant.
4. The pharmaceutical composition as claimed in claim 1, wherein the composition is prepared by wetting, mixing, and homogenization.
5. The pharmaceutical composition as claimed in claim 3, wherein the composition remains stable at 40°C ± 2° /75% RH ± 5 for at least 6 months.
6. The pharmaceutical composition as claimed in claim 3, wherein the composition remains stable at 30°C ± 2°/ 65 % RH ± 5 % for at least 12 months.
7. The pharmaceutical composition as claimed in claim 1, wherein the composition is in the solution form.
8. The pharmaceutical composition as claimed in claim 7, wherein the composition is filled into syringe, wherein said syringe is 1 to 5 mL syringe.
9. The pharmaceutical composition as claimed in claim 1, wherein the composition is ready to use and administered using oral syringe with single shot.
10. The pharmaceutical composition as claimed in claim 1, wherein the composition has pH of 4 to 5.
11. The pharmaceutical composition as claimed in claim 1, wherein the composition is palatable.
Dated this 30th day of September 2021
Digitally signed by
Name: Kirti Kathiriya
IN/PA 3421