DESC:TECHNICAL FIELD OF THE INVENTION:
The invention relates to a taste masked stable herbal composition containing extracts of Amla, Noni, Panch Tulsi, Piperine, and Curcumin.

OBJECTIVES OF THE INVENTION:
The present invention provides a taste masked stable herbal containing extracts of Amla, Noni, Panch Tulsi, Piperine, and Curcumin.
One of the objectives of invention is to provide a taste masked stable herbal composition comprising extracts of Amla (Phyllanthus Emblica), Noni (Morinda Citrifolia), Panch Tulsi (Ocimum Tenuiflorum), concentrated Piperine, and concentrated Curcumin
One of the objectives of invention is to provide a stable taste masked herbal composition comprising extracts of Amla (Phyllanthus Emblica), Noni (Morinda Citrifolia), Panch Tulsi (Ocimum Tenuiflorum), concentrated Piperine, concentrated Curcumin, and a one or more pharmaceutically acceptable excipient selected from a sweetener, and a pH adjusting agent.
One of the objectives of invention is to provide a stable taste masked herbal composition comprising extracts of Amla (Phyllanthus Emblica), Noni (Morinda Citrifolia), Panch Tulsi (Ocimum Tenuiflorum), concentrated Piperine, concentrated Curcumin, and a one or more pharmaceutically acceptable excipient selected from a sweetener, a preservative, a pH adjusting agent, a stabilizer, or an antioxidant.
One of the objectives of invention is to design a method for manufacturing a storage-stable herbal composition.
DETAILED DESCRIPTION:
Amla, known by various names such as Amlaka and Amlaki, is a commonly used herb in Ayurveda. It is derived from the fruit of the Phyllanthus emblica plant, also known as Emblica officinalis. While the appearance of amla fruit resembles that of the common gooseberry (a type of currant called Ribes spp.), they are botanically unrelated. However, due to the similar appearance of their fruit clusters, amla is often referred to as the "Indian gooseberry." This plant, a member of the Euphorbiaceae family, grows into a medium-sized tree and can be found in the plains and sub-mountain regions throughout the Indian subcontinent, ranging from 200 to nearly 2000 meters above sea level. The Indian gooseberry is highly regarded as a remarkable herb and a valuable gift of nature to humanity, contributing to health and longevity.
Amla (Phyllanthus emblica), is renowned for its exceptional immune bolstering and enhancing properties. Rich in vitamin C and a wide array of antioxidants, amla plays a crucial role in fortifying the body's defenses against illnesses. It helps stimulate the production of white blood cells, which are integral to the immune system's functioning, and combats harmful free radicals that can weaken immunity. Amla's immunomodulatory effects help balance the immune response, making it more efficient in warding off infections and diseases. Additionally, the anti-inflammatory and anti-microbial properties of amla further contribute to its immune-enhancing abilities, making it a valuable natural remedy for maintaining and strengthening overall health.
Noni, scientifically known as Morinda citrifolia, possesses immune-boosting and enhancing properties that make it a notable contributor to overall health. Rich in phytochemicals, antioxidants, and essential nutrients, noni plays a vital role in supporting the immune system. It contains compounds like xeronine and proxeronine that help regulate cell function, which in turn strengthens the body's natural defense mechanisms. Noni also exhibits anti-inflammatory and antimicrobial properties, aiding in the prevention and management of infections. Furthermore, its high vitamin C content bolsters the immune response by promoting the production of white blood cells and neutralizing free radicals. By fortifying the immune system and promoting a state of balance, noni is a valuable natural resource for enhancing the body's ability to fend off illnesses and maintain overall well-being.
Tulsi, scientifically known as Ocimum tenuiflorum, is celebrated for its remarkable immune-boosting and enhancing properties. This revered herb, often referred to as Holy Basil, is rich in antioxidants and bioactive compounds that strengthen the immune system. It helps stimulate the production of antibodies and white blood cells, crucial components of the body's defense mechanism. Tulsi's immunomodulatory effects not only enhance the immune response but also promote a state of balance in the immune system, making it more effective at fending off infections and illnesses. Additionally, Tulsi possesses potent anti-inflammatory and antimicrobial properties that contribute to its immune-boosting abilities. Regular consumption of Tulsi, in various forms such as teas or supplements, can be a valuable natural strategy to bolster the immune system and maintain overall health and vitality.
Piperine, the bioactive compound found in black pepper, is known for its immune-boosting and enhancing properties. It has demonstrated its potential to strengthen the immune system by stimulating the production of white blood cells and promoting the body's defense mechanisms. Piperine also exhibits anti-inflammatory and antioxidant properties, which help in reducing inflammation and combating free radicals that can weaken the immune response. Furthermore, piperine enhances the absorption of various nutrients, including vitamins and minerals, which play a crucial role in supporting overall immune function. By incorporating piperine into one's diet, individuals can harness its immune-enhancing benefits, bolstering their body's ability to fend off infections and maintain robust health.
Curcumin, the active compound in turmeric, is renowned for its potent immune-boosting and enhancing properties. It has been shown to strengthen the immune system by stimulating the activity of immune cells, such as macrophages and lymphocytes, which play a vital role in defending the body against pathogens. Curcumin's powerful anti-inflammatory and antioxidant effects further contribute to its immune-enhancing capabilities by reducing inflammation and neutralizing harmful free radicals. Additionally, curcumin supports the body's immune response by promoting the production of immunomodulatory proteins. Regular consumption of curcumin, often in the form of dietary supplements or as a spice in cooking, can be an effective natural strategy to bolster the immune system, enhancing its ability to ward off infections and maintain overall health and well-being.
Therefore it is much needed to prepare a storage stable formulation that combining Amla (Phyllanthus emblica), celebrated for its rich vitamin C and antioxidant content that fortifies the body's defences, Noni (Morinda citrifolia), known for its immune-supportive compounds and anti-inflammatory properties, Tulsi (Ocimum tenuiflorum), renowned for its immune-strengthening antioxidants and immunomodulatory effects, Piperine from black pepper, with its immune-stimulating and absorption-enhancing abilities, and Curcumin from turmeric, praised for its immune-boosting qualities through anti-inflammatory and antioxidant actions, along with natural sweetener and pharmaceutically acceptable excipients creates a potent synergy for enhancing the immune system. This combination stimulates the production of immune cells, regulates immune responses, combats free radicals, and promotes the absorption of essential nutrients, offering a comprehensive approach to fortifying the body's defenses, warding off infections, and maintaining overall health and well-being.
A taste masked stable herbal composition comprising amla extract, noni, panch tulsi, piperine, and curcumin.
A taste masked stable herbal composition comprising amla extract, noni, panch tulsi, piperine, and curcumin, wherein a pH of the composition is in range of 2 to 3, preferable 2 to 2.5.
A taste masked stable herbal composition comprising about 1 to 7% w/v of amla extract, about 2 to 9% w/v of noni, about 1 to 10% w/v of panch tulsi, about 0.01 to 0.5% w/v of piperine, and about 0.1 to 3% w/v of curcumin, wherein a pH of the composition is in range of 2 to 3, preferable 2 to 2.5.
A taste masked stable herbal composition comprising about 2 to 5% w/v of amla extract, about 3 to 7% w/v of noni, about 3 to 7% w/v of panch tulsi, about 0.01 to 0.2% w/v of piperine, and about 0.5 to 2% w/v of curcumin, wherein a pH of the composition is in range of 2 to 3, preferable 2 to 2.5.
A taste masked stable herbal composition comprising about 3% w/v of amla extract, about 5% w/v of noni, about 5% w/v of panch tulsi, about 0.10% w/v of piperine, and about 1% w/v of curcumin having a pH of 2 to 3, preferable 2 to 2.5.
A taste masked stable herbal composition further comprising one or more pharmaceutically acceptable excipients selected from a sweetener, pH adjusting agent, a preservative, a viscosity enhancer, and a solvent.
A taste masked stable herbal composition comprising amla extract, noni, panch tulsi, piperine, curcumin, and one or more pharmaceutically acceptable excipients selected from a sweetener, a pH adjusting agent, a preservative, a viscosity enhancer, and a solvent.
According to the present invention a sweetener is selected from acesulfame potassium, sucralose, saccharin, steviol glycosides, saccharin or combination thereof. According to the present invention a sweetener is present in amount preferably from 0.5 to 4.0% w/v, and more preferably from 1 to 3.5% w/v.
A pharmaceutically acceptable pH adjusting agent is a compound or mixture that is used in pharmaceutical formulations to control and maintain the pH of a drug product within a desired and stable range. According to present invention a preferred pH adjusting agent is selected from ascorbic acid, potassium citrate, citric acid, sodium citrate, and maleic acid. According to the present invention a pH adjusting agent is present at 10% w/v of the total composition, preferably from 8 to 16% w/v, more preferably from 10 to 14% w/v, and most preferably 11 to 13% w/v of the total composition. A taste masked stable herbal composition is stable at a pH preferably between 1.5 to 2.5 and more preferably 2.2.
Pharmaceutically acceptable preservative is a substance used in pharmaceutical and healthcare products to prevent the growth of microorganisms and maintain the sterility and stability of the formulation over time. According to present invention a preferred preservative is selected from sodium benzoate, potassium sorbate, sodium methyl paraben, sodium propyl paraben, or combination thereof.
The invention involves the utilization of viscosity enhancers, and solvents. Pharmaceutically acceptable viscosity enhancers, also known as thickening agents or rheology modifiers, are substances used to adjust the consistency and flow properties of pharmaceutical formulations, making them easier to handle, administer, and improve drug delivery. These additives can serve various purposes, including improving the stability of suspensions and emulsions or controlling the release of active pharmaceutical ingredients. Common examples of pharmaceutically acceptable viscosity enhancers include hydroxypropyl methylcellulose (HPMC), sodium carboxymethylcellulose (NaCMC), xanthan gum, guar gum, pectin, and polyethylene glycol (PEG). According to present invention one of the preferred viscosity enhancers is Xanthan Gum.
A taste masked stable herbal composition comprising amla extract, noni, panch tulsi, piperine, curcumin, and about 0.5 to 4.0% w/v of a sweetener, 10% w/v of a pH adjusting agent, a preservative, a viscosity enhancer, and a solvent.
According to present invention storage stable composition stored in opaque Poly Propylene bottle used as a primary packaging material to protect the Herbal Suspension from the light, and it was packed in carton as a secondary packaging for extra protection. According to present invention one bottle contains approximately 60 servings.
The following Examples provide a detailed description of such a taste masked stable herbal composition.

Quantitative Composition:
Sr. No Name of the Ingredients Example 1 Example 2 Example 3
1 Amla Extract 3.00% 3.00% 3.00%
2 Noni Liq. 5.00% 5.00% 5.00%
3 Panch Tulsi Liq. 5.00% 5.00% 5.00%
4 95% Piperine 0.10% 0.10% 0.10%
5 95% Curcumin 1.00% 1.00% 1.00%
6 Acesulfame potassium 0.50% 1.00% 0.00%
7 Sucralose 1.50% 1.50% 0.00%
8 Steviol Gycosides - - 2.50%
9 Monk fruit Sweetener 1.00% - -
10 Pottasium Citrate 0.10% 0.10% 0.10%
11 Citric Acid 1.72% 1.72% 1.72%
12 Sodium Citrate 0.16% 0.16% 0.16%
13 Maleic Acid 10.00% 10.00% 10.00%
14 Potassium Sorbate 0.01% 0.01% 0.01%
15 Sodium Methyl Paraben 0.10% 0.10% 0.10%
16 Sodium Propyl Paraben 0.03% 0.03% 0.03%
17 xanthan gum 0.10% 0.10% 0.10%
pH 2.2 2.2 2.2

Manufacturing Process:
The preparation process involves several key steps. First, all ingredients and excipients are individually dispensed into appropriate containers and sealed to prevent exposure to the external environment. Next, demineralized water (DM) is collected, ensuring its clarity and a pH range of 5 to 7. In the third step, 60 % of the DM is heated to 80 °C, and preservatives are slowly added and stirred until a clear solution is achieved, then cooled to 25°C. The fourth step involves the addition of a pH adjusting aent, and in the fifth step, herbal extracts are introduced sequentially and homogenized to create a uniform mixture. Step six involves the addition of a sweetener solution and xanthan gum for viscosity enhancement. In step seven, the volume is adjusted to 100% using DM, and the mixture is stirred to homogeneity. Finally, in step eight, the prepared solution is filtered through a #300 mesh double-fold nylon cloth (Muslin Cloth) into a separate holding vessel.
Table 1 and 2 presented below elucidates the % assay values for each of the active ingredients in Example 2 and 3, both initially and upon the conclusion of a 6-month stability assessment conducted under conditions of 40 °C and 75% relative humidity (RH). The assessment employs High Performance Liquid Chromatography (HPLC) for the determination of % assay values. Significantly, upon completion of the stability period, it has been discerned that the % assay values for each of the active ingredients lie within the specified pharmacopeial range, confirming the formulation's adherence to established pharmacopeial standards.
Table 1: Stability Data of Example 2 composition
Condition Assay in (%)
95% Curcumin 95% Piperine Eugenol (Tulsi) Scopoletin (Noni) Emblicanin (Amla)
Initial 103.00 102.92 117.05 112.93 105.82
1 M 40° C/ 75% RH 99.23 100.63 110.35 105.60 103.26
2 M 40° C/ 75% RH 97.87 98.78 97.57 104.45 101.18
3 M 40° C/ 75% RH 96.50 96.39 96.90 98.64 99.57
6M 40° C/ 75% RH 94.69 94.46 95.06 93.59 97.63
1 M 25° C/ 60% RH 102.48 101.58 115.60 110.67 104.21
6M 25° C/ 60% RH 98.65 96.94 99.85 95.44 99.28
Limit 95-115% 90-120% 90-125% 90-125% 95-110%

Table 2: Stability Data of Example 3 composition
Condition Assay in (%)
95% Curcumin 95% Piperine Eugenol (Tulsi) Scopoletin (Noni) Emblicanin (Amla)
Initial 104.35 103.43 117.90 113.71 106.49
1 M 40° C/ 75% RH 100.52 101.13 111.13 106.31 103.91
2 M 40° C/ 75% RH 99.13 99.27 98.24 105.16 101.82
3 M 40° C/ 75% RH 97.74 96.86 97.56 99.30 100.20
6M 40° C/ 75% RH 95.90 94.92 95.70 94.21 98.24
1 M 25° C/ 60% RH 103.82 102.08 116.43 111.43 104.87
6M 25° C/ 60% RH 99.93 97.42 100.54 96.07 99.90
Limit 95-115% 90-120% 90-125% 90-125% 95-110%

In summary, the experiments and their outcomes demonstrate the storage stable herbal composition having a pH of 2.2.
,CLAIMS:We claim,

1. A taste masked stable herbal composition comprising amla extract, noni, panch tulsi, piperine, curcumin and about 0.5 to 4.0% w/v of a sweetener, wherein a pH of the composition is in range of 2 to 3.
2. The composition claimed in claim 1, wherein the composition comprising about 1 to 7% w/v of amla extract, about 2 to 9% w/v of noni, about 1 to 10% w/v of panch tulsi, about 0.01 to 0.5% w/v of piperine, and about 0.1 to 3% w/v of curcumin.
3. The composition claimed in claim 1, wherein a pH of the composition is in range of 2 to 2.5.
4. The composition claimed in claim 5, wherein a sweetener acesulfame potassium, sucralose, and steviol Gycosides.
5. The composition claimed in claim 1 further comprising one or more pharmaceutically acceptable excipient.
6. The composition claimed in claim 5, wherein one or more pharmaceutically acceptable excipients selected from pH adjusting agent, a preservative, a viscosity enhancer, and a solvent.
7. The composition claimed in claim 1 comprising about 1 to 7% w/v of amla extract, about 2 to 9% w/v of noni, about 1 to 10% w/v of panch tulsi, about 0.01 to 0.5% w/v of piperine, about 0.1 to 3% w/v of curcumin.
8. The composition claimed in claim 7 comprising about 0.5 to 4.0% w/v of a sweetener, 10% w/v of a pH adjusting agent, a preservative, a viscosity enhancer, and a solvent.