Description:DESCRIPTION OF INVENTION
FIELD OF INVENTION
The invention pertains to the field of nutritional supplements and herbal compositions;
More specifically, the present invention focuses on the production and application of a caffeine and fortified chemical free herbal composition aimed at providing variety of nutritional and health benefits.
BACKGROUND OF THE INVENTION
One of the prominent features of modern is daily exposure to different kinds of stresses which include physical, mental, biological and work-related stress. These different stresses are induced by variety of stressors or their combinations which result in various harmful effects on the health and well-being of humans. Stressors comprise of acute and long term (chronic) elements such as environmental pollution, dietary habits, climate change, radioactive stress and other compelling factors which continuously increase the risk of various health problems like obesity, acidity, constipation, caffeine and sugar dependency etc.
Handling and overcoming these stressors denote a significant challenge for humans and it is considerably dependent on the age. While different individuals have different mechanisms of coping with the stress, it is known that stressful situations lead to altered lifestyles with increased consumption of fast food that contains artificial sweeteners and preservatives as well as caffeinated beverages with added sugar. These altered food habits and the nutritional gap in our regular food intake causes health issues like weak immune system, anemia, weak bones etc. among a sizeable fraction of the total population.
Majority of the people have started using dietary supplements in recent times to address these health problems and support the immunity to fight various diseases and health conditions. However, consumption of these synthetic supplements is significantly hindered by their severe side effects and limited range of benefits. Therefore, a significant population all over the world is moving towards utilization of herbal products/solutions. The herbal products are shown to possess several broad complementary actions on the physiological systems of human beings without displaying the adverse effects of their synthetic or chemical counterparts. Owing to the increased demand, numerous herbal products are available in the market that are intended to maintain health or solve various health problems.
But majority of the existing herbal beverages in the market currently are also observed to contain caffeine, fortified chemicals such as sugar, artificial sweetener (INS 950), artificial colors/flavors, stabilizers (E339 (ii), E 339 (iii)), chemicals (Zinc citrate, Calcium Carbonate, Potassium Carbonate, Zinc Oxide, Retinyl palmitate) etc. as well as preservatives like sorbate, citrate, benzoate, etc. These substances are known to have several harmful effects on the human health. For instance, intake of higher quantities of caffeine can have negative impact on digestive health, mental health, tremors, heart palpitations etc. Continuous intake of artificial sweeteners is known to results in weight gain, cardiovascular diseases, and many other health hazards including cancers. Consumption of additives and preservatives is observed to cause health issues such as heart difficulties, cancer, obesity, attention deficit hyperactivity disorder (ADHD), and asthma.
Furthermore, these ingredients in existing herbal beverages are not standardized under “Schedule II” and “Schedule III” of FSSAI guidelines and thereby these herbal beverages are considered as "Proprietary Food (14.1.5– Herbal Infusions)” under FSSAI Regulation. Moreover, the health benefits claimed by these herbal products which include stress relief, increase energy and vitality, boosting immunity etc. are not standardized by NABL (National Accreditation Board for Testing and Calibration Laboratories) approved laboratories and Food Safety & Standards (Advertising & Claims) Regulations, 2018. Another limitation of these products is that they are not soluble in water (warm or cold) or milk and need to strain or used in the form of bags (tea).
The present invention describes a fortified herbal nutraceutical premix powder and method of its production which has been developed with an incremental technology in herbal supplements.

OBJECT OF THE INVENTION
The primary object of the present invention is to address the limitations associated with existing herbal products/beverages and provide a healthy herbal beverage composition in the form of a premix powder characterized by absence of caffeine, added sugar, fortified chemicals and preservatives;
Further object of the present invention is to provide an herbal beverage composition that offers various health benefits which have been standardized by NABL approved laboratories and approved by Food Safety & Standards (Advertising & Claims) Regulations, 2018.
BRIEF DESCRIPTION OF DRAWINGS
The accompanying drawings constitute a part of this specification and illustrate one or more embodiments of the invention. Preferred embodiments of the invention are described in the following with reference to the drawings, which are for the purpose of illustrating the present preferred embodiments of the invention and not for the purpose of limiting the same.
For simplicity and clarity of illustration, the drawing figures illustrate the general manner of construction, and descriptions and details of well-known features and techniques may be omitted to avoid unnecessarily obscuring the invention. Additionally, elements in the drawing figures are not necessarily drawn to scale. For example, the dimensions of some of the elements in the figures may be exaggerated relative to other elements to help improve understanding of embodiments of the present invention. The same reference numerals in different figures denotes the same elements.
In the drawings:
Figure 1 illustrates results of ELISA lab test showing Interleukin 4 levels which indicate B-cell proliferation in accordance with the embodiments of the present invention;
Figure 2 shows results of ELISA lab test showing Interleukin 2 levels which indicate T-cell proliferation in accordance with the embodiments of the present invention;

SUMMARY OF THE INVENTION
Embodiments of the present disclosure present technological improvements as solution to one or more of the above-mentioned technical problems recognized by the inventor in conventional practices and existing state of the art.
The present disclosure seeks to provide a fortified herbal nutraceutical beverage composition in the form of a premix powder which offers wide range of health benefits for well-being of humans.
In accordance with an aspect of the present invention, the said herbal composition integrates a number of herbs and seeds of Indian origin that have been proven to have several health benefits.
As per another aspect of the invention, the herbal composition contains vitamins (Vitamin C & E), trace elements (Selenium, Iron, Calcium, Zinc), Dietary Fiber, and bioactive components that improve immunity through B cell & T cell proliferation.
Further aspect of the invention involves the several health benefits of the said herbal composition including reduction in caffeine and sugar dependency, increase in mental alertness, reduction in obesity (weight), relief from constipation, detoxification, fight against anemia, improvement in bone health, and natural enhancement of the immune system.
Additionally, the all the health benefits of the present invention have been are approved by Food Safety & Standards (Advertising & Claims) Regulations, 2018 and standardized from NABL (National Accreditation Board for Testing and Calibration Laboratories) approved laboratories and NIPER (National Institute of Pharmaceutical Education and Research), Hyderabad.
While the invention has been described with reference to specific embodiments, various modifications and alterations can be made without departing from the scope of the invention, as defined by the appended claims.
The objects and the advantages of the invention are achieved by the process elaborated in the present disclosure.
DETAILED DESCRIPTION OF THE INVENTION
The following detailed description illustrates embodiments of the present disclosure and ways in which the disclosed embodiments can be implemented. Although some modes of carrying out the present disclosure have been disclosed, those skilled in the art would recognize that other embodiments for carrying out or practicing the present disclosure are also possible.
The present invention describes a fortified herbal nutraceutical premix powder which offers wide range of health benefits for well-being of humans. This herbal composition contains various herbs and seeds of Indian origin that have been proven to have several health benefits. It consists of vitamins like vitamin C and E, trace elements such as Selenium, Iron, Calcium, and Zinc, Dietary Fiber, as well as bioactive components that enhance the immunity through B cell & T cell proliferation.
Composition:
The composition of the fortified herbal nutraceutical premix powder contains various herbs and seeds of Indian origin. According to the embodiments of the present invention, these ingredients are utilized in the form of extracts or powders to prepare the final herbal premix product. The herbs and seeds used in the herbal premix powder are:
- Zingiber officinale (Ginger) in the form of rhizome standardized extract at a concentration of 15-20%.
- Tinospora cordifolia (Guduchi) extract at a concentration of 10-15%.
- Linum usitatissimum (Flax) seed powder at a concentration of 10-15%.
- Citrus limon (Lemon fruit) spray dried powder at a concentration of 8-13%.
- Syzygium aromaticum (Clove) powder at a concentration of 8-13%.
- Cichorium intybus (Chicory) roasted root powder at a concentration of 5-10%.
- Trigonella foenum-graecum (Fenugreek) seed extract at a concentration of 5-10%.
- Camellia sinensis (Tea) extract at a concentration of 3-8%.
- Cinnamomum verum (Cinnamon) extract at a concentration of 3-8%.
- Ocimum sanctum (Tulsi) leaf powder at a concentration of 3-8%.
- Elettaria cardamomum (Cardamom) seed powder at a concentration of 1-5%.
The concentration indicates the percentage of the ingredient used in the product (Per Serving = 1.25 g). All of these ingredients are scheduled under Nutraceutical Regulations (schedule II and III).
Method of Production:
According to preferred embodiments of the present invention, the method of production of the herbal premix composition comprises of following steps:
Procurement and inspection of raw ingredients
- The raw ingredients containing these herbs and seeds are procured from FSSAI (Food Safety and Standards Authority of India), HACCP (Hazard Analysis and Critical Control Point), and ISO 22000:2005, ISO 9001:2015 certified approved supplier/vendor as well as from directly from the field or farmers. They are categorized as Nutraceuticals, as all ingredients are enlisted under “Schedule II and III” of FSSAI guidelines.
- All the packaging materials used in the production are also procured from “Approved Supplier/Vendor List for Packaging Materials” certified with ISO 9001:2015, with reference to Good Manufacturing Practice (GMP) which ensure the quality of the final product while also helping to maintain their optimum shelf life.
- Rigorous visual inspection of raw and packaging materials is carried out to confirm the quality of the finished products as well as to detect biological, chemical, or physical hazards. This includes:
- Rejection of materials with potential pathogen contamination due to damaged packaging (Biological Hazards).
- Rejection of materials showing potential chemical contamination, including allergens or non-food items (Chemical Hazards).
- Rejection of materials due to damaged packaging and the presence of extraneous metallic material (Physical Hazards).
- Rejection of materials due to improper transport conditions (cleanliness, odor, temperature, relative humidity).
Storage of raw ingredients
- Raw materials are stored at the temperature of 1°C to 6°C to prevent growth of foodborne pathogens.
- Certain ingredients are stored inside cabinets to protect them from sunlight and maintain potency
- Herbs are adequately separated from any raw ingredients that may contain any allergen
Cleaning and drying of raw ingredients
- Fresh herbs are rinsed under fresh and cold running water to remove soil and other contaminants (Chemical and Physical Hazards).
- These rinsed herbs are then dried by passing through a multi-stage single-belt dryer at 50°C±5°C.
Treatment of raw ingredients
- In the next step, the raw herbs are irradiated in order to control microbial contaminants such as E. coli and Salmonella.
- The FDA guideline on the limitations on radiation dosages (under 21 CFR 179.26(b)) is followed wherein it is stated that radiation usage should not exceed 30 kGy (3 Mrad).
- The raw ingredients treated with radiation are stored separately from the untreated herbs.
Cutting/grinding of raw ingredients
- Herbs are cut into smaller pieces, followed by grinding vigorously into finer particles to improve homogeneity of the raw material mix.
Technology used in the Processing of raw ingredients:
- A distinctive method for extracting and condensing herbal ingredients to produce the final produce is followed;
- Steam distillation is used method for extracting essential oils and bioactive compounds from herbal ingredients;
- In this process, steam is passed through the herbal material, causing the essential oils and other volatile compounds to evaporate;
- After steam distillation, the vapor containing the extracted compounds is cooled down to condense it into a powder form;
- This powder contains the concentrated bioactive components from the herbs.
- The process involves a systematic and controlled approach to achieving the desired concentration of each ingredient which includes precision in temperature control, extraction duration, and the use of advanced equipment to optimize the extraction efficiency.
Screening of ingredients
- Screening process allows only particles of specific mesh size (NLT Mesh Size 90) to enter into the next step of the process.
- This step contributes to the complete solubility of end product in water/milk along with reduction in risk associated with down times of production process.
- Magnets are used in order to restrict potential physical contamination in the whole process.
Batching/weighing
- Next, batching or weighing is carried out which involves weighing the ingredients in accordance with the formulation before mixing.
Mixing/blending
- The primary ingredients are then mixed/blended together in accordance with the composition at the temperature of 20°C±5°C to achieve desired quality of the end products.
Packaging/labelling/coding
- For packaging of the end product, Modified Atmosphere Packaging (MAP) is employed in order to extend the shelf life of the products and ensure quality of the finished product within the extended shelf-life period without using any chemical preservative.
- Packaging seals are monitored carefully and preventive measures are employed immediately to reduce percentage of damaged product and to restrict potential pathogen contamination due to improper seals.
- Product labels are monitored carefully with respect to correct batch number, manufacturing date and expiry date for better traceability of the finished goods.
Health benefits:
1) Natural immunity booster
The immune system is the body's defense against diverse types of harmful agents including pathogens like bacteria, viruses, and fungi as well as toxins. The B and T lymphocytes (B and T Cells) are the most vital components of immune system that are involved in neutralization of pathogenic agents in a highly specific manner. The composition of present herbal premix contains various herbs and seeds which have been known to be beneficial for the immune system. The combination of all the herbs and seeds in specific concentrations in the premix produces a synergistic effect that boosts the immune system naturally. This has been validated by the presence of Zinc and Vitamin C in high concentrations of 41.2 mg/kg and 94.10 mg/100g respectively. Moreover, the positive effect of the composition on the immune system has been experimentally proven in lab tests through the B-cell and T-cell proliferation assays performed by NIPER, Hyderabad.
In these lab tests, the levels of Interleukins which are a type of cytokines that play an essential role in activation and differentiation of immune cells, are monitored by ELISA Enzyme-linked Immunosorbent Assay) immunochemical assay. Interleukin-4 (IL-4), also known as B cell-stimulatory factor-1, is a cytokine that promotes cell proliferation and survival. Interleukin-2 (IL-2) is also known as T cell-stimulatory factor that plays a key role in mediation of T-cell immune response. As observed in Figures 1 & 2, the cells that were treated with the proposed product displayed higher levels of interleukins which in turn indicate the greater proliferation of B- and T-cells. The product was observed to provide greater efficiency when consumed with milk than without milk.
2) Fight against anemia
Anemia is a common health condition that develops when the blood produces a lower-than-normal amount of Red Blood Cells (RBC). Anemic condition is characterized by lack of enough oxygen-rich blood in the body and the most common cause of anemia worldwide is iron deficiency. Iron is needed form hemoglobin synthesis, the component of RBCs that carries oxygen and removes carbon dioxide. The present herbal composition represents a rich source of iron. The concentration of iron in the present composition is 214.5 mg of iron per 1 kg of the product. This concentration of iron has been scientifically proven by the test carried out in NABL approved laboratories and NIPER, Hyderabad.
3) Weight reduction
Obesity has emerged as a dangerous health condition globally in recent times as a result of the altered lifestyle. The present herbal premix composition helps in reduction of weight as it consists of ingredients rich in Vitamin C and dietary fiber.
4) Easing constipation
Constipation is a health condition wherein the person suffering from it displays infrequent and uncomfortable bowel movements. Diet and lifestyle are shown to be major causes of rise in constipation among the general population worldwide. Scientific studies have reported that dietary fiber is able to address the issue of constipation by increasing stool frequency, improving stool consistency and it has no obvious adverse effects. The proposed herbal premix comprises of 17.58 grams of dietary fiber per 100 g of the product. Such high quantity of dietary fiber in the present composition has been validated through lab tests carried out in the NABL approved laboratories and NIPER, Hyderabad.
5) Acid reflux
Acid reflux occurs when the stomach acid persistently and regularly flows up into the esophagus (throat) which results in heartburn and other symptoms. Unhealthy food habits are known to be one of the major causes of acid reflux including intake of fatty and fried foods as well as caffeine. The present premix composition possesses significant acid neutralizing capacity. The lab tests performed in the NABL approved laboratories and NIPER, Hyderabad show that the herbal premix has acid neutralizing capacity of 7.75, which makes it a good candidate for “Antacid” that can compete with any antacid available in the market.
6) Increased mental alertness
The proposed composition consists of DRDO approved herbal adaptogen which helps to stay mentally alert. Additionally, the product is without caffeine unlike the caffeinated beverages available in market. Thus, the present product helps to achieve increased mental alertness while also avoiding the side-effects associated with caffeinated beverages.
Working example:
The composition of the fortified herbal nutraceutical premix powder is obtained by analyzing various compositions containing the above-mentioned herbs and seeds in different proportions through numerous experiments.
Experimental method:
The experiments comprised of a comparative evaluation of 25 different compositions of the herbal premix powder with regard to the solubility in water. Steps include:
- 1.25 g of premix powder is weighed accurately.
- The weighed powder is added to 125 ml of water, stirred well and kept for 20 minutes.
- Filtration is carried out and the residue is carefully transferred into in a tared aluminum dish (about 7.5 cm in diameter and 2.5 cm deep).
- This is followed by drying into an air oven at 100 ±2° C for 30 minutes.
- Weight is recorded and solubility is computed by the following formula:
Solubility = (weight of residue / weight of premix powder) × 100%
Results:
The solubility percentages of 25 different compositions (denoted by C1 to C25) have been determined and shown in the following table.

Composition Solubility (%)
C1 30
C2 67
C3 38
C4 42
C5 55
C6 55
C7 62
C8 75
C9 93
C10 100
C11 71
C12 82
C13 100
C14 48
C15 67
C16 32
C17 59
C18 64
C19 69
C20 84
C21 91
C22 100
C23 87
C24 74
C25 72
Table 1: Comparative study of water solubility of various compositions of premix powder
It was observed that three compositions (C10, C13, and C22) showed 100% solubility in water within 30 seconds (FSSAI guideline & I.S.I Hand book of Food Analysis (Part IX) – 1984). These three compositions of the herbal premix were sent to NABL approved laboratories for checking bioavailability of active ingredients. In the experimental assays, the composition proposed in the current invention (composition C13) displayed 100% solubility in water along with optimal bioavailability of various active ingredients. These active ingredients include Zinc (41.2 mg/kg), Iron (214.5 mg/kg), Vitamin C (94.10 mg/100g) and Selenium (3.6 mg/kg), as shown below in Table 2.
Bioactive Ingredients C10 C13 C22
Zinc 3.59 mg/kg 41.2 mg/kg 10.81 mg/kg
Iron 16.68 mg/kg 214.5 mg/kg 58.75 mg/kg
Vitamin C <1.0 mg/100g 94.10 mg/100g 121.20 mg/100g
Selenium <0.25 mg/kg 3.6 mg/kg 0.22 mg/kg
Table 2: Summary of bioactive ingredients available in compositions C10, C13 and C22
The best composition in terms of solubility and active ingredients identified in the comparative study was evaluated with experimental tests for T cell and B cell proliferation assays in NIPER, Hyderabad. The results of T cell and B cell proliferation assays further substantiated the efficiency of the herbal premix powder composition in boosting immunity due to synergistic effect of active ingredients.
These embodiments are provided to demonstrate the various aspects and features of the fortified herbal nutraceutical beverage and method of its production. The invention is not limited to these specific embodiments and can be implemented in different configurations and variations without departing from the scope of the invention as defined in the claims. , Claims:We Claim:
1. A fortified herbal nutraceutical premix powder, the said premix powder comprising:
- Zingiber officinale (Ginger) in the form of rhizome standardized extract at a concentration of 15-20%;
- Tinospora cordifolia (Guduchi) extract at a concentration of 10-15%;
- Linum usitatissimum (Flax) seed powder at a concentration of 10-15%;
- Citrus limon (Lemon fruit) spray dried powder at a concentration of 8-13%;
- Syzygium aromaticum (Clove) powder at a concentration of 8-13%;
- Cichorium intybus (Chicory) roasted root powder at a concentration of 5-10%;
- Trigonella foenum-graecum (Fenugreek) seed extract at a concentration of 5-10%;
- Camellia sinensis (Tea) extract at a concentration of 3-8%;
- Cinnamomum verum (Cinnamon) extract at a concentration of 3-8%;
- Ocimum sanctum (Tulsi) leaf powder at a concentration of 3-8%;
- Elettaria cardamomum (Cardamom) seed powder at a concentration of 1-5%;
wherein the ingredients are grinded and screened for a particle of a mesh size (NLT 90) reducing the risk of down times of production process;
characterized by acid neutralizing capacity of 7.75 and complete solubility in water as well as milk, devoid of any synthetic additives, and further maintaining its solubility even when subjected to Modified Atmosphere Packaging (MAP) for extending shelf life without the use of chemical preservatives; and further characterized by the presence of DRDO-approved herbal adaptogen, promoting increased mental alertness without the inclusion of caffeine, providing a natural and sustainable alternative to caffeinated beverages.
2. The fortified herbal nutraceutical premix powder as claimed in Claim 1, wherein the extracts of herbs, roots, seeds are obtained using steam distillation followed by condensation yielding powder form.
3. The fortified herbal nutraceutical premix powder as claimed in Claim 1, wherein the B-cell and T-cell proliferation assays of the said premix powder showcased increased levels of Interleukin-4 (IL-4) and Interleukin-2 (IL-2) validating natural immunity boost.
4. The fortified nutraceutical premix powder as claimed in Claim 1, wherein the said premix powder contains vitamins, including Vitamin C and E, trace elements such as Selenium, Iron, Calcium, and Zinc, alongside dietary fiber, synergistically providing diverse health benefits.
5. A method for the production of a fortified herbal nutraceutical premix powder, the said comprising:
- procurement of raw ingredients from FSSAI, HACCP, and ISO 22000:2005, ISO 9001:2015 certified suppliers, and direct sourcing from farmers;
- inspecting raw and packaging materials, including rejection of materials with potential hazards (Biological, Chemical, Physical), and rejection of materials delivered without proper transport conditions;
- storing of raw ingredients at 1°C to 6°C, with certain ingredients stored in cabinets to protect from sunlight, and adequate separation of herbs from allergen-containing raw ingredients;
- cleaning and drying of raw ingredients through rinsing under fresh water and passing through a multi-stage single-belt dryer at 50°C±5°C;
- treating raw ingredients by irradiation to control microbial contaminants;
- cutting as well as grinding of raw ingredients, followed by extraction through steam distillation and condensation to achieve optimal bioavailability;
- screening of ingredients to allow only particles of specific mesh size (NLT Mesh Size 90) to enter the next step;
- batching/weighing of ingredients according to the formulation;
- mixing/blending of primary ingredients at 20°C±5°C to achieve the desired quality;
- packaging using Modified Atmosphere Packaging (MAP) to extend shelf life without chemical preservatives.
- monitoring packaging seals and product labels for quality and traceability.
6. The method as claimed in Claim 1, wherein the irradiation of raw herbs, aimed at controlling microbial contaminants is conducted in accordance with the FDA guidelines specified under 21 CFR 179.26(b), ensuring that the radiation dosage does not exceed 30 kGy (3 Mrad), and further consisting of the step of segregating the irradiated raw ingredients from the untreated herbs during subsequent storage.