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 life is continuous exposure to different kinds of stresses which include physical, mental, biological and work-related stress. These different stresses are induced by variety of factors that can induce stress, called as stressors. These stressors or their combinations lead to number of harmful effects on the health and well-being of humans which in turn affects their quality of life. Stressors include acute and chronic elements such as environmental pollution, dietary habits, climate change, radioactive stress and other compelling factors which incessantly increase the risk of various health issues such as obesity, acidity, weak bones and muscles, constipation, caffeine and sugar dependency etc.
One of the most prominent challenges of present lifestyle is dealing with and managing these stressors. The capability of individuals to handle these challenges depend significantly on their age, with different individuals possess different mechanisms of coping with the stress. It has been observed that stressful situations lead to altered lifestyles with increased consumption of fast food that contains harmful ingredients such as artificial sweeteners and preservatives as well as caffeinated beverages with added sugar. These altered dietary habits and the nutritional gap in our regular food intake results in serious health issues like weak immune system, anemia, weak bones etc. among a major chunk of the total global population.
In recent years, the focus of significant number of people has shifted towards use of dietary supplements in order to address the variety of health issues and bolster the immunity to fight various diseases and health conditions. However, consumption of these synthetic supplements is considerably limited by their severe side effects and inadequate benefits. As a result, a significant population from all over the world preferring use of herbal products/solutions over the synthetic/artificial supplements. The herbal products are observed to have several broad complementary actions on the physiological systems of human beings without showing the adverse effects of their synthetic or chemical counterparts. Currently, number of herbal products which are proposed to support health or solve various health problems are available in the market due to their higher demand.
But most of the existing herbal beverages in the market at present are also observed to contain caffeine, fortified chemicals such as sugar, artificial sweetener (INS 950), artificial colors/flavors, stabilizers [E339(ii), E339(iii)], chemicals agents (Calcium Carbonate, Zinc citrate, Potassium Carbonate, Zinc Oxide, Retinyl palmitate) etc. along with preservatives like citrate, sorbate, benzoate, etc. These substances have been shown to exert numerous harmful effects on the human health. For instance, regular intake of higher quantities of caffeine can have negative impact on digestive and mental health, while also leading to occurrence of tremors, heart palpitations etc. Continuous intake of artificial sweeteners has been proven to cause weight gain, cardiovascular diseases, and many other fatal health hazards including cancers. Increased consumption of additives and preservatives can lead to serious health issues such as heart problems, cancer, obesity, attention deficit hyperactivity disorder (ADHD), and asthma.
Moreover, the ingredients in prevailing herbal beverages are not standardized under “Schedule II” and “Schedule III” of FSSAI (Food Safety and Standards Authority of India) guidelines and thereby these herbal beverages are considered as "Proprietary Food (14.1.5– Herbal Infusions)” under FSSAI Regulation. Furthermore, the health benefits claimed by these herbal products which mainly include boosting immunity, increased energy and vitality, stress relief, 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 major drawback 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.
The present invention describes a bioactive fortified powder formulation 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;
Figure 3 shows the graph depicting comparative study of solubility of the herbal premix in milk 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 bioactive fortified powder formulation and method of its production which offers wide range of health benefits for well-being of humans.
In accordance with an aspect of the present invention, the said bioactive fortified powder formulation integrates a number of herbs and seeds of Indian origin that have been proven to provide several health benefits.
As per another aspect of the invention, the said formulation contains trace elements (Selenium, Iron, Calcium, Zinc), Vitamin E, 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 formulation including natural augmentation of the immune system, detoxification, improvement in bone health, fight against anemia, relief from constipation, increase in mental alertness, and reduction in caffeine and sugar dependency.
Additionally, all the health benefits provided by the present invention have been 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 bioactive fortified powder formulation and method of its production 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 comprises of trace elements such as Selenium, Iron, Calcium, and Zinc, Vitamin E, Dietary Fiber, as well as bioactive components that enhance the immunity through B cell & T cell proliferation.
Composition:
The composition of the bioactive fortified powder formulation 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:
- Cichorium intybus (Chicory) roasted root powder at a concentration of 20-25%;
- Zingiber officinale (Ginger) in the form of rhizome standardized extract at a concentration of 15-20%;
- Tinospora cordifolia (Guduchi) extract at a concentration of 15-20%;
- Linum usitatissimum (Flax) seed powder at a concentration of 10-15%;
- Syzygium aromaticum (Clove) powder at a concentration of 10-15%;
- Camellia sinensis (Tea) extract at a concentration of 5-10%;
- Cinnamomum verum (Cinnamon) extract at a concentration of 5-10%;
- Ocimum sanctum (Tulsi) leaf powder at a concentration of 5-10%;
- 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 = 1.50 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 bioactive fortified powder formulation 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 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 utilized 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.
- Thorough visual inspection of raw and packaging materials is carried out to verify the quality of the finished products as well as to discover biological, chemical, or physical hazards. This includes:
- Rejection of materials because of potential pathogen contamination due to damaged packaging (Biological Hazards).
- Rejection of materials caused by potential chemical contamination, including allergens or non-food items (Chemical Hazards).
- Rejection of materials owing to damaged packaging and the presence of extraneous metallic material (Physical Hazards).
- Rejection of materials due to inappropriate transport conditions (based on factors like 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 shield them from direct sunlight and maintain their potency.
- Herbs are adequately separated from any raw ingredients that may contain any allergens.
Cleaning and drying of raw ingredients
- Fresh herbs are rinsed under fresh and cold running water to get rid of 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 human immune system represents the body's defense against diverse sorts of harmful agents including pathogens like viruses, bacteria and fungi as well as toxins. Two types of lymphocytes, known as the B and T Cells are the most important components of the adaptive immune system which act in specific and coordinated way to neutralize and remove pathogens. The herbal premix composition proposed here contains various herbs and seeds of Indian origin which are 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 results in enhancement of the immune system in a natural manner. This has been experimentally validated by the presence of micronutrients like Zinc and Selenium at high concentration of 54.8 mg and 5.8 mg respectively, per kg of the product. 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 the lab tests carried out, the levels of Interleukins are monitored by a type of immunochemical assay known as ELISA Enzyme-linked Immunosorbent Assay). Interleukins are a kind of cytokines that play an essential role in immune system through activation and differentiation of immune cells. 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.
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 proposed composition is 245.6 mg of iron per kg of the product. This high concentration of iron has been scientifically proven by the test carried out in NABL approved laboratories and NIPER, Hyderabad.
3) Detoxification
Detoxification is a critical process that gets rid of the various toxins and harmful elements from the human body. Through various scientific studies, Vitamin E and Selenium have been shown to play crucial roles in supporting detoxification processes in the body. They act as an antioxidant which protects body tissues from damage caused by reactive oxygen species or free radicals that can severely harm cells and tissues. The proposed premix composition comprises of 15.08 mg of Vitamin E and 5.8 mg of Selenium per kg of the product, as proven by NABL approved laboratories and NIPER, Hyderabad. Thus, the premix powder can act as a potent source of Vitamin E and Selenium that can aid in detoxification of the body.
4) Supports bone health
Calcium represents the most important component of bones in the human body and it is essential for building and maintaining healthy and strong bones. The supplements containing calcium have become widespread in their use in order to fortify bone health. The proposed herbal premix composition consists of 4195.4 mg of Calcium per kg of the product, as validated by experimental tests performed in NABL approved laboratories and NIPER, Hyderabad. As a result of this high concentration of Calcium, the proposed premix composition can be utilized for daily Calcium supplementation to support and maintain bone health.
5) Easing constipation
Constipation represents an increasingly prevalent health condition worldwide which can be attributed to issues associated with diet and lifestyle. A person suffering from constipation has infrequent and uncomfortable bowel movements. Dietary fiber has been shown to play a key role in alleviating the problems allied with constipation by addressing the frequency of stool and improving its consistency without any obvious adverse effects. The herbal premix powder proposed in the present invention contains 16.38 grams of dietary fiber per 100 g of the product. This high quantity of dietary fiber in the premix composition which has been validated through lab tests carried out in the NABL approved laboratories and NIPER, Hyderabad, can be helpful in easing the health issue of constipation.
6) Increase in stamina
The maintenance and enhancement of stamina or physical endurance is a vital requirement to cope with the intense needs of modern hectic lifestyle. As a result of unhealthy diets and stress-filled daily routines, it has become essential to supplement nutrients that can help in maintaining the stamina. The present composition contains various nutrients such as Zinc, Calcium, Vitamin E, Selenium which help in enhancing the muscle and bone health, thereby increasing the physical endurance of the human body.
7) Increase mental alertness
The proposed herbal composition comprises of DRDO approved herbal adaptogen which increases mental alertness. The proposed composition enhances mental alertness in a healthier manner as it does not contain caffeine, unlike the caffeinated beverages available in market. Therefore, the premix powder aids in achieving increased mental preparedness while also eluding the adverse effects associated with caffeinated beverages.
Working example:
The bioactive fortified powder formulation is obtained by analyzing various compositions containing the above-mentioned herbs and seeds in different proportions through numerous experiments.
Experimental method:
The experiments consist of a comparative evaluation of 30 different compositions of the herbal premix powder with regard to the solubility in milk. Steps include:
- 1.50 g of premix powder is weighed accurately.
- The weighed powder is added to 125 ml of milk, 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 milk solubility percentages of 30 different compositions (denoted by C1 to C30) have been determined and presented in the following table.

Composition Solubility (%)
C1 10
C2 15
C3 12
C4 23
C5 43
C6 31
C7 17
C8 51
C9 72
C10 76
C11 85
C12 91
C13 95
C14 100
C15 56
C16 73
C17 91
C18 100
C19 87
C20 51
C21 23
C22 28
C23 63
C24 77
C25 82
C26 88
C27 92
C28 100
C29 75
C30 91
Table 1: Comparative study of milk solubility of various compositions of premix powder
It was observed that three compositions (C14, C18, and C28) showed 100% solubility in milk 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 C18) displayed 100% solubility in milk along with optimal bioavailability of various active ingredients. These active ingredients include Zinc (54.8 mg/kg), Iron (245.6 mg/kg), Calcium (4195.4 mg/kg) and Selenium (5.8 mg/kg), as shown below in Table 2.
Bioactive Ingredients C14 C18 C28
Zinc 4.32 mg/kg 54.8 mg/kg 3.78 mg/kg
Iron 18.05 mg/kg 245.6 mg/kg 220.01 mg/kg
Calcium 138.65 mg/kg 4195.4 mg/kg 98.58 mg/kg
Selenium <0.25 mg/kg 5.8 mg/kg <0.25 mg/kg
Table 2: Summary of bioactive ingredients available in compositions C14, C18 and C28
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 NABL approved laboratories. 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 bioactive fortified powder formulation 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:CLAIMS:
We Claim:
1. A bioactive fortified powder formulation, the said powder formulation comprising:
- Cichorium intybus (Chicory) roasted root powder at a concentration of 20-25%;
- Zingiber officinale (Ginger) in the form of rhizome standardized extract at a concentration of 15-20%;
- Tinospora cordifolia (Guduchi) extract at a concentration of 15-20%;
- Linum usitatissimum (Flax) seed powder at a concentration of 10-15%;
- Syzygium aromaticum (Clove) powder at a concentration of 10-15%;
- Camellia sinensis (Tea) extract at a concentration of 5-10%;
- Cinnamomum verum (Cinnamon) extract at a concentration of 5-10%;
- Ocimum sanctum (Tulsi) leaf powder at a concentration of 5-10%;
- 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 2.25 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 herbal adaptogen, promoting increased mental alertness without the inclusion of caffeine, providing a natural and sustainable alternative to caffeinated beverages.
2. The bioactive fortified powder formulation 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 bioactive fortified powder formulation 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 bioactive fortified powder formulation as claimed in Claim 1, wherein the said premix powder contains trace elements such as Selenium, Iron, Calcium, and Zinc, alongside Vitamin E, dietary fiber, synergistically providing diverse health benefits.
5. A method for the production of a bioactive fortified powder formulation, the said comprising:
- procurement of raw ingredients;
- inspecting raw and packaging materials, including rejection of materials owing to 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 5, wherein the irradiation of raw herbs to control the microbial contaminants is conducted in accordance with the radiation dosage of 30 kGy (3 Mrad), and then segregating the irradiated raw ingredients from the untreated herbs during subsequent storage.