Abstract: The present invention discloses a nutraceutical dietary supplement for prevention of Oncological therapeutic conditions. The present invention particularly further discloses the aforementioned a nutraceutical dietary supplement for the prevention of cancer and risk of cancer like symptoms in any individual.
DESC:FIELD OF THE INVENTION
The present invention relates to a nutraceutical dietary supplement for oncological therapeutic conditions. The present invention particularly relates to the aforementioned nutraceutical dietary supplement for preventing cancer and the risk of cancer-like symptoms in any individual.
BACKGROUND OF THE INVENTION
Background description includes information that may be useful in understanding the present invention. It is not an admission that any of the information provided herein is prior art or relevant to the presently claimed invention, or that any publication specifically or implicitly referenced is prior art.
Patients suffering from various illnesses have specific nutritional needs. Many a times the regular diet is either incompatible as well as insufficient to meet the nutritional requirements of such patients. A regular diet does not help in recovery from the illness. Critically ill patients often are not able to consume food orally (due to reduced level of consciousness or dysphagia). Enteral nutrition is provided to such patients. Enteral nutrition support refers to the introduction of a nutritionally complete liquid formula directly into the stomach or small intestine via a narrow, often specifically designed tube.
As cancer has a long latency period, its causes and risk factors could be eliminated or reduced in the long term, thus yielding a broader impact on Public Health. Interventions are not limited to surgical or pharmacological treatments, but include a variety of programs and measures aimed at correcting unhealthy lifestyles and favouring continuous transformation, for example through regulation against occupational or environmental exposure to certain substances. By empowering and educating people, promoting healthy behaviours and teaching self-care, a virtuous cycle can be set in motion, meaning that these preventive efforts do not need to be renewed with every generation. This is important in periods of economic and financial hardship, when public resources are scarce. Moreover, some regulatory measures could help to prevent various types of cancer and other pathologies; for example, cigarette smoking, besides being associated with lung cancer, could lead to an increased risk of developing breast cancer, prostate cancer, lymphoma and other diseases. In addition, avoiding exposure to carcinogenic substances may contribute to preventing other non-communicable diseases (NCDs), such as cardiovascular, reproductive, endocrine and dysmetabolic pathologies. In conclusion, a single public health measure would have multiple, enduring "cascade effects" which a single clinical intervention would not have.
Prevention is cost-effective and can impact positively on socio-economic inequalities. Since up to half of cancers could be prevented on the basis of present knowledge of etiopathogenesis and risk factors, preventive medicine can act as a rapid and effective means of connecting research with clinical practice.
Cancer patients require easily digestible nutrient and energy dense diet to overcome the side effects and maintain adequate nutrition status. Change in nutritional status was significantly associated with change in quality of life, change in Karnofsky performance status and change in lean body mass. Also the harmful effects of cancer treatment on healthy cells can be minimized with the use of various medicinal herbs proven to be effective in reducing the adverse effects of such treatment.
SUMMARY OF THE INVENTION
The present invention relates to a nutraceutical dietary supplement for oncological therapeutic conditions comprising a combination of bioactive compounds and minerals. The supplement is particularly formulated for the prevention of cancer and the risk of cancer-like symptoms in any individual. The bioactive compounds include Quercetin, Phyllaemblic compounds, Gallic Acid, Tannins, Coenzyme Q10, Nano Curcumins (100% water-soluble), Allicin, Bioflavonoids, Holy Basil Extract, Withaferin A, Ginger Extract, and L-Arginine. The minerals include Vitamin C, Iron, Potassium, Calcium, Phosphorous, Copper, Nickel, Selenium, Tin, Chloride, Manganese, Silicon, Boron, and Vanadium.
In an embodiment of the present invention, the composition of each dietary supplement tablet comprises the following:
Each Tablet Contains:
QUERCETIN 100mg
PHYLLAEMBLIC COMPOUNDS 10mg
GALLIC ACID 15mg
TANNINS 5mg
COENZYME Q10 150mg
NANO CURCUMINS (100% WATER SOLUBLE) 200mg
ALLICIN 15 MG 15mg
BIOFLAVANOIDS 10mg
HOLY BASIL EXTRACT 67mg
WITHAFERIN A 100mg
GINGER EXTRACT 50mg
L ARGININE 60mg
VITAMIN C 100mg
IRON 17mg
POTTASIUM 10mg
CALCIUM 5mg
PHOSPHOROUS 3.86mg
COPPER 1.7mg
NICKEL 130mcg
SELENIUM 35mcg
TIN 2mcg
CHLORIDE 9.7mcg
MANGENESE 4mg
SILION 2mg
BORON 1mg
VANADIUM 10mcg
In another embodiment of the present invention, the manufacturing process of the tablet formulation includes dry granulation or direct compression methods. The in-process quality control is performed during production, and a thorough sampling plan is implemented to ensure uniformity and adherence to specifications. The packaging of the tablets is carried out using suitable packaging materials to protect the tablets from moisture, light, and other external factors, thereby maintaining their stability and efficacy.
Further objectives, advantages, and features of the present invention will become apparent from the detailed description provided hereinbelow, in which various embodiments of them disclosed invention are illustrated by way of example
DETAILED DESCRIPTION OF THE INVENTION
The present invention relates to a to a nutraceutical dietary supplement for oncological therapeutic conditions comprising a combination of bioactive compounds and minerals. The supplement is particularly formulated for the prevention of cancer and the risk of cancer-like symptoms in any individual. The bioactive compounds include Quercetin, Phyllaemblic compounds, Gallic Acid, Tannins, Coenzyme Q10, Nano Curcumins (100% water-soluble), Allicin, Bioflavonoids, Holy Basil Extract, Withaferin A, Ginger Extract, and L-Arginine. The minerals include Vitamin C, Iron, Potassium, Calcium, Phosphorous, Copper, Nickel, Selenium, Tin, Chloride, Manganese, Silicon, Boron, and Vanadium.
In an embodiment, the nutraceutical dietary supplement of the present invention incorporates medicinal plant products with health promoting properties that aid in recovery from illness and surgery. These plant products that aid in recovery from illness and surgery and their beneficial properties are described in the subsequent paragraphs.
QUERCETIN: Quercetin is not harmful for healthy cells, while it can impose cytotoxic effects on cancer cells through several mechanisms, making it a good candidate to treat ovarian cancer or to be employed as a supplementary factor along with other anti-cancer medications. In this review, we summarized the recent and eminent researches on quercetin properties in cancer therapy, especially ovarian cancer.
PHYLLAEMBLIC COMPOUNDS: Phyllanthus emblica is a tree indigenous to tropical regions of Southeast Asia. The tree produces a fruit commonly known as Indian Gooseberry or Amla. The Phyllanthus emblica fruit (also known as Emblica officinalis) or extract from these fruits has been used in traditional medicine for generations to treat symptoms ranging from constipation to the treatment of tumors. Most commonly, the gooseberry was employed as a gentle laxative. However, the potential of Phyllanthus emblica extract to be utilized as an anticancer agent has been scrutinized using modern medical techniques over the past two decades. To date, there is substantial evidence that these extracts contain small molecules with both cancer-preventative and antitumor activity. Here, we will provide an overview of the literature supporting these concepts and attempt to lend insight into possible mechanisms whereby the anticancer properties are achieved.
GALLIC ACID: GA decreases the viability of A549 cells; A549 cells were treated with GA (0–52 µg/ml) for 24 h and cell viability was detected by MTT assay. It was observed that GA decreased cell viability in a dose-dependent manner. Specifically, 12 µg/ml GA significantly decreased cell viability when compared with that of control cells (P<0.05); the greater concentration of 28 µg/ml in turn caused a greater inhibition of cell viability when compared with 12 µg/ml GA (P<0.05); cell viability was <10% when A549 cells were treated with GA at a dose of 36 µg/ml GA; and cell viability was further inhibited when cells were treated with 52 µg/ml GA. Based on these findings, 12–28 µg/ml GA was adopted for subsequent studies. It was further identified that the viability of cells was significantly inhibited by GA in dose- and time-dependent manners.
TANNINS: Non-small cell lung cancer (NSCLC) is one among the most common cancers worldwide. Recently, dietary phytochemicals have been reported as an attractive approach to improve the symptoms of NSCLC patients. Tannic acid is a natural polyphenol, which is known to have anticancer effects on in vitro models of breast, gingival and colon cancer. However, the molecular mechanisms associated with the actions of tannic acid on A549 human lung cancer cells have not been elucidated. Materials and Methods: In this study, we analysed the effect of tannic acid on A549 cells and their underlying mechanisms using western blotting, flow cytometry, invasion assay and tumor-sphere formation assay. Results: Tannic acid treatment suppressed the viability of A549 cells through cell cycle arrest and induction of the intrinsic pathways of apoptosis. In addition, the various malignant phenotypes of A549 cells including invasion, migration, and stemness were inhibited by tannic acid treatment. Conclusion: Tannic acid could be used as an effective inhibitor of lung cancer progression.
COENZYME Q10: Coenzyme Q10 (CoQ10) is a biological quinone compound that has two major physiological activities, as an antioxidant and as a redox component in the respiratory chain. Those CoQ10 activities among others may be of importance for the prognosis and treatment of breast cancer, which is the most commonly diagnosed cancer among women. Six studies were included in this literature review. A relationship between CoQ10 levels and the risk of breast cancer was established. In those studies where patients were supplemented with a daily recommended dose of CoQ10, resulted in increased antioxidant levels, decreased cytokines plasma levels and reduced cancer biomarkers.
NANO CURCUMINS (100% WATER SOLUBLE): It acts as a potential agent against human lung, breast, prostate, colorectal, liver, carcinoma, pancreatic, myeloma, and melanoma cancers due to the capability of inducing apoptosis, preventing cancer cell growth and suppression of cell cycle development (Shishodia et al., 2005). It was seen that curcumin prevents the growth of metastasis of cancer cells. Curcumin averts the attack of cancer cells in the normal tissue by obstructing the activity of matrix metalloproteinases that regulate the process. Curcumin suppresses the expression of genes cyclin D1, c-myc, bcl-2, Bcl-xL that are involved in tumor growth, proliferation, and apoptosis. For instance, the inhibition of nuclear factor-kappa (NF-?B) is important in carcinogenesis and proliferation. Curcumin deters the NF-?B activity that can increase the expression of genes related to proliferation (e.g., cyclin D1, c-myc), invasion (e.g., matrix metalloproteinases) and
ALLICIN: Digestive system cancer tumors are one of the major causes of cancer-related fatalities; the vast majority of them are colorectal or gastric malignancies. Epidemiological evidence confirmed that allium-containing food, such as garlic, reduces the risk of developing malignancies. Among all compounds in garlic, allicin has been most researched, as it contains sulfur and produces many second degradation compounds, such as sulfur dioxide, diallyl sulfide (DAS), diallyl trisulfide (DATS), and diallyl disulfide (DADS) in the presence of enzymatic reactions in gastric juice. These substances have shown anti-inflammatory, antidiabetic, antihypertensive, antifungal, antiviral, antibacterial, and anticancer efficacy, including gastrointestinal (GI) cancers, leukemia, and skin cancers. Herein, we summarize the therapeutic potential of allicin in the treatment of GI cancers.
BIOFLAVANOIDS: Citrus bioflavonoids and related substances are widely used in Europe to treat diseases of the blood vessels and lymph system, including hemorrhoids, chronic venous insufficiency, leg ulcers, easy bruising, nosebleeds, and lymphedema following breast cancer surgery.
HOLY BASIL EXTRACT: Holy Basil Leaf Extract Decreases Tumorigenicity and Metastasis of Aggressive Human Pancreatic Cancer Cells in vitro and in vivo: Potential Role in Therapy.
WITHAFERIN A: In the last two decades, an active component of Withaferin A (WFA) has shown tremendous cytotoxic activity suggesting its potential as an anti-carcinogenic agent in treatment of several cancers. In spite of enormous progress, a thorough elaboration of the proposed mechanism and mode of action is absent.
GINGER EXTRACT: Anticancer activities of ginger against colorectal cancer have been well documented. Numerous in vitro studies showed that ginger and its active components inhibit growth and proliferation of colorectal cancer cells. In a study, 6-gingerol inhibited growth of colon cancer HCT116 cells.
L ARGININE: Arginine is involved in a number of biosynthetic pathways that significantly influence carcinogenesis and tumor biology. Since the discovery that arginine metabolism generates a ubiquitous signal transduction molecule, nitric oxide (NO),3 arginine-derived NO has been found to play a significant role in many of the specific events that lead to cancer.
VITAMIN C: In cancer, vitamin C is associated with prevention, progression, and treatment, due to its general properties or its role as a pro-oxidant at high concentration. This review explores the role of vitamin C in cancer clinical trials and the aspects to consider in future studies, such as plasmatic vitamin C and metabolite excretion recording, and metabolism and transport of vitamin C into cancer cells.
Multimineral: The necessary minerals improve immunity, removes free radicals & also cell bioanalyzer. Added Minerals are Iron, Potassium, Calcium, Phosphorous, Copper, Nickel, Selenium, Tin, Chloride, Mangenese, Silion, Boron, & Vanadium.
The present invention may be understood more readily by reference to the following detailed description of the invention taken in connection with the accompanying drawing figures, which form a part of this disclosure. It is to be understood that this invention is not limited to the specific devices, methods, conditions or parameters described and/or shown herein and that the terminology used herein is for the example only and is not intended to be limiting of the claimed invention. Also, as used in the specification including the appended claims, the singular forms ‘a’, ‘an’, and ‘the’ include the plural, and references to a particular numerical value includes at least that particular value unless the content clearly directs otherwise. Ranges may be expressed herein as from ‘about’ or ‘approximately’ another particular value when such a range is ex- pressed another embodiment. Also, it will be understood that unless otherwise indicated, dimensions and material characteristics stated herein are by way of example rather than limitation, and are for better understanding of sample embodiment of suitable utility, and variations outside of the stated values may also be within the scope of the invention depending upon the particular application.
Embodiments will now be described in detail with reference to the accompanying drawings. To avoid unnecessarily obscuring the present disclosure, well- known features may not be described or substantially the same elements may not be redundantly described, for example. This is for ease of understanding.
The following description are provided to enable those skilled in the art to fully understand the present disclosure and are in no way intended to limit the scope of the present disclosure as set forth.
According to one embodiment of the present invention is to optimize the technological procedure used in manufacturing process.
Another embodiment of the present invention is to monitor, control, and improve effectively the whole applied operations at every stage of the finished pharmaceutical products.
Another embodiment of the present invention is the inspection of raw material, equipment, environment, process, testing with respect to specification, packing, etc. Quality and process control.
Another embodiment of the present invention, all the in-process controls including those made in the production area by production personnel perform according to methods approved by quality control department (GMP guideline). Usually, tests are carried out by production personnel, especially for convenience. The personnel in the production area do not have to be directly responsible to the production manager or head with disciplinary responsibility.
On the basis of organizational instruction and process description, quality control personnel have carried out the necessary tasks, if carried out by the production personnel the head must make sure that the controls are used as a means of controlling process in accordance with the instructions and the results taken into account. The responsibility and tasks for the in-process control must be clearly laid down in the organizational instruction. When deviation occurs or where release analyses of intermediate are carried out outside production area, a method must be defined that prevent continued processing of the materials until the decision or the result is available. Materials may be rejected by means of operating data. Physical designation of the product by means of labelling is recommended.
The composition of each dietary supplement as disclosed herein:
Each Tablet Contains:
QUERCETIN 100mg
PHYLLAEMBLIC COMPOUNDS 10mg
GALLIC ACID 15mg
TANNINS 5mg
COENZYME Q10 150mg
NANO CURCUMINS (100% WATER SOLUBLE) 200mg
ALLICIN 15 MG 15mg
BIOFLAVANOIDS 10mg
HOLY BASIL EXTRACT 67mg
WITHAFERIN A 100mg
GINGER EXTRACT 50mg
L ARGININE 60mg
VITAMIN C 100mg
IRON 17mg
POTTASIUM 10mg
CALCIUM 5mg
PHOSPHOROUS 3.86mg
COPPER 1.7mg
NICKEL 130mcg
SELENIUM 35mcg
TIN 2mcg
CHLORIDE 9.7mcg
MANGENESE 4mg
SILION 2mg
BORON 1mg
VANADIUM 10mcg
In an embodiment of the present invention the manufacturing process of composition in Tablet – Solid Form is disclosed as:
Manufacturing process of composition in Tablet – Solid Form
The primary Process include:
To formulate tablets that are strong and hard to withstand mechanical shock encountered during manufacturing, packing, shipping, dispensing and use.
To formulate tablets that are uniform in weight and in drug content.
To formulate tablets that are bioavailable according to indication requirements.
To formulate tablets that are chemically and physically stable over a long period of time. (Up to the Claimed Shelf-Life)
To formulate tablets that have elegant product identity which is free from any tablet defects.
Manufacturing process of Tablet formulation
In general, formulation process of tablet manufacturing as per factors stated below:
Compression of the Active Pharmaceutical Ingredient (API) / drug substance.
Physical and chemical stability of the API during the manufacturing process.
Particle size of the formulation ingredients.
Availability of the necessary processing equipment.
Cost of the manufacturing/formulation process.
Manufacturing Process through its defined Area:
Raw material warehouse
Receiving quarantine Area
Approved raw material Area Dispensing Area Production AreaMixing, Granulation and Drying Section Compression Section (Tablet Punching)
Coating Section (Tablet Coating) Quality control section (QC) Packaging Section.
In another embodiment of the present invention, the manufacturing process of the supplement includes dry granulation or direct compression method.
Dry Granulation Method / Process Diagram Flowchart of dry granulation process
A stepwise summary of the manufacturing steps used in the manufacture of tablets by the dry granulation method are listed below.
Weighing and milling of formulation ingredients (drug substance and excipients)
Mixing of milled powders.
Compression of mixed powders into slugs.
Milling and sieving of slugs.
Mixing with disintegrant and lubricant.
Compression into tablets
Flowchart of direct compression process
A stepwise summary of the manufacturing steps used in the manufacture of tablets by the dry granulation method are listed below.
Milling of therapeutic agent and excipients
Mixing of milled powders, disintegrants and lubricants
Compression into tablets.
It is worth noting that tablets produced by direct compression are often softer than their counterparts that have been produced by wet granulation and therefore they may be difficult to film-coat.
On the basis of organizational instruction and process description, quality control personnel have carried out the necessary tasks, if carried out by the production personnel the head must make sure that the controls are used as a means of controlling process in accordance with the instructions and the results taken into account. The responsibility and tasks for the in-process control must be clearly laid down in the organizational instruction. When deviation occurs or where release analyses of intermediate are carried out outside production area, a method must be defined that prevent continued processing of the materials until the decision or the result is available. Materials may be rejected by means of operating data. Physical designation of the product by means of labelling is recommended.
3) Location of In-Process Quality Control
In-process control may be carried out within production area provided they do not jeopardize production. It means that care must be taken when sampling or testing. Examples of in-process tests influence on production are the influence of disintegration test on room humidity and the risk of microbial contamination posed by leak test on blisters. Tests are normally carried out in a segregated area and not directly at the manufacturing location.
4) Sampling
According to another embodiment of the present invention, uniform sampling is carried out throughout the entire batch production. A sampling plan includes the process and location for sampling, the number of samples and other information.
State the type of sample container to be used,
According to another embodiment of the present invention, a collection technique is disclosed that prevents contamination of product being sampled, prevents the contamination of sample taken and the aseptic technique if necessary, Specify sampling instrument i.e. type and requirement (clean, sterile, pyrogen-free) Justify the use of composite sample.
According to another embodiment of the present invention, samples are tested to verify conformance with specifications such as identity, components conformity to written specifications, container/closure conformity with written specifications and examination for contamination. The tests to be performed and the methods to be used have to be defined and specifications also established. Also, use of certificates of analysis or certificates of conformance has to be established.
According to another embodiment of the present invention, any necessary in-process controls and environmental controls carried out must be recorded. This documentation record must include a record of the in-process controls, the initials of the person(s) carrying them out, and the results obtained. In case of deviation, the signature of the person who approved the deviation is required. Each deviation from the specifications must be countersigned by a qualified person. Also, reasons for deviation, measures including the justification for deviation, date, and name of the person authorizing it must be documented. The head of production is responsible for deviation procedure.
In addition to the numerical compilation of data, a graphical representation of process control values is recommended. This provides simplified overview that makes it possible for trends to be easily detected at early stage.
The quality of pharmaceutical dosage forms is essential to assure the maximum level of patient’s satisfaction. To safeguard quality, pharmaceutical companies should possess an organization which enables a proper system of quality assurance of pharmaceutical products and active ingredients. They should able to define in quantifiable terms the quality of raw materials used in the production processes and the quality of products/ drugs they manufacture. This will enhance a safe and healthier society.
PHARMACOPOEIA OR OFFICIAL TESTS
They are called official tests because the test methods are described in official compendia such as the British Pharmacopoeia, American Pharmacopoeias etc. They are standardized test procedures which have clearly stated limits under which compressed tablets could be accepted. These tests include:
1) Content of Active Ingredient/ Absolute drug content test
Uniformity of Weight
Uniformity of Content
Disintegration time test
Dissolution test
Content of Active Ingredient
This is determined from a sample of 20 tablets which should be randomly selected from a batch of tablets. The tablets are weighed together and are crushed in a mortar with a pestle.
An amount equivalent to the theoretical content of each tablet or the average of the crushed tablets is weighed out in an analytical balance. The weighed powder is dispersed in a solvent in which the active drug is freely soluble or in a solvent prescribed in the individual drug monograph.
This is filtered and an aliquot of the resultant filtrate is subjected to the stipulated assay procedures. The assay procedures are usually given in the individual drug monograph.
Analysis of the active drug is usually carried out using spectrophotometry or High-Performance Liquid Chromatography (HPLC).
2) Uniformity of Weight / Weight variation test: The test for uniformity of weight is performed by weighing individually 20 tablets randomly selected from a tablet batch and determining their individual weights. The individual weights are compared with the average weight.
3) Uniformity of Content: Content uniformity test was developed to ensure content consistency of active drug substances within a narrow range around the label claim in dosage units. This test is crucial for tablets having a drug content of less than 2 mg or when the active ingredient comprises less than 2% of the total tablet weight.
4) Disintegration Time Test: For tablets, the first important step towards drug dissolution is breakdown of the tablets into granules or primary powder particles, a process known as disintegration. All USP tablets must pass a test for disintegration, which is conducted using a disintegration test apparatus.
5) Dissolution Test: This test measures the amount of time required for a given percentage of the drug substance in a tablet to go into solution under a specified set of conditions. It is intended to provide a step toward the evaluation of the physiological availability of the drug substances.
NON-PHARMACOPOEIA OR NON-OFFICIAL TESTS:
These are tests that are performed on tablets and which are not listed in official compendia and concern a variety of quality attributes that need to be evaluated, such as the porosity of tablets, hardness or crushing strength test, friability test, tensile strength determination, thickness test etc. Some of these tests have no officially set limits for acceptance or rejection and thus may vary from manufacturer to manufacturer and from formulation to formulation.
Crushing strength and friability appeared in the 2001 Edition of British Pharmacopoeia (Appendix A324). There were however no definite set limits. The two tests are, therefore, here considered under non-pharmacopoeia tests.
Tablet Hardness or Crushing Strength Test: This measures the degree of force (in kilograms, pounds, or in arbitrary units) needed to fracture a tablet. Besides the concentration of binders used and the compression force, the hardness of a tablet depends on
The characteristics of the granules to be compressed e.g., hardness and deformation under load.
The type and concentration of lubricant used and
The space between the upper and lower punches at the time of compression.
Friability Test: This measures the resistance of tablets or granules to abrasion or fracture. The idea behind this test is to mimic the kind of forces, caused by phenomena such as collisions and sliding of tablets towards each other, which a tablet is subjected to during coating, packaging, handling, and shipping.
A minimum of 20 tablets are dedusted, weighed and subjected to a uniform tumbling motion for a specified time. They are then dedusted and reweighed.
The measure of abrasion/ friability loss is usually expressed as a percentage loss in weight. It is calculated from the equation:
Friability loss (%) = (Initial Weight-Final Weight)/(Initial weight) X 100
Tablet Thickness: Tablet thickness is determined by the diameter of the die, the amount of fill permitted to enter the die cavity, the compaction characteristics of the fill material, and the force or pressure applied during compression. To manufacture tablets of uniform thickness during and between batch productions for the same formulation, care must be exercised to employ the same factors of fill, die, and pressure.
The degree of pressure affects not only thickness but also hardness of the tablet; hardness is perhaps the more important criterion since it can affect disintegration and dissolution. Thus, for tablets of uniform thickness and hardness, it is doubly important to control pressure. Tablet thickness also becomes an important characteristic in packing operations and in counting of tablets using filling equipment which uses the uniform thickness of the tablets as a counting mechanism.
Tablet thickness is measured with a vernier calliper, thickness gauge or automated equipment (Automatic weight, hardness, thickness, and tablet diameter test instrument). The thickness of a tablet should be controlled within ±5% variation of a standard value depending on the size of the tablet.
Other non-pharmacopoeia tests include measurement of tablet diameter, porosity, liquid penetration, mechanical strength, and density.
Quality control of tablets involves various tests which require keen attention. To ensure that established product quality standards are met, these tests are being performed during production (in-process controls) and verified after the production of each batch.
Packaging and storing of tablets
Before tablets are sent out for distribution, they are usually packaged using appropriate packaging materials. The type of packaging material used is a matter of choice and is dependent on several factors including:
The degree of protection required
Compatibility of the packaging material with the formulation.
Presentation, particularly for those products which may be the subject of impulse buying
Customer convenience in terms of size, weight, method of opening or reclosing legibility of printing, etc.
Tablets are commonly packaged using blister and strip packs and are kept in places of low humidity, and protected from extremes temperature. The packaging provides excellent environmental protection for each unit of tablet, coupled with an aesthetically pleasing and efficacious appearance. Blister and strip packaging also provide some degree of tamper resistance to the dosage form.
For larger quantities delivered to the pharmacist, glass or plastic bottles, metal containers, cartons, or paperboard drums may be used along with polyethylene liners, where necessary, to give added protection from moisture. If cotton wool stuffing is used under these circumstances it is an advantage for it to be external to the liners so that any moisture that it contains does not gain access to the tablets. Tablets that are decomposed when exposed to moisture can also be packaged with a desiccant packet. Light sensitive tablets are packaged in light-resistant containers. With a few exceptions, tablets that are properly stored will remain stable for many years.
ADVANTAGE OF THE PRESENT INVENTION
The main advantage of the present invention is to provide a nutraceutical dietary supplement for the prevention of Oncological therapeutic conditions.
Another advantage of the present invention is to provide preventive medicine for unusual lumps or swelling that are often painless and may increase in size as cancer progresses.
Yet another advantage of the present invention is to provide preventive medicine for coughing, breathlessness, or difficulty swallowing.
Yet another advantage of the present invention is to provide preventive medicine for constipation and diarrhoea and/or blood found in the stools.
Yet another advantage of the present invention is to provide preventive medicine for unexpected bleeding including bleeding from the vagina, anal passage, or blood found in stools, in urine, or when coughing.
Yet another advantage of the present invention is to provide preventive medicine for unexplained weight loss.
Yet another advantage of the present invention is to provide preventive medicine for fatigue which shows itself as extreme tiredness and a severe lack of energy.
Yet another advantage of the present invention is to provide preventive medicine for pain or ache including unexplained or ongoing pain or pain that comes and goes.
Yet another advantage of the present invention is to provide a supplement for complications with urinating including needing to urinate urgently, more frequently, or being unable to go when you need to or experiencing pain while urinating.
Yet another advantage of the present invention is to provide a supplement for unusual breast changes – look for changes in size, shape or feel, skin changes and pain.
Yet another advantage of the present invention is to provide a supplement for Appetite loss – feeling less hungry than usual for a prolonged period of time.
Yet another advantage of the present invention is to provide a supplement for a sore or ulcer that won’t heal – including a spot, sore wound or mouth ulcer.
Yet another advantage of the present invention is to provide a supplement for heartburn or indigestion – persistent or painful heartburn or indigestion.
Yet another advantage of the present invention is to provide a supplement for heavy night sweats – be aware of very heavy, drenching night sweats.
,CLAIMS:We Claim
1. A nutraceutical dietary supplement for oncological therapeutic conditions comprising a combination of:
a) Quercetin in the range of 75-150mg;
b) Phyllaemblic compounds in the range of 5-15 mg;
c) Gallic acid in the range of 10-20mg;
d) Tannins in the range of 2-7mg;
e) Coenzyme Q10 in the range of 100-200mg;
f) Nano curcumins in the range of 150-250mg;
g) Allicin in the range of 10-20mg;
h) Bioflavonoids in the range of 7-15mg;
i) Holy basil Extract in the range of 60-70mg;
j) Withaferin A in the range of 75-150mg;
k) Ginger Extract in the range of 45-55 mg;
l) L arginine in the range of 55-70mg; and
m) Multimineral in the range of 140-147mg.
2. The nutraceutical dietary supplement as claimed in claim 1, wherein the supplement preferably comprises a combination of:
a) Quercetin in 100mg;
b) Phyllaemblic compounds in 10mg;
c) Gallic acid in 15mg;
d) Tannins in 5mg;
e) Coenzyme Q10 in 150mg;
f) Nano curcumins in 200mg;
g) Allicin in 15mg;
h) Bioflavonoids in 10mg;
i) Holy basil Extract in 67mg;
j) Withaferin A in 100mg;
k) Ginger Extract in 50mg;
l) L arginine in 60mg; and
m) Multimineral in 144mg.
3. The nutraceutical dietary supplement as claimed in claim 1 or 2, wherein the multimineral comprising a combination of Vitamin C in 100mg, Iron in 17mg, potassium in 10mg, calcium in 5mg, phosphorous in 3.86mg, copper in 1.7mg, nickel in 130mcg, selenium in 35mcg, tin in 2mcg, chloride in 9.7mcg, manganese in 4mg, silicon in 2mg, boron in 1mg, and vanadium in 10mcg.
4. The nutraceutical dietary supplement as claimed in claim 1, wherein nano curcumins are water-soluble.
5. The nutraceutical dietary supplement as claimed in claim 1, wherein the supplement is presented in tablet formulation, wherein the formulation is designed to ensure uniformity in weight and drug content and to maintain chemical and physical stability over time.
6. The nutraceutical dietary supplement as claimed in claim 1, wherein the manufacturing process of the supplement includes dry granulation or direct compression method.
7. The nutraceutical dietary supplement as claimed in claim 1, wherein the supplement is particularly formulated for preventing cancer and the risk of cancer-like symptoms in any individual.
8. A method for preventing cancer and risk of cancer-like symptoms in an individual, comprising administering the nutraceutical dietary supplement of any of the preceding claims to the individual in need thereof.
| # | Name | Date |
|---|---|---|
| 1 | 202221044303-PROVISIONAL SPECIFICATION [02-08-2022(online)].pdf | 2022-08-02 |
| 2 | 202221044303-FORM FOR SMALL ENTITY(FORM-28) [02-08-2022(online)].pdf | 2022-08-02 |
| 3 | 202221044303-FORM FOR SMALL ENTITY [02-08-2022(online)].pdf | 2022-08-02 |
| 4 | 202221044303-FORM 3 [02-08-2022(online)].pdf | 2022-08-02 |
| 5 | 202221044303-FORM 1 [02-08-2022(online)].pdf | 2022-08-02 |
| 6 | 202221044303-EVIDENCE FOR REGISTRATION UNDER SSI(FORM-28) [02-08-2022(online)].pdf | 2022-08-02 |
| 7 | 202221044303-EVIDENCE FOR REGISTRATION UNDER SSI [02-08-2022(online)].pdf | 2022-08-02 |
| 8 | 202221044303-ENDORSEMENT BY INVENTORS [01-08-2023(online)].pdf | 2023-08-01 |
| 9 | 202221044303-COMPLETE SPECIFICATION [01-08-2023(online)].pdf | 2023-08-01 |
| 10 | 202221044303-Proof of Right [29-08-2023(online)].pdf | 2023-08-29 |
| 11 | 202221044303-FORM-26 [29-08-2023(online)].pdf | 2023-08-29 |