DESC:FIELD
The present disclosure relates to the field of homeopathy based formulation.
DEFINITIONS
As used in the present disclosure, the following terms are generally intended to have the meaning as set forth below, except to the extent that the context in which they are used indicate otherwise.
Nosode: The term “nosode” refers to homeopathic preparations of organic material derived from inactivated disease products, cultures of microorganisms (e.g. bacteria, fungi and viruses) or parasites, infected or pathologically changed material or decomposition products from humans or animals, rendered safe during the homeopathic manufacturing process.
Decimal Potency: The term “decimal potency” refers to the principle that the first potency should contain one-tenth part of the original drug and each succeeding potency should contain one-tenth part of the potency preceding it. The decimal potency is denoted by suffixing the letter 'X' or 'D' to the number indicating the potency, i.e. the first potency is 1X or 1D in the decimal scale, followed by 2X or 2D and so on.
Centesimal Potency: The term “centesimal potency” refers to the principle that the first potency must contain one-hundredth part of the original drug and each succeeding potency must contain one-hundredth part of the preceding one. This scale is designated by suffixing the letter 'C' or 'CH' to the number indicating the potency i.e. the first potency is 1C or 1CH, followed by 2C or 2CH and so on.
Potentization: The term “potentization” refers to a process of making a remedy more potent by serial dilution. Potentization is the process for the reduction, according to scale, of crude, inert or poisonous medical substances to a state of physical solubility, physiological assimilability and therapeutic activity and harmlessness, for use as Homeopathic healing remedies.
Trituration: The term “trituration” refers to grinding one compound into another to dilute one of the ingredients, add volume for processing and handling, or to mask undesirable qualities.
Succussion: The term “succussion” refers to the vigorous shaking of a diluted homeopathic preparation in order to activate the medicinal substance. Succussion is a process of potentization, by which preparation of medicine takes place by the use of a liquid vehicle like alcohol or water, by shaking in a definite manner.
Potency: The term “potency” refers to the power that is derived by the grades of medicinal power developed by the process of dynamization. Potency is a result of a series of successive dilutions, according to scale and friction through succussion or trituration.
BACKGROUND
In recent years, there has been a dramatic increase in the use of non-allopathic compositions and therapeutic regimens for the treatment of cancers—referred to generally as complementary and alternative medicines (CAM). Use of alternative medical approaches and medicines, such as homeopathy, is widespread. Cancer, also known as a malignant tumour or malignant neoplasm, refers to a group of diseases involving abnormal cell growth with the potential to invade or spread to other parts of the body.
Conventionally, generally three treatments for cancer, i.e. surgery, radiation, and chemotherapy, have been used for years with very little long-term success. Alternative cancer treatments are much less expensive than surgery, radiation, and chemotherapy and have fewer unwanted side effects. Allopathic medicine, with its emphasis on moderate drug doses, works to inhibit undesired physical symptoms and to kill undesired pathogens. Homeopathic medicine, in contrast, begins with small doses and moves towards progressively higher dilutions to stimulate the body's own natural electromagnetic forces.
There is, therefore, felt a long awaited need for the preparation of a cancer nosode with known characterization and histopathological features which is effective and easily available at an affordable price.
OBJECTS
Some of the objects of the present disclosure, which at least one embodiment herein satisfies, are as follows:
It is an object of the present disclosure to ameliorate one or more problems of the prior art or to at least provide a useful alternative.
An object of the present disclosure is to provide a homeopathy based formulation.
Another object of the present disclosure is to provide a homeopathy based formulation which is effective against cancer.
Still another object of the present disclosure is to provide a homeopathy based formulation that is free of side effects, is non-toxic, easy to administer and has a long-lasting effect.
Other objects and advantages of the present disclosure will be more apparent from the following description, which is not intended to limit the scope of the present disclosure.

SUMMARY
In accordance with an aspect of the present disclosure, envisaged is a homeopathy based formulation and a cancer nosode prepared from at least one cancer tissues. The homeopathy based formulation of the present disclosure comprises at least one serially diluted and potentized cancer nosode and a vehicle. In another embodiment of the present disclosure, the ratio of the cancer nosode to the vehicle is in the range of 1:9 for 1C potency and 1:99 for 1D potency. The present disclosure also envisages a process for preparing the homeopathy based formulation. In the process of the present disclosure, initially a cancer nosode is prepared by procuring at least one cancer tissue and treating the cancer tissue to obtain cancer tissue free of infection/contamination. This cancer tissue free of infection/contamination is then suspended in a vehicle and potentized to obtain a processed material followed by diluting and succussing the processed material serially in the vehicle to obtain the homeopathy based cancer nosode. Typically, the ratio of the cancer tissue to the vehicle is in the range of 1:99 to 1:1 for preparing the homeopathy based cancer nosode. Further, the cancer nosode so obtained is diluted and succussed in a vehicle to obtain a potentised mixture. Typically, the step of diluting and succussing the cancer nosode is repeated 30 to 10,000 times, to obtain the homeopathy based formulation having 30C to 10,000C potency. Typically, the vehicle is at least one selected from the group consisting of alcohol, water and sugar preparation. Typically, the ratio of the cancer nosode to the vehicle is in the range of 1:9 to 1:99.
In an embodiment of the present disclosure, the cancer tissue is selected from the group consisting of squamous cell carcinoma, duct carcinoma, adenocarcinoma, soft tissue sarcomas, lymphomas, tumors of esophagus, uterine cervix, bone, lung, endometrium, bladder, breast, larynx, colon/rectum, stomach, ovary, pancreas, adrenal gland and prostate. Typically, the cancer tissue has a cell count in the range of 3 x 106 to 3 x 1010 cells per mm of the cancer tissue. Typically, the cancer tissue has a size ranging from 0.1 mm to 3.0 mm. Typically, the vehicle is selected from the group consisting of alcohol, water and sugar preparation.
In an embodiment of the present disclosure, the serial dilution is performed in the range of 1c to 1 million c.
Typically, the potentization is performed using an electro-mechanical potentizer. Typically, the electro-mechanical potentizer exerts a force in the range of ___ to ___ dynes rhythmically at a frequency of ___ strokes per minute.
DETAILED DESCRIPTION
The traditional therapies for treating cancer, i.e. surgery, radiation, and chemotherapy, results in undesirable side effects and are expensive. The available alternative therapies for cancer are not reliable and do not provide satisfactory results.
Homeopathy is a system of alternative medicine created in 1796 by Samuel Hahnemann based on his doctrine of like cures like (similia similibus curentur): a claim that a substance that causes the symptoms of a disease in healthy people would cure similar symptoms in sick people. Homeopathy is based on the principles of:
i. like cures like: if the symptoms of your cold are similar to poisoning by mercury, then mercury would be your homeopathic remedy;
ii. minimal dose: the remedy is taken in an extremely dilute form; typically, one part of the remedy to around 1,000,000,000,000 parts of water; and
iii. the single remedy: no matter how many symptoms are experienced, only one remedy is taken, and that remedy will be aimed at all those symptoms.
Nosodes are broad-spectrum, widely used homoeopathic preparations sourced from biological materials, such as, cultures or clinical samples of microorganisms (e.g. bacteria, fungi, and viruses) or from parasites, diseased tissues (cancerous tissues), or decomposition products from humans or animals. Nosodes are applied for the treatment as well as alleviating the symptoms of acute as well as chronic diseases. The Homoeopathy Pharmacopeia of India (HPI) had divided the source material into four groups N-I, N-II, N-III, and N-IV, depending on the nature of the source material, whether organisms are capable of producing endotoxins, exotoxins, made from purified toxins or made from microbes, viruses, or clinical material from diseased subjects.
In an embodiment of the present disclosure, cancer nosode is prepared by using appropriately treated cancer tissue(s) from patients or from commercially available cancer cell lines. Cancer nosode is therefore grouped in N-IV, in accordance with the HPI.
In accordance with an aspect of the present disclosure, envisaged is a homeopathy based formulation and a cancer nosode prepared from specific cancer tissues. The homeopathy based formulation of the present disclosure comprises at least one serially diluted and potentized cancer nosode and a vehicle. In another embodiment of the present disclosure, the ratio of the cancer nosode to the vehicle is in the range of 1:9 for 1C potency and 1:99 for 1D potency. Typically, the vehicle is selected from the group consisting of alcohol, water and sugar preparation.
In yet another embodiment of the present disclosure, the cancer tissue is selected from the group consisting of squamous cell carcinoma, duct carcinoma, adenocarcinoma, soft tissue sarcomas, lymphomas, tumors of esophagus, uterine cervix, bone, lung, endometrium, bladder, breast, larynx, colon/rectum, stomach, ovary, pancreas, adrenal gland and prostate. Typically, the cancer tissue has a cell count in the range of 3 x 106 to 3 x 1010 cells per mm of the cancer tissue. Typically, the cancer tissue has a size ranging from 0.1 mm to 3.0 mm.
In an embodiment of the present disclosure, disclosed is the process for preparing the cancer nosode (original stock). Typically, for preparing the cancer nosode, initially at least one cancer tissue is procured and treated to obtain cancer tissue free of infection/contamination. This cancer tissue free of infection/contamination is then suspended in a vehicle and potentized to obtain a processed material followed by diluting and succussing the processed material serially in the vehicle to obtain the homeopathy based cancer nosode. Typically, the ratio of the cancer tissue to the vehicle is in the range of 1:99 to 1:1 for preparing the homeopathy based cancer nosode.
In still another embodiment of the present disclosure, the cancer tissue is obtained from a fresh biopsy in which at least 0.1 to 3.0 mm of tumor is obtained. Typically, the cancer tissue is obtained by needle biopsy or by open resection. In an embodiment of the present disclosure, one or more tissue samples can be used as a source to prepare the nosode.
In yet another embodiment of the present disclosure, the vehicle is selected from the group consisting of alcohol, water and sugar preparation.
In accordance with another aspect of the present disclosure also envisaged is a process for preparing the homeopathy based formulation. In the process of the present disclosure, initially a cancer nosode is prepared by procuring at least one cancer tissue and treating the cancer tissue to obtain cancer tissue free of infection/contamination. This cancer tissue free of infection/contamination is then suspended in a vehicle and potentized to obtain a processed material followed by diluting and succussing the processed material serially in the vehicle to obtain the homeopathy based cancer nosode. Further, the cancer nosode so obtained is diluted and succussed in a vehicle to obtain a potentised mixture. The more physically dilute the solution, the higher the potency. Typically, the step of diluting and succussing the cancer nosode is repeated 30 to 10,000 times, to obtain the homeopathy based formulation having 30C to 10,000C potency. Typically, the vehicle is at least one selected from the group consisting of alcohol, water and sugar preparation. Typically, the ratio of the cancer nosode to the vehicle is in the range of 1:9 to 1:99.
In another embodiment of the present disclosure, the ratio of the cancer nosode to the vehicle is in the range of 1:9 for 1C potency and 1:99 for 1D potency. In an exemplary embodiment of the present disclosure, the serial dilution is in the range of 1c to 1 million c.
Typically, the cancer tissue is acquired commercially from the market and hence its geographical origin is not known. Typically, appropriately treated cancer tissue(s) from the patient or commercially available cancer cell lines can be used.
In an embodiment of the present disclosure, the cancer tissue is selected from the group consisting of squamous cell carcinoma, duct carcinoma, adenocarcinoma, soft tissue sarcomas, lymphomas, tumors of esophagus, uterine cervix, bone, lung, endometrium, bladder, breast, larynx, colon/rectum, stomach, ovary, pancreas, adrenal gland and prostate.
In an embodiment of the present disclosure, the cancer tissue for preparing the nosodes are live organisms. In another embodiment of the present disclosure, the cancer tissue can be heat inactivated. The heat inactivation is carried out to inactivate the pathogen(s) that may be present in the cancer tissue. Typically, the source of the nosode is checked for any possible contaminant(s). Infections, if present, are removed, before further processing. The nosode source can be standardized with respect to cell count, protein profile, and pH.
Typically, the strength of the cancer nosode (mother preparation) is determined by cell count, using techniques, including, but not limited to, digital counters and turbidity match method. Typically, the cell count in the 1C potency is carried out to confirm the cell count.
The original stock is then subjected to potentization after determining the strength. Depending on the nature of the cancer tissue, succussion or trituration type of potentization is carried out. Typically, trituration process is done when the size of the biological material is visible to the naked eye (cancerous tissue), and for the cancer tissue that are microscopic in nature and not visible to the naked eye, succussion is carried out.
In an embodiment of the present disclosure, the water used is water for injection. In another embodiment of the present disclosure, the water for injection is selected such that it is free from organisms, pyrogens, and sodium chloride (NaCl). In yet another embodiment of the present disclosure, the sugar preparation is saccharum lactis. Typically, the vehicle is saccharum lactis.
In an embodiment of the present disclosure, potentization is performed using an electro-mechanical potentizer. Typically, the electro-mechanical potentizer exerts a force in the range of ___ to ___ dynes rhythmically at a frequency of ___ strokes per minute to obtain the 1C potency. The efficacy of the nosode depends upon the power exerted by the strokes. In an exemplary embodiment of the present disclosure, 10 strokes of the abovementioned potentizer are applied to obtain 1C potency (10-2 dilution) nosode. The 1C potency nosode is further diluted with the vehicle till a desired potency is obtained.
Typically, the safety of nosode in various potencies can be established as per the sterility testing mentioned in the HPI. Further, the presence and growth of the source organism(s) in various potencies must be established and documented. Additional testing, including, but not limited to, DNA test, pro-viral DNA test, ultra-electron microscopy, Reverse Transcription Polymerase Chain Reaction (RT-PCR) method with positive and negative control can be carried out to establish the safety of the nosode for human use.
Typically, the prepared nosode can be lyophilized, so that nosode having the same characteristics can be reproduced.
Typically, all the preparations are carried out in stringent biosafety compliant environment with minimum handling, using sealed containers and disposable auto-tip pipettes.
Typically, the safety regarding the oral use of the nosodes is established through pathogenetic trials in healthy volunteers and clinical trials.
Typically, the homeopathic formulation is prepared in a liquid vehicle and may thereafter be prepared in various delivery forms, including liquid delivery forms, solid delivery forms such as tablets or other solid carriers on which the liquid is deposited, and other oral delivery forms, including time release formulations.
Typically, the cancer nosodes envisaged in accordance with the present disclosure exhibit anti-cancer activity. The in vitro studies of the cancer nosode of the present disclosure, has revealed anti-cancer activity. The cancer nosode displays induction of apoptosis supported by the increase in cells having distorted membrane morphology, nuclear condensation, DNA fragmentation, which are typical of apoptosis. Further, the cancer nosode enhanced pro-apoptotic signal proteins like p53, death programming genes, such as, bax, cytochrome c, caspase-3, inhibited anti-apoptotic signal proteins bcl2, TERT and Top II, changed mitochondrial membrane potential and caused externalization of phosphatidylserine.
The present disclosure is further described in light of the following laboratory scale experiments which are set forth for illustration purpose only and not to be construed for limiting the scope of the disclosure. The following experiments can be scaled up to industrial/commercial scale and the results obtained can be extrapolated to industrial/commercial scale.
Experiment 1: Preparation of the homeopathy based formulation:
__ gm of a cancer affected lung tissue was procured from _______. This cancer tissue was then treated with _______, to obtain cancer tissue free of infection/contamination. This cancer tissue which is free of infection/contamination is then suspended with ____ml of water in a reaction vessel, followed by potentization to obtain a processed material. The processed material is then diluted and succussed serially in ____ ml of water to obtain the homeopathy based cancer nosode having a potency of __C. Further, ___ml of the cancer nosode is diluted and succussed with __ ml of water to obtain the homeopathy based formulation having __C potency.

Experiment 2: Demonstrating the safety of the oral use of the nosodes:

Experiment 3: In vitro studies of the cancer nosode for anti-cancer activity:

TECHNICAL ADVANCEMENTS
The present disclosure described herein above has several technical advantages including, but not limited to, the realization of
? a nosode, that can be used for alleviating the symptoms of cancer;
? a formulation using natural ingredients which are effective, safe and can be taken with other medicines without any side effects;
? a formulation which does not suppress the immune system; and
? a formulation which is non-addictive.

The embodiments as described herein above, and various features and advantageous details thereof are explained with reference to the non-limiting embodiments in the description. Descriptions of well-known aspects, components and molecular biology techniques are omitted so as to not unnecessarily obscure the embodiments herein.
The foregoing description of specific embodiments so fully reveal the general nature of the embodiments herein, that others can, by applying current knowledge, readily modify and/or adapt for various applications of such specific embodiments without departing from the generic concept, and, therefore, such adaptations and modifications should and are intended to be comprehended within the meaning and range of equivalents of the disclosed embodiments. It is to be understood that the phraseology or terminology employed herein is for the purpose of description and not of limitation. Therefore, while the embodiments herein have been described in terms of preferred embodiments, those skilled in the art will recognize that the embodiments herein can be practiced with modification within the spirit and scope of the embodiments as described herein. Further, it is to be distinctly understood that the foregoing descriptive matter is to be interpreted merely as illustrative of the disclosure and not as a limitation.
Having described and illustrated the principles of the present disclosure with reference to the described embodiments, it will be recognized that the described embodiments can be modified in arrangement and detail without departing from the scope of such principles.
While considerable emphasis has been placed herein on the particular features of this disclosure, it will be appreciated that various modifications can be made, and that many changes can be made in the preferred embodiment without departing from the principles of the disclosure. These and other modifications in the nature of the disclosure or the preferred embodiments will be apparent to those skilled in the art from the disclosure herein, whereby it is to be distinctly understood that the foregoing descriptive matter is to be interpreted merely as illustrative of the disclosure and not as a limitation.

,CLAIMS:WE CLAIM:
1. A homeopathy based formulation comprising:
? at least one serially diluted and potentized cancer nosode; and
? a vehicle;
wherein said cancer nosode is prepared from at least one cancer tissue;
wherein the ratio of said cancer nosode to said vehicle is in the range of 1:9 for 1C potency and 1:99 for 1D potency.
2. The formulation as claimed in claim 1, wherein said cancer tissue is selected from the group consisting of squamous cell carcinoma, duct carcinoma, adenocarcinoma, soft tissue sarcomas, lymphomas, tumors of esophagus, uterine cervix, bone, lung, endometrium, bladder, breast, larynx, colon/rectum, stomach, ovary, pancreas, adrenal gland and prostate.
3. The formulation as claimed in claim 1, wherein said cancer tissue has a cell count in the range of 3 x 106 to 3 x 1010 cells per mm of said cancer tissue.
4. The formulation as claimed in claim 1, wherein said at least one cancer tissue has a size ranging from 0.1 mm to 3.0 mm.
5. The formulation as claimed in claim 1, wherein said vehicle is selected from the group consisting of alcohol, water and sugar preparation.
6. The formulation as claimed in claim 1, wherein said serial dilution is performed in the range of 1c to 1 million c.
7. A process for preparing a homeopathy based formulation, said process comprising the steps of:
i. preparing a cancer nosode by:
o procuring at least one cancer tissue and treating said cancer tissue to obtain cancer tissue free of infection/contamination;
o suspending said cancer tissue free of infection/contamination in a vehicle and potentizing to obtain a processed material;
o diluting and succussing said processed material serially in said vehicle to obtain said homeopathy based cancer nosode;
ii. diluting and succussing said cancer nosode in a vehicle to obtain a potentised mixture;
iii. iterating step (ii) for 30 to 10,000 times, to obtain the homeopathy based formulation having 30C to 10,000C potency;

wherein said vehicle is at least one selected from the group consisting of alcohol, water and sugar preparation; and
wherein the ratio of said cancer nosode to said vehicle is in the range of 1:9 to 1:99.
8. The process as claimed in claim 7, wherein the ratio of said processed material to the vehicle is in the range of 1:99 to 1:1.
9. The process as claimed in claim 7, wherein said cancer tissue is selected from the group consisting of squamous cell carcinoma, duct carcinoma, adenocarcinoma, soft tissue sarcomas, lymphomas, tumors of esophagus, uterine cervix, bone, lung, endometrium, bladder, breast, larynx, colon/rectum, stomach, ovary, pancreas, adrenal gland and prostate.
10. The process as claimed in claim 7, wherein said potentization is performed using an electro-mechanical potentizer.

11. The process as claimed in claim 10, wherein said electro-mechanical potentizer exerts a force in the range of ___ to ___ dynes rhythmically at a frequency of ___ strokes per minute.