DESC:FIELD
The present disclosure relates to a pharmaceutical composition.
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 indicates otherwise.
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 the 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 the 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 method.
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
The background information herein below relates to the present disclosure but is not necessarily prior art.
Vitiligo, also known as leucoderma, is a long-term skin condition characterized by patches of skin losing their pigment. The white patches with usually sharp margins appear on the affected skin. Typically, inside and outside of the body are affected. The hair from the skin may become white. The inside of the mouth and nose may also be involved. Often the patches begin on areas of skin that are exposed to the sun. Vitiligo is more noticeable in people with dark skin.
The exact cause of vitiligo is not known. Vitiligo occurs when the cells that produce melanin, die or stop functioning. The condition is not life-threatening or contagious. If the skin patches are visible, the social stigma of vitiligo can be difficult to cope with. Embarrassment can lead to problems with self-esteem, and in some cases, anxiety and depression can result.
Treatments are available to help restore skin color or even skin tone. Some of the treatments include use of sunscreen, phototherapy using ultra violet light. Skin camouflage, di-pigmenting, topical corticosteroids, and skin grafts. However, the results vary and are unpredictable. Some treatments can have serious side effects. Further, even if the treatment is successful for a while, the results may not last or new patches may appear.
Therefore, there still remains a scope to develop an effective alternative to mitigate the herein above mentioned drawbacks.

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.
Another object of the present disclosure is to provide a pharmaceutical composition.
Still another object of the present disclosure is to provide a pharmaceutical composition that is free of side effects, non-toxic, easy to administer and has a long-lasting effect.
Yet another object of the present disclosure is to provide a process for the preparation of the pharmaceutical composition
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
The present disclosure relates to a pharmaceutical composition having potency in the range of 2c to 250c comprising, a potentized mixture of at least two compounds selected from i) Hydrogen peroxide; ii) Nle4,DPhe7-a-melanocyte-stimulating hormone, iii) Kojic acid and iv) 6-biopterin.
The present disclosure further relates to a process for preparing the pharmaceutical composition. The process comprises mixing a predetermined quantity of at least two compounds selected from i) Hydrogen peroxide, ii) Nle4,DPhe7-a-melanocyte-stimulating hormone, iii) Kojic acid, and iv) 6-biopterin in a vehicle to obtain a homogeneous mixture. The homogeneous mixture is potentized by diluting with the vehicle to obtain a potentized primary dilution. The potentized primary dilution is serially diluted with the vehicle to obtain the composition having potency in the range of 2c and 250c. The serial dilution is carried out by using an electro-mechanical potentizer.
DETAILED DESCRIPTION
Embodiments are provided so as to thoroughly and fully convey the scope of the present disclosure to the person skilled in the art. Numerous details are set forth, relating to specific components, and methods, to provide a complete understanding of embodiments of the present disclosure. It will be apparent to the person skilled in the art that the details provided in the embodiments should not be construed to limit the scope of the present disclosure. In some embodiments, well-known processes, well-known apparatus structures, and well-known techniques are not described in detail.
The terminology used, in the present disclosure, is only for the purpose of explaining a particular embodiment and such terminology shall not be considered to limit the scope of the present disclosure. As used in the present disclosure, the forms "a,” "an," and "the" may be intended to include the plural forms as well, unless the context clearly suggests otherwise. The terms "comprises," "comprising," “including,” and “having,” are open ended transitional phrases and therefore specify the presence of stated features, integers, steps, operations, elements, modules, units and/or components, but do not forbid the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof. The particular order of steps disclosed in the method and process of the present disclosure is not to be construed as necessarily requiring their performance as described or illustrated. It is also to be understood that additional or alternative steps may be employed.
The terms first, second, third, etc., should not be construed to limit the scope of the present disclosure as the aforementioned terms may be only used to distinguish one element, component, region, layer or section from another component, region, layer or section. Terms such as first, second, third etc., when used herein do not imply a specific sequence or order unless clearly suggested by the present disclosure.
Vitiligo, also known as leucoderma, is a long-term skin condition characterized by patches of skin losing their pigment. Vitiligo is more noticeable in people with dark skin. The exact cause of vitiligo is not known. Vitiligo occurs when the cells that produce melanin, die or stop functioning. Melanin, is produced by melanocytes through a complicated process called melanogenesis that is catalyzed by tyrosinase and other tyrosinase-related proteins. The condition is not life-threatening or contagious. If the skin patches are visible, the social stigma of vitiligo can be difficult to cope with. Embarrassment can lead to problems with self-esteem, and in some cases, anxiety and depression can result.
Treatments are available to help restore skin color or even skin tone. Some of the treatments include use of sunscreen, phototherapy using ultra violet light, skin camouflage, di-pigmenting, topical corticosteroids and skin grafts. However, the results vary and are unpredictable. Traditional treatments can have serious side effects. Further, even if the treatment is successful for a while, the results may not last or new patches may appear.
The pharmaceutical composition comprises a potentized mixture of at least two compounds selected from oxidizing agent, a melanocyte stimulating hormone, a chelating agent and a pterin derivative.
The present disclosure provides a pharmaceutical composition which mitigates the drawbacks mentioned in the art.
The pharmaceutical composition having potency in the range of 2c to 250c comprising, a potentized mixture of at least two compounds selected from,
i. Hydrogen peroxide;
ii. Nle4,DPhe7-a-melanocyte-stimulating hormone;
iii. Kojic acid; and
iv. 6-biopterin.
In accordance with the present discosure, the composition has a potency in the range of 6c- 200c.
In accordance with the present disclosure, 6-biopterin is a pterin derivative which function as endogenous enzyme cofactors in many species of animals and in some bacteria and fungi. 6-biopterin is an enzymatic co-factor derived from pterin and involved in certain oxidation-reduction reactions. It is widely distributed in nature; naturally occurring as the L-erythro-form. It is an oxidation product of the process of melanin formation which regulates the cofactor (6R) 5,6,7,8 tetrahydrobiopterin (6-BH4). 6-biopterin is cytotoxic to melanocytes in in- vitro conditions.
A 4-Norleucine, 7-D-phenylalanine [Nle4, D-Phe7] is a synthetic analogue of alpha melanocyte stimulating hormone (a- MSH ), which plays a vital role in melanin production. It helps in the regulation of multiple skin diseases such as cutaneous inflammation and hyper-proliferation of skin by exerting effect on inflammatory and immune responses. The 4-Norleucine, 7-D-phenylalanine [Nle4, D-Phe7] is reported to activate adenylase cyclase and stimulates a rate limiting enzyme of melanogenesis i.e. melanoma tyrosinase in mouse melanoma.
Kojic acid (KA) is a chelation agent obtained from fungi. The KA and its derivatives have medicinal importance based on their biocompatibility as antimicrobial and antiviral, antitumor, anti-diabetic, anticancer and anti-parasitic properties. In addition, it inhibits and prevents the formation of tyrosine, which is an amino acid that's needed to produce melanin. It is a skin whitening agent and is potential depigmenting agents to treat hyperpigmentation.
A vehicle is selected from the group consisting of saccharum lactis, alcohol, potentized alcohol, lactose and water; and is used for potentizing the mixture of Hydrogen peroxide; Nle4,DPhe7-a-melanocyte-stimulating hormone, Kojic acid and 6-biopterin.
In an exemplary embodiment, the vehicle is alcohol. In another exemplary embodiment, the vehicle is water.
In an embodiment of the present disclosure, the concentration of the alcohol is in the range 10 to 90 vol%.
In an exemplary embodiment, the pharmaceutical composition having potency in the range of 6c to 200c comprising, a potentized mixture of i) Hydrogen peroxide; ii) Nle4,DPhe7-a-melanocyte-stimulating hormone, in water (as a vehicle).
In an exemplary embodiment, the pharmaceutical composition having potency in the range of 6c to 200c comprising, a potentized mixture of Kojic acid, and iv) 6-biopterin in alcohol (as vehicle).
In still another exemplary embodiment, the pharmaceutical composition having potency in the range of 6c to 200c comprising, a potentized mixture of i) Hydrogen peroxide; ii) Nle4,DPhe7-a-melanocyte-stimulating hormone and Kojic acid in water (as a vehicle).
In yet another exemplary embodiment, the pharmaceutical composition having potency in the range of 6c to 200c comprising, a potentized mixture of i) Hydrogen peroxide; ii) Nle4,DPhe7-a-melanocyte-stimulating hormone, Kojic acid and iv) 6-biopterin in water (as a vehicle).
In another aspect, the present disclosure provides a process for preparing the pharmaceutical composition. The process comprise mixing a predetermined quantity of at least two compounds selected from i) Hydrogen peroxide, ii) Nle4,DPhe7-a-melanocyte-stimulating hormone, iii) Kojic acid, and iv) 6-biopterin in a vehicle to obtain a homogeneous mixture. The homogeneous mixture is diluted with the vehicle to obtain a potentized primary dilution. The potentized primary dilution is serially diluted with the vehicle to obtain the composition having potency in the range of 2c and 250c. The at least two compounds selected from i) Hydrogen peroxide, ii) Nle4,DPhe7-a-melanocyte-stimulating hormone, iii) Kojic acid, and iv) 6-biopterin are present in an equal proportion in the composition of the present disclosure.
In accordance with the present disclosure, the serial dilution is carried out by using an electro-mechanical potentizer.
In one embodiment of the present disclosure, the ratio of mixture of two compounds to the vehicle is 2:98.
In another embodiment of the present disclosure, the ratio of mixture of three compounds to the vehicle is 3:97.
In still another embodiment of the present disclosure, the ratio of mixture of four compounds to the vehicle is 4:96.
The pharmaceutical composition of the present disclosure is effective against vitiligo by possibly regulating the immune mechanism for controlling the progression of vitiligo by correcting the immune system and for enhancing the natural melanocyte formation (melanogenesis).
The pharmaceutical composition of the present disclosure does not exhibit any adverse side effects. The pharmaceutical composition of the present disclosure can be taken by its own or it can be taken along with conventional medications/treatments for vitiligo.
Typically, the safety regarding the oral use of the pharmaceutical composition is established through pathogenic trials in healthy volunteers and clinical trials. The pharmaceutical composition is capable of anti-vitiligo activity as evidenced in a laboratory model, by showing an increase in the melanin content in the cell line.
Typically, the pharmaceutical composition 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.
The pharmaceutical composition in accordance with the present disclosure exhibits anti-vitiligo activity.
The foregoing description of the embodiments has been provided for purposes of illustration and is not intended to limit the scope of the present disclosure. Individual components of a particular embodiment are generally not limited to that particular embodiment, but are interchangeable. Such variations are not to be regarded as a departure from the present disclosure and all such modifications are considered to be within the scope of the present disclosure.
The present disclosure is further described in light of the following 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 scale.
Example 1: Preparation of pharmaceutical composition in accordance with the present disclosure
Experiment 1: Pharmaceutical composition with two compounds
1 ml (20 µg) of Hydrogen peroxide and 1 ml (20 µg) of Nle4, DPhe7-a-melanocyte-stimulating hormone, were mixed with 98 parts of water to obtain a homogenous mixture. The homogenous mixture was thoroughly shaken and 10 powerful strokes were given using a mechanical device (electro-mechanical potentizer). This potentized mixture was labeled as 1c (1c potency).
In the next step, l mL of above mixture of 1c potency of was mixed with 99 parts of water in another vial to undergo potentization with about 10 mechanical strokes and repeated it to next five times to arrive at 2c potency. Likewise, the procedure was repeated to reach to 5..10..15..20c up to 200c.

Experiment 2: Pharmaceutical composition with two compounds
1 ml (20 µg) of Kojic acid, and 1 ml (20 µg) of 6-biopterin, were mixed with 98 parts of alcohol to obtain a homogenous mixture. The homogenous mixture was thoroughly shaken and 10 powerful strokes were given using a mechanical device (electro-mechanical potentizer). This potentized mixture was labeled as 1c (1c potency).
In the next step, l mL of above mixture of 1c potency of was mixed with 99 parts of alcohol in another vial to undergo potentization with about 10 mechanical strokes and repeated it to next five times to arrive at 2c potency. Likewise, the procedure was repeated to reach to 5..10..15..20c up to 200c.

Experiment 3: Pharmaceutical composition with three compounds
1 ml (20 µg) of Hydrogen peroxide and 1 ml (20 µg) of Nle4, DPhe7-a-melanocyte-stimulating hormone, and 1 ml (20 µg) of Kojic acid were mixed with 97 parts of water to obtain a homogenous mixture. The homogenous mixture was thoroughly shaken and 10 powerful strokes were given using a mechanical device (electro-mechanical potentizer). This potentized mixture was labeled as 1c (1c potency).
In the next step, l mL of above mixture of 1c potency of was mixed with 99 parts of water in another vial to undergo potentization with about 10 mechanical strokes and repeated it to next five times to arrive at 2c potency. Likewise, the procedure was repeated to reach to 5..10..15..20c up to 200c.

Experiment 4: Pharmaceutical composition with four compounds
1 ml (20 µg) of Hydrogen peroxide and 1 ml (20 µg) of Nle4, DPhe7-a-melanocyte-stimulating hormone, 1 ml (20 µg) of Kojic acid, and 1 ml (20 µg) of 6-biopterin were mixed with 96 parts of water to obtain a homogenous mixture. The homogenous mixture was thoroughly shaken and 10 powerful strokes were given using a mechanical device (electro-mechanical potentizer). This potentized mixture was labeled as 1c (1c potency).
In the next step, l mL of above mixture of 1c potency of was mixed with 99 parts of water in another vial to undergo potentization with about 10 mechanical strokes and repeated it to next five times to arrive at 2c potency. Likewise, the procedure was repeated to reach to 5..10..15..20c up to 200c.

Example 2: Assay method
Cell culture: The murine B16F10 melanoma cell line, procured from ATCC, was cultured in DMEM (Dulbecco's Modified Eagle Medium) containing 10% fatal bovine serum and 1% penicillin/streptomycin (10,000 U/100 µg/mL) at 37°C with 5% CO2 in a humidified atmosphere.
Cell Viability Assay
Cell viability after treatment with the study medicines was determined using MTT. Briefly, 1 x 104 cells were added in each well of a 96-well plate. After 24 hours, cells were exposed to the given study medicines for 48 and 96 hours. Untreated cells were kept as the cell control group, and the cells treated with alcohol and potentized alcohols were kept as the vehicle control group. MTT solution was added and cell viability was then assessed in a colorimetric assay through mitochondrial dehydrogenase activity in active mitochondria to form purple formazan. The absorbance of each well was read at 570 nm using a plate reader.
Result: The composition of the present disclosure comprising potentized mixture of Hydrogen peroxide (HP), melanocyte-stimulating hormone- Nle4, DPhe7, Kojic acid (KA) and 6-biopterin (BP) did not show any cytotoxic effect on the cells at the end of 48 hours or 96 hours when compared with the untreated cell control and the alcohol treated groups.
Determination of Melanin Content in Melanocytes
The influence of the composition of the present disclosure on the production of melanin in melanocytes was determined. Murine B16F10 melanoma cells were added to the wells of a 24-well plate (1 x 104 cells per well). After 24 hours, different concentrations of the given preparations were added to the cells and incubated at 37 °C in 5% CO2 humidified atmosphere for 48 hours and 96 hours, respectively. The control group was incubated only with DMEM, and the vehicle control group was incubated with alcohol and potentized alcohol. Then, the medium was removed and cells were lysed with 500 µL of 1 N NaOH in 10% DMSO at 80°C for 1 hour. The relative melanin content was determined by measuring the absorbance at 405 nm in a plate reader.
Result: At the end of the 48 hours, the composition of the present disclosure having 30c potency had significantly greater melanin content as compared with controls.
Mushroom Tyrosinase Activity Assay
Tyrosinase is the rate-limiting enzyme for melanin biosynthesis. The effect of the pharmaceutical composition on tyrosinase activity was evaluated.
In a 96-well microplate, the composition of the present disclosure with various potencies, 20 µL of mushroom tyrosinase (500 U/mL in phosphate buffer, pH 6.5), and 170 µL of a mixture (1 mM L-tyrosine solution, 50 mM potassium phosphate buffer [pH 6.5], and distilled water [10:10:9, v/v/v], were added respectively.
The micro plate was incubated at 37°C for 40 minutes, and the absorbance of the mixture was measured at 490 nm using a microplate reader. One unit (U) of enzymatic activity is defined as the amount of enzyme needed to increase the
absorbance at 490 nm by 0.001 per minute in a 3ml reaction mixture containing L-tyrosine at pH 6.5 and 25°C.The value of each measurement was expressed as a percentage change from the control reaction mixture without the test medicines.
Result: The pharmaceutical composition of the present disclosure having 30c potency showed inhibition of tyrosinase activity.
Example 3: Anecdotal Studies:
Provided below are case studies involving the use of the formulation of the present disclosure:
1. Seven years old child was brought to the clinic with segmental vitiligo on the abdomen for about six months. He had a family history of autoimmune diseases such as Diabetes and Underactive Thyroid. He was prescribed with the pharmaceutical composition of experiment 1 (6c), twice a day for one month, followed by 30 c potency for the next two months and then 200c potency for the subsequent four months. His vitiligo repigmented about 70 to 80 percent. (This medicine is useful for segmental vitiligo.)
2. Mrs P Laxmi, 47 years old lady with associate hormonal imbalance related to her menstrual cycles. She was administered with the pharmaceutical composition of experiment 2 in 30c potency, twice a day for about six weeks. She improved by about 20%. The medicine was continued in 200c potency for the next six months. Many of her vitiligo cleared significantly. (This medicine is suitable for other hormonal irregularities.)
3. 12 years old boy was brought to our clinic for vitiligo on his face and neck. It possibly developed after exposure to chemicals mixed in colors used during the Holi festival. The vitiligo was induced by chemicals. The child did not have a family history of auto-immune diseases. He was prescribed with the pharmaceutical composition of experiment 3 in 30c and 50c potencies for about six weeks. Some improvement was observed. He has then prescribed the same medicine in 100c and 200c potencies. There was a remarkable improvement.
4. 37 years old lady approached us with the spots of vitiligo on her face and upper arms after use of some chemical peeling and cosmetics. She tried to use those cosmetics for making her skin fair complexioned. In the bargain the chemicals caused vitiligo. She was prescribed with the pharmaceutical composition of experiment 4 in 30c potency, three times a day for two months and subsequently for four months. Many of her spots improved significantly.
5. A 26 years old lady was suffering from extensive vitiligo. She was receiving various medicines for over five years. She experienced increase in the zone as well as decrease in skin tone in various body parts. She was then prescribed a with the pharmaceutical composition of experiment 4 with 6c potency prepared in accordance with the present disclosure which brought in about 30% relief in most of white patch spots within 12 weeks. Subsequently, she was treated with composition of 30c potency. Excellent results were seen and there was more than 60% relief in most of her white patches and the results were visually seen with normal skin tone.
6. A 55 year male is diagnosed with vitiligo (leucoderma) which started with small white spots on face that spread to his body. He tried home remedies for white spots and also used a vitiligo cream that promised to cure white spots, but did not yield required results. He was then later prescribed with the with the pharmaceutical composition of experiment 3 with 30c potency. The treatment resulted in noticeable reduction in white spots within 4 months of the treatment having 200 c. After continuing, the treatment for one year, no new vitiligo spots appeared and the skin tone was improved.
7. A 30 years old lady was suffering from with severe leucoderma. She was prescribed a formulation of 30c potency prepared in accordance with the present disclosure. The with the pharmaceutical composition of experiment 2 of 30c potency was prescribed thrice a day. There was 30% relief in her dermis tone and whiteness.
8. A 14 years old school girl was under treatment for very severe and extensive vitiligo. She was suffering with a severe, acutely spreaded vitiligo on most parts of her body including eye brows. The hair color was also changed as the disease progressed. Her leucoderma was genetically inherited. Her white patches were prominently present on her face. For eight weeks, she was prescribed with the pharmaceutical composition of experiment 3 of 30c potency prepared in accordance with the present disclosure. Almost 70% recovery was observed without any other mode of medication.
9. A 40 years old lady was suffering from leucoderma on many parts of body for ten years. For 6 weeks, she was treated with the pharmaceutical composition of experiment 3 having 200c potency prepared according to the present disclosure. 40% of her skin white patch were improved within one month.
10. A 31 years old lady was suffering with extensive vitiligo. She was treated with the formulation of 10c potency prepared according to the present disclosure. Still she had acute, white skin patch all over her body. For next 12 weeks, she was then treated with the pharmaceutical composition of experiment 1 having 100c potency. About 40% improvement in most of the areas was observed.
11. A 60 years old person was suffering from leucoderma especially on face and was under treatment. He responded well to certain medicine. After his visit to Rajasthan, severe increase in the white patch of his skin was observed. For next 6 months, 3 times a day, he was then treated with formulation of 10c potency prepared according to the present disclosure. His acute skin patches were significantly resolved.
12. A 26 years old lady was suffering with severe and chronic leucoderma since childhood. She was taking allopathic medicines for over two years. For 3 months, she was treated with the pharmaceutical composition of experiment 2 having 30c potency of the present disclosure. Excellent improvement was observed and her disease condition was under control.
13. A 30 years old male was suffering with leucoderma and skin patch on many parts of the body. He was prescribed with the pharmaceutical composition of experiment 4, having 30c potency which was prepared according to the present disclosure. The skin condition of the patient improved and has less visually representable skin patch. The skin tone also normalized.
The clinical trials of the pharmaceutical composition of the present disclosure are underway over the different human/animal models, and the same will be provided after completion of the study.
TECHNICAL ADVANCEMENTS
The present disclosure described herein above has several technical advantages including, but not limited to, the realization of
? a pharmaceutical composition that can be used for alleviating the symptoms of vitiligo;
? an effective and safe composition which can be used in combination with other medicines.
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 reveals 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.
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.
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.
,CLAIMS:I CLAIM:
1. A pharmaceutical composition having potency in the range of 2c to 250c comprising, a potentized mixture of at least two compounds selected from,
i. Hydrogen peroxide;
ii. Nle4,DPhe7-a-melanocyte-stimulating hormone;
iii. Kojic acid; and
iv. 6-biopterin.
2. The composition as claimed in claim 1, wherein the potency of said composition is in the range of 6c- 200c.
3. A process for preparing a composition, said process comprising the following steps:
i. mixing a predetermined quantity of at least two compounds selected from Hydrogen peroxide, Nle4,DPhe7-a-melanocyte-stimulating hormone, Kojic acid, and 6-biopterin in a vehicle to obtain a homogeneous mixture;
ii. diluting said homogeneous mixture with said vehicle to obtain a potentized primary dilution; and
iii. serially diluting said potentized primary dilution with said vehicle to obtain the composition having potency in the range of 2c to 250c.
4. The process as claimed in claim 3, wherein said serial dilution is carried out by using an electro-mechanical potentizer.
5. The process as claimed in claim 3, wherein said at least two compounds are present in an equal proportion.
6. The process as claimed in claim 3, wherein the ratio of a mixture of two compounds to the vehicle is 2:98.
7. The process as claimed in claim 3, wherein the ratio of a mixture of three compounds to the vehicle is 3:97.
8. The process as claimed in claim 3, wherein the ratio of a mixture of four compounds to the vehicle is 4:96.
9. The process as claimed in claim 3, wherein the vehicle is selected from alcohol, and water.
10. The process as claimed in claim 9, wherein the concentration of said alcohol is in the range 10 to 90%.