Title of Invention	A UNIQUE SYNERGISTIC COMPOSITION FOR TREATMENT OF DANDRUFF AND A METHOD OF PREPARING THE SAME
Abstract	This invention relates to a unique synergistic composition for treatment of dandruff and related bacterial infections and to a method of preparing the same. The composition comprises of at least one antifungal agent such as miconazole or ketoconazole in combination with an antibacterial agent such as metronidazole or tinidazole; an astringent such as zinc sulphate; a cooling - soothing agent such as Menthol; and optionally an anti inflammatory agent in a phannaceutically acceptable vehicle. The antifungal agent and antibacterial agents are present in the range of upto 10% w/v of the composition. The composition controls dandruff and related bacterial infections and prevents recurrence of dandruff for considerably longer period.

Title of Invention

A UNIQUE SYNERGISTIC COMPOSITION FOR TREATMENT OF DANDRUFF AND A METHOD OF PREPARING THE SAME

Abstract

This invention relates to a unique synergistic composition for treatment of dandruff and related bacterial infections and to a method of preparing the same. The composition comprises of at least one antifungal agent such as miconazole or ketoconazole in combination with an antibacterial agent such as metronidazole or tinidazole; an astringent such as zinc sulphate; a cooling - soothing agent such as Menthol; and optionally an anti inflammatory agent in a phannaceutically acceptable vehicle. The antifungal agent and antibacterial agents are present in the range of upto 10% w/v of the composition. The composition controls dandruff and related bacterial infections and prevents recurrence of dandruff for considerably longer period.

Full Text	The present invention relates to a unique synergistic composition for the treatment of dandruff and related bacterial infections and to a method of preparing the same. Dandruff is a popular collective name signifying a scaly flaking scalp condition. It occurs when the scalp sheds dead epithelial cells in large clumps, usually due to primary flmgal infection, which is often affected by secondary bacterial infection. Dandruff scales appear dry, white grayish, appearing as small, unsightly patches especially on top of the head. It is often accompanied with one or other form of skin inflammation sometimes with too much of oily secretions known as seborrhea. The most common cause is probably due to fungus, previously known as "Pityrosporum ovale" Malassezia ovalis. The fungus is found naturally on the skin surface of both healthy people and those with dandruff Presently, many types of products in the form of shampoos / drugs are available in the market for the treatment of dandruff. However, the above mentioned conventional dandruff treatment shampoos / drugs have many disadvantages, some of which are mentioned below. Although conventional dandruff medication is based on forms of therapy targeted mainly at fungal infection, they do not treat fungi lilce T.podis, T.oppora. T.rubrum, etc. Currently used antifungal based products are not satisfactory against secondary bacterial infection, which is very common in dandruff. The possible causative organism of seborrheic dermatitis is Pitryosporum ovalie. The conventiona] dandruff treatment drugs are also not effective against anaerobic bacteria. The object of the present invention is to develop a uniqije synergistic composition for treatment of dandruff and plated infections) which could overcome the disadvantages of the conventional dandruff treatments and provide a better alternative. The composition of the present invention not only shows good clinical efficacy in the treatment of dandruff but also prevents recurrence of dandruff within a reasonably short time. The composition, according to this invention, is also effective against flingal infection, especially from fungi like T.podis, T.oppora. T.rubrum, etc. It is also effective against secondary bacterial infections, mcluding anaerobic bacterial infections. The present invention relates to a unique, synergistic combination of antiftingal and anti bacterial agents, for the~ffeaGnenr Accordingly, the present invention provides a unique synergistic composition for treatment of dandruff and related bacterial infections comprising of at least one antifungal agent selected from the class of Azoles and Allylamines e.g. Miconazole , Ketoconazole and the like in combination with an antibacterial agent selected from the class of cephalosporins, quinolones, diaminopyrimidines and the like or involving imidazole, e.g. metronidazole and Tinidazole; an astringent as healing agent; a cooling - soothing agent and a pharmaceutically acceptable solvent, said antifungal agent and said antibacterial agent independently being present in the range of up to 10% w/v of said composition. The composition may contain a steroidal or non - steroidal anti-inflammatory agent in respective active form and concentrations, for the intended anti-inflammatory activity. The present invention also provides a method of preparing a unique synergistic composition for treatment of dandruff and related bacterial infections, wherein suspensions of at least one antifungal agent such as miconazole, Ketoconazole and the like and an antibacterial agent, such as metronidazole or tinidazole are made separately and added to a solvent, such as water, containing stabilizers, preservatives, cooling agents and astringents in an acidic pH under stirring. The preparation may contain an anti inflmnmatory agent. The preferred combinations of antifungal and anti bacterial agents are Miconazole - Metronidazole, Miconazole - Tinidazole, Fluconazole -Metronidazole, Fluconazole - Tinidazole, Clotrimazole - Metronidazole, Clotrimazole - Tinidazole, Ketoconazole - Metronidazole and Ketoconazole -Tinidazole etc.. These combinations exhibit synergistic interaction against yeasts, dermatophytes and bacteria causing possible secondary infections. Superior clinical efficacy shown against dandruff is the result of this synergistic action, Zinc sulphate is the preferred astringent, which may be added upto 10% w/v of the composition. Zinc sulphate is preferred because of its wound healing action. Any other natural or synthetic astringent may also be mixed without affecting the potency of the composition. Cooling and soothing agent(s) like menthol may be added to the composition, individually unto 3% w/v. Stabilizers, antioxidants, colourants, perfumes and preservatives may also be added to the composition. The pharmaceutically acceptable solvents can be water, alcohols, glycols, polymeric solvents and mixtures thereof The composition may optionally contain a buffering agent and an acid, which may be an organic or inorganic acid. Then to the main tank, about 10% of alcohol e.g. Glycerol is added under stirring, ensuring homogeneity of the composition. In a separate tank, the antifungal agent, or its derivative, e.g. Miconazole is added to a part of suitable solvent e.g. substituted / polyethylene glycol, during stirring. This solution may be made mobile by externally controlled heating. On attaining homogeneity, this is transferred to the main tank, slowly under stirring. In separate dry container, antioxidant(s) in active proportion e.g. Butylated Hydroxy toluene, 0.08% are dissolved in volatile oil(s) e.g. Lemon Grass Oil, Oil Orange etc. with or without suitable fixative. To this camphor and Menthol are added. To this container, the surfactant, oil solubilizer -synthetic or semi synthetic or of natural origin is added and mixed to solubilize the oil phase in previous step of manufacture. Prior to addition of the oil phase, suitable antioxidant is added to the surfactant. Now this is very slowly added under stirring to the main tank ensuring homogeneity throughout the addition, and then mixed to uniformity. The pH is checked and if required adjusted to required acidic range, using q.s. Acid solution. It is filtered through suitable screen, if required - under modified pressure. This solution is dispensed in glass, metallic or suitable polymeric containers and tightly closed with closure system (single or composite) and labeled appropriately. Stored at temperature, not allowing freezing and not exceeding 30°C, protected from sunlight. Though this invention has been described herein above with specific embodiments, alterations and modifications known to persons skilled in the art are within the scope and ambit of the appended claims. WE CLAIM: 1. A unique synergistic composition for treatment of dandruff and related bacterial infections comprising of at least one antifungal agent selected from the class of Azoles and Allylamines e.g. Miconazole, Ketoconazole and the like in combination with an antibacterial agent selected from the class of cephalosporins, quinolones, diaminopyrimidines and the like or involving imidazole, e.g. metronidazole and Tinidazole; an astringent as healing agent; a cooling - soothing agent and a pharmaceutically acceptable solvent, said antifungal agent and said antibacterial agent independently being present in the range of up to 10% w/v of said composition. 2. The composition as claimed in claim 1, wherein a known steroidal or non¬steroidal anti-inflammatory agent is optionally present in the composition. 3. The composition as claimed in claim I, wherein antioxidants, stabilizers, preservatives, aromatic chemicals as herein described as perfumes or for their synergetic activity with antifungal, antibacterial agents or the preservatives and colourants are optionally present. 4. The composition as claimed m claims 1 and 2, wherein the astringent is Zinc Sulphate and is present in the concentration up to 10 % w/v of the composition. 5. The composition as claimed in claims 1, 2 and 3, wherein the said soothing -cooling agent is menthol and is present in concentration up to- 3 % w/v of the composition. 6. The composition as claimed in claims 1, 2, 3 and 4, wherein the said pharmaceutically acceptable solvent system is selected from water, glycol and polyehtylene glycol. 9. A method of preparing a unique synergistic composition for treatment of dandruff and related bacterial infections, wherein suspensions of at least one antifungal agent such as miconazole, Ketoconazole and the like and an antibacterial agent ,such as metronidazole or tinidazole are made separately and added to a solvent, such as water, containing stabilizers, preservatives, cooling agents and astringents in an acidic pH under stirring. 10. The method as claimed in claim 9 wherein the resulting composition is filtered, packed and labeled. 11. A unique synergistic composition for treatment of dandruff and related bacterial infections substantially as herein described. 12. A method of preparing a unique synergistic composition fgr the treatment of dandruff and related bacterial infections substantially as herein described.

Full Text

The present invention relates to a unique synergistic composition for the treatment of dandruff and related bacterial infections and to a method of preparing the same.
Dandruff is a popular collective name signifying a scaly flaking scalp condition. It occurs when the scalp sheds dead epithelial cells in large clumps, usually due to primary flmgal infection, which is often affected by secondary bacterial infection. Dandruff scales appear dry, white grayish, appearing as small, unsightly patches especially on top of the head. It is often accompanied with one or other form of skin inflammation sometimes with too much of oily secretions known as seborrhea. The most common cause is probably due to fungus, previously known as "Pityrosporum ovale" Malassezia ovalis. The fungus is found naturally on the skin surface of both healthy people and those with dandruff
Presently, many types of products in the form of shampoos / drugs are available in the market for the treatment of dandruff.
However, the above mentioned conventional dandruff treatment shampoos / drugs have many disadvantages, some of which are mentioned below.

Although conventional dandruff medication is based on forms of therapy targeted mainly at fungal infection, they do not treat fungi lilce T.podis, T.oppora. T.rubrum, etc.
Currently used antifungal based products are not satisfactory against secondary bacterial infection, which is very common in dandruff. The possible causative organism of seborrheic dermatitis is Pitryosporum ovalie. The conventiona] dandruff treatment drugs are also not effective against anaerobic bacteria.
The object of the present invention is to develop a uniqije synergistic composition for treatment of dandruff and plated infections) which could overcome the disadvantages of the conventional dandruff treatments and provide a better alternative.
The composition of the present invention not only shows good clinical efficacy in the treatment of dandruff but also prevents recurrence of dandruff within a reasonably short time.
The composition, according to this invention, is also effective against flingal infection, especially from fungi like T.podis, T.oppora. T.rubrum, etc. It is also effective against secondary bacterial infections, mcluding anaerobic bacterial infections.
The present invention relates to a unique, synergistic combination of antiftingal and anti bacterial agents, for the~ffeaGnenr Accordingly, the present invention provides a unique synergistic composition for treatment of dandruff and related bacterial infections

comprising of at least one antifungal agent selected from the class of Azoles and Allylamines e.g. Miconazole , Ketoconazole and the like in combination with an antibacterial agent selected from the class of cephalosporins, quinolones, diaminopyrimidines and the like or involving imidazole, e.g. metronidazole and Tinidazole; an astringent as healing agent; a cooling - soothing agent and a pharmaceutically acceptable solvent, said antifungal agent and said antibacterial agent independently being present in the range of up to 10% w/v of said composition.
The composition may contain a steroidal or non - steroidal anti-inflammatory agent in respective active form and concentrations, for the intended anti-inflammatory activity.
The present invention also provides a method of preparing a unique synergistic composition for treatment of dandruff and related bacterial infections, wherein suspensions of at least one antifungal agent such as miconazole, Ketoconazole and the like and an antibacterial agent, such as metronidazole or tinidazole are made separately and added to a solvent, such as water, containing stabilizers, preservatives, cooling agents and astringents in an acidic pH under stirring. The preparation may contain an anti inflmnmatory agent.
The preferred combinations of antifungal and anti bacterial agents are Miconazole - Metronidazole, Miconazole - Tinidazole, Fluconazole -Metronidazole, Fluconazole - Tinidazole, Clotrimazole - Metronidazole, Clotrimazole - Tinidazole, Ketoconazole - Metronidazole and Ketoconazole -Tinidazole etc.. These combinations exhibit synergistic interaction against yeasts, dermatophytes and bacteria causing possible secondary infections.

Superior clinical efficacy shown against dandruff is the result of this synergistic action,
Zinc sulphate is the preferred astringent, which may be added upto 10% w/v of the composition. Zinc sulphate is preferred because of its wound healing action. Any other natural or synthetic astringent may also be mixed without affecting the potency of the composition. Cooling and soothing agent(s) like menthol may be added to the composition, individually unto 3% w/v.
Stabilizers, antioxidants, colourants, perfumes and preservatives may also be added to the composition. The pharmaceutically acceptable solvents can be water, alcohols, glycols, polymeric solvents and mixtures thereof The composition may optionally contain a buffering agent and an acid, which may be an organic or inorganic acid.

Then to the main tank, about 10% of alcohol e.g. Glycerol is added under stirring, ensuring homogeneity of the composition.
In a separate tank, the antifungal agent, or its derivative, e.g. Miconazole is added to a part of suitable solvent e.g. substituted / polyethylene glycol, during stirring. This solution may be made mobile by externally controlled heating.
On attaining homogeneity, this is transferred to the main tank, slowly under stirring.
In separate dry container, antioxidant(s) in active proportion e.g. Butylated Hydroxy toluene, 0.08% are dissolved in volatile oil(s) e.g. Lemon Grass Oil, Oil Orange etc. with or without suitable fixative. To this camphor and Menthol are added. To this container, the surfactant, oil solubilizer -synthetic or semi synthetic or of natural origin is added and mixed to solubilize the oil phase in previous step of manufacture. Prior to addition of the oil phase, suitable antioxidant is added to the surfactant. Now this is very slowly added under stirring to the main tank ensuring homogeneity throughout the addition, and then mixed to uniformity. The pH is checked and if required adjusted to required acidic range, using q.s. Acid solution. It is filtered through suitable screen, if required - under modified pressure.
This solution is dispensed in glass, metallic or suitable polymeric containers and tightly closed with closure system (single or composite) and labeled appropriately. Stored at temperature, not allowing freezing and not exceeding 30°C, protected from sunlight.

Though this invention has been described herein above with specific embodiments, alterations and modifications known to persons skilled in the art are within the scope and ambit of the appended claims.

WE CLAIM:
1. A unique synergistic composition for treatment of dandruff and related
bacterial infections comprising of at least one antifungal agent selected from the class of Azoles and Allylamines e.g. Miconazole, Ketoconazole and the like in combination with an antibacterial agent selected from the class of cephalosporins, quinolones, diaminopyrimidines and the like or involving imidazole, e.g. metronidazole and Tinidazole; an astringent as healing agent; a cooling - soothing agent and a pharmaceutically acceptable solvent, said antifungal agent and said antibacterial agent independently being present in the range of up to 10% w/v of said composition.
2. The composition as claimed in claim 1, wherein a known steroidal or non¬steroidal anti-inflammatory agent is optionally present in the composition.
3. The composition as claimed in claim I, wherein antioxidants, stabilizers, preservatives, aromatic chemicals as herein described as perfumes or for their synergetic activity with antifungal, antibacterial agents or the preservatives and colourants are optionally present.
4. The composition as claimed m claims 1 and 2, wherein the astringent is Zinc Sulphate and is present in the concentration up to 10 % w/v of the composition.
5. The composition as claimed in claims 1, 2 and 3, wherein the said soothing -cooling agent is menthol and is present in concentration up to- 3 % w/v of the composition.
6. The composition as claimed in claims 1, 2, 3 and 4, wherein the said pharmaceutically acceptable solvent system is selected from water, glycol and polyehtylene glycol.

9. A method of preparing a unique synergistic composition for treatment of dandruff and related bacterial infections, wherein suspensions of at least one antifungal agent such as miconazole, Ketoconazole and the like and an antibacterial agent ,such as metronidazole or tinidazole are made separately and added to a solvent, such as water, containing stabilizers, preservatives, cooling agents and astringents in an acidic pH under stirring.
10. The method as claimed in claim 9 wherein the resulting composition is filtered, packed and labeled.
11. A unique synergistic composition for treatment of dandruff and related bacterial infections substantially as herein described.
12. A method of preparing a unique synergistic composition fgr the treatment of dandruff and related bacterial infections substantially as herein described.

Documents:

25-che-2004 abstract.pdf

25-che-2004 claims.pdf

25-che-2004 correspondence others.pdf

25-che-2004 correspondence po.pdf

25-che-2004 description (complete).pdf

25-che-2004 form-1.pdf

25-che-2004 form-19.pdf

25-che-2004 form-3.pdf

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Patent Number

204294

Indian Patent Application Number

25/CHE/2004

PG Journal Number

26/2007

Publication Date

29-Jun-2007

Grant Date

13-Feb-2007

Date of Filing

12-Jan-2004

Name of Patentee

SHRI. KARTAR LALVANI

Applicant Address

VITABIOTICS HOUSE 1 APSLEY WAY LONDON NW2 7HF.

Inventors:

#	Inventor's Name	Inventor's Address
1	KOICHIRO CHAEN	VITABIOTICS HOUSE 1 APSLEY WAY LONDON NW2 7HF.

PCT International Classification Number

A61K 31/00

PCT International Application Number

N/A

PCT International Filing date

PCT Conventions:

#	PCT Application Number	Date of Convention	Priority Country
1			NA