GB2541158A

GB2541158A - Composition

Info

Publication number: GB2541158A
Application number: GB1511697.3A
Authority: GB
Inventors: Balu; Lata Pushpa
Original assignee: STIGMA Inc
Current assignee: STIGMA Inc
Priority date: 2015-07-03
Filing date: 2015-07-03
Publication date: 2017-02-15
Also published as: WO2017005629A1; GB201511697D0

Abstract

A composition for stimulating hair growth comprises coconut oil, Phyllanthus emblica extract, Camellia sinensis leaf extract and Murraya koenigii stem extract, wherein the coconut oil is present in an amount of at least 50wt% relative to the total weight of the composition. The composition may further comprise one or more additional components selected from the group consisting of Trigonella Foenum-Graecum seeds, Ocimum sanctum extract, Aloe Barbadensis extract, Citrus limon juice extract, Rosa canina L. Extract, Acorus calamus rhizome extract, Terminalia Catappa leaf extract, sesame oil (e.g. Sesamum indicum oil), Berberis lyceum extract, Adhatoda vasica extract, Cuscuta reflexa extract, cuminum cyminum oil, Crataegus laevigata extract and mixtures thereof. A process for preparing the composition comprising (i) mixing coconut oil, Phyllanthus emblica extract, Camellia sinensis leaf extract and Murraya koenigii stem extract; and (ii) heating the mixture to a temperature of at least 50oC is provided. Preferably the composition is administered topically for the treatment of hair loss wherein a mild irritant (e.g. onion juice) is administered prior to each administration of the composition.

Description

Composition

Technical field

The present invention relates to a composition for stimulating hair growth. Specifically, the composition comprises four key ingredients: coconut oil, Phyllanthus emblica extract, Camellia Sinensis leaf extract and Murraya Koenigii stem extract. The invention further relates to a process for preparing the composition and to the composition for use as a medicament, in particular for use in the treatment of hair loss.

Background of the invention

Hair loss currently affects millions of the population worldwide. Roughly 50% of women suffer from hair loss and, in men, 40% are reported to have noticeable hair loss by age 35, 65% by age 60, and 80% by age 80. A reduction in the amount or thickness of hair on a person’s head can significantly impact upon self-confidence and thus many suffers seek medical treatment for the condition.

Normal hair loss is considered to be 100 hairs per day, based on the average scalp containing 100,000 hair follicles. There are many causes of an increased rate of hair loss, these can include medication, stress, poor nutrition, surgery and even hair care techniques. The most common conditions which lead to hair loss are male pattern baldness and female pattern hair loss. Genetics also play an important role.

Male-pattern baldness affects around half of all men by the age of fifty. It usually starts around the late twenties or early thirties and most men have some degree of hair loss by their late thirties. It generally follows a pattern of a receding hairline, followed by thinning of the hair on the crown and temples, leaving a horseshoe shape around the back and sides of the head. Sometimes it can progress to complete baldness, although this is uncommon. Male-pattern baldness is hereditary. It's thought to be caused by oversensitive hair follicles, linked to having too much of a certain male hormone.

During female-pattern hair loss, hair usually only thins on top of the head. It's not clear if female-pattern baldness is hereditary and the causes are less well understood. However, it tends to be more noticeable in women who have been through the menopause, perhaps because they have fewer female hormones.

Whilst hair loss in older age may be more common, many suffers are young men. Sometimes boys as young as 15 begin to notice the signs and there is some indication that hair loss is becoming more prevalent in younger men. Whilst there are multiple lifestyle and environmental factors that are thought to contribute to an earlier onset of hair loss in men, stress is thought to be a leading cause. Certain other lifestyle choices are also considered to play a part in the development of hair loss in young men, such as smoking. The chemicals and carcinogens found in tobacco are believed to slow down hair growth which leads to thinning hair and can result in significant hair loss if not addressed. Recreational drug use also has the potential to cause hair loss because such drugs can be a shock to the system. Drug use is often accompanied by nutrient depletion and deteriorated health, which means temporary or permanent hair loss is a very probable side effect.

It is therefore clear that there is a significant market for products which can treat hair loss. Propecia and minoxidil are the only products currently clinically proven and medically approved for the treatment of hair loss.

Propecia is an oral medicine, the active ingredient of which is Finasteride.

This chemical compound is a type II 5a-reductase inhibitor. It thus inhibits the enzyme 5a-reductase, which converts testosterone to dihydrotestosterone (DHT).

The tablets must be taken once a day and if treatment is stopped, the beneficial effects of Propecia start to wear off after six months. By 9 to 12 months all of the beneficial effects will have worn off and the hair loss will be the same as it was before treatment started. Propecia is also solely for use by men.

Minoxidil is the active ingredient in Regaine® and is suitable for use by both men and women. This chemical is applied topically to the scalp area twice a day. Its mechanism of action is thought to be due to its action as a vasodilator and potassium channel opener, causing hyperpolarization of cell membranes. By widening blood vessels and opening potassium channels, more oxygen, blood, and nutrients can flow to the hair follicle.

The problem with both these products are that they are chemical based which means that they carry with them a wide variety of potential side effects. These can include headaches, scalp itchiness and dryness often due to localised dermatitis.

Recently, a natural product based hairloss treatment was developed, Nourkrin®. The primary ingredient is Marilex®, which is a fractionated fish extract with specific lecitan proteoglycans. This product is taken in tablet form twice a day, which presents challenges with patient compliance. The effectiveness is also less than with the more potent chemical products.

The present invention is conceived to solve or at least alleviate the problems identified above. An object of the invention is to provide a safe and effective composition which stimulates hair growth, and thus is suitable for the treatment of hair loss. Ideally, the composition should comprise natural ingredients and be at least as effective as the chemical products currently on the market. It is also desirable to develop a composition which can be administered in a manner which optimises patient compliance.

The present inventors have surprisingly found that this may be achieved by a composition as herein defined. Unexpectedly, this composition, which comprises natural ingredients, is capable of stimulating hair growth and thus may be used in the treatment of hair loss. The composition of the present invention represents a significant improvement compared to those treatments currently available in terms not only of visible results but also patent compliance.

Summary of the Invention

In a first aspect, the invention provides a composition for stimulating hair growth comprising coconut oil, Phyllanthus emblica extract, Camellia Sinensis leaf extract and Murraya Koenigii stem extract, wherein said coconut oil is present in an amount of at least 50 wt% relative to the total weight of the composition.

In a second aspect, the invention provides a process for preparing a composition as herein defined, said process comprising the steps: (i) Mixing coconut oil, Phyllanthus emblica extract, Camellia Sinensis leaf extract and Murraya Koenigii stem extract; and (ii) Heating said mixture to a temperature of at least 50 °C.

In a third aspect, the invention provides a composition as herein defined for use as a medicament.

In a further aspect, the invention provides the use of a composition as herein defined for stimulating hair growth.

In a yet further aspect the invention provides a composition as herein defined for use in the treatment of hair loss.

In a further aspect the present invention provides a method of treating hair loss comprising administering to a patient (e.g. a human) in need thereof a composition as herein defined.

Detailed Description of the Invention

The present invention describes a composition for stimulating hair growth.

The composition comprises a mixture of natural ingredients, namely coconut oil, Phyllanthus emblica extract, Camellia Sinensis leaf extract and Murraya Koenigii stem extract. The coconut oil is present in an amount of at least 50 wt% relative to the total weight of the composition.

In a preferable embodiment, the coconut oil is present in an amount of at least 60 wt%, more preferably at least 70 wt%, even more preferably at least 80 wt% relative to the total weight of the composition. Typically, the coconut oil is present in an amount of up to 95 wt%, more preferably up to 90 wt%, even more preferably up to 85 wt% relative to the total weight of the composition.

The coconut oil is preferably Cocos Nucifera oil.

The composition of the invention usually comprises the Phyllanthus emblica extract in an amount of at least 0.5 wt%, preferably at least 1 wt%, more preferably at least 1.5 wt%, even more preferably at least 2 wt% relative to the total weight of the composition. Typically, the Phyllanthus emblica extract is present in an amount of up to 10 wt%, preferably up to 8 wt%, more preferably up to 5 wt%, even more preferably up to 4 wt% relative to the total weight of the composition.

The Camellia Sinensis leaf extract may be present in an amount of at least 0.5 wt%, preferably at least 1.0 wt%, more preferably at least 2.5 wt%, even more preferably at least 3.5 wt% relative to the total weight of the composition. Typically, the Camellia Sinensis leaf extract is present in an amount of up to 15 wt%, preferably up to 10 wt%, more preferably up to 8 wt%, even more preferably up to 5 wt% relative to the total weight of the composition

Usually, the Murraya Koenigii stem extract is present in an amount of at least 1 wt%, preferably at least 1.5 wt%, more preferably at least 2 wt%, even more preferably at least 4 wt% relative to the total weight of the composition. Typically, the Murraya Koenigii stem extract is present in an amount of up to 12 wt%, preferably up to 10 wt%, more preferably up to 8 wt%, even more preferably up to 5 wt% relative to the total weight of the composition

In addition to the ingredients listed above, the composition may further comprise other natural ingredients selected from the group consisting of Trigonella Foenum-Graecum seeds, Ocimum Sanctum extract, Aloe Barbadensis extract, Citrus limon juice extract, Rosa canina L. extract, Acorns Calamus rhizome extract, Terminalia Catappa leaf extract, sesame oil (e.g. Sesamum indicum oil), Berberis lyceum extract, Adhatoda vasica extract, Cuscuta reflexa extract, cuminum cyminum oil and Crataegus laevigata extract, or mixtures thereof. Any one or more of these additional ingredients may independently be present in an amount of 0.5 to 10 wt%, preferably 0.8 to 8 wt%, more preferably 1 to 5 wt%, even more preferably 1.5 to 3 wt% relative to the total weight of the composition.

Preferably, the composition further comprises one or more of Citrus limon juice extract, Cuscuta reflexa extract, Aloe Barbadensis extract, Trigonella Foenum-Graecum seed extract and Ocimum Sanctum extract.

In a particularly preferred embodiment, the composition further comprises Citrus limon juice extract and/or Cuscuta reflexa extract.

In a further preferred embodiment, the composition further comprises Trigonella Foenum-Graecum seeds, Ocimum Sanctum extract, Aloe Barbadensis extract, Citrus limon juice extract, Rosa canina L. extract, Acorns Calamus rhizome extract, Terminalia Catappa leaf extract, sesame oil (e.g. Sesamum indicum oil), Berberis lyceum extract, Adhatoda vasica extract, Cuscuta reflexa extract, cuminum cyminum oil and Crataegus laevigata extract. Any one or more of these ingredients may independently be present in an amount of 0.5 to 10 wt%, preferably 0.8 to 8 wt%, more preferably 1 to 5 wt%, even more preferably 1.5 to 3 wt% relative to the total weight of the composition.

The ingredients of the composition are all natural ingredients, primarily plant extracts.

The compositions of the invention are typically prepared by mixing the plant extracts in the coconut oil and heating that mixture to a temperature of at least 50 °C. Thus, in a further embodiment, the invention relates to process for preparing a composition as herein defined, said process comprising the steps: (i) Mixing coconut oil, Phyllanthus emblica extract, Camellia Sinensis leaf extract and Murraya Koenigii stem extract; and (ii) Heating said mixture to a temperature of at least 50 °C.

Preferably, the mixture is heated to a temperature of at least 60 °C, more preferably at least 80 °C, even more preferably at least 100 °C. Usually, the heating step is performed at temperatures of up to 200 °C, such as up to 150 °C.

It will be appreciated that in circumstances wherein the composition comprises further ingredients in addition to coconut oil, Phyllanthus emblica extract, Camellia Sinensis leaf extract and Murraya Koenigii stem extract, these extra ingredients will be also be added in step (i) above and will form part of the mixture to be heated in step (ii).

Additional steps may also be performed in the preparation methods of the invention. As such, the above process may further comprise the step: (iii) Filtering said mixture.

The filtering, heating and mixing steps may be performed by any known process in the art. Mixing may involve crushing any solid plant extracts.

Typically the mixture will be allowed to cool to room temperature (e.g. 18 to 35 °C) between steps (ii) and (iii).

The compositions of the invention typically consist of the ingredients herein described. Alternatively, the compositions of the invention may be formulated as a pharmaceutical composition, further comprising a pharmaceutically acceptable diluent, excipient and/or carrier. The phrase "pharmaceutically acceptable", as used in connection with compositions of the invention, refers to molecular entities and other ingredients of such compositions that are physiologically tolerable and do not typically produce untoward reactions when administered to a mammal (e.g. a human).

The compositions of the present invention can be used in medicine. Thus, in one embodiment the invention relates to a composition as herein defined for use as a medicament. In particular, the compositions find specific application in the treatment of hair loss. Thus, in a further embodiment, the invention relates to a composition as herein defined for use in the treatment of hair loss. In an additional embodiment, the invention relates to a method of treating hair loss comprising administering to a patient in need thereof a composition as herein defined.

The inventors have found a unique mix of natural ingredients, which when administered to a patient can successfully treat hair loss. Without wishing to be bound by theory, the efficacy of the compositions is considered to result from their ability to stimulate new growth at the hair follicle and to strengthen any new and existing hair as it grows.

In a further embodiment, the invention relates to the use a composition as herein defined for stimulating hair growth.

The compositions described herein are typically administered topically and thus may be prepared in a semi-solid or liquid form suitable for topical administration. Formulations for topical administration can include gels, creams, ointments, hydrogels, pastes, emulsions, sprays, solutions, lotions, topical suspensions, patches, foams, rubbing sticks, electrolysis patchs or other formulation technology exhibiting slow release, adherence to the skin and/or increased penetration. Alternatively, the compositions described herein can be prepared as sterile aqueous or non-aqueous solutions, suspensions, and emulsions. Examples of non-aqueous carriers include water, alcoholic/aqueous solutions, emulsions or suspensions, including saline and buffered media. Parenteral vehicles, if needed for collateral use of the disclosed compositions and methods, include sodium chloride solution,

Ringer's dextrose, dextrose and sodium chloride, lactated Ringer's, or fixed oils. Intravenous vehicles, if needed for collateral use of the disclosed compositions and methods, include fluid and nutrient replenishers, electrolyte replenishers (such as those based on Ringer's dextrose), and the like. Preservatives and other additives can also be present such as, for example, antimicrobials, anti-oxidants, chelating agents, and inert gases and the like.

In a preferable embodiment, the composition is administered topically direct to the scalp.

The compositions of the present invention may be administered as a monotherapy, or in combination with another agent prescribed for the treatment of hair loss. The term "combination" applied to active ingredients is used herein to define a single pharmaceutical composition (formulation) comprising two active agents (e.g. a pharmaceutical composition comprising the components of the present invention together with another agent prescribed for the treatment of hair loss) or two separate pharmaceutical compositions, each comprising an active agent (e.g. a pharmaceutical composition comprising the components of the present invention invention, and another pharmaceutical composition comprising another agent prescribed for the treatment of hair loss), to be administered conjointly.

Within the meaning of the present invention, the term "conjoint administration" is used to refer to administration of a composition of the present invention, and one or more additional active agents (e.g. another agent prescribed for the treatment of hair loss) simultaneously in one composition, or simultaneously in different compositions, or sequentially. For the sequential administration to be considered "conjoint", however, the composition of the present invention, and the one or more additional active agents must be administered separately within a time interval which still permits the resultant beneficial effect for treating hair loss.

Preferably, the compositions are administered as a monotherapy.

Treatment duration may be short-term, e.g., several weeks (for example 8-14 weeks), or long-term until it is deemed administration is no longer necessary. A typical treatment regime will last for at least three months, such as at least six months or at least twelve months.

Administration of the composition of the invention will usually take place on every alternate day for the duration of the treatment, i.e. the composition is administered every second day.

In one embodiment, the composition is administered in a dose of at least 0.2 ml, preferably at least 0.5 ml, more preferably at least 1 ml, such as at least 1.5 ml (e.g. 2 ml). The dosage for each administration will not normally exceed 5 ml, more preferably 3 ml. It will be understood that these dosages refer to the amount of composition given to the patient on each administration, e.g. the amount given each alternate day.

Typically the composition is applied topically direct to the scalp and allowed to soak in for at least 6 hours, preferably at least 12 hours. The composition may then be washed off. For convenience, the composition is preferably applied to the patient in the evening, allowed to soak in overnight and then washed off the following morning.

During the first two months of treatment, it is typical for administration of the composition of the invention to be combined with shaving of the area to be treated. Shaving the new hair growth allows the follicles to become stronger, thus increasing the strength of further new hair and is typically carried out at least every 7 days, more preferably at least every 14 days, even more preferably at least every 28 days (e.g. once a month). Usually, after two months of treatment, shaving is often ceased and the new hair is allowed to grow as normal. Administration of the composition may continue after shaving of the area has ceased and will be applied directly to the scalp and areas of new growth.

In one particularly preferable embodiment, each administration of the composition is preceded by the application of a mild irritant directly to the scalp. This helps to open pores and increase the effectiveness of the treatment. Examples of mild irritants include onion juice. This may be in the form of an onion juice extract which has optionally and preferably been mixed with a preservative. Alternatively, the onion juice is obtained directly from a raw onion at the time of application. This is usually carried out by way of direct contact of a peeled and halved raw onion with the scalp area to be treated.

The composition of the invention is typically used to treat patients aged up to 70 years, such as in the age range 18 to 68 years. It is particularly well suited for patients aged up to 50 years.

Examples

Thirty patients were split into three groups. Group 1 were supplied with a composition according to the invention and raw onion. Group 2 were supplied with a composition according to the invention and an onion juice extract mixed with a preservative. Group 3 were given a placebo. Each group of patients applied the composition (and source of onion juice if applicable) to the scalp every alternate day for 30 days. The results of this study are presented in Tables 1 to 3.

Table 1 shows the baseline figures for Groups 1 to 3 and Table 2 shows the same figures after one month of treatment. The integer numbers in the left hand columns of Tables 1 and 2 represent the percentage of each area not covered by hair, so the higher the number the less hair is present. Each area was allocated a weighting according to its size relative to the total of all areas. The percentage figures in the right hand columns represent the weighted percentage of hair loss in each area, which are combined to give a figure for total hair loss. The lower these percentages, the greater the hair coverage.

Table 3 shows a comparison between the mean values calculated for the baseline and one month measurements. Group 3, who were administering the placebo saw very little different in hair coverage after one month. Groups 1 and 2 both displayed a mean increase in total hair coverage after this period of at least 10%.

Table 1: Baseline Figures for Groups 1 to 3.

* Percentage of area of scalp not covered by hair # Weighted percentage

Table 2: Figures after one month of treatment for Groups 1 to 3.

*Percentage of area of scalp not covered by hair # Weighted percentage

Table 3: Comparison of mean data at baseline and after one month of treatment for Groups 1 to 3.

(P-values: Group 1: 3.43E-06; Group 2: 3.23E-08; Group 3: 4.59E-01)

Claims

CLAIMS:

1. A composition for stimulating hair growth comprising coconut oil, Phyllanthus emblica extract, Camellia Sinensis leaf extract and Murraya Koenigii stem extract, wherein said coconut oil is present in an amount of at least 50 wt% relative to the total weight of the composition

2. The composition as claimed in claim 1, wherein the Phyllanthus emblica extract is present in an amount of at least 0.5 wt%, preferably at least 1.0 wt%, more preferably at least 1.5 wt%, even more preferably at least 2.0 wt% relative to the total weight of the composition.

3. The composition as claimed in claim 1 or 2, wherein the Camellia Sinensis leaf extract is present in an amount of at least 0.5 wt%, preferably at least 1.0 wt%, more preferably at least 2.5 wt%, even more preferably at least 3.5 wt% relative to the total weight of the composition.

4. The composition as claimed in any of claims 1 to 3, wherein the Murraya Koenigii stem extract is present in an amount of at least 1.0 wt%, preferably at least 1.5 wt%, more preferably at least 2.0 wt%, even more preferably at least 4.0 wt% relative to the total weight of the composition.

5. The composition as claimed in any of claims 1 to 4, further comprising one or more additional components selected from the group consisting of Trigonella Foenum-Graecum seeds, Ocimum Sanctum extract, Aloe Barbadensis extract, Citrus limon juice extract, Rosa canina L. extract, Acorns Calamus rhizome extract, Terminalia Catappa leaf extract, sesame oil (e.g. Sesamum indicum oil), Berberis lyceum extract, Adhatoda vasica extract, Cuscuta reflexa extract, cuminum cyminum oil, Crataegus laevigata extract and mixtures thereof.

6. The composition as claimed in claim 5, wherein said one or more additional components are each independently present in an amount of 0.5 to 10 wt%, preferably 0.8 to 8 wt%, more preferably 1 to 5 wt%, even more preferably 1.5 to 3 wt% relative to the total weight of the composition.

7. A process for preparing a composition as claimed in any of claims 1 to 6, said process comprising the steps: (i) Mixing coconut oil, Phyllanthus emblica extract, Camellia Sinensis leaf extract and Murraya Koenigii stem extract; and (ii) Heating said mixture to a temperature of at least 50 °C.

8. A composition as claimed in any of claims 1 to 6 for use a medicament.

9. A composition as claimed in any of claims 1 to 6 for use in the treatment of hair loss.

10. A composition for use as claimed in claim 9, wherein said composition is administered topically.

11. A composition for use as claimed in claim 9 or 10, wherein said composition is administered every alternate day.

12. A composition for use as claimed in any of claims 9 to 11, wherein a mild irritant (e.g. onion juice) is administered prior to each administration of said composition.

13. A method of treating hair loss comprising administering to a patient (e.g. a human) in need thereof a composition as defined in any of claims 1 to 6.

14. A method as claimed in claim 13, wherein said composition is administered topically.

15. A method as claimed in claim 13 or 14, wherein said composition is administered every alternate day.

16. A method as claimed in any of claims 13 to 15, wherein a mild irritant (e.g. onion juice) is administered prior to each administration of said composition.

17. Use of a composition as claimed in any of claims 1 to 6 for stimulating hair growth.