DESC:Technical Field of the Invention

The invention relates to a combination formulation for blocking the production of Dihydrotestosterone (DHT) and increasing the overall hair growth. This combination is made in such a way that all the ingredients act synergistically to block DHT and increase hair growth and slow ageing of hair. The combination is optimized for efficacy.

Background of the Invention

Hair loss, or alopecia, is one of the most distressing disorders for both adults and children because society places a great emphasis on physical appearance. The importance of the patient’s cosmetic concerns should not be underestimated. The importance of the patient’s cosmetic concerns should not be underestimated. Alopecia may be associated with a wide variety of causes like hormones, genes, illness, stress, drugs, autoimmune disorder, medical condition or diet. Identification of cause is of utmost importance for treatment.
One of the forms of alopecia is male/female pattern baldness. This common problem is characterized by miniaturizing hair follicles. It is an androgen hormone dependent process. The most potent androgen, DHT reduces the amount of scalp hair.
DHT is the most potent male sex hormone produced in both men and women. In the presence of increased DHT, the hair anagen (growth) phase is shortened and the telogen (resting) phase is increased, causing increased hair loss. A DHT blocker is a substance that either inhibits the conversion of testosterone to DHT or reduces the DHT buildup on the scalp. A follicle overloaded with DHT becomes small, receives few nutrients, functions in imbalance, produces more oil, and does not allow hair to grow. Therefore, stopping DHT-follicle binding is the first step against hair loss.
Summary of the Invention
The object of the invention is to provide a formulation for blocking the production of Dihydrotestosterone (DHT) and increasing the overall hair growth.
In one general aspect, the present invention relates to a formulation for managing alopecia where in the formulation comprises:
a) Dihydrotestosterone (DHT) blocker;
b) Hair growth promotor (natural, semi-natural or quasi natural); and
c) Pharmaceutically acceptable excipients.

In an embodiment of the above aspect, the DHT blockers are selected from Beta sitosterol, Stinging nettle, Licorice, Amla, Jatamansi, Giloy, Tribulus, Bhibhitaki , Grape seed extract and Ginseng and combinations thereof. The DHT blocker may be present in an amount of about 5% to about 40% by weight of the formulation.
In another embodiment of the above aspect, the hair growth promoter are selected from fat soluble or water soluble vitamins, proteins, pumpkin seed extract, zinc, iron and combinations thereof. The natural hair growth promoter may be present in an amount of about 0.00001% to about 5% by weight of the formulation.
In another embodiment of the above aspect, the formulation may be formulated into a dosage form selected from dry powder, liquid, beverage, food product, dietary supplement any suitable form such as tablet, capsule, sachet, ointments, liquid alcohol extracts, oils, gels, etc. for both oral and topical application providing an effective dosage.
In another embodiment of the above aspect, the formulation is a tablet that contains biotin, vitamin E, copper, zinc, Beta sitosterol, stinging nettle leaf extract and soya protein.

Description of the Drawing
Figure 1 describes the results of a study in human consumers that used a tablet formulation of the invention to treat their hair fall.

Detailed Description of the Invention
Androgenetic alopecia (male pattern baldness) is the most common cause of hair loss in men. The hair loss is progressive. Gradual conversion of terminal hairs into vellus hairs occurs in a highly reproducible pattern, denudes the scalp and leads to baldness. Intrafollicular androgen over-activity may also be the result of local factors including an increased number of androgen receptors, functional polymorphisms of the androgen receptor, increased local production of dihydrotestosterone (DHT), and reduced local degradation of DHT. In androgen synthesis, the 5a-reductase enzyme acts as a catalyst converting testosterone to the more potent DHT. By introducing a 5a-reductase inhibitor, the conversion of testosterone to DHT can be decreased and help in reducing hair loss. For instance, DHT may interfere with the Wnt signaling pathway in the hair. The Wnt signaling pathway is an ancient and evolutionarily conserved pathway that regulates crucial aspects of cell fate determination, cell migration, cell polarity, neural patterning and organogenesis during embryonic development. The Wnts are secreted glycoproteins and comprise a large family of nineteen proteins in humans hinting to a daunting complexity of signaling regulation, function and biological output. The Wnt pathway is an important mechanism that is used to maintain the anagen phase in the body by inducing the dermal papilla cells. Hence, the disruption of Wnt pathway by the presence of excess DHT may interfere with the hair growth cycle.
Medications that claim to treat androgenic alopecia have a steadily growing market worldwide. The major nonsurgical therapeutic strategies for hair growth promotion include angiogenesis (through endogenous substances), androgen antagonism, vasodilation through potassium channel opening 5a-reductase inhibition and modulation of the hair cycle.
Nowadays, many studies have proven that natural drugs made from plant derivative may give a promising impact to treat the androgenic alopecia. Most of the plant derivatives or extract used in treating androgenic alopecia are targeting the inhibition of the 5a-reductase enzyme. Combining the plant extract would work synergistically in order to increase the inhibition of 5a-reductase enzyme .
This invention is related to the use of plant derived DHT blockers like Beta sitosterol, Stinging nettle, Licorice, Amla, Jatamansi, Giloy, Tribulus, Bhibhitaki and some other minerals. This formulation is proposed to enhance the body's own capacity for hair growth and/or block the DHT from binding to follicles and stopping the hair fall. The DHT blocker may be present in an amount of about 5% to about 40% by weight of the formulation.
The formulation may additionally contain Hair growth promoters like Grape seed, Ginseng, Fat or Water soluble Vitamins, Biotin, protein, Soy protein, Pumpkin seed extract ,zinc, iron and combinations thereof. The natural hair growth promoter may be present in an amount of about 0.00001% to about 5% by weight of the formulation.
The outcome of the formulation will be slow ageing of hair, which will be expressed in the form of enhanced hair growth, reduction in hair fall and healthy hair follicle leading to healthy scalp.
The active ingredients can be used in crushed powdered form or can be subjected to extraction with chemical solvents to prepare extracts that contain the active chemical compounds responsible for biological activity. The solvents used for preparing the extracts and fractions used in the formulations is not limited to alcohols, like ethanol, methanol, water, and combinations or any suitable solvent or mixture of the same.
The formulations of the present invention may be formulated into a dosage form selected from dry powder, liquid, beverage, food product, dietary supplement any suitable form such as tablet, capsule, sachet, ointments, liquid alcohol extracts, oils, gels, etc. for both oral and topical application providing an effective dosage.
The formulation of Example 9 in the form of a tablet was used by consumers for treating hair fall. The consumers took tablets for at least three months. The results showed that 66% of the users could obtain positive results and within these users, 72% could feel the positive effects on hair fall within the first three months. At least 84% of the consumers could experience reduced hair fall. At least 54% of the consumers decided to continue treatment with the formulation of the invention. Thus, the present invention provides an effective treatment for hair fall.
The presented examples illustrate the invention, but they should not be considered to limit the scope of the invention in any way.
This synergistic blend formulation includes the powder/ liquid extracts or powder of below mentioned sources in the given quantities:

Example 1:
Active Ingredients Qty (g)
D- Biotin 0.00005
Vitamin E 0.003
Zinc Sulphate Monohydrate 0.070
Beta Sitosterol Powder 0.02
Stinging Nettle Leaf Powder 0.1
Soya extract 0.5
Grapeseed powder 0.01
Pumpkin Seed Extract 0.3
Licorice Powder 0.05

Example 2:
Active Ingredients Qty (g)
D-Biotin 0.00008
Vitamin E 0.03
Zinc Sulphate Monohydrate 0.070
Beta Sitosterol Extract 0.02
Stinging Nettle Leaf extract 0.1
Protein extract 0.7
Grapeseed extract 0.01
Pumpkin Seed Powder 0.4
Licorice Extract 0.04

Example 3
Active Ingredients Qty (g)
D- Biotin 0.00004
Vitamin E 0.02
Copper Salt 0.0067
Beta Sitosterol 0.05
Stinging Nettle Leaf extract 0.2
Zinc sulphate Monohydrate 0.036
Soya Protein Isolate 0.3

Example 4:
Active Ingredients Qty (g)
D- Biotin 0.00007
Ginseng 0.06
Vitamin E 0.03
Zinc Sulphate Monohydrate 0.080
Green Tea Extract 0.04
Soyabean extract 0.4
Giloy 0.06
Grapeseed Powder 0.01
Pumpkin Seed Extract 0.2

Example 5:
Active Ingredients Qty
Copper Sulphate Pentahydrate 0.005
Vitamin E 0.001
Zinc Sulphate Monohydrate 0.038
Beta Sitosterol 0.03
Stinging Nettle Leaf extract 0.1
Soya powder 0.4
Grapeseed extract 0.03

Example 6:
Active Ingredients Qty (g)
D- Biotin 0.00002
Zinc Sulphate Monohydrate 0.06
Copper Sulphate Pentahydrate 0.060
Beta Sitosterol 0.04
Stinging Nettle Leaf extract 0.2
Grapeseed extract 0.01
Bhibhitaki 0.2

Example 7:
Active Ingredients Qty (g)
Zinc Salt 0.6
Iron 0.009
Bhibhitaki 0.2
Copper Sulphate 0.06
Jatamansi 0.05
Giloy 0.06

Example 8:
Ingredients QTY (g)
Giloy 0.15
Tribulus 0.15
Amla 0.15
Bhibhitaki 0.20
Licorice 0.15
Jatamansi 0.10

Example 9
Ingredients QTY (g)
Biotin 0.00004
Vitamin E 0.01
Copper 0.0017
Zinc 0.0132
Beta Sitosterol 0.05
Stinging Nettle Leaf Extract 0.2
Soya Protein 0.3 ,CLAIMS:1. A formulation for treating alopecia where in the formulation comprises:
a) Dihydrotestosterone (DHT) blocker;
b) Hair growth promotor (natural, semi-natural or quasi natural); and
c) Pharmaceutically acceptable excipients.

2. The formulation as claimed in claim 1, wherein the DHT blocker is selected from Beta sitosterol, Stinging nettle, Licorice, Amla, Jatamansi, Giloy, Tribulus, Bhibhitaki , Grape seed extract and Ginseng and combinations thereof.

3. The formulation as claimed in claim 1, wherein the DHT blocker is present in an amount of about 5% to about 40% by weight of the formulation.

4. The formulation as claimed in claim 1, wherein the natural hair growth promoter is selected from fat soluble or water-soluble vitamins, biotin, proteins, pumpkin seed extract, zinc, iron and combinations thereof.

5. The formulation as claimed in claim 1, wherein the natural hair growth promoter is present in an amount of about 0.00001% to about 5% by weight of the formulation.

6. The formulation as claimed in claim 1, wherein the formulation is formulated into a dosage form selected from dry powder, liquid, beverage, food product, dietary supplement any suitable form such as tablet, capsule, sachet, ointments, liquid alcohol extracts, oils, gels, etc. for both oral and topical application providing an effective dosage.

7. The formulation as claimed in any of the preceding claims, wherein the formulation is a tablet that contains biotin, vitamin E, copper, zinc, Beta sitosterol, stinging nettle leaf extract and soya protein.