Title of Invention

TOPICAL COMPOSITION FOR MINIMIZING HAIR LOSS

Abstract A topical composition for minimizing hair loss comprising 0.0.1-10% by wight gallic acid or an alkyl ester of gallic acid or a mixture thereof.
Full Text FORM - 2
THE PATENTS ACT, 1970
(39 of 1970)
&
The Patents Rules, 2006
PROVISIONAL SPECIFICATION
(See Section 10 and Rule 13)
TOPICAL COMPOSITION FOR MINIMIZING HAIR LOSS
HINDUSTAN LEVER LIMITED, a company incorporated under the Indian Companies Act, 1913 and having its registered office at Hindustan Lever House, 165/166, Backbay Reclamation, Mumbai -400 020, Maharashtra, India
The following specification describes the invention

Technical Field:
The present invention relates to compositions for preventing or minimizing fall or loss of keratinic fibers. The present invention more particularly relates to preventing fall/loss of human scalp hair.
Background and Prior art:
Hairs are filamentous, keratinized structures consisting of a shaft and a root. The shaft is composed of specialized keratinocytes. The root lies within the hair follicle and comprises the germinative matrix and the keratogenous zone.
There has been continuous effort to find a safe, reliable method of minimizing hair loss and thus baldness to various degrees. Though loss of hair is not a disease condition, the loss of hair, in general, bothers the persons concerned psychologically and seriously affects the individual's self-esteem. The cause for the problem of hair loss is not always the same in all. There are several factors that influence the process by which hair grows and there are many contributory factors that can alter the normal vigorous growth of hair. The hair growth cycle is divided into three phases: an anagen phase, in which the hair is growing actively, with a very substantial level of cell proliferation occurring in the hair follicle; a catagen phase, when the follicle slows down its proliferative activity temporarily to permit hair development; and a telogen phase, in which the follicle simply stops growing and regresses, until the hair is shed, and a new anagen phase begins. It is natural to lose some hair on a daily basis as this is a part of the hair renewal process. This cycling process of hair growth continues throughout the life of an individual.
But when this loss becomes excessive it becomes a problem which people try to solve by the use of cosmetic formulations. As appearance and looks is an important aspect in society hair loss is considered a major problem. Millions of people worldwide suffer from hair loss and are keen to find a solution to treat such hair loss. Different hair growth products and treatments have been developed to solve such a problem but the problem still persists.
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JP09136839 (NITTO DENKO CORP, 1996) discloses a composition for antiviral action, immunologically enhancing action, etc., useful as an agent for treating viral infections, as an immunopotentiator, a hair growth promoter, etc., containing an extract of a number of herbs including Terminalia chebula.
JP61212509 (CHUBU SEIYAKU KK KAWAI FUTOSHI, 1985) discloses hair tonic containing natural germanium compound separated or extracted from a plant and effective in improving nutrition to hair root and promoting the growth of hair by supplying sufficient oxygen to the cells of the subcutaneous hair root by topical application. This document mentions a number of herbs including Terminalia chebula as part of a hair growth promoting mixture
JP2003321330 (LION CORP, 2002), discloses a hair growth tonic composition. They mention the use of gallates for hair growth, but specifically in the form of glucosides.
JP2005015410 (KANEBO COSMETICS INC, 2003), discloses a hair growth suppressive skin preparation for external use characterized by being formulated with at least one ingredient selected from the group consisting of gallate (all gallates), capsaicin, methyl nicotinate, vitamin A and carnitine chloride.
The above mentioned prior art cite gallates in general, including all its derivatives. However, many of them cite the use of gallates for hair growth inhibition. There is also mention of use of gallates only as their glucosides for hair growth stimulation. None of them really mention about minimizing hair loss.
All the above mentioned disclosures are different from the present invention as we have found that when we use gallic acid or its alkyl esters in definite amounts we can minimize hair loss significantly.
It is an object of the present invention to minimize hair loss in a very short time without any significant side effects, since it is predominantly a natural product.
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Description of the Invention:
According to the present there is provided a composition for minimizing hair loss comprising 0.001-10% by weight gallic acid or an alkyl ester of gallic acid or a mixture thereof.
According to a preferred aspect of the present invention, there is provided a composition for minimizing hair loss comprising 0.001-10% by weight a mixture of gallic acid and an alkyl ester of gallic acid.
According to another preferred aspect of the invention there is provided a composition for minimizing hair loss wherein the alkyl ester is selected from methyl, ethyl or propyl ester or mixtures thereof.
It is particularly preferred that the alkyl ester is methyl gallate.
According to another aspect of the invention there is provided a process for minimising hair loss by contacting human hair and/or scalp with a composition comprising 0.001-10% by weight gallic acid or an alkyl ester of gallic acid or a mixture thereof for a period of at least 10 minutes
Detailed Description of the Invention:
The present invention relates to a composition for minimising hair loss.
Process of Application on Hair:
The present invention also relates to a composition for minimising hair loss wherein the composition comprising 0.001-10% by weight gallic acid or an alkyl ester of gallic acid or a mixture thereof is applied to human hair or scalp for period in the range 10 min to 24 hours and optionally washed with water subsequently. It is useful to saturate the hair/scalp with the composition. A most preferred time of contact is for period of 20-40 minutes. It is recommended that the process is repeated at least once a week and for better results it may be more often.
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The hair is preferably washed with water or shampoo or any suitable composition. It is preferred that the component system is present as a kit with clear instructions on the application of the kit components.
Gallic acid and its esters:
For minimizing hair loss alkyl ester is selected from methyl, ethyl or propyl ester or
a mixture thereof. It is particularly preferred that the ester is methyl gallate. The
source of methyl gallate is Acacia nilotica, Mangifera indica, Anachardium
oxydentale, or chemically synthesized from gallo tannins using reported
procedures.
The source of gallic acid or its esters is synthetic or any gallic acid rich plant source. The source of gallic acid is preferably gall nuts, Terminalia species for e.g. chebula, bellerica, arjuna etc, tea, Embelica officinalis, Mucuna pruriens and other gallic acid rich sources.
Product form:
Examples of suitable product forms include solutions, emulsions, microemulsions, gels, creams, sprays and lotions. The composition may be in an aqueous, oily, alcoholic, emulsion, or a micro emulsion medium. The pH of the composition is maintained in the pH range 4-9.
It is preferable to formulate the product in the form of a gel by using suitable gelling agents. A suitable commercially available gelling agent is carbopol.
Reducing Agent:
It is preferable to incorporate a reducing agent in the composition and when present it is in the range 0.5 to 2% by weight. The reducing agent is preferably selected from one or more of sodium dithionate, sodium sulphite, sodium metabisulphite, sodium thiosulphate, sodium dithionite or ascorbic acid.
Other conventional ingredients such as surfactants, gelling/thickening agents, emollients, humectants, perfumes and preservatives may be incorporated to formulate the composition as desired.
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The invention is further illustrated by the following non-limiting examples, in which parts and percentages are by weight unless otherwise specified.
Examples:
In vitro hair bulb culture:
Anagen hair follicles were isolated from scalp biopsies of volunteers undergoing hair transplant operations. Isolated follicles were maintained in William's E Media (Sigma # W 4128) in the absence or presence of various actives. The movement of hair bulbs from anagen (growth phase) to catagen phase (phase of hair fall) was monitored by daily photography and measurement of the size of the hair bulb.
Example 1a
The effect of different concentrations of gallic acid and methyl gallate on isolated hair bulbs in culture:
Isolated hair bulbs were incubated in different concentrations of gallic acid and methyl gallate over a period of 8 days. The results presented in Table 1, show that both gallic acid (GA) and methyl gallate (MG) help to retain hair bulbs in anagen phase thus suggesting that they would prevent hair fall. In untreated hair bulbs, only 33% of the hairs remain in anagen phase, whereas the percentages in both GA and MG groups are significantly higher. Ratios of GA and MG also showed good responses.
Table 1

Active tested % hair bulbs in anagen
Control 37.5

GA 0.001% 45.7
GA 0.002% 49.2
GA0.01% 83.3

MG 0.001% 75.0
MG 0.002% 75.2
MG0.01% 93.8

GA 0.001 +MG 0.001 68.8 75.0
GA 0.001 + MG 0.002
GA 0.001 + MG 0.005 100

Example 1b
Effect of different gallate esters on isolated hair bulb cultures: Isolated hair bulbs were incubated in either gallic acid or gallic acid esters over a period of 8 days. The results presented in Table 2 show that the number of hair bulbs in anagen phase was seen to be similar in all the gallate esters tested.
Table 2

Active tested % hair bulbs in anagen
Control 33.3
Gallic acid 83.3
Methyl gallate 93.8
Ethyl gallate 82.4
Propyl gallate 94.6
Example 2a
Isolated hair bulbs were incubated in different concentrations of gallic acid and methyl gallate over a period of 4 days. The growth of hair bulbs over that time was recorded. The results show that gallic acid has a better effect on the growth of hairs in culture than methyl gallate. The results also show that combinations of gallic acid and methyl gallate show significantly superior benefit.
Table 3
Active tested [ Growth after
2 days 4 days
Control 0J2 1.30
GA 0.001% 0.72 1.23
GA 0.002% 0M 1.48
MG 0.001% 0.68 0.88
MG 0.002% 07(5 0.88
GA 0.001 + MG 0.001 | 0.85 | 1.48
Example 3
Human volunteer study using gel containing methyl gallate and Terminalia chebula extract.
A water based gel containing 1% Methyl gallate and 0.3% Terminalia Chebula extract a rich source of gallic acid, was tested on 10 human volunteers in an in-
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house human study. The volunteers were asked to apply the gel at least once a week for two weeks. The daily hair fall (before and during gel usage) was collected and stored in a ziploc bag. The hair was weighed and recorded.
Table 4 - Composition of gel
Chebula extract 0.3 g (containing 0.2g gallic acid)
Methyl gallate 1g
Na2S03 0.38 g
Carbopol 0.6 g
Glydant Plus 0.1 g
EDTA 0.05 g
water Makeupto 100 g
NaOH( caustic lye) 0.6 g
It was observed that the volunteers showed some difference in the degree to which hair loss was prevented, but there was a significant reduction in hair fall post usage of the gel. The average of 10 volunteers was 57.21% reduction in hair loss.
Thus, by the use of the composition of the present invention it has been possible to minimize fall or loss of keratinic fibers and particularly to preventing fall/loss of human scalp hair.
Dated this Twenty Eighth day of July 2006.
HINDUSTAN LEVER LIMITED.


Documents:

1197-mum-2006-abstract(11-7-2007).pdf

1197-MUM-2006-ABSTRACT(GRANTED)-(31-8-2011).pdf

1197-MUM-2006-CANCELLED PAGES(25-5-2011).pdf

1197-mum-2006-claims(11-7-2007).pdf

1197-MUM-2006-CLAIMS(AMENDED)-(15-2-2011).pdf

1197-MUM-2006-CLAIMS(AMENDED)-(25-5-2011).pdf

1197-MUM-2006-CLAIMS(AMENDED)-(25-5-2011).tif

1197-MUM-2006-CLAIMS(GRANTED)-(31-8-2011).pdf

1197-mum-2006-correspondence 1(11-7-2007).pdf

1197-mum-2006-correspondence 2(15-10-2007).pdf

1197-MUM-2006-CORRESPONDENCE(16-7-2008).pdf

1197-MUM-2006-CORRESPONDENCE(2-9-2009).pdf

1197-MUM-2006-CORRESPONDENCE(25-5-2011).pdf

1197-MUM-2006-CORRESPONDENCE(29-7-2010).pdf

1197-MUM-2006-CORRESPONDENCE(30-12-2009).pdf

1197-MUM-2006-CORRESPONDENCE(6-3-2009).pdf

1197-MUM-2006-CORRESPONDENCE(8-2-2012).pdf

1197-MUM-2006-CORRESPONDENCE(IPO)-(5-9-2011).pdf

1197-MUM-2006-CORRESPONDENCE-(16-07-2008).pdf

1197-mum-2006-correspondence-received.pdf

1197-mum-2006-description (provisional).pdf

1197-mum-2006-description(complete)-(11-7-2007).pdf

1197-MUM-2006-DESCRIPTION(GRANTED)-(31-8-2011).pdf

1197-mum-2006-form 13(17-10-2007).pdf

1197-MUM-2006-FORM 18-(16-07-2008).pdf

1197-mum-2006-form 2(11-7-2007).pdf

1197-MUM-2006-FORM 2(GRANTED)-(31-8-2011).pdf

1197-mum-2006-form 2(title page)-(11-7-2007).pdf

1197-MUM-2006-FORM 2(TITLE PAGE)-(GRANTED)-(31-8-2011).pdf

1197-mum-2006-form 3(11-7-2007).pdf

1197-MUM-2006-FORM 3(15-2-2011).pdf

1197-MUM-2006-FORM 3(24-2-2010).pdf

1197-MUM-2006-FORM 3(28-7-2006).pdf

1197-MUM-2006-FORM 3(4-8-2010).pdf

1197-mum-2006-form 5(11-7-2007).pdf

1197-mum-2006-form-1.pdf

1197-mum-2006-form-2.doc

1197-mum-2006-form-2.pdf

1197-mum-2006-form-3.pdf

1197-MUM-2006-GENERAL POWER OF ATTORNEY(29-7-2010).pdf

1197-MUM-2006-REPLY TO EXAMINATION REPORT(15-2-2011).pdf


Patent Number 248853
Indian Patent Application Number 1197/MUM/2006
PG Journal Number 35/2011
Publication Date 02-Sep-2011
Grant Date 31-Aug-2011
Date of Filing 28-Jul-2006
Name of Patentee HINDUSTAN UNILEVER LIMITED
Applicant Address HINDUSTAN LEVER HOUSE, 165/166 BACKBAY RECLAMATION, MUMBAI - 400020,
Inventors:
# Inventor's Name Inventor's Address
1 RAUT JANHAVI SANJAY K-61 DIAMOND DIST, KODIHALLI, AIRPORT ROAD, BANGLORE 560 008
2 SUDHIR SAVITHA NO.37,'VIJAYSHREE', 3RD CROSS, BEHIND KMF, AYAPPA LAYOUT, MUNIAKOLALA, MARATHAHALLI P.O.BANGLORE-560 037
3 BALAKRISHNAN LALITHA #28 SANGAM ROAD KAMARAJ ROAD CROSS, BANGLORE 560 042
4 MANI INDU #502 ROYAL MANOR APTS, KODIHALLI MAIN ROAD, HAL III STAGE, BANGLORE 560 008
5 NAYYAR NEERU B2/6, SHATATARAKA CO-OP HOUSING SOCIETY, FOUR BUNGLOWS, (NEAR RTO), ANDHERI (WEST) MUMBAI 400 053
PCT International Classification Number A61K8/00
PCT International Application Number N/A
PCT International Filing date
PCT Conventions:
# PCT Application Number Date of Convention Priority Country
1 NA