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Composition Comprising Orchid Callus Extract And A Tonic, And Uses Thereof

Abstract: The present disclosure relates to a composition comprising Follicare Complex (FCC) tonic and orchid callus extract which at specific ratios and concentrations can be used for the management of hair growth problems. Also provided are methods of preparation and uses of said composition.

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Patent Information

Application #
Filing Date
29 December 2017
Publication Number
27/2019
Publication Type
INA
Invention Field
CHEMICAL
Status
Email
iprdel@lakshmisri.com
Parent Application
Patent Number
Legal Status
Grant Date
2024-02-08
Renewal Date

Applicants

ITC LIMITED
ITC LIFE SCIENCES & TECHNOLOGY CENTRE #3. 1st Main, Peenya Industrial Area, Phase - 1, Bengaluru 560 058.

Inventors

1. KALLUKALAM, Bobby Cherian
ITC Limited, ITC Life Sciences & Technology Centre, No.3, 1st Main Road, Peenya Industrial Area, Phase I, Bengaluru 560 058.
2. BANDYOPADHYAY, Balaji
ITC Limited, ITC Life Sciences & Technology Centre, No.3, 1st Main Road, Peenya Industrial Area, Phase I, Bengaluru 560 058.
3. KALSI, Gurpreet
ITC Limited, ITC Life Sciences & Technology Centre, No.3, 1st Main Road, Peenya Industrial Area, Phase I, Bengaluru 560 058.
4. CHANDRASEKHARAN, Lakshmanan Chittur
ITC Limited, ITC Life Sciences & Technology Centre, No.3, 1st Main Road, Peenya Industrial Area, Phase I, Bengaluru 560 058.

Specification

FIELD OF THE INVENTION
[001] The present disclosure relates to the field of cosmetic compositions in general. In particular, present disclosure relates to a composition for hair care, comprising an orchid callus extract to promote hair growth and density.
BACKGROUND OF THE INVENTION
[002] Hair loss is a common problem and is a source of distress and concern for many patients across the world. Hair loss can be categorised into different types namely, androgenic alopecia, alopecia areata, traction alopecia, alopecia totalis, cicatricial alopecia and telogen effluvium.
[003] One of the most widespread and significant type of hair loss is androgenic alopecia also known as pattern baldness more common in males than females. It affects at least 50% of men by the age of 50 years and up to 70% of all males in later life (Norwood. South. Med. J, 1975: 68.11: 1359-1365). In case of females, it affects approximately 6% of them under the age of 50 years, and 30%-40% of women aged 70 years and above (O'tar et al, Dermatol. Surg, 2001: 27.1: 53-54). Androgenic alopecia is caused by a combination of genetic and hormonal factors. In males, dihydrotestosterone (DHT) plays a major role in weakening of the hair roots and in females it is a result of interplay between various hormones. Telogen effluvium is the second most common type of hair loss where hair is typically in a dormant phase (telogen) than moving to growth phase (anagen). It is not a permanent situation and once the hormonal balance is regained hair will start growing normally. Alopecia totalis and alopecia areata both are auto-immune disorders that causes the immune system to attack the hair follicles.
[004] The different treatment options in the case of hair loss includes administering drugs such as minoxidil, finasteride, dutasteride and ketoconazole. There are different treatment regimens and methods of administering the drugs according to the type of

hair loss. Although said drugs have been found effective in restoration of hair growth but they are also accompanied by undesired side effects (Rogers et al, J. Am. Acad. Dermatol, 2008: 59.4: 547-566). Therefore, they are not preferred in most of the cases. The other options are low-light therapy and hair transplantation but they also cannot be implemented in most of the cases.
[005] Therefore, to increase our armoury to fight hair loss, apart from synthetic drugs there is a serious need to consider natural extracts including plants and herbal extracts as a potent source capable of treating the disorder. The added advantage would be of minimal side effects and prolonged effectiveness.
[006] US20070036742A1 discloses a composition for modulating hair growth or for regrowth of hair. The composition comprises administering extracts from Boswellia serrata, Undaria pinnatifida, green tea (e.g., Camellia sinensis), shiso, Pureraria mirifica, luteolin (e.g. Perilla ocymoides leaf extract), astilbin, vitamin E, amentoflavone, tetrahydropiperine, licochalcone, astaxanthin, red clover, Brassica juncea, unfermented green rooibos, enzyme CoQIO, salvia, ximenynic acid, hops oleoresin, apple, soy, saw palmetto, or ellagic extract. The composition claimed is expected to improve hair growth by inhibiting synthesis of dihydrotestosterone, inhibiting proteasomal activity, inhibiting IL-1 activity, increasing secretion of keratinocyte growth factor or increasing secretion of vascular endothelial growth factor.
[007] US5972345A discloses a composition for treatment of male pattern baldness comprising Saw Palmetto extract, African Pygeum extract, stinging nettle extract, and optionally zinc, vitamin B6 and green tea extract. The composition being a combination of herbal extract and minerals was shown to be effective in preventing hair loss and effective in promoting hair growth.
[008] Hair loss has been an area of increasing concern with latest reports showing an urge in investigating novel treatment methods for preventing hair loss. The effectiveness of various herbal extracts varies from one type of hair loss to another therefore more studies need to be envisaged for addressing this problem.

SUMMARY OF THE INVENTION
[009] The subject matter described herein is directed towards a composition comprising orchid callus extract and FCC (follicare complex) tonic for promoting hair growth.
[0010] In an aspect of the present disclosure, there is provided a composition for promoting hair growth, said composition comprising: (a) climbazole; (b) caffeine; (c) diaminopyrimidine oxide; and (d) orchid callus extract, wherein climbazole to caffeine w/w ratio in said composition is in the range of 1:0.50-1:6, climbazole to diaminopyrimidine oxide w/w ratio in said composition is in the range of 1:1.0-1:12, climbazole to the orchid callus extract w/w ratio in said composition is in the range of 1:0.2 - 1:1, and caffeine to diaminopyrimidine oxide w/w ratio in said composition is in the range of 1:0.5 -1:5.
[0011] In an aspect of the present disclosure, there is provided a method for preparing a composition comprising: (a) climbazole; (b) caffeine; (c) diaminopyrimidine oxide; and (d) orchid callus extract, said method comprising: (i) obtaining climbazole; (ii) obtaining caffeine; (iii) obtaining diaminopyrimidine oxide; (iv) obtaining the orchid callus extract; and (v) contacting climbazole, caffeine, diaminopyrimidine oxide and the orchid callus extract to obtain said composition, wherein climbazole to caffeine w/w ratio in said composition is in the range of 1:0.50-1:6, climbazole to diaminopyrimidine oxide w/w ratio in said composition is in the range of 1:1.0-1:12, climbazole to orchid callus extract w/w ratio in said composition is in the range of 1:0.2 - 1:1, and caffeine to diaminopyrimidine oxide w/w ratio in said composition is in the range of 1:0.5 -1:5.
[0012] In an aspect of the present disclosure, there is provided a method for preparing a composition comprising: (a) climbazole; (b) caffeine; (c) diaminopyrimidine oxide; (d) orchid callus extract; (e) ethanol; (f) diethyl phthalate; (g) polysorbate 20; (h) PEG-12 dimethicone; (i) propylene glycol; (j) PEG-7 glyceryl cocoate; (k) D-panthenol; (1) perfume oil; (m) a combination of magnesium aspartate, zinc

gluconate, and copper gluconate; (n) a combination of phenoxyethanol, methyl paraben, ethylparaben, propylparaben, butylparaben, and isobutylparaben; and (o) allantoin, said method comprising: (i) obtaining ethanol; (ii) obtaining diethyl phthalate; (iii) obtaining polysorbate 20; (iv) obtaining PEG-12 dimethicone; (v) obtaining propylene glycol; (vi) obtaining PEG-7 glyceryl cocoate; (vii) obtaining D-panthenol; (viii) obtaining perfume oil; (ix) obtaining diaminopyrimidine oxide; (x) obtaining caffeine; (xi) obtaining climbazole; (xii) obtaining the orchid callus extract; (xiii) obtaining a combination of magnesium aspartate, zinc gluconate, and copper gluconate; (xiv) obtaining a combination of phenoxyethanol, methylparaben, ethylparaben, propylparaben, butylparaben, and isobutylparaben; (xv) obtaining allantoin; and (xvi) contacting ethanol, diethyl phthalate, polysorbate 20, PEG-12 dimethicone, propylene glycol, PEG-7 glyceryl cocoate, D-panthenol, perfume oil, diaminopyrimidine oxide, caffeine, climbazole, the orchid callus extract, a combination of magnesium aspartate, zinc gluconate, and copper gluconate, a combination of phenoxyethanol, methylparaben, ethylparaben, propylparaben, butylparaben, and isobutylparaben, and allantoin to obtain said composition, wherein climbazole to caffeine w/w ratio in said composition is in the range of 1:0.50-1:6, climbazole to diaminopyrimidine oxide w/w ratio in said composition is in the range of 1:1.0-1:12, climbazole to orchid callus extract w/w ratio in said composition is in the range of 1:0.2-1:1, and caffeine to diaminopyrimidine oxide w/w ratio in said composition is in the range of 1:0.5 -1:5.
[0013] In an aspect of the present disclosure, there is provided a method for promoting hair length, said method comprising: (a) obtaining a composition comprising: (i) climbazole; (ii) caffeine; (iii) diaminopyrimidine oxide; and (iv) orchid callus extract, wherein climbazole to caffeine w/w ratio in said composition is in the range of 1:0.50-1:6, climbazole to diaminopyrimidine oxide w/w ratio in said composition is in the range of 1:1.0-1:12, climbazole to the orchid callus extract w/w ratio in said composition is 1:0.2- 1:1, and caffeine to diaminopyrimidine oxide w/w

ratio in said composition is in the range of 1:0.5 -1:5; and (b) contacting said composition with hair follicles, wherein said method promotes hair length. [0014] In an aspect of the present disclosure, there is provided a method of promoting hair density, said method comprising: (a) obtaining a composition comprising: (i) climbazole; (ii) caffeine; (iii) diaminopyrimidine oxide; and (iv) orchid callus extract, wherein climbazole to caffeine w/w ratio in said composition is in the range of 1:0.50-1:6, climbazole to diaminopyrimidine oxide w/w ratio in said composition is in the range of 1:1.0-1:12, climbazole to the orchid callus extract w/w ratio in said composition is 1:0.2- 1:1, and caffeine to diaminopyrimidine oxide w/w ratio in said composition is in the range of 1:0.5 -1:5; and (b) contacting said composition with hair follicles, wherein said method promotes hair density.
[0015] These and other features, aspects, and advantages of the present subject matter will be better understood with reference to the following description and appended claims. This summary is provided to introduce a selection of concepts in a simplified form. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter.
BRIEF DESCRIPTION OF THE DRAWINGS
[0016] The following drawings form part of the present specification and are
included to further illustrate aspects of the present disclosure. The disclosure may be
better understood by reference to the drawings in combination with the detailed
description of the specific embodiments presented herein.
[0017] Figure 1 depicts the effect of a combination of FCC tonic and methanolic
extract of orchid callus at different combinations on the growth of human hair
follicle, in accordance with an embodiment of the present disclosure.
[0018] Figure 2 depicts the effect of a combination of FCC tonic and orchid callus
extract (aqueous extract and methanolic extract) on the growth of human hair
follicles, in accordance with an embodiment of the present disclosure.

[0019] Figure 3 depicts the effect of a combination of FCC tonic and orchid callus extract (aqueous extract and methanolic extract) on the clonogenicity of human hair follicle stem cells (hFSC), in accordance with an embodiment of the present disclosure.
DETAILED DESCRIPTION OF THE INVENTION
[0020] Those skilled in the art will be aware that the present disclosure is subject to variations and modifications other than those specifically described. It is to be understood that the present disclosure includes all such variations and modifications. The disclosure also includes all such steps, features, compositions and compounds referred to or indicated in this specification, individually or collectively, and any and all combinations of any or more of such steps or features.
Definitions
[0021] For convenience, before further description of the present disclosure, certain
terms employed in the specification, and examples are collected here. These
definitions should be read in the light of the remainder of the disclosure and
understood as by a person of skill in the art. The terms used herein have the meanings
recognized and known to those of skill in the art, however, for convenience and
completeness, particular terms and their meanings are set forth below.
[0022] The articles "a", "an" and "the" are used to refer to one or to more than one
(i.e., to at least one) of the grammatical object of the article.
[0023] The terms "comprise" and "comprising" are used in the inclusive, open sense,
meaning that additional elements may be included. It is not intended to be construed
as "consists of only".
[0024] Throughout this specification, unless the context requires otherwise the word
"comprise", and variations such as "comprises" and "comprising", will be understood

to imply the inclusion of a stated element or step or group of element or steps but not the exclusion of any other element or step or group of element or steps. [0025] The term "including" is used to mean "including but not limited to". "Including" and "including but not limited to" are used interchangeably. [0026] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the disclosure, the preferred methods, and materials are now described. All publications mentioned herein are incorporated herein by reference.
[0027] The present disclosure is not to be limited in scope by the specific embodiments described herein, which are intended for the purposes of exemplification only. Functionally-equivalent products, compositions, and methods are clearly within the scope of the disclosure, as described herein. [0028] The Orchidaceae family is the largest family of angiosperm, accounting for about 10% of angiosperm diversity. These plants grow in almost all kinds of environments worldwide, except in very dry regions. These plant varieties are extremely diversified with respect to morphological characteristics, thus it is not inconceivable, that extracts obtained from various components of individual members will vary in their properties. Extracts obtained from plants of Orchidaceae may be used in various cosmetic applications such as moisturizing effect, skin-conditioning effect, skin-whitening effect, anti-aging effect etc. However, the varying effect of extracts obtained from various components needs to be identified and characterized, given the significant diversity as discussed previously.
[0029] Climbazole is an imidazole anti- fungal agent which has similar chemical structure and properties as other fungicides such as ketoconazole and miconazole. It functions by inhibiting synthesis of the fungal enzyme 14a-demethylase which produces ergosterol, an essential component of the fungal cytoplasmic membrane (Kathiravan et al, Bioorganic and Medicinal Chemistry, 2012, 20(19), 5678-5698). It

is used predominantly in medical and cosmetic preparations as an anti-dandruff agent; it may be accompanied by other active ingredients such as zinc pyrithione or triclosan.
[0030] Solutions to different hair problems and search for a remedy for baldness or hair loss is an active area of research in the modern era. Androgenic alopecia (AA), commonly known as male pattern baldness is a typical hair loss condition affecting about 70% men. The root cause of AA is the susceptibility of hair follicles to androgen hormone-induced miniaturization (Lattanand et al., J. Cutan. Pathol., 1975, 2(58), 70). Compared to AA in men, Female Pattern Hair Loss (FPHL) generally occurs at a later age, about 40 years or older (Tajima et al., J. Dermatol. Soc, 2007, 45: 93-103). Despite several decades of research, only two FDA approved drugs, namely minoxidil (for topical application) and finasteride (for systemic delivery) are successfully used for hair growth, although several potential actives/class of compounds have been identified through in vitro and in vivo studies (Paus R., Drug Disc. Today, 2006, 3(1), 101- 110). Till date only 35% and 48% success, respectively in treating AA has been obtained with minoxidil and finasteride. Thus, a search for novel and effective compounds is still required (Jain and De-Eknamkul, Expert Opin. Ther. Targets, 2014, 18(7):787-806). The present disclosure provides a solution to the hair problems caused by various genetic and environmental effects by providing a composition comprising FCC tonic and orchid callus extract which helps in significant increase in hair growth and quality. Thus, the current composition can be used in different formulations to address varied hair problems.
[0031] In an embodiment of the present disclosure, there is provided a composition for promoting hair growth, said composition comprising: (a) climbazole; (b) caffeine; (c) diaminopyrimidine oxide; and (d) orchid callus extract, wherein climbazole to caffeine w/w ratio in said composition is in the range of 1:0.50 - 1:6, climbazole to diaminopyrimidine oxide w/w ratio in said composition is in the range of 1:1.0 - 1:12, climbazole to the orchid callus extract w/w ratio in said composition is in the range of

1:0.1 - 1:4, and caffeine to diaminopyrimidine oxide w/w ratio in said composition is
in the range of 1:0.66 - 1:6.
[0032] In an embodiment of the present disclosure, there is provided a composition
for promoting hair growth, said composition comprising: (a) climbazole; (b) caffeine;
(c) diaminopyrimidine oxide; and (d) orchid callus extract, wherein climbazole to
caffeine w/w ratio in said composition is 1:2, climbazole to diaminopyrimidine oxide
w/w ratio in said composition is 1:3, climbazole to the orchid callus extract w/w ratio
in said composition is 1:2, and caffeine to diaminopyrimidine oxide w/w ratio in said
composition is 1:1.5.
[0033] In an embodiment of the present disclosure, there is provided a composition
for promoting hair growth, said composition comprising: (a) climbazole; (b) caffeine;
(c) diaminopyrimidine oxide; and (d) orchid callus extract, wherein climbazole to
caffeine w/w ratio in said composition is 1:2.
[0034] In an embodiment of the present disclosure, there is provided a composition
for promoting hair growth, said composition comprising: (a) climbazole; (b) caffeine;
(c) diaminopyrimidine oxide; and (d) orchid callus extract, wherein climbazole to
diaminopyrimidine oxide w/w ratio in said composition is 1:3.
[0035] In an embodiment of the present disclosure, there is provided a composition
for promoting hair growth, said composition comprising: (a) climbazole; (b) caffeine;
(c) diaminopyrimidine oxide; and (d) orchid callus extract, wherein climbazole to the
orchid callus extract w/w ratio in said composition is 1:2.
[0036] In an embodiment of the present disclosure, there is provided a composition
for promoting hair growth, said composition comprising: (a) climbazole; (b) caffeine;
(c) diaminopyrimidine oxide; and (d) orchid callus extract, wherein caffeine to
diaminopyrimidine oxide w/w ratio in said composition is 1:1.5.
[0037] In an embodiment of the present disclosure, there is provided a composition
for promoting hair growth, said composition comprising: (a) climbazole; (b) caffeine;
(c) diaminopyrimidine oxide; and (d) orchid callus extract, wherein caffeine to the
orchid callus extract w/w ratio in said composition is 1:1.

[0038] In an embodiment of the present disclosure, there is provided a composition for promoting hair growth as described herein, wherein the orchid callus extract is at least one of a methanolic extract, an aqueous extract, a dichloromethane extract, and an ethanolic extract of orchid callus.
[0039] In an embodiment of the present disclosure, there is provided a composition for promoting hair growth as described herein, wherein the orchid callus extract is a methanolic extract of orchid callus.
[0040] In an embodiment of the present disclosure, there is provided a composition for promoting hair growth, said composition comprising: (a) climbazole; (b) caffeine; (c) diaminopyrimidine oxide; and (d) orchid callus extract, wherein climbazole to caffeine w/w ratio in said composition is 1:2, climbazole to diaminopyrimidine oxide w/w ratio in said composition is 1:3, climbazole to the orchid callus extract w/w ratio in said composition is 1:2, and caffeine to diaminopyrimidine oxide w/w ratio in said composition is 1:1.5, and the orchid callus extract is a methanolic extract of orchid callus.
[0041] In an embodiment of the present disclosure, there is provided a composition for promoting hair growth, said composition comprising: (a) climbazole; (b) caffeine; (c) diaminopyrimidine oxide; and (d) orchid callus extract, wherein climbazole to caffeine w/w ratio in said composition is in the range of 1:0.50 - 1:6, climbazole to diaminopyrimidine oxide w/w ratio in said composition is in the range of 1:1.0 - 1:12, climbazole to the orchid callus extract w/w ratio in said composition is in the range of 1:0.1 - 1:4, and caffeine to diaminopyrimidine oxide w/w ratio in said composition is in the range of 1:0.66 - 1:6, and the orchid callus extract is an aqueous extract of orchid callus.
[0042] In an embodiment of the present disclosure, there is provided a composition for promoting hair growth, said composition comprising: (a) climbazole; (b) caffeine; (c) diaminopyrimidine oxide; and (d) orchid callus extract, wherein climbazole to caffeine w/w ratio in said composition is 1:2, climbazole to diaminopyrimidine oxide w/w ratio in said composition is 1:3, climbazole to the orchid callus extract w/w ratio

in said composition is 1:2, and caffeine to diaminopyrimidine oxide w/w ratio in said composition is 1:1.5, and the orchid callus extract is an aqueous extract of orchid callus.
[0043] In an embodiment of the present disclosure, there is provided a composition for promoting hair growth, said composition comprising: (a) climbazole; (b) caffeine; (c) diaminopyrimidine oxide; and (d) orchid callus extract, wherein climbazole to caffeine w/w ratio in said composition is 1:2, climbazole to diaminopyrimidine oxide w/w ratio in said composition is 1:3, climbazole to the orchid callus extract w/w ratio in said composition is 1:2, and caffeine to diaminopyrimidine oxide w/w ratio in said composition is 1:1.5, climbazole weight percentage in said composition is in the range of 0.1-1.0 %, caffeine weight percentage in said composition is in the range of 0.5-1.5 %, diaminopyrimidine oxide weight percentage in said composition is in the range of 1.0-3.0 %, and the orchid callus extract weight percentage in said composition is in the range of 0.1-1.0%.
[0044] In an embodiment of the present disclosure, there is provided a composition for promoting hair growth, said composition comprising: (a) climbazole; (b) caffeine; (c) diaminopyrimidine oxide; and (d) orchid callus extract, wherein climbazole weight percentage in said composition can be in the range of 0.25-1.0 %, 0.30- 1.0%, 0.5- 0.7%, 0.5- 0.7%, and 0.4- 0.8%, provided the w/w ratio of climbazole to caffeine in said composition is in the range of 1:0.50-1:6, and climbazole to diaminopyrimidine oxide w/w ratio in said composition is in the range of 1:1.0-1:12. In another embodiment, climbazole weight percentage in said composition is 0.5%. [0045] In an embodiment of the present disclosure, there is provided a composition for promoting hair growth, said composition comprising: (a) climbazole; (b) caffeine; (c) diaminopyrimidine oxide; and (d) orchid callus extract, wherein caffeine weight percentage in said composition can be in the range of 0.5-1.5 %, 1.0-1.5%, 0.5-1.0%), 0.5-0.7%), 0.7-1.5%), and 0.9-1.5%), provided the w/w ratio of climbazole to caffeine in said composition is in the range of 1:0.50-1:6. In another embodiment, caffeine weight percentage in said composition is 1%.

[0046] In an embodiment of the present disclosure, there is provided a composition for promoting hair growth, said composition comprising: (a) climbazole; (b) caffeine; (c) diaminopyrimidine oxide; and (d) orchid callus extract, wherein diaminopyrimidine oxide weight percentage in said composition can be in the range of 1.0-2.0%, 1.5- 2.0%, 1.0-1.5%, 2-3%, and 1.25-1.75%, provided the w/w ratio of caffeine to diaminopyrimidine oxide in said composition is in the range of 1:0.66 -1:6. In another embodiment, diaminopyrimidine oxide weight percentage in said composition is 1.5%.
[0047] In an embodiment of the present disclosure, there is provided a composition for promoting hair growth, said composition comprising: (a) climbazole; (b) caffeine; (c) diaminopyrimidine oxide; and (d) orchid callus extract, wherein the orchid callus extract weight percentage in said composition can be in the range of 0.1-0.4 %, 0.2-0.4%, 0.5-0.75%, 0.8-1.0%, 0.5-5%, 0.1-0.3%, and 0.3-0.7% provided the w/w ratio of climbazole to the orchid callus extract in said composition is in the range of 1:0.1-1:4. In another embodiment, orchid callus extract weight percentage in said composition is 1%.
[0048] In an embodiment of the present disclosure, there is provided a composition for promoting hair growth as described herein, wherein the orchid callus extract is obtained from at least one species belonging to the genus Dendrobium. [0049] In an embodiment of the present disclosure, there is provided a composition herein for promoting hair growth, wherein the orchid callus extract is obtained from Dendrobium halawa.
[0050] In an embodiment of the present disclosure, there is provided a composition for promoting hair growth, said composition comprising: (a) climbazole; (b) caffeine; (c) diaminopyrimidine oxide; (d) orchid callus extract; (e) at least one solvent; (f) at least one denaturing agent; (g) at least one emulsifier; (h) at least one conditioning agent; (i) at least one moisturizing agent; (j) at least one revitalizing agent; (k) at least one antimicrobial agent; and (1) at least one perfume oil, wherein climbazole to caffeine w/w ratio in said composition is in the range of 1:0.50-1:6, climbazole to

diaminopyrimidine oxide w/w ratio in said composition is in the range of 1:1.0-1:12, climbazole to the orchid callus extract w/w ratio in said composition is in the range of 1:0.1- 1:4, and caffeine to diaminopyrimidine oxide w/w ratio in said composition is in the range of 1:0.66 - 1:6.
[0051] In an embodiment of the present disclosure, there is provided a composition for promoting hair growth, said composition comprising: (a) climbazole; (b) caffeine; (c) diaminopyrimidine oxide; (d) orchid callus extract; (e) at least one solvent; (f) at least one denaturing agent; (g) at least one emulsifier; (h) at least one conditioning agent; (i) at least one moisturizing agent; (j) at least one revitalizing agent; (k) at least one antimicrobial agent; and (1) at least one perfume oil, wherein climbazole to caffeine w/w ratio in said composition is in the range of 1:0.50-1:6, climbazole to diaminopyrimidine oxide w/w ratio in said composition is in the range of 1:1.0-1:12, climbazole to orchid callus extract w/w ratio in said composition is in the range of 1:0.1- 1:4, caffeine to diaminopyrimidine oxide w/w ratio in said composition is in the range of 1:0.66 - 1:6, and the orchid callus extract is a methanolic extract of orchid callus. In another embodiment, the orchid callus extract is a methanolic extract of Dendrobium halawa.
[0052] In an embodiment of the present disclosure, there is provided a composition for promoting hair growth, said composition comprising: (a) climbazole; (b) caffeine; (c) diaminopyrimidine oxide; (d) orchid callus extract; (e) at least one solvent; (f) at least one denaturing agent; (g) at least one emulsifier; (h) at least one conditioning agent; (i) at least one moisturizing agent; (j) at least one revitalizing agent; (k) at least one antimicrobial agent; and (1) at least one perfume oil, wherein climbazole to caffeine w/w ratio in said composition is in the range of 1:0.50-1:6, climbazole to diaminopyrimidine oxide w/w ratio in said composition is in the range of 1:1.0-1:12, climbazole to orchid callus extract w/w ratio in said composition is in the range of 1:0.1 - 1:4, caffeine to diaminopyrimidine oxide w/w ratio in said composition is in the range of 1:0.66 - 1:6, and the orchid callus extract is an aqueous extract of orchid

callus. In another embodiment, the orchid callus extract is an aqueous extract of Dendrobium halawa.
[0053] In an embodiment of the present disclosure, there is provided a composition for promoting hair growth, said composition comprising: (a) climbazole having a weight percentage in said composition in the range of 0.25-1.0 %; (b) caffeine having a weight percentage in said composition in the range of 0.5-1.5 %; (c) diaminopyrimidine oxide having a weight percentage in said composition in the range of 1.0-3.0 %; (d) orchid callus extract having a weight percentage in said composition in the range of 0.10-1.0%; (e) at least one solvent; (f) at least one denaturing agent; (g) at least one emulsifier; (h) at least one conditioning agent; (i) at least one moisturizing agent; (j) at least one revitalizing agent; (k) at least one antimicrobial agent; and (1) at least one perfume oil, wherein climbazole to caffeine w/w ratio in said composition is in the range of 1:0.50-1:6, climbazole to diaminopyrimidine oxide w/w ratio in said composition is in the range of 1:1.0-1:12, climbazole to orchid callus extract w/w ratio in said composition is in the range of 1:0.1- 1:4, and caffeine to diaminopyrimidine oxide w/w ratio in said composition is in the range of 1:0.66 -1:6.
[0054] In an embodiment of the present disclosure, there is provided a composition for promoting hair growth, said composition comprising: (a) climbazole; (b) caffeine; (c) diaminopyrimidine oxide; (d) orchid callus extract; (e) at least one solvent; (f) at least one denaturing agent; (g) at least one emulsifier; (h) at least one conditioning agent; (i) at least one moisturizing agent; (j) at least one revitalizing agent; (k) at least one antimicrobial agent; and (1) at least one perfume oil, wherein climbazole to caffeine w/w ratio in said composition is 1:2, climbazole to diaminopyrimidine oxide w/w ratio in said composition is 1:3, climbazole to orchid callus extract w/w ratio in said composition is 1:2, and caffeine to diaminopyrimidine oxide w/w ratio in said composition is 1:1.5.
[0055] In an embodiment of the present disclosure, there is provided a composition for promoting hair growth, said composition comprising: (a) climbazole; (b) caffeine;

(c) diaminopyrimidine oxide; (d) orchid callus extract; (e) at least one solvent; (f) at least one denaturing agent; (g) at least one emulsifier; (h) at least one conditioning agent; (i) at least one moisturizing agent; (j) at least one revitalizing agent; (k) at least one antimicrobial agent; and (1) at least one perfume oil, wherein the at least one solvent is selected from the group consisting of ethanol, polyethylene glycol, mineral oil, and combinations thereof.
[0056] In an embodiment of the present disclosure, there is provided a composition for promoting hair growth, said composition comprising: (a) climbazole; (b) caffeine; (c) diaminopyrimidine oxide; (d) orchid callus extract; (e) at least one solvent; (f) at least one denaturing agent; (g) at least one emulsifier; (h) at least one conditioning agent; (i) at least one moisturizing agent; (j) at least one revitalizing agent; (k) at least one antimicrobial agent; and (1) at least one perfume oil, wherein the denaturing agent is diethyl phthalate.
[0057] In an embodiment of the present disclosure, there is provided a composition for promoting hair growth, said composition comprising: (a) climbazole; (b) caffeine; (c) diaminopyrimidine oxide; (d) orchid callus extract; (e) at least one solvent; (f) at least one denaturing agent; (g) at least one emulsifier; (h) at least one conditioning agent; (i) at least one moisturizing agent; (j) at least one revitalizing agent; (k) at least one antimicrobial agent; and (1) at least one perfume oil, wherein the at least one emulsifier is selected from the group consisting of polysorbate 20, PEG-40, hydrogenated castor oil, and combinations thereof.
[0058] In an embodiment of the present disclosure, there is provided a composition for promoting hair growth, said composition comprising: (a) climbazole; (b) caffeine; (c) diaminopyrimidine oxide; (d) orchid callus extract; (e) at least one solvent; (f) at least one denaturing agent; (g) at least one emulsifier; (h) at least one conditioning agent; (i) at least one moisturizing agent; (j) at least one revitalizing agent; (k) at least one antimicrobial agent; and (1) at least one perfume oil, wherein the at least one conditioning agent is selected from the group consisting of PEG-12 dimethicone, allantoin, and combinations thereof.

[0059] In an embodiment of the present disclosure, there is provided a composition for promoting hair growth, said composition comprising: (a) climbazole; (b) caffeine; (c) diaminopyrimidine oxide; (d) orchid callus extract; (e) at least one solvent; (f) at least one denaturing agent; (g) at least one emulsifier; (h) at least one conditioning agent; (i) at least one moisturizing agent; (j) at least one revitalizing agent; (k) at least one microbial agent; and (1) at least one perfume oil, wherein the at least one moisturizing agent is selected from the group consisting of glycol distearate, mineral oil, glyceryl stearate, isopropyl palmitate, glycol distearate, shea butter, and combinations thereof.
[0060] In an embodiment of the present disclosure, there is provided a composition for promoting hair growth, said composition comprising: (a) climbazole having a weight percentage in the range of 0.1-1%; (b) caffeine having a weight percentage in the range of 0.5-1.5%; (c) diaminopyrimidine oxide having a weight percentage in the range of 1-3%; (d) orchid callus extract having a weight percentage in the range of 0.1-1%; (e) ethanol having a weight percentage in the range of 9.5-14.5%; (f) diethyl phthalate having a weight percentage in the range of 0.1 -2%; (g) polysorbate 20 having a weight percentage in the range of 5-15%; (h) PEG 12 dimethicone having a weight percentage in the range of 2-10%; (i) PEG 7-glyceryl cocoate having a weight percentage in the range of 0.5-2%; (j) propylene glycol having a weight percentage in the range of 1-10%; (k) D-panthenol having a weight percentage in the range of 0.05-0.15%; (1) a combination of magnesium aspartate, zinc gluconate, and copper gluconate having a weight percentage in the range of 0.08-1.5%; (m) a combination of phenoxyethanol, methylparaben, ethylparaben, propylparaben, butylparaben, and isobutylparaben having a weight percentage in the range of 0.08-0.8%; (n) allantoin having a weight percentage in the range of 0.01-0.1%; and (o) at least one perfume oil having a weight percentage in the range of 0.1-1%, wherein climbazole to caffeine w/w ratio in said composition is in the range of 1:0.50-1:6, climbazole to diaminopyrimidine oxide w/w ratio in said composition is in the range of 1:1.0-1:12, climbazole to orchid callus extract w/w ratio in said composition is in the range of

1:0.1 - 1:4, and caffeine to diaminopyrimidine oxide w/w ratio in said composition is in the range of 1:0.66 -1:6.
[0061] In an embodiment of the present disclosure, there is provided a composition for promoting hair growth, said composition comprising: (a) climbazole having a weight percentage of 0.5%; (b) caffeine having a weight percentage of 0.5%; (c) diaminopyrimidine oxide having a weight percentage of 1.5%; (d) orchid callus extract having a weight percentage of 1%; (e) ethanol having a weight percentage of 12.3%; (f) diethyl phthalate having a weight percentage of 1%; (g) polysorbate 20 having a weight percentage of 10%; (h) PEG 12 dimethicone having a weight percentage of 6%; (i) PEG 7-glyceryl cocoate having a weight percentage of 1%; (j) propylene glycol having a weight percentage of 3%; (k) D-panthenol having a weight percentage of 0.1%; (1) a combination of magnesium aspartate, zinc gluconate, and copper gluconate having a weight percentage of 0.1%; (m) a combination of phenoxyethanol, methylparaben, ethylparaben, propylparaben, butylparaben, and isobutylparaben having a weight percentage of 0.5%; (n) allantoin having a weight percentage of 0.05%; and (o) at least one perfume oil having a weight percentage of 0.6%), wherein climbazole to caffeine w/w ratio in said composition is in the range of 1:0.50-1:6, climbazole to diaminopyrimidine oxide w/w ratio in said composition is in the range of 1:1.0-1:12, climbazole to orchid callus extract w/w ratio in said composition is in the range of 1:0.1 - 1:4, and caffeine to diaminopyrimidine oxide w/w ratio in said composition is in the range of 1:0.66 -1:6.
[0062] In an embodiment of the present disclosure, there is provided a composition for promoting hair growth as described herein, wherein ethanol weight percentage in said composition can be in the range of 9.5-14.5%, 10-12%, 11- 14.5%, and 9.5%-12%.
[0063] In an embodiment of the present disclosure, there is provided a composition for promoting hair growth as described herein, wherein diethyl phthalate weight percentage in said composition can be in the range of 0.1-2 %, 0.1-0.5%), 1- 2%, 0.7-2%, 0.8- 1.5% and 0.5- 1.5%.

[0064] In an embodiment of the present disclosure, there is provided a composition
for promoting hair growth as described herein, wherein polysorbate 20 weight
percentage of in said composition can be in the range of 5-15 %, 5-10%, 10-15%, 8-
12%, and 5-12%.
[0065] In an embodiment of the present disclosure, there is provided a composition
for promoting hair growth as described herein, PEG-12 dimethicone weight
percentage in said composition can be in the range of 2-10 %, 5-10%, 2-8%, 3-9%
and 4-7%.
[0066] In an embodiment of the present disclosure, there is provided a composition
for promoting hair growth as described herein, wherein propylene glycol weight
percentage in said composition can be in the range of 1-10 %, 5-10%, 7-10%, 4-8%
and 3-7%.
[0067] In an embodiment of the present disclosure, there is provided a composition
for promoting hair growth as described herein, wherein allantoin weight percentage in
said composition can be in the range of 0.01-0.1%, 0.04- 0.07%, 0.045- 0.075%.
[0068] In an embodiment of the present disclosure, there is provided a composition
for promoting hair growth as described herein, wherein PEG-7 glyceryl cocoate
weight percentage in said composition can be in the range of 0.5-2 %, 1-2%, and
1.5-2%.
[0069] In an embodiment of the present disclosure, there is provided a composition
for promoting hair growth as described herein, wherein D-panthenol weight
percentage oin said composition can be in the range of 0.05-0.15 %, and 0.05-1%.
[0070] In an embodiment of the present disclosure, there is provided a composition
for promoting hair growth a described herein, wherein perfume oil weight percentage
in said composition can be in the range of 0.1-1.0 %, 0.5-1.0%, 0.2-0.8%, 0.2-1.0%,
and 0.4-0.8%.
[0071] In an embodiment of the present disclosure, there is provided a composition
for promoting hair growth as described herein, wherein the combination of

magnesium aspartate, zinc gluconate, and copper gluconate weight percentage in said combination can be in the range of 0.08-1.5 %, 1-1.5%, and 0.08- 1.0%. [0072] In an embodiment of the present disclosure, there is provided a composition for promoting hair growth as described herein, wherein the combination of phenoxyethanol, methylparaben, ethylparaben, propylparaben, butylparaben, and isobutylparaben weight percentage in said composition can be in the range of 0.08-0.12 %, 0.08- 0.2%, 0.1-0.5%, and 0.08-0.5%.
[0073] In an embodiment of the present disclosure, there is provided a method for preparation of a composition comprising: (a) climbazole; (b) caffeine; (c) diaminopyrimidine oxide; and (d) orchid callus extract, said method comprising: (i) obtaining climbazole; (ii) obtaining caffeine; (iii) obtaining diaminopyrimidine oxide; (iv) obtaining the orchid callus extract; and (v) contacting climbazole, caffeine, diaminopyrimidine oxide and the orchid callus extract to obtain said composition, wherein climbazole to caffeine w/w ratio in said composition is in the range of 1:0.50-1:6, climbazole to diaminopyrimidine oxide w/w ratio in said composition is in the range of 1:1.0-1:12, climbazole to the orchid callus extract w/w ratio in said composition is in the range of 1:0.1-1:4, and caffeine to diaminopyrimidine oxide w/w ratio in said composition is in the range of 1:0.66-l :6.
[0074] In an embodiment of the present disclosure, there is provided a method for preparation of a composition comprising: (a) climbazole; (b) caffeine; (c) diaminopyrimidine oxide; and (d) orchid callus extract, said method comprising: (i) obtaining climbazole; (ii) obtaining caffeine; (iii) obtaining diaminopyrimidine oxide; (iv) obtaining the orchid callus extract; and (v) contacting climbazole, caffeine, diaminopyrimidine oxide and orchid callus extract to obtain said composition, wherein climbazole to caffeine w/w ratio in said composition is in the range of 1:0.50-1:6, climbazole to diaminopyrimidine oxide w/w ratio in said composition is in the range of 1:1.0-1:12, climbazole to the orchid callus extract w/w ratio in said composition is in the range of 1:0.1-1:4, and caffeine to diaminopyrimidine oxide w/w ratio in said composition is in the range of 1:0.66 -1:6, wherein climbazole

weight percentage in said composition is in the range of 0.1-1.0%, caffeine weight percentage in said composition is in the range of 0.5-1.5%, diaminopyrimidine oxide weight percentage in said composition is in the range of 1.0-3.0%), and the orchid callus extract weight percentage in said composition is in the range of 0.1-1%. [0075] In an embodiment of the present disclosure, there is provided a method for preparation of a composition comprising: (a) climbazole; (b) caffeine; (c) diaminopyrimidine oxide; and (d) orchid callus extract, said method comprising: (i) obtaining climbazole; (ii) obtaining caffeine; (iii) obtaining diaminopyrimidine oxide; (iv) obtaining orchid callus extract; and (v) contacting climbazole, caffeine, diaminopyrimidine oxide and orchid callus extract to obtain said composition, wherein climbazole to caffeine w/w ratio in said composition is 1:2, climbazole to diaminopyrimidine oxide w/w ratio in said composition is 1:3, climbazole to orchid callus extract w/w ratio in said composition is 1:2, and caffeine to diaminopyrimidine oxide w/w ratio in said composition is 1:1.5.
[0076] In an embodiment of the present disclosure, there is provided a method for preparation of a composition comprising: (a) climbazole; (b) caffeine; (c) diaminopyrimidine oxide; and (d) orchid callus extract, said method comprising: (i) obtaining climbazole; (ii) obtaining caffeine; (iii) obtaining diaminopyrimidine oxide; (iv) obtaining orchid callus extract; and (v) contacting climbazole, caffeine, diaminopyrimidine oxide and orchid callus extract to obtain said composition, wherein climbazole to caffeine w/w ratio in said composition is in the range of 1:0.50-1:6, climbazole to diaminopyrimidine oxide w/w ratio in said composition is in the range of 1:1.0-1:12, climbazole to orchid callus extract w/w ratio in said composition is in the range of 1:0.1-1:4, and caffeine to diaminopyrimidine oxide w/w ratio in said composition is in the range of 1:0.66 -1:6, and the orchid callus extract is at least one of a methanolic extract, an aqueous extract, a dichloromethane extract, and an ethanolic extract of orchid callus.
[0077] In an embodiment of the present disclosure, there is provided a method for preparation of a composition comprising: (a) climbazole; (b) caffeine; (c)

diaminopyrimidine oxide; and (d) orchid callus extract, said method comprising: (i) obtaining climbazole; (ii) obtaining caffeine; (iii) obtaining diaminopyrimidine oxide; (iv) obtaining orchid callus extract; and (v) contacting climbazole, caffeine, diaminopyrimidine oxide and orchid callus extract to obtain said composition, wherein climbazole to caffeine w/w ratio in said composition is in the range of 1:0.50-1:6, climbazole to diaminopyrimidine oxide w/w ratio in said composition is in the range of 1:1.0-1:12, climbazole to orchid callus extract w/w ratio in said composition is in the range of 1:0.1-1:4, and caffeine to diaminopyrimidine oxide w/w ratio in said composition is in the range of 1:0.66 -1:6, and the orchid callus extract is a methanolic extract of orchid callus.
[0078] In an embodiment of the present disclosure, there is provided a method for preparation of a composition comprising: (a) climbazole; (b) caffeine; (c) diaminopyrimidine oxide; and (d) orchid callus extract, said method comprising: (i) obtaining climbazole; (ii) obtaining caffeine; (iii) obtaining diaminopyrimidine oxide; (iv) obtaining orchid callus extract; and (v) contacting climbazole, caffeine, diaminopyrimidine oxide and orchid callus extract to obtain said composition, wherein climbazole to caffeine w/w ratio in said composition is in the range of 1:0.50-1:6, climbazole to diaminopyrimidine oxide w/w ratio in said composition is in the range of 1:1.0-1:12, climbazole to orchid callus extract w/w ratio in said composition is in the range of 1:0.1-1:4, and caffeine to diaminopyrimidine oxide w/w ratio in said composition is in the range of 1:0.66 -1:6, and the orchid callus extract is an aqueous extract of orchid callus.
[0079] In an embodiment of the present disclosure, there is provided a method for preparing a composition comprising: (a) climbazole; (b) caffeine; (c) diaminopyrimidine oxide; (d) orchid callus extract; (e) at least one solvent; (f) at least one denaturing agent; (g) at least one emulsifier; (h) at least one conditioning agent; (i) at least one moisturizing agent; (j) at least one revitalizing agent; (k) at least one antimicrobial; and (1) at least one perfume oil, said method comprising: (i) obtaining climbazole; (ii) obtaining caffeine; (iii) obtaining diaminopyrimidine oxide; (iv)

obtaining orchid callus extract; (v) obtaining the at least one solvent; (vi) obtaining the at least one denaturing agent; (vii) obtaining the at least one emulsifier; (viii) obtaining the at least one conditioning agent; (ix) obtaining the at least one moisturizing agent; (x) obtaining the at least one revitalizing agent; (xi) obtaining the at least one antimicrobial; (xii) obtaining the at least one perfume oil; and (xiii) contacting climbazole, caffeine, diaminopyrimidine oxide, the orchid callus extract, the at least one solvent, the at least one denaturing agent, the at least one emulsifier, the at least one conditioning agent, the at least one moisturizing agent, the at least one revitalizing agent, the at least one antimicrobial, the at least one perfume oil to obtain said composition, wherein climbazole to caffeine w/w ratio in said composition is in the range of 1:0.50-1:6, climbazole to diaminopyrimidine oxide w/w ratio in said composition is in the range of 1:1.0-1:12, climbazole to the orchid callus extract w/w ratio in said composition is in the range of 1:0.1-1:4, and caffeine to diaminopyrimidine oxide w/w ratio in said composition is in the range of 1:0.66 -1:6. [0080] In an embodiment of the present disclosure, there is provided a method for preparing a composition comprising: (a) climbazole; (b) caffeine; (c) diaminopyrimidine oxide; (d) orchid callus extract; (e) ethanol; (f) diethyl phthalate; (g) polysorbate 20; (h) PEG-12 dimethicone; (i) propylene glycol; (j) PEG-7 glyceryl cocoate; (k) D-panthenol; (1) perfume oil; (m) a combination of magnesium aspartate, zinc gluconate, and copper gluconate; (n) allantoin; and (o) phenoxyethanol, methyl paraben, ethylparaben, propylparaben, butylparaben, and isobutylparaben, said method comprising: (i) obtaining ethanol; (ii) obtaining diethyl phthalate; (iii) obtaining polysorbate 20; (iv) obtaining PEG-12 dimethicone; (v) obtaining propylene glycol; (vi) obtaining PEG-7 glyceryl cocoate; (vii) obtaining D-panthenol; (viii) obtaining perfume oil; (ix) obtaining diaminopyrimidine oxide; (x) obtaining caffeine; (xi) obtaining climbazole; (xii) obtaining orchid callus extract; (xiii) obtaining a combination of magnesium aspartate, zinc gluconate, and copper gluconate; (xiv) obtaining phenoxyethanol, methylparaben, ethylparaben, propylparaben, butylparaben, and isobutylparaben; (xv) obtaining allantoin; and (xvi)

contacting ethanol, diethyl phthalate, polysorbate 20, PEG-12 dimethicone, propylene glycol, PEG-7 glyceryl cocoate, D-panthenol, perfume oil, diaminopyrimidine oxide, caffeine, climbazole, orchid callus extract, a combination of magnesium aspartate, zinc gluconate, and copper gluconate, a combination of phenoxyethanol, methylparaben, ethylparaben, propylparaben, butylparaben, and isobutylparaben to obtain said composition, wherein climbazole to caffeine w/w ratio in said composition is 1:2, climbazole to diaminopyrimidine oxide w/w ratio in said composition is 1:3, climbazole to orchid callus extract w/w ratio in said composition is 1:2, and caffeine to diaminopyrimidine oxide w/w ratio in said composition is 1:1.5.
[0081] In an embodiment of the present disclosure, there is provided a method for preparing a composition comprising: (a) climbazole having weight percentage in the range of 0.1 - 1 %; (b) caffeine having weight percentage in the range of 0.5 - 1.5 %; (c) diaminopyrimidine oxide having weight percentage in the range of 1- 3 %; (d) orchid callus extract having weight percentage in the range of 0.1 - 1.0%; (e) ethanol having weight percentage in the range of 9.5 - 14.5 %; (f) diethyl phthalate having weight percentage in the range of 0.1 - 2 %; (g) polysorbate 20 having weight percentage in the range of 5- 15 %; (h) PEG-12 dimethicone having weight percentage in the range of 2 - 10 %; (i) allantoin having weight percentage in the range of 0.01-0.1%; (j) propylene glycol having weight percentage in the range of 1-10%; (k) PEG-7 glyceryl cocoate having weight percentage in the range of 0.5 - 2 %; (1) D-panthenol having weight percentage in the range of 0.05 - 0.15 %; (m) perfume oil having weight percentage in the range of 0.1 - 1.0 %; (n) a combination of magnesium aspartate, zinc gluconate, and copper gluconate having weight percentage in the range of 0.08 - 1.5 %; and (o) phenoxyethanol, methyl paraben, ethylparaben, propylparaben, butylparaben, and isobutylparaben having weight percentage in the range of 0.08-0.5 %, said method comprising: (i) obtaining ethanol; (ii) obtaining diethyl phthalate; (iii) obtaining polysorbate 20; (iv) obtaining PEG-12 dimethicone; (v) obtaining propylene glycol; (vi) obtaining PEG-7 glyceryl cocoate; (vii) obtaining

D-panthenol; (viii) obtaining perfume oil; (ix) obtaining diaminopyrimidine oxide; (x) obtaining caffeine; (xi) obtaining climbazole; (xii) obtaining the orchid callus extract; (xiii) obtaining a combination of magnesium aspartate, zinc gluconate, and copper gluconate; (xiv) obtaining phenoxyethanol, methylparaben, ethylparaben, propylparaben, butylparaben, and isobutylparaben; (xv) allantoin and (xvi) contacting ethanol, diethyl phthalate, polysorbate 20, PEG-12 dimethicone, propylene glycol, PEG-7 glyceryl cocoate, D-panthenol, perfume oil, diaminopyrimidine oxide, caffeine, climbazole, orchid callus extract, a combination of magnesium aspartate, zinc gluconate, and copper gluconate, phenoxyethanol, methylparaben, ethylparaben, propylparaben, butylparaben, and isobutylparaben, and allantoin to obtain said composition, wherein climbazole to caffeine w/w ratio in said composition is in the range of 1:0.50-1:6, climbazole to diaminopyrimidine oxide w/w ratio in said composition is in the range of 1:1.0-1:12, climbazole to orchid callus extract w/w ratio in said composition is in the range of 1:0.1-1:4, and caffeine to diaminopyrimidine oxide w/w ratio in said composition is in the range of 1:0.66-l :6. [0082] In an embodiment of the present disclosure, there is provided a method for preparing a composition comprising: (a) climbazole having weight percentage of 0.5%; (b) caffeine having weight percentage of 1%; (c) diaminopyrimidine oxide having weight percentage of 1.5%; (d) orchid callus extract having weight percentage of 1.0%; (e) ethanol having weight percentage of 12.3%; (f) diethyl phthalate having weight percentage of 1%; (g) polysorbate 20 having weight percentage of 10%; (h) PEG-12 dimethicone having weight percentage of 6%; (i) propylene glycol having weight percentage of 3%; (j) PEG-7 glyceryl cocoate having weight percentage of 1 %; (k) D-panthenol having weight percentage of 0.1%; (1) perfume oil having weight percentage of 0.6%; (m) a combination of magnesium aspartate, zinc gluconate, and copper gluconate having weight percentage of 0.1%; (n) allantoin having a weight percentage of 0.05%; and (n) phenoxyethanol, methyl paraben, ethylparaben, propylparaben, butylparaben, and isobutylparaben having weight percentage of 0.5%, said method comprising: (i) obtaining ethanol; (ii) obtaining diethyl phthalate; (iii)

obtaining polysorbate 20; (iv) obtaining PEG-12 dimethicone; (v) obtaining propylene glycol; (vi) obtaining PEG-7 glyceryl cocoate; (vii) obtaining D-panthenol; (viii) obtaining perfume oil; (ix) obtaining diaminopyrimidine oxide; (x) obtaining caffeine; (xi) obtaining climbazole; (xii) obtaining orchid callus extract; (xiii) obtaining a combination of magnesium aspartate, zinc gluconate, and copper gluconate; (xiv) obtaining phenoxyethanol, methylparaben, ethylparaben, propylparaben, butylparaben, and isobutylparaben; and (xv) contacting ethanol, diethyl phthalate, polysorbate 20, PEG-12 dimethicone, propylene glycol, PEG-7 glyceryl cocoate, D-panthenol, perfume oil, allantoin, diaminopyrimidine oxide, caffeine, climbazole, orchid callus extract, a combination of magnesium aspartate, zinc gluconate, and copper gluconate, a combination of a combination of phenoxyethanol, methylparaben, ethylparaben, propylparaben, butylparaben, and isobutylparaben to obtain said composition, wherein climbazole to caffeine w/w ratio in said composition is 1:2, climbazole to diaminopyrimidine oxide w/w ratio in said composition is 1:3, climbazole to orchid callus extract w/w ratio in said composition is 1:2, and caffeine to diaminopyrimidine oxide w/w ratio in said composition is 1:1.5.
[0083] In an embodiment of the present disclosure, there is provided a method for promoting hair length, said method comprising: (a) obtaining a composition comprising: (i) climbazole; (ii) caffeine; (iii) diaminopyrimidine oxide; and (iv) orchid callus extract; and (b) contacting said composition with hair follicles, wherein said composition promotes hair length and climbazole to caffeine w/w ratio in said composition is in the range of 1:0.50-1:6, climbazole to diaminopyrimidine oxide w/w ratio in said composition is in the range of 1:1.0-1:12, climbazole to the orchid callus extract w/w ratio in said composition is in the range of 1:0.1-1:4, and caffeine to diaminopyrimidine oxide w/w ratio in said composition is in the range of 1:0.66-1:6.
[0084] In an embodiment of the present disclosure, there is provided a method for promoting hair length, said method comprising: (a) obtaining a composition

comprising: (i) climbazole having weight percentage in the range of 0.1 - 1.0 %; (ii) caffeine having weight percentage in the range of 0.5 - 1.5 %; (iii) diaminopyrimidine oxide having weight percentage in the range of 1.0 - 3.0 %; and (iv) orchid callus extract having weight percentage in the range of 0.1 - 1.0%; and (b) contacting said composition with hair follicles, wherein said composition promotes hair length and climbazole to caffeine w/w ratio in said composition is in the range of 1:0.50-1:6, climbazole to diaminopyrimidine oxide w/w ratio in said composition is in the range of 1:1.0-1:12, climbazole to orchid callus extract w/w ratio in said composition is in the range of 1:0.1-1:4, and caffeine to diaminopyrimidine oxide w/w ratio in said composition is in the range of 1:0.66 -1:6.
[0085] In an embodiment of the present disclosure, there is provided a method for promoting hair length, said method comprising: (a) obtaining a composition comprising: (i) climbazole having weight percentage of 0.5%; (ii) caffeine having weight percentage of 1%; (iii) diaminopyrimidine oxide having weight percentage of 1.5 %; and (iv) orchid callus extract having weight percentage of 0.25%; and (b) contacting said composition with hair follicles, wherein said composition promotes hair length and climbazole to caffeine w/w ratio in said composition is 1:2, climbazole to diaminopyrimidine oxide w/w ratio in said composition is 1:3, climbazole to orchid callus extract w/w ratio in said composition is 1:2, and caffeine to diaminopyrimidine oxide w/w ratio in said composition is 1:1.5. [0086] In an embodiment of the present disclosure, there is provided a method for promoting hair density, said method comprising: (a) obtaining a composition comprising: (i) climbazole; (ii) caffeine; (iii) diaminopyrimidine oxide; and (iv) orchid callus extract; and (b) contacting said composition with hair follicles, wherein said composition promotes hair density and climbazole to caffeine w/w ratio in said composition is in the range of 1:0.50-1:6, climbazole to diaminopyrimidine oxide w/w ratio in said composition is in the range of 1:1.0-1:12, climbazole to orchid callus extract w/w ratio in said composition is in the range of 1:0.1-1:4, and caffeine

to diaminopyrimidine oxide w/w ratio in said composition is in the range of 1:0.66 -
1:6.
[0087] In an embodiment of the present disclosure, there is provided a composition
for promoting hair growth as described herein, for topical use.
[0088] In an embodiment of the present disclosure, there is provided a composition
for promoting hair growth as described herein, for use as a gel.
[0089] In an embodiment of the present disclosure, there is provided a composition
for promoting hair growth as described herein, for use as an oil.
[0090] In an embodiment of the present disclosure, there is provided a composition
for promoting hair growth as described herein, for use as a serum.
[0091] Although the subject matter has been described with reference to specific
embodiments, this description is not meant to be construed in a limiting sense.
Various modifications of the disclosed embodiments, as well as alternate
embodiments of the subject matter, will become apparent to persons skilled in the art
upon reference to the description of the subject matter. It is therefore contemplated
that such modifications can be made without departing from the spirit or scope of the
present subject matter as defined.
EXAMPLES
[0092] The disclosure will now be illustrated with working examples, which is intended to illustrate the working of disclosure and not intended to take restrictively to imply any limitations on the scope of the present disclosure. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood to one of ordinary skill in the art to which this disclosure belongs. Although methods and materials similar or equivalent to those described herein can be used in the practice of the disclosed methods and compositions, the exemplary methods, devices and materials are described herein. It is to be understood that this disclosure is not limited to particular methods, and experimental conditions described, as such methods and conditions may vary.

[0093] The paragraphs below provide exemplification for the claimed composition. There are provided examples and best method for preparing the composition. As the composition is directed towards a hair growth formulation, working examples with respect to hair growth assay and clonogenic assay have been demonstrated.
Materials and Methods Example 1
[0094] Generation and cultivation of callus from orchid: The protocol for cultivating callus from orchid had been disclosed in Indian application number -2401/CHE/2014. Briefly, for the preparation of callus culture, mother plant from in-vitro cultures of orchid was taken. The particular orchid species used for the study was Dendrobium halawa. The species was obtained from Singapore Botanical Garden as an in-vitro culture bottle. The meristematic tissue in the mother plant is dissected and inoculated into callus inducing media. Callus induction takes place in 3 to 4 week time in 20 to 30% of the explants. The induced callus is further sub-cultured once in 3 weeks for 3 to 4 sub-cultures. By this time, the size of the callus is that of a pepper seed. In subsequent two transfers, the callus grows into a size of 1cm diameter. The calluses are re sub-cultured in callus multiplication media where the callus multiplies at the rate of 2 to 3 times during each sub-culture. Usually the callus is sub-cultured in 4 week time in multiplication media. Once an adequate amount of callus was obtained, the extracts were prepared. Example 2
[0095] Extraction protocol for plant calluses: The process for obtaining dichloromethane extract, methanolic extract, and aqueous extract from orchid callus had been disclosed in Indian application Number - 2401/CHE/2014. [0096] Example 3
[0097] FCC (Follicare Complex) Formulation: The components of the FCC formulation were chosen with the aim of targeting the prostaglandin pathway to

stimulate hair growth. The prostaglandin pathway has been implicated in hair loss as it has been observed that the prostaglandin pathway is up-regulated in tissue undergoing hair loss. Thus, the composition chosen comprises climbazole or caffeine or diaminopyrimidine oxide or combinations thereof at various w/w ratios and concentrations, to stimulate hair growth via the prostaglandin pathway. Table 1 below lists the various components of the Follicare Complex (FCC Tonic).


Example 4
[0098] In-vitro hair growth assay: Following consent, hair follicles from the scalp of healthy donors were plucked using a standardized protocol by medical doctors. Hair follicles were collected and maintained in William's E medium (Invitrogen, CA, USA) till use. Following PBS (Sigma) wash, the hair follicles were trimmed to about lcm from the bulb using scissors without harming the root. Hair follicles with an intact bulb and root sheath (RS) were selected for this study. Hair follicles were treated with various combinations of the composition as described herein, and cultured in 24 well plates in a standard cell culture incubator. Single hair follicles were maintained in a free-floating and isolated state in each well. On day zero, the length of each hair follicle was measured under the microscope (Leica DMI 4000B) using Leica Q Win Image processing and analysis software V.3.5.0. Medium change was carried out on every alternate day and the length of hair follicles were measured on Day 6 of the assay. Each treatment was tested on 10 hair follicles and this was repeated independently. An average of 20 hair follicles was calculated and taken as the average growth of a hair follicle (increase in length). Standard deviation (SD) and P values were calculated. Example 5
[0099] Clonogenic assay: Human hair follicle stem cells (hFSC) were cultured in serum free medium diluted at 1:1000 ratio with FCC supplemented with orchid extract (aqueous extract and methanolic extract) or without extract for 3 days in a normal cell culture incubator. As a positive control, hFSC were cultured in medium containing serum. Thereafter these stem cells were trypsinised and seeded at a low density in ECM coated T25 flasks in triplicates and incubated at 37°C for 9 days. Colony forming units (CFUs) were stained with crystal violet and counted with naked eye.
Results of the experiment performed
Effect of a combination of FCC tonic and orchid callus extract on hair growth

[00100] Figure 1 depicts the effect of a combination of FCC tonic and orchid callus extract on hair cell growth. FCC tonic in combination with the methanolic orchid callus extract was tested. A concentration in the range of 0.1 % - 1 % of orchid callus was tested. Williams E media with supplements was taken as a positive control. FCC tonic in isolation was able to promote hair growth to a length of less than 20 um. Unexpectedly and surprisingly, a combination of FCC tonic with the methanolic orchid callus extract at concentration of 0.25% could induce further hair growth in comparison to FCC alone. 0.25 % of orchid callus extract with FCC tonic showed an average hair growth of 24 um which represents a 30% increase in the growth of hair as compared to the FCC tonic on its own. This effect is not observed using other combinations of FCC tonic with orchid callus extract. For instance, using 0.5% orchid callus extract with FCC tonic, resulted in a decrease of average hair growth at 16.8 um, in comparison to FCC alone. Thus, all combinations of FCC tonic with the callus extract does not yield the same effect, and the present composition cannot be arrived at without undue experimentation. Overall, these set of results suggest that while FCC tonic shows potential of to be used for supporting hair problems, the effect of a combination of FCC tonic with orchid callus extract at 0.25% exhibits a better result in promoting the growth of hair follicle. Further this effect can be obtained only at specific ratios of the FCC tonic and orchid callus extract.
Effect of a combination of FCC tonic and orchid callus extract (methanolic extract and aqueous extract) on hair growth
[00101] Figure 2 depicts the effect of a combination of FCC tonic and orchid callus aqueous extract, and a combination of FCC tonic and orchid callus methanolic extract on hair cell growth. This experiment was performed to compare the effects of orchid callus aqueous extract in combination with FCC tonic to orchid callus methanolic extract in combination with FCC tonic on hair growth. Hair growth with Williams E media along with supplements was tested and regarded as a positive control and hair growth without the supplement was tested and regarded as a negative control. FCC

tonic was tested with two different concentrations of 1% and 0.1% of the orchid callus aqueous extract, while it was tested with 0.1% of methanolic extract of orchid callus. On observing Figure 2, it can be appreciated that the combination of FCC tonic and 1% aqueous extract of orchid callus results in highest hair growth (13um), more than that observed with only FCC tonic (9um) or with a combination of FCC tonic and 0.1 % aqueous extract (lOum). The growth of hair on treatment with a combination of FCC tonic and 0.1% methanolic extract of orchid callus is around Hum. Therefore, it can be ascertained that the combination of FCC tonic and 1% of aqueous extract of orchid callus is surprisingly resulting in better hair growth as compared to a combination of FCC tonic and 0.1% of methanolic extract of orchid callus. It can also be observed that a combination of FCC with 0.1% methanolic extract of orchid callus results in higher hair growth as compared to treatment with only FCC tonic.
Effect of a combination of FCC tonic and orchid callus extract (methanolic extract and aqueous extract) on human hair follicle stem cells
[00102] Clonogenic assay was performed to elucidate the roles of combination of FCC tonic with methanolic extract and also with aqueous extract of orchid callus on proliferation of human hair follicle stem cells. The result has been depicted in Figure 3. In this study, 1% and 0.1% aqueous extract (LP) were used in combination with FCC tonic, also 0.1% methanolic extract was used in combination with FCC tonic. The proliferation of hFSC in presence of serum was considered as a positive control while its proliferation in absence of serum was considered as a negative control. According to Figure 3, in the presence of a combination of FCC tonic with 0.1% aqueous extract of orchid callus, around 22 CFUs are formed which are unexpectedly more than the CFUs formed in presence of a combination of FCC tonic with 0.1% methanolic extract of orchid callus which is only around 17. On observing Figure 3, it is clearly inferred that best result is observed in presence of a combination of FCC tonic with 1% aqueous extract of orchid callus in which around 27 colony forming units (CFUs) are formed. Therefore, it can be concluded that a combination of FCC

tonic with 1% aqueous extract of orchid callus displays the best effect on hair growth. This has been proven by performing in vitro hair growth assay. Also, said combination displays a positive effect on the proliferation of hFSC which is one of the best parameter for assessing growth of hair.
Advantages of the present disclosure
[00103] The present disclosure discloses compositions of FCC tonic and orchid callus extract, wherein the orchid callus extract is an aqueous extract in one of the composition and a methanolic extract in another composition. The examples clearly assert that the use of FCC tonic in a combination with either aqueous extract of orchid callus or with methanolic extract of orchid callus result in better hair growth as compared to the treatment with only FCC tonic. Therefore, the composition as prepared in the present disclosure can be employed in preparation of hair formulations, application of which would result in enhancement of hair length as well as hair density.

I/We Claim:
1. A composition for promoting hair growth, said composition comprising:
a) climbazole;
b) caffeine;
c) diaminopyrimidine oxide; and
d) orchid callus extract,
wherein climbazole to caffeine w/w ratio in said composition is in the range of 1:0.50-1:6, climbazole to diaminopyrimidine oxide w/w ratio in said composition is in the range of 1:1.0-1:12, climbazole to the orchid callus extract w/w ratio in said composition is in the range of 1:0.1- 1:4, and caffeine to diaminopyrimidine oxide w/w ratio in said composition is in the range of 1:0.66 -1:6.
2. The composition as claimed in claim 1, wherein climbazole weight percentage in said composition is in the range of 0.25-1.0 %.
3. The composition as claimed in claim 1, wherein caffeine weight percentage in said composition is in the range of 0.5-1.5 %.
4. The composition as claimed in claim 1, wherein diaminopyrimidine oxide weight percentage in said composition is in the range of 1.0-3.0%.
5. The composition as claimed in claim 1, wherein said orchid callus extract is in the range of 0.1-1.0%.
6. The composition as claimed in claim 1, wherein said orchid callus extract is obtained from at least one species belonging to the genus Dendrobium.
7. The composition as claimed in claim 1, wherein said orchid callus extract is selected from the group consisting of an aqueous extract, a methanolic extract, a dichloromethane extract, and an ethanolic extract of orchid callus.
8. The composition as claimed in claim 1, wherein said orchid callus extract is a methanolic extract of orchid callus.
9. The composition as claimed in claim 1, wherein said orchid callus extract is an aqueous orchid callus extract.

10. The composition as claimed in claim 1, further comprising: (a) at least one
solvent; (b) at least one denaturing agent; (c) at least one emulsifier; (d) at least one
conditioning agent; (e) at least one moisturizing agent; (f) at least one revitalizing
agent; (g) at least one antimicrobial; and (h) at least one perfume oil.
11. The composition as claimed in claim 10, wherein the at least one solvent is ethanol, the at least one denaturing agent is diethyl phthalate, the at least one emulsifier is polysorbate 20, the at least one conditioning agent is PEG-12 dimethicone and allantoin, the at least one moisturizing agent is selected from the group consisting of glycol distearate, propylene glycol, PEG-7 glyceryl cocoate, D-panthenol, mineral oil, glyceryl stearate, isopropyl palmitate, shea butter, and combinations thereof, the at least one revitalizing agent is a combination of magnesium aspartate, zinc gluconate, and copper gluconate, and the at least one antimicrobial is a combination of phenoxyethanol, methylparaben, ethylparaben, propylparaben, butylparaben, and isobutylparaben.
12. The composition as claimed in claim 1, wherein said composition comprises:

a) ethanol having weight percentage in the range of 9.5-14.5 %;
b) diethyl phthalate having weight percentage in the range of 0.1 -2 %;
c) polysorbate 20 having weight percentage in the range of 5-15 %;
d) PEG-12 dimethicone having weight percentage in the range of 2-10
%;
e) propylene glycol having weight percentage in the range of 1-10 %;
f) PEG-7 glyceryl cocoate having weight percentage in the range of 0.5-2%;
g) D-panthenol having weight percentage in the range of 0.05-0.15 %;
h) perfume oil having weight percentage in the range of 0.1 -1.0 %;
i) diaminopyrimidine oxide having weight percentage in the range of 1-
3%; j) caffeine having weight percentage in the range of 0.5-1.5 %; k) climbazole having weight percentage in the range of 0.25-1.0%;

1) orchid callus extract having weight percentage in the range of 0.1-
1.0%; m) allantoin having weight percentage in the range of 0.01-0.1% n) a combination of magnesium aspartate, zinc gluconate, copper
gluconate having weight percentage in the range of 0.08-1.5 %; and
0) a combination of phenoxyethanol, methylparaben, ethylparaben,
propylparaben, butylparaben, and isobutylparaben having weight
percentage in the range of 0.08-0.8%).
13. The composition as claimed in claim 12, wherein said composition comprises:
a) ethanol having weight percentage of 12.3%;
b) diethyl phthalate having weight percentage of 1%;
c) polysorbate 20 having weight percentage of 10%;
d) PEG-12 dimethicone having weight percentage of 6%;
e) propylene glycol having weight percentage of 3%;
f) PEG-7 glyceryl cocoate having weight percentage in the range of 1%;
g) D-panthenol having weight percentage of 0.1%; h) perfume oil having weight percentage of 0.6%;
i) diaminopyrimidine oxide having weight percentage of 1.5%;
j) caffeine having weight percentage of 1%;
k) climbazole having weight percentage of 0.5%;
1) orchid callus extract having a weight percentage of 1.0%;
m) a combination of magnesium aspartate, zinc gluconate, and copper
gluconate having weight percentage of 0.1%; and n) a combination of phenoxyethanol, methylparaben, ethylparaben, propylparaben, butylparaben, and isobutylparaben having weight percentage of 0.5%; and o) allantoin having weight percentage of 0.05%.

14. A method for preparing a composition as claimed in claim 1, said method
comprising:
a) obtaining climbazole;
b) obtaining caffeine;
c) obtaining diaminopyrimidine oxide;
d) obtaining orchid callus extract; and
e) contacting climbazole, caffeine, diaminopyrimidine oxide and the orchid callus extract to obtain said composition.
15. A method for preparing a composition as claimed in any of the claims 1-13,
said method comprising:
a) obtaining ethanol;
b) obtaining diethyl phthalate;
c) obtaining polysorbate 20;
d) obtaining PEG-12 dimethicone;
e) obtaining propylene glycol;
f) obtaining PEG-7 glyceryl cocoate;
g) obtaining D-panthenol; h) obtaining perfume oil;
i) obtaining diaminopyrimidine oxide;
j) obtaining caffeine;
k) obtaining climbazole;
1) obtaining orchid callus extract;
m) obtaining a combination of magnesium aspartate, zinc gluconate, and
copper gluconate; n) obtaining a combination of phenoxyethanol, methylparaben,
ethylparaben, propylparaben, butylparaben, and isobutylparaben; o) obtaining allantoin; and p) contacting ethanol, diethyl phthalate, polysorbate 20, PEG-12
dimethicone, propylene glycol, PEG-7 glyceryl cocoate, D-panthenol,

perfume oil, diaminopyrimidine oxide, caffeine, climbazole, the orchid callus extract, magnesium aspartate, zinc gluconate, copper gluconate, phenoxyethanol, methylparaben, ethylparaben, propylparaben, butylparaben, and isobutylparaben to obtain said composition.
16. A method of promoting hair length, said method comprising:
a) obtaining a composition as claimed in any of the claims 1-13; and
b) contacting said composition with hair follicles, wherein said composition promotes hair length.
17. A method of promoting hair density, said method comprising:
a) obtaining a composition as claimed in any of the claims 1-13; and
b) contacting said composition with hair follicles, wherein said composition promotes hair density.

Documents

Application Documents

# Name Date
1 201741047353-STATEMENT OF UNDERTAKING (FORM 3) [29-12-2017(online)].pdf 2017-12-29
2 201741047353-FORM 1 [29-12-2017(online)].pdf 2017-12-29
3 201741047353-DRAWINGS [29-12-2017(online)].pdf 2017-12-29
4 201741047353-DECLARATION OF INVENTORSHIP (FORM 5) [29-12-2017(online)].pdf 2017-12-29
5 201741047353-COMPLETE SPECIFICATION [29-12-2017(online)].pdf 2017-12-29
6 201741047353-Proof of Right (MANDATORY) [05-02-2018(online)].pdf 2018-02-05
7 201741047353-FORM-26 [05-02-2018(online)].pdf 2018-02-05
8 Correspondence by Agent_Form1_Power of Attorney_07-02-2018.pdf 2018-02-07
9 201741047353-FORM 18 [22-11-2021(online)].pdf 2021-11-22
10 201741047353-FER.pdf 2023-05-29
11 201741047353-FER_SER_REPLY [29-11-2023(online)].pdf 2023-11-29
12 201741047353-US(14)-HearingNotice-(HearingDate-05-01-2024).pdf 2023-11-30
13 201741047353-Correspondence to notify the Controller [03-01-2024(online)].pdf 2024-01-03
14 201741047353-FORM-26 [04-01-2024(online)].pdf 2024-01-04
15 201741047353-US(14)-ExtendedHearingNotice-(HearingDate-22-01-2024).pdf 2024-01-15
16 201741047353-Correspondence to notify the Controller [19-01-2024(online)].pdf 2024-01-19
17 201741047353-US(14)-ExtendedHearingNotice-(HearingDate-23-01-2024).pdf 2024-01-22
18 201741047353-US(14)-ExtendedHearingNotice-(HearingDate-24-01-2024).pdf 2024-01-23
19 201741047353-Written submissions and relevant documents [06-02-2024(online)].pdf 2024-02-06
20 201741047353-PatentCertificate08-02-2024.pdf 2024-02-08
21 201741047353-IntimationOfGrant08-02-2024.pdf 2024-02-08

Search Strategy

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