HAIR REGROWTH TREATMENT AND GROWTH STIMULANT

Abstract

A composition for hair regrowth and hair growth stimulation, a method of use therefore, and a method of making. In an embodiment, the invention is directed toward a hair regrowth and growth stimulant containing the active ingredient minoxidil in combination with a stem cell activating hair growth/regrowth promoter in a non-irritating vehicle/carrier formulation. The non-irritating and scalp-friendly embodiments of the invention are particularly useful in methods for treating all hair types and ethnicities, and are especially useful in the treatment of African-American patients suffering from various forms of non-androgenetic alopecia.

Claims

1. A topical pharmaceutical composition comprising a therapeutic amount of minoxidil or a pharmaceutically acceptable derivative thereof, in combination with a therapeutic amount of a stem cell activating hair growth/regrowth promoter, which comprises an aqueous composition including about 50-55% (wt/wt) Glycerin, about 1% (wt/wt) Larix Europaea Wood Extract, about 1% (wt/wt) Glycine, about 0.1% (wt/wt) Zinc Chloride, about 0.1% (wt/wt) Camellia Sinensis Leaf Extract and 45-50% (wt/wt) purified water.

2. The composition of claim 1 wherein said pharmaceutically acceptable derivative of minoxidil may comprise one or more pharmaceutically acceptable salts, solvates, hydrates, isomers, esters, tautomers, anhydrates, enantiomers, complexes, polymorphs or prodrugs.

3. The composition of claim 1, further including one or more pharmaceutically acceptable excipients, including one or more solvents, one or more surfactants, one or more penetration enhancers, one or more pH regulators, one or more preservatives, one or more viscosity modifiers, one or more anti-inflammatory agents, one or more moisturizers, one or more conditioning agents, one or more colorants, one or more fragrances, and one or more chelating agents.

4. A topical pharmaceutical composition comprising: a) a therapeutic amount of minoxidil or a pharmaceutically acceptable derivative thereof; b) a therapeutic amount of a stem cell activating hair growth/regrowth promoter, which is an aqueous composition including about 50-55% (wt/wt) Glycerin, about 1′% (wt/wt) Larix Europaea Wood Extract, about 1% (wt/wt) Glycine, about 0.1% (wt/wt) Zinc Chloride, about 0.1% (wt/wt) Camellia Sinensis Leaf Extract and 45-50% (wt/wt) purified water; and c) a pharmaceutically acceptable carrier, wherein the composition is effective to treat alopecia.

5. The topical pharmaceutical composition in accordance with claim 4, wherein the minoxidil or a pharmaceutically acceptable derivative thereof is present in an amount of about 5% (wt/wt).

6. The topical pharmaceutical composition in accordance with claim 4, wherein the stem cell activating hair growth/regrowth promoter is present in an amount of about 3% (wt/wt).

7. The topical pharmaceutical composition in accordance with claim 4, further including an alcohol solvent selected from the group consisting of ethanol and isopropanol.

8. The topical pharmaceutical composition according to claim 1, wherein said composition is in the form of a solution, shampoo, ointment, cream, lotion, emulsion, dispersion, suspension or gel.

9. A topical pharmaceutical composition comprising: about 5% (wt/wt) minoxidil, or a pharmaceutically acceptable derivative thereof; about 30% (wt/wt) Propylene Glycol; about 15% (wt/wt) Isopropyl Alcohol (Anhydrous); about 9.00% (wt/wt) Dimethyl Isosorbide; about 3.00% (wt/wt) Trimethylpentanediol/Adipic Acid Copolymer; about 3.50% (wt/wt) Cetearyl Alcohol, Dicetyl Phosphate, and Ceteth-10 Phosphate; about 3.0% (wt/wt) of a stem cell activating hair growth/regrowth promoter, which is an aqueous composition comprising about 50-55% (wt/wt) Glycerin, about 1% (wt/wt) Larix Europaea Wood Extract, about 1% (wt/wt) Glycine, about 0.1% (wt/wt) Zinc Chloride, about 0.1% (wt/wt) Camellia Sinensis Leaf Extract and 45-50% (wt/wt) purified water; about 1.4% (wt/wt) Cetyl Alcohol; about 0.7% (wt/wt) Argania spinosa (Argan) Nut Oil; about 0.28% (wt/wt) fragrance; about 0.07% (wt/wt) Cocos Nucifera Oil/Aloe Barbadensis Leaf Extract; about 0.525% (wt/wt) Cetrimonium Chloride; about 0.2% (wt/wt) Disodium EDTA; about 0.7% (wt/wt) Bisabolol; about 0.07% (wt/wt) Hydroxypropyl Guar; Citric Acid in an amount sufficient to maintain pH in a range of 6.4-6.6; about 0.0175 kg/lb Methylchloroisothiazolinone, Methylisothiazolinone; approximately 0.0001-0.0002 kg/lb of a colorant; and purified water to dilute to 100% (wt/wt).

10. A topical pharmaceutical composition comprising: about 5% (wt/wt) minoxidil, or a pharmaceutically acceptable derivative thereof; about 50% (wt/wt) Propylene Glycol; about 20% (wt/wt) Ethanol; about 3.00% (wt/wt) Trimethylpentanediol/Adipic Acid Copolymer; about 2.40% (wt/wt) Cetearyl Alcohol, Dicetyl Phosphate, and Ceteth-10 Phosphate; about 3.0% (wt/wt) of a stem cell activating hair growth/regrowth promoter, which comprises an aqueous composition including about 50-55% (wt/wt) Glycerin, about 1% (wt/wt) Larix Europaea Wood Extract, about 1% (wt/wt) Glycine, about 0.1% (wt/wt) Zinc Chloride, about 0.1% (wt/wt) Camellia Sinensis Leaf Extract and 45-50% (wt/wt) purified water; about 0.8% (wt/wt) Cetyl Alcohol; about 0.2% (wt/wt) Argania spinosa (Argan) Nut Oil; about 0.14% (wt/wt) fragrance; about 0.20% (wt/wt) Cocos Nucifera Oil/Aloe Barbadensis Leaf Extract; about 0.30% (wt/wt) Cetrimonium Chloride; about 0.2% (wt/wt) Disodium EDTA; about 0.2% (wt/wt) Bisabolol; about 0.04% (wt/wt) Hydroxy propyl Guar; Citric Acid in an amount sufficient to maintain pH in a range of 6.4-6.6; about 0.01 kg/lb of a mixture of Methylchloroisothiazolinone and Methylisothiazolinone; approximately 0.0001-0.0002 kg/lb of a colorant; and purified water to dilute to 100% (wt/wt).

11. (canceled)

12. A process for preparing the topical pharmaceutical composition according to claim 1, wherein the process comprises blending minoxidil or a pharmaceutically acceptable derivative thereof, in combination with a stem cell activating hair growth/regrowth promoter, with at least one pharmaceutically acceptable excipient.

13. The topical pharmaceutical composition according to claim 1, wherein the alopecia is a non-androgenetic alopecia.

14. The topical pharmaceutical composition according to claim 1, wherein the non-androgenetic alopecia is selected from the group consisting of vertex alopecia, chemical alopecia, traction alopecia, traumatic alopecia or central centrifugal cicatricial alopecia (CCCA).

15. The topical pharmaceutical composition according to claim 1, wherein the subject is an Afro-American human subject.

16. The topical pharmaceutical composition according to claim 1, wherein the composition is effective to mitigate miniaturization of hair follicles in androgen-sensitive areas of the scalp, and to re-launch stem cell activity and proliferation, without substantial scalp irritation.

17. A method for treating alopecia comprising administering topically a therapeutic amount of the composition of claim 1, wherein the therapeutic amount of the composition is effective: (a) to induce hair growth; or (b) to stimulate hair growth; or (c) to reduce hair loss; or (d) to reduce scalp irritation; or (e) to reduce contact dermatitis.

18. The method according to claim 17, wherein the therapeutic amount of the composition is effective to mitigate miniaturization of hair follicles in androgen-sensitive areas of the scalp, and to re-launch stem cell activity and proliferation, without substantial scalp irritation.

19. The method according to claim 16, wherein the alopecia is a non-androgenetic alopecia.

20. The method according to claim 10, wherein the non-androgenic alopecia is selected from the group consisting of vertex alopecia, chemical alopecia, traction alopecia, traumatic alopecia and central centrifugal cicatricial alopecia (CCCA).

21. The method according to claim 17, wherein the subject is an Afro-American human subject.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0026] The accompanying figures, where like reference numerals refer to identical or functionally similar elements throughout the separate views and which together with the detailed description below are incorporated in and form part of the specification, serve to further illustrate various embodiments and explain various principles and advantages all in accordance with the present invention.

[0027] FIG. 1A illustrates a view of vertex alopecia prior to treatment;

[0028] FIG. 1B illustrates a view of vertex alopecia after treatment;

[0029] FIG. 2A illustrates a view of vertex alopecia prior to treatment;

[0030] FIG. 2B illustrates a view of vertex alopecia after treatment;

[0031] FIG. 3A illustrates a view of traction alopecia prior to treatment;

[0032] FIG. 3B illustrates a view of traction alopecia after treatment.

DETAILED DESCRIPTION OF THE INVENTION

[0033] The compositions of the present invention can comprise, consist of, or consist essentially of the essential elements and limitations of the invention described herein, as well any of the additional or optional ingredients, components, or limitations described herein.

[0034] The term “comprising” (and its grammatical variations) as used herein is used in the inclusive sense of “having” or “including” and not in the exclusive sense of “consisting only of” The terms “a” and “the” as used herein are understood to encompass the plural as well as the singular.

[0035] All percentages, parts and ratios are based upon the total weight of the composition of the present invention, unless otherwise specified. All such weights as they pertain to the listed ingredients are based on the active level and, therefore, do not include earners or byproducts that may be included in commercially available materials, unless otherwise specified.

[0036] The term “safe and effective amount” or “therapeutically effective amount” as used herein means an amount of a compound or composition such as a topical or system active sufficient to significantly induce a positive benefit, for example, hair growth or regrowth, but low enough to avoid serious side effects, i.e., to provide a reasonable benefit to risk ratio, within the scope of sound judgment of the skilled artisan.

[0037] The topical compositions useful in this invention contain formulations suitable for topical application to skin and scalp. The term “topical” as employed herein relates to the use of a composition along with a suitable pharmaceutical carrier, and applied according to the method of the present invention at the site of hair loss, reduced hair growth or baldness for exertion of local action. Accordingly, such topical compositions useful in the methods of the present invention include those pharmaceutical forms in which the compound is applied externally by direct contact with the skin surface to be treated.

[0038] In certain embodiments, a topical pharmaceutical composition according to the instant invention may be in the form of a solution, shampoo, ointment, cream, lotion, emulsion, dispersion, suspension or gel.

[0039] In certain embodiments, the compositions according to this invention may further contain one or more additional cosmetically active agent(s) as well as the particularly-mentioned components. What is meant by a “cosmetically acceptable active agent” is a compound, which may be a synthetic compound or a compound isolated, purified or concentrated from a natural source, or a natural extract containing a mixture of compounds, that has a cosmetic effect on the tissue, including, but not limited to: anti-aging agents, sunscreens, photoprotectors, antioxidants, keratolytic agents, detergents/surfactants, moisturizers, nutrients, vitamins, minerals, energy enhancers, anti-perspiration agents, astringents, hair growth enhancing agents, hair coloring agents, pigments, firming agents, agents for skin conditioning, and odor-control agents such as odor masking or pH-changing and buffering agents.

[0040] In certain embodiments, the cosmetically acceptable active is a hair growth active, including, albeit not limited to compounds known to promote hair growth and available as drugs, such as diazoxide, pinacidil, bimatoprost, finasteride, a type 2 5-alpha-reductase inhibitor, and dutasteride, a type 1- and 2-5-alpha-reductase inhibitor, as well as flutamide, bicalutamide, pregnane derivatives, progesterone derivatives, experimental agents such as FCE 28260 and the like. Spironolactone and other diuretics may also be utilized as it is indicated for women in some cases (also known as aldactone: an aldosterone receptor antagonist).

[0041] The topical compositions or topical pharmaceutical compositions useful in this invention contain formulations suitable for topical application to skin and scalp. The term “topical” as employed herein relates to the use of a composition along with a suitable pharmaceutical carrier, and applied according to the method of the present invention at the site of hair loss, reduced hair growth or baldness for exertion of local action. Accordingly, such topical compositions useful in the methods of the present invention include those pharmaceutical forms in which the compound is applied externally by direct contact with the skin surface to be treated.

[0042] Suitable carrier forms include ointments, pastes, gels, jellies, serums, aerosol and non-aerosol sprays, foams, creams, lotions, solutions, suspensions and the like. The term “ointment” embraces formulations (including creams) having oleaginous, absorption, water-soluble and emulsion-type bases, e.g., petrolatum, lanolin, polyethylene glycols, as well as mixtures of these.

[0043] Various other materials may also be present in the compositions useful in the subject invention. These include any manner of humectants, proteins and polypeptides, an alkaline agent and mixtures thereof. The compositions of the present invention may also comprise one or more of various additives and excipients including plant extracts, oily ingredients, surfactants, alcohols, fatty acids, preservatives, antioxidants, colorants, fragrances, UV absorbers, viscosity modifiers, chelating agents(e.g., EDTA), pH-adjusting agents, and vitamins. In addition, the topical compositions useful herein can contain conventional 15 cosmetic adjuvants, such as dyes, sunscreen (e.g., titanium dioxide), pigments, and fragrances.

[0044] In a particular embodiment, the pharmaceutically acceptable excipients may include one or more solvents, one or more surfactants, one or more penetration enhancers, one or more pH regulators, one or more preservatives, one or more viscosity modifiers, one or more anti-inflammatory agents, one or more moisturizers, one or more conditioning agents, one or more colorants, one or more fragrances, and one or more chelating agents.

[0045] In one or more embodiments of the present disclosure, illustrative, albeit non-limiting examples of chelating agents may be at least one of ethylenediaminetetraacetic acid (“EDTA”) and salts thereof such as disodium EDTA, tetrasodium EDTA and calcium disodium EDTA; diethylenetriammepentaacetic acid (“DTPA”) and salts thereof; hydroxyethlethylenediaminetriacetic acid (“HEDTA”) and salts thereof and nitrilotriacetic acid (“NTA”); more preferably EDTA, HEDTA and their salts; most preferably EDTA and its saltsacetyl trihexyl citrate, aminotrimethylene phosphonic acid, beta-alanine diacetic acid, bismuth citrate, citric acid, cyclohexanediamine tetraacetic acid, diammonium citrate, dibutyl oxalate, diethyl oxalate, diisobutyl oxalate, diisopropyl oxalate, dilithium oxalate, dimethyl oxalate, dipotassium oxalate, dipropyl oxalate, disodium pyrophosphate, etidronic acid, methyl cyclodextrin, oxalic acid, pentapotassium, triphosphate, pentasodium aminotrimethylene phosphonate, pentasodium pentetate, pentasodium triphosphate, pentetic acid, phytic acid, potassium citrate, sodium citrate, sodium dihydroxyethylglycinate, sodium gluceptate, sodium gluconate, sodium hexametaphosphate, sodium metaphosphate, sodium metasilicate, sodium oxalate, sodium trimetaphosphate, tetrahydroxypropyl ethylenediamine, tetrapotassium etidronate, tetrapotassium pyrophosphate, tetrasodium etidronate, tetrasodium pyrophosphate, trisodium NTA, trisodium phosphate, malic acid, fumaric acid, maltol, succimer, penicillamine, dimercaprol, and desferrioxamine mesilate.

[0046] In one or more embodiments of the present disclosure, illustrative, albeit non-limiting examples of moisturizing agents may be at least one of amino acids, chondroitin sulfate, diglycerin, erythritol, fructose, glucose, glycerin, glycerol polymers, glycol, 1,2,6-hexanetriol, honey, hyaluronic acid, hydrogenated honey, hydrogenated starch hydrolysate, inositol, lactitol, maltitol, maltose, mannitol, natural moisturizing factor, PEG-15 butanediol, polyglyceryl sorbitol, salts of pyrollidone carboxylic acid, potassium PCA, propylene glycol, sodium glucuronate, sodium PCA, sorbitol, sucrose, trehalose, urea, and xylitol, acetylated lanolin, acetylated lanolin alcohol, acrylates/C.sub.10-30 alkyl acrylate crosspolymer, acrylates copolymer, alanine, algae extract, aloe barbadensis, aloe-barbadensis extract, aloe barbadensis gel, althea officinalis extract, aluminum starch octenylsuccinate, aluminum stearate, apricot (prunus armeniaca) kernel oil, arginine, arginine aspartate, arnica montana extract, ascorbic acid, ascorbyl palmitate, aspartic acid, avocado (persea gratissima) oil, barium sulfate, barrier sphingolipids, butyl alcohol, beeswax, behenyl alcohol, beta-sitosterol, BHT, birch (betula alba) bark extract, borage (borago officinalis) extract, 2-bromo-2-nitropropane-1,3-diol, butcherbroom (ruscus aculeatus) extract, butylene glycol, calendula officinalis extract, calendula officinalis oil, candelilla (euphorbia cerifera) wax, canola oil, caprylic/capric triglyceride, cardamon (elettaria cardamomum) oil, camauba (copemicia cerifera) wax, carrageenan (chondrus crispus), carrot (daucus carota sativa) oil, castor (ricinus communis) oil, ceramides, ceresin, ceteareth-5, ceteareth-12, ceteareth-20, 10 cetearyl octanoate, ceteth-20, ceteth-24, cetyl acetate, cetyl octanoate, cetyl palmitate, chamomile (anthemis nobilis) oil, cholesterol, cholesterol esters, cholesteryl hydroxystearate, citric acid, clary (salvia sclarea) oil, cocoa (theobroma cacao) butter, coco-caprylate/caprate, coconut (cocos nucifera) oil, collagen, collagen amino acids, corn (zea mays) oil, fatty acids, decyl oleate, dextrin, diazolidinyl urea, dimethicone copolyol, dimethiconol, dioctyl adipate, dioctyl succinate, dipentaerythrityl hexacaprylate/hexacaprate, DMDM hydantoin, DNA, erythritol, ethoxydiglycol, ethyl linoleate, eucalyptus globulus oil, evening primrose (oenothera biennis) oil, fatty acids, tructose, gelatin, geranium maculatum oil, glucosamine, glucose glutamate, glutamic acid, glycereth-26, glycerin, glycerol, glyceryl distearate, glyceiyl hydroxystearate, glyceryl laurate, glyceryl linoleate, glyceryl myristate, glyceryl oleate, glyceryl stearate, glyceryl stearate SE, glycine, glycol stearate, glycol stearate SE, glycosaminoglycans, grape (vitis vinifera) seed oil, hazel (corylus americana) nut oil, hazel (corylus avellana) nut oil, hexylene glycol, honey, hyaluronic acid, hybrid safflower (carthamus tinctorius) oil, hydrogenated castor oil, hydrogenated coco-glycerides, hydrogenated coconut oil, hydrogenated lanolin, hydrogenated lecithin, hydrogenated palm glyceride, hydrogenated palm kernel oil, hydrogenated soybean oil, hydrogenated tallow glyceride, hydrogenated vegetable oil, hydrolyzed collagen, hydrolyzed elastin, hydrolyzed glycosaminoglycans, hydrolyzed keratin, hydrolyzed soy protein, hydroxylated lanolin, hydroxyproline, imidazolidinyl urea, iodopropynyl butylcarbamate, isocetyl stearate, isocetyl stearoyl stearate, isodecyl oleate, isopropyl isostearate, isopropyl lanolate, isopropyl myristate, isopropyl palmitate, isopropyl stearate, isostearamide DEA, isostearic acid, isostearyl lactate, isostearyl neopentanoate, jasmine (jasminum officinale) oil, jojoba (buxus chinensis) oil, kelp, kukui (aleurites moluccana) nut oil, lactamide MEA, laneth-16, laneth-10 acetate, lanolin, lanolin acid, lanolin alcohol, lanolin oil, lanolin wax, lavender (lavandula angustifolia) oil, lecithin, lemon (citrus medica limonum) oil, linoleic acid, linolenic acid, macadamia ternifolia nut oil, magnesium stearate, magnesium sulfate, maltitol, matricaria (chamomilla recutita) oil, methyl glucose sesqui stearate, methylsilanol PCA, microcrystalline wax, mineral oil, mink oil, mortierella oil, myristyl lactate, myristyl myristate, myristyl propionate, neopentyl glycol dicaprylate/dicaprate, octyldodecanol, octyldodecyl myristate, octyldodecyl stearoyl stearate, octyl hydroxy stearate, octyl palmitate, octyl salicylate, octyl stearate, oleic acid, olive (olea europaea) oil, orange (citrus aurantium dulcis) oil, palm (elaeis guineensis) oil, palmitic acid, pantethine, panthenol, panthenyl ethyl ether, paraffin, PCA, peach (prunus persica) kernel oil, peanut (arachis hypogaea) oil, PEG-8 C.sub.12-18 ester, PEG-15 cocamine, PEG-150 distearate, PEG-60 glyceryl isostearate, PEG-5 glyceryl stearate, PEG-30 glyceryl stearate, PEG-7 hydrogenated castor oil, PEG-40 hydrogenated castor oil, PEG-60 hydrogenated castor oil, PEG-20 methyl glucose sesqui stearate, PEG40 sorbitan peroleate, PEG-5 soy sterol, PEG-10 soy sterol, PEG-2 stearate, PEG-8 stearate, PEG-20 stearate, PEG-32 stearate, PEG-40 stearate, PEG-50 stearate, PEG-100 stearate, PEG-150 stearate, pentadecalactone, peppermint (mentha piperita) oil, petrolatum, phospholipids, polyamino sugar condensate, polyglyceryl-3 diisostearate, polyquatemium-24, polysorbate 20, polysorbate 40, polysorbate 60, polysorbate 80, polysorbate 85, potassium myristate, potassium palmitate, potassium sorbate, potassium stearate, propylene glycol, propylene glycol dicaprylate/dicaprate, propylene glycol dioctanoate, propylene glycol dipelargonate, propylene glycol laurate, propylene glycol stearate, propylene glycol stearate SE, PVP, pyridoxine dipalmitate, quatemium-15, quatemium-18 hectorite, quatemium-22, retinol, retinol palmitate, rice (oryza sativa) bran oil, RNA, rosemary (rosmarinus officinalis) oil, rose oil, safflower (carthamus tinctorius) oil, sage (salvia officinalis) oil, salicylic acid, sandalwood (santalum album) oil, serine, semm protein, sesame (sesamum indicum) oil, shea butter (butyrospermum parkii), silk powder, sodium chondroitin sulfate, sodium hyaluronate, sodium lactate, sodium palmitate, sodium PCA, sodium polyglutamate, sodium stearate, soluble collagen, sorbic acid, sorbitan laurate, sorbitan oleate, sorbitan palmitate, sorbitan sesquioleate, sorbitan stearate, sorbitol, soybean (glycine soja) oil, sphingolipids, squalane, squalene, stearamide MEA-stearate, stearic acid, stearoxy dimethicone, stearoxytrimethylsilane, stearyl alcohol, stearyl glycyrrhetinate, stearyl heptanoate, stearyl stearate, sunflower (helianthus annuus) seed oil, sweet almond (prunus amygdalus dulcis) oil, synthetic beeswax, tocopherol, tocopheryl acetate, tocopheryl linoleate, tribehenin, tridecyl neopentanoate, tridecyl stearate, triethanolamine, tristearin, urea, vegetable oil, water, waxes, wheat (triticum vulgare) germ oil, and ylang ylang (cananga odorata) oil.

[0047] In one or more embodiments of the present disclosure, illustrative, albeit non-limiting examples of thickening agents (viscosity modifiers) may be at least one of thickener or gelling agents, including substances that can increase the viscosity of a composition. Thickeners include those that can increase the viscosity of a composition without substantially modifying the efficacy of the active ingredient within the composition. Thickeners can also increase the stability of the compositions of the present invention. Non-limiting examples of thickening agents that can be used in the context of the present invention include carboxylic acid polymers, crosslinked polyacrylate polymers, polyacrylamide polymers, polysaccharides, and gums. Examples of carboxylic acid polymers include crosslinked compounds containing one or more monomers derived from acrylic acid, substituted aciylic acids, and salts and esters of these acrylic acids and the substituted acrylic acids, wherein the crosslinking agent contains two or more carbon-carbon double bonds and is derived from a polyhydric alcohol (see U.S. Pat. Nos. 5,087,445; 4,509,949; 2,798,053, CTFA International Cosmetic Ingredient Dictionary, Fourth edition, 1991, pp. 12 and 80). Examples of commercially available carboxylic acid polymers include carbomers, which are homopolymers of acrylic acid crosslinked with allyl ethers of sucrose 10 or pentaerytritol (e.g., CARBOPOL™ 900 series from B. F. Goodrich).

[0048] In one or more embodiments of the present disclosure, illustrative, albeit non-limiting examples of preservatives may be at least one of benzoic acid, the esters and salts thereof, propionic acid and salts thereof, salicylic acid and salts thereof, 2,4-hexanoic acid (sorbic acid) and salts thereof, formaldehyde and paraformaldehyde, 2-hydroxybiphenyl ether and salts thereof, 2-zincsulphidopyridine-N-oxide, inorganic sulphites and bisulphites, sodium iodate, chlorobutanolum, 4-hydroxybenzoic acid, the salts and esters thereof, dehydroacetic acid, formic acid, 1,6-bis(4-amidino-2-bromophenoxy)-n-hexane and salts thereof, the sodium salt of ethylmercury-(II)-thiosalicylic acid, phenyl mercury and salts thereof, 10-undecylenic acid and salts thereof, 5-amino-1,3-bis(2-ethylhexyl)-5-methylhexahydropyrimidine, 5-bromo-5-nitro-1,3-dioxane, 2-bromo-2-nitro-1,3-propanediol, 2,4-dichlorobenzyl alcohol, N-(4-chlorophenyl)-N′-(3,4-dichlorophenyl)urea, 4-chloro-m-cresol, 2,4,4′-trichloro-2′-bydroxy-diphenyl ether, 4-chloro-3,5-dimethylphenol, 1,1′-methylene-bis(3-(1-hydroxymethyl-2,4-dioximidazolidin-5-yl)urea), poly-(hexamethylene diguanide) hydrochloride, 2-phenoxyethanol, hexamethylentetramine, 1-(3-chloroallyl)-3,5,7-triaza-1-azonia-adamantane chloride, 1 (4-chloro-phenoxy)-1(1H-imidazol-1-yl)-3,3-dimethyl-2-butanone, 1,3-bis-(hydroxy-inethyl)-5,5-dimethyl-2,4-imidazolidinedione, benzyl alcohol, Octopirox, 1,2-dibromo-2,4-dicyanobutane, 2,2′-methylene-bis(6-bromo-4-chloro-phenol), bromochlorophene, mixture of 5-chloro-2-methyl-3(2H)-isothiazolinone and 2-methyl-3(2H)isothiazolinone with magnesium chloride and magnesium nitrate, 2-benzyl-4-chlorophenol, 2-chloracetamide, chlorhexidine, chlorhexidine acetate, chlorhexidine gluconate, chlorhexidine hydrochloride, 1-phenoxy-propan-2-ol, N-alkyl(C.sub.12-C.sub.22) trimethylammonium bromide and chloride, 4,4-dimethyl-1,3-oxazolidine, N-hydroxymethyl-N-(1,3-di(hydroxymethyl)-2,5-dioxo-imidazolidin-4-yl)-N′—hydroxymethylurea, 1,6-bis(4-amidino-phenoxy)-n-hexane and salts thereof, glutaraldehyde 5-ethyl-1-aza-3,7-dioxa-bicyclo(3.3.0)octane, 3-(4-chlorphenoxy)-I,2-propanediol, hyamine, alkyl-(C.sub.8-C.sub.18)-dimethylbenzylammonium chloride, alkyl-(C.sub.8-C.sub.18)-dimethylbenzylammonium bromide, alkyl-(C.sub.8-C.sub.18)-dimethyl-benzyl-ammonium saccharinate, benzylhemiformal, 3-iodo-2-propinylbutyl carbamate, sodium hydroxymethylaminoacetate or sodium hydroxy-methylaminoacetate.

[0049] Minoxidil (i.e. 2,4-diamino-6-piperidinylpyrimidine-3-oxide) is a well-known pharmaceutical compound. It is marketed by The Upjohn Company as the active ingredient in LONITEN® tablets for the treatment of hypertension. It is also useful in topical compositions for the treatment of baldness and is sold under the tradename ROGAINE® by Johnson & Johnson Corporation. The structure and use of this compound for this purpose, and topical compositions containing it, are described in U.S. Pat. No. 4,139,619 and U.S. Pat. No. 4,596,812. In particular, U.S. Pat. No. 4,139,619 discloses topical Minoxidil compositions containing carriers selected from ointments, lotions, pastes, jellies, sprays and aerosols.

[0050] It is within the purview of this invention to further utilize, either alone, or in combination, compounds which are similar in structure and function to Minoxidil, exemplified by, albeit not limited to PDPO (Pyrrolidinyl Diaminopyrimidine Oxide—trade name Triaminodil™) and diaminopyrimidine oxide, trade name Aminexil.

[0051] It is further within the purview of this invention to utilize minoxidil in the form of a pharmaceutically acceptable derivative which optionally comprises pharmaceutically acceptable salts, solvates, hydrates, isomers, esters, tautomers, anhydrates, enantiomers, complexes, polymorphs or prodrugs.

[0052] It is noted that products such as liquid ROGAIN® (a commercially available Minoxidil containing scalp treatment for both men and women) contains about 60% alcohol and ROGAINE® foam contains about 30% alcohol, while the formulation of the instant invention only contains about 20% alcohol.

EXAMPLE I

[0053] In one illustrative, albeit non-limiting embodiment of the invention, the active ingredient Minoxidil—at about 5% (wt/wt) is combined with the following additional ingredients (all ingredients are % (wt/wt)): [0054] about 30% (wt/wt) Propylene Glycol; [0055] about 15% (wt/wt) Isopropyl Alcohol (Anhydrous); [0056] about 9.00% (wt/wt)Dimethyl Isosorbide (ARLASOLYE DMI); [0057] about 3.00% (wt/wt) Trimethylpentanediol/Adipic Acid Copolymer (LEXOREZ TL-8); [0058] about 3.50% (wt/wt) Cetearyl Alcohol, Dicetyl Phosphate, and Ceteth-10 Phosphate (CRODAFOS CES-PA); [0059] about 3.0% (wt/wt) of a stem cell activating hair growth/regrowth promoter exemplified by, albeit not limited to REDENSYL” hair growth promoter, which is an aqueous composition including about 50-55% (wt/wt) Glycerin, about 1% (wt/wt) Larix Europaea Wood Extract, about 1% (wt/wt) Glycine, about 0.1% (wt/wt) Zinc Chloride, about 0.1% (wt/wt) Camellia 5 Sinensis Leaf Extract and 45-50% (wt/wt) purified water; [0060] about 1.4% (wt/wt) Cetyl Alcohol; [0061] about 0.7% (wt/wt) Argania spinosa (Argan) Nut Oil; [0062] about 0.28% (wt/wt) Perfume (e.g. Fragrance79734); [0063] about 0.07% (wt/wt) Cocos Nucifera Oil/Aloe Barbadensis Leaf Extract—(Aloe Butter); about 0.525% (wtlwt) Cetrimonium Chloride; [0064] about 0.2% (wtlwt) Disodium EDTA; [0065] about 0.7% (wtlwt) Bisabolol; [0066] about 0.07% (wt/wt)Hydroxypropyl Guar (N-HANCE HP-40); [0067] Citric Acid in an amount sufficient to maintain pH in range of 6.4-6.6; [0068] about 0.0175 Methylchloroisothiazolinone, Methylisothiazolinone—(KATHON CG); [0069] approximately 0.0001-0.0002 FD&C Yellow #6—(to achieve desired coloration); and purified water to dilute to 100% (wt/wt).

[0070] In this illustrative embodiment, the formulation may be manufactured in accordance with the following steps:

Part A

[0071] Add into the main tank A the following ingredients one at a time and mix well until completely dissolved.

DI Water to 100

Disodium EDTA 0.20

FD&C Yellow #6 q.c.

[0072] Mix for 15 minutes. Add the following ingredients and mix until completely hydrated.

N-HANCE® HP40 0.07

[0073] Start to heat the main tank to 175° F. while mixing.

Part B

[0074] Add all ingredients from part B. Start to heat the tank to 175° F. while mixing until all ingredients are melted.

Crodafos CES-PA 3.50

Cetyl Alcohol 1.40

Aloe Butter 0.07

Argan Oil 0.70

[0075] Keep mixing with moderate speed for 45 minutes.

Part C

[0076] Start to cool down the tank to 104° F. and add the ingredients from Part C to the tank one at a time while mixing after each ingredient.

Centrimonium Chloride 0.525

KATHON®CG 0.0175

Fragrance 79/34 0.28

Part D

[0077] Keep mixing until uniform smooth cream.

Part E

[0078] In a separate container dissolve Minoxidil in Propylene Glycol and IPA (Isopropyl alcohol).

Minoxidil 5.00

Propylene Glycol 30.00

ARLASOLVE® DMI 9.00

IPA Anhydrous 15.00

LEXOREZ® TL-8 3.00

Part F

[0079] Add conditioner into Part E and mix well until the cream becomes uniform again. Use homogenizer if needed.

Part G

[0080] Add the following ingredients and mix well until uniform.

REDENSYL® 3.00

Citric Acid q.s.

Typical Properties

pH: 4.5-5.0 Viscosity: TBDcPs @20 RPM Spindle 5

EXAMPLE 2

[0081] In another illustrative, albeit non-limiting embodiment of the invention, the active ingredient Minoxidil—at about 5% (wt/wt) is combined with the following additional ingredients (all ingredients are % (wt/wt)): [0082] about 50% (wt/wt) Propylene Glycol; [0083] about 20% (wt/wt) Ethanol (SDA 40/200 proof); [0084] about 3.00% (wt/wt) Trimethylpentanediol/Adipic Acid Copolymer (LEXOREZ TL-8); [0085] about 2.40% (wt/wt) Cetearyl Alcohol, Dicetyl Phosphate, and Ceteth-10 Phosphate (CRODAFOS CES-PA); [0086] about 3.0% (wt/wt) of a stem cell activating hair growth/regrowth promoter exemplified by, albeit not limited to REDENSYL® hair growth promote, which is an aqueous composition including about 50-55% (wt/wt) Glycerin, about 1% (wt/wt) Larix Europaea Wood Extract, about 1% (wt/wt) Glycine, about 0.1% (wt/wt) Zinc Chloride, about 0.1% (wt/wt) Camellia Sinensis Leaf Extract and 45-50% (wt/wt) purified water— [0087] about 0.8% (wt/wt) Cetyl Alcohol; [0088] about 0.2% (wt/wt) Argania spinose (Argan) Nut Oil; [0089] about 0.14% (wt/wt) Perfume (e.g. Fragrance 79734); [0090] about 0.20% (wt/wt) Cocos Nucifera Oil/Aloe Barbadensis Leaf Extract—(Aloe Butter); [0091] about 0.30% (wt/wt) Cetrimonium Chloride; [0092] about 0.2% (wt/wt) Disodium EDTA; [0093] about 0.2% (wt/wt) Bisabolol; [0094] about 0.04% (wt/wt) Hydroxypropyl Guar (N-HANCE HP-40); [0095] Citric Acid in an amount sufficient to maintain pH in range of 6.4-6.6; [0096] about 0.01 Methylchloroisothiazolinone, Methylisothiazolinone—(KATHON CG); [0097] approximately 0.0001-0.0002 FD&C Yellow #6—(to achieve desired coloration); and [0098] purified water to dilute to 100% (wt/wt).

[0099] In this illustrative embodiment, the formulation may be manufactured in accordance with the following the steps:

Part A

[0100] Add into the main tank A the following ingredients one at a time and mix well until completely dissolved.

DI Water to 100

Disodium EDTA 0.20

FD&C Yellow #6 q.c.

[0101] Mix for 15 minuies. Add the following ingredient and mix until completely hydrate.

N-HANCE HP-40 0.04

[0102] Start to heat the main tank to 175° F. while mixing.

Part B

[0103] Add all ingredients from part B. Start to heat the tank to 175° F. while mixing until all ingredients are melted.

Crodafos CES-PA 2.40

Cetyl Alcohol 0.80

Aloe Butter 0.20

Argan Oil 0.20

[0104] Keep mixing with moderate speed for 45 minutes.

Part C

[0105] Start to cool down the tank to 104° F. and add the ingredients from Part C to the tank one at a time while mixing after each ingredient.

Cetrimonium Chloride 0.30

Kathon CG 0.01

Fragrance 79734 0.14

Bisabolol 0.20

Part D

[0106] Keep mixing until uniform smooth cream.

Part E

[0107] In a separate container dissolve Minoxidil in Propylene Glycol and IPA.

Minoxidil 5.00

Propylene Glycol 50.00

[0108] SDA 40/200 proof 20.00

Lexorez TL-8 3.00

Part F

[0109] Add conditioner into Part E and mix well until cream is uniform again. Use homogenizer if needed.

Part G

[0110] Add the following ingredient and mix until uniform.

Redensyl 3.00

Citric Acid q.s.

Typical Properties

pH:4.5-5.0 Viscosity: TBD cPs @20 RPM Spindle 5

[0111] Specifically recited ingredients are commercially available as follows:

TABLE-US-00001 TRADE NAME INCI MANF. ACTION DI Water Aqua Solvent Disodium EDTA Di sodium Prochem Chelating Agent EDTA N-HANCE ® HP40 Hydroxypropyl Ashland Specialties Conditioner Guar Argan Oil Argania spinosa CAC Farpint Moisturizer, Regenerate (Argan) Nut Oil Crodafos CES-PA Cetearyl Alcohol Croda Conditioning Agent (and) Dicetyl Phosphate (and) Ceteth-10 Phosphate Cetyl Alcohol Cetyl Alcohol Lipo Viscosity Modifier Chemicals/Protameen Aloe Butter Cocos Nucifera Flail Star Moisturizer Oil/Aloe Barbadensis Leaf Extract Cetrimonium Cetrimonium Essential Ingredients Conditioning Agent Chloride Chloride KATHON ® CG Methyl chloro Rohm&Haas; Dow Preservative isothiazolinone; Chemicals Methyl isothiazolinone Fragrance 79734 Fragrance Belle-Aire Fragrances Aroma FD&C Yellow #6 FD&C Yellow Essential Ingredients Colorant #6 LEXOREZ ® TL-8 Trimethylpentanediol/ Inolex Delivery System Adipic Acid Copolymer Minoxidil Minoxidil Letco Medical Hair Growth REDENSYL ® Glycerin (and) Induchem USA Hair Growth Aqua (and) Sodium Metabisulfite (and) Larix Europaea Wood Extract (and) Glycine (and) Zinc Chloride (and) Camellia Sinensis Leaf Extract Bisabolol Bisabolol BASF Anti-inflammatory ARLASOLVE ® Dimethyl Croda Solvent, Delivery for DMI Isosorbide actives Citric Acid Citric Acid Prochem Chelating Agent SDA40/200 Proof Ethanol Univar Solvent IPA Isopropyl Isopropanol Sigma-Aldrich Solvent Alcohol

[0112] In an illustrative embodiment of the instant invention, the formulation is provided for use in a bottle pump. An illustrative method of treatment is outlined in the following steps: [0113] With the bottle pump, apply one pump (approximately 1 mL) of the formulation two 5 times a day (once in the morning and one hour before bedtime) to the scalp in the hair loss area. [0114] Massage into scalp with fingers, then wash hands well. [0115] Continue daily use in order to maintain hair regrowth and mitigate continued hair loss.

[0116] Patients generally begin to see results in about four months. Up to eight months of usage may be needed to achieve the best results. Those patients who achieve a positive response will need to continue to use the formulation two times a day to keep and continue the hair regrowth.

[0117] FIG. 1A illustrates a view of vertex alopecia prior to treatment;

[0118] FIG. 1B illustrates a view of vertex alopecia after 4-6 months of treatment;

[0119] FIG. 2A illustrates a view of vertex alopecia prior to treatment;

[0120] FIG. 2B illustrates a view of vertex alopecia after 4-6 months of treatment;

[0121] FIG. 3A illustrates a view of traction alopecia prior to treatment;

[0122] FIG. 3B illustrates a view of traction alopecia after 4-6 months of treatment.

[0123] All patents and publications mentioned in this specification are indicative of the levels of those skilled in the art to which the invention pertains. All patents and publications are herein incorporated by reference to the same extent as if each individual publication was specifically and individually indicated to be incorporated by reference.

[0124] It is to be understood that while a certain form of the invention is illustrated, it is not to be limited to the specific form or arrangement herein described and shown. It will be apparent to those skilled in the art that various changes may be made without departing from the scope of the invention and the invention is not to be considered limited to what is shown and described in the specification and any drawings/figures included herein.

[0125] One skilled in the art will readily appreciate that the present invention is well adapted to carry out the objectives and obtain the ends and advantages mentioned, as well as those inherent therein. The embodiments, methods, procedures and techniques described herein are presently representative of the preferred embodiments, are intended to be exemplary and are not intended as limitations on the scope. Changes therein and other uses will occur to those skilled in the art which are encompassed within the spirit of the invention and are defined by the scope of the appended claims. Although the invention has been described in connection with specific preferred embodiments, it should be understood that the invention as claimed should not be unduly limited to such specific embodiments. Indeed, various modifications of the described modes for carrying out the invention which are obvious to those skilled in the art are intended to be within the scope of the following claims.