Method of making a hair growth product

Abstract

A composition and method for treating hair loss is disclosed. The composition comprises water-soluble ionizable metal and non-metal components, aqueous and alcohol-based solvents, potassium iodide and citrus essential oil, and is preferably provided as a non-aerosol spray product that is applied to the hair and scalp. The invention further provides a method of making and using the composition.

Claims

1. A method of making a composition to treat hair loss comprising: solubilizing a first combination of water-soluble ionizable metal compounds consisting of potassium phosphate, potassium oxide, potassium chloride, copper ethylenediaminetretraacetic acid (Cu-EDTA), iron hydroxy-2-ethylenediaminetretraacetic acid (Fe-HEDTA), manganese ethylenediaminetretraacetic acid (Mn-EDTA), zinc ethylenediaminetretraacetic (Zn-EDTA) in a first quantity of purified water; solubilizing a second combination of non-metal ionic compounds consisting of ammonium sulfate, urea, and boric acid in a second quantity of purified water; and combining said solubilized first combination and said solubilized second combination with mixing to produce a solubilized third combination.

2. The method of claim 1, further comprising: adding a quantity of a short chain alcohol to said solubilized third combination.

3. The method of claim 2, wherein said short chain alcohol is selected from ethyl alcohol, isopropyl alcohol, and combinations thereof.

4. The method of claim 3, wherein said quantity of short chain alcohol further comprises methyl salicylate.

5. The method of claim 1, wherein said purified water is distilled or deionized water.

6. The method of claim 1, further comprising: adding one or more stabilizing components selected from water-soluble polymers, soluble silicates, polysaccharides, gums, celluloses, clays, xanthan gum, acacia gum, guar gum, carrageenan, alginic acid, hydroxyethyl cellulose, methyl cellulose, pectin, rice starch, wheat starch, corn starch, aluminum monostearate, polyethylene glycol, sodium silicate, sodium bentonite, attapulgite, and combinations thereof, to said first combination of water-soluble ionizable metal compounds prior to solubilizing in water.

7. The method of claim 1, further comprising: adding one or more stabilizing components selected from water-soluble polymers, soluble silicates, polysaccharides, gums, celluloses, clays, xanthan gum, acacia gum, guar gum, carrageenan, alginic acid, hydroxyethyl cellulose, methyl cellulose, pectin, rice starch, wheat starch, corn starch, aluminum monostearate, polyethylene glycol, sodium silicate, sodium bentonite, attapulgite, and combinations thereof, to said second combination of water-soluble non-metal ionic compounds prior to solubilizing in water.

Description

BRIEF DESCRIPTION OF THE FIGURES

(1) FIG. 1 is a photograph of the scalp crown area of User #1 after using the formulation for 2 years.

(2) FIG. 2 is a photograph of the frontal area of the scalp of User #1 after using the formulation for 2 years.

DETAILED DESCRIPTION

(3) A composition for treating hair loss along with a method for making and using the composition is herein disclosed. The composition comprises a combination of metal and non-metal ions, short chain alcohols and citrus oils. Preferably the composition is formulated as a hair spray for topical application to the scalp, and the metal ions are preferably provided as either water soluble salts or chelated complexes. The composition is particularly beneficial for treating hair loss on the scalp, but may be applied to other areas of the skin as well. The composition is useful for remedying hair loss in both men and women.

(4) The hair loss composition is preferably formulated as a hair spray for application to a user's scalp. Preferably the non-aerosol spray will deliver the composition in a light mist to coat the treatment area in such a manner that the composition remains on the treatment area without running off. In an alternative embodiment, the composition may be formulated as a liquid that is applied with a sponge or other means and massaged into the scalp.

(5) Hair growth on the human scalp follows a cycle with three phasesthe anagen phase, the catagen phase and the telogen phase.

(6) The anagen (or growth) phase varies by individual and may last anywhere from 2-6 years. In this phase, a hair typically grows at a rate of about 1.25 cm (0.5 inch) per month. Around 85%-90% of the hair on a typical individual's scalp will be in the anagen phase at any given point.

(7) The catagen phase occurs after the anagen phase and during this phase, hair growth ceases. The hair follicle tightens around the hair shaft and the hair root shrinks away from the hair. The catagen phase is a transitional phase lasting around from a few days to a few weeks. Around 4%-5% of the hair on a typical individual's scalp will be in the catagen phase.

(8) During the last or telogen phase, the hair is released from the hair follicle and will eventually fall away from the scalp. After the hair is released, the hair follicle enters a resting phase for around three months. Following this resting phase, the hair growth cycle starts again with the anagen (growth) phase. Around 6%-10% of the hair on a typical individual's scalp will be in the telogen phase. Approximately 80-100 hairs are shed each day, typically just prior to the anagen or growth phase beginning.

(9) Application of the hair loss composition should continue for several months to ensure that all of the hair follicles in the treatment area are in contact with the hair loss composition through all three phases of the hair growth cycle for at least one cycle and preferably through more than one cycle. The hair loss composition is preferably applied to a user's scalp one to three times per day for at least six months to determine efficacy for an individual user.

(10) Preparation of Exemplary Hair Loss Formulations

(11) The hair loss composition invention can be prepared starting with the metal and non-metal ionic components in either a dry form or in a solubilized form. Additional active components are mixed with the ionic compounds and the formulation is diluted to the final volume.

Exemplary Formulation 1Preparation of Formulation from Dry Components

(12) The formulation of a preferred hair spray composition with the ionic components in a dry form is exemplified below. A dry composition containing metal and non-metal ions is mixed with a quantity of purified water, then mixed with a quantity of alcohol-based solvent. The resultant mixture is combined with a quantity of a solution having solubilized iodine and kelp extract. A quantity of citrus oil is then added to the mixture. Purified water is added to the mixture to reach the final volume desired. Exemplary Formulation 1 will have a final volume of 750 m L.

(13) Step 1: Dry Components

(14) Metal and nonmetal ions useful for the claimed hair product are provided in a dry composition comprised of water-soluble and chelated compounds as characterized in Table I below.

(15) TABLE-US-00001 TABLE I Ingredient Total Nitrogen, total 24% Ammoniacal nitrogen 3.5% (as ammonium sulfate) Urea nitrogen 20.5% (as urea and urea phosphate) Phosphate, available (as potassium phosphate) 8% Potassium, soluble (as potash (potassium oxide) 16% and potassium chloride) Boron (as boric acid) 0.02% Copper (Cu), soluble (as copper sulfate) 0.07% Iron (Fe), chelated (as EDTA-Fe) 0.10% Manganese (Mn), chelated (as EDTA-Mn) 0.05% Molybdenum (Mo), (as sodium molybdate) 0.0005% Zinc (Zn), soluble (as zinc sulfate) 0.06%

(16) The dry composition of metal and non-metal ions contains excipient ingredients such as binders, thickening agents, and stabilizing agents and combination thereof. The excipient ingredients provide bulk to the dry composition and help to maintain the components in a powder or granular state prior to mixing. The excipient ingredients also assist with solubilizing, suspending or thickening the ionic components after the dry components are solubilized. Stabilizing agents may also increase shelf-life by inhibiting microbial growth in the formulation of solubilized components.

(17) Binders, thickening agents and stabilizing agents are selected from materials that will not react with the metal and non-metal iconic components and which are suitable for a topical skin formulation. Materials may be selected from natural and synthetic water-soluble polymers, soluble silicates, polysaccharides, gums, celluloses, clays, and combinations thereof. Suitable materials include xanthan gum, acacia gum (gum Arabic), guar gum, carrageenan, alginic acid, hydroxyethyl cellulose, methyl cellulose, pectin, starch (rice, wheat or corn derived), aluminum monostearate, polyethylene glycol, sodium silicate, sodium bentonite and attapulgite. Other binders and stabilizing agents that are suitable for topical application and which do not react with the metal and non-metal ionic components may be used in addition to or instead of the agents listed herein.

(18) The concentration of binders and stabilizers is adjusted to achieve a suitable topical formulation that will decrease run-off of the composition from the treatment area, and may vary as needed to achieve a viscosity suitable for a composition formulated as a non-aerosol spray or for a liquid or gel formulation applied by sponge or other application means to the skin treatment area.

(19) Step 2: Solubilizing Dry Components

(20) 20 grams to 40 grams of the dry composition characterized in Table I above is vigorously mixed with 60 mL to 120 mL (2-4 ounces) of purified water to solubilize the components. Up to an additional 60 mL to 120 mL of purified water may be added a few milliliters at a time if necessary to fully solubilize the components. The solubilized mixture is then combined with 60 mL to 120 mL of alcohol-based solvent and stirred until a uniform mixture results.

(21) The preferred alcohol-based solvent comprises a short chain alcohol that can be safely applied to human skin. The percentage of short chain alcohol in the alcohol-based solvent is preferably 50% to 70% by volume with the remaining volume comprising purified water. The short chain alcohol is preferably selected from ethyl alcohol, isopropyl alcohol, and combinations thereof. The ethyl alcohol, isopropyl alcohol, and combinations thereof, may further comprise 0.5% methyl salicylate (wintergreen oil). Preferably, the short chain alcohol is 70% isopropyl alcohol. In a most preferred embodiment, the isopropyl alcohol further comprises 0.5% methyl salicylate (wintergreen oil).

(22) Step 3: Addition of Remaining Active Components

(23) A quantity of a solution having solubilized potassium iodide and kelp extract is added to the mixture prepared in Step 2 and stirred until fully incorporated into the mixture. After the potassium iodide and kelp extract is incorporated into the mixture, a quantity of citrus oil is added and stirred until fully incorporated.

(24) A preferred solution containing potassium iodide and kelp extract has approximately 3-4 mg of solubilized potassium iodide and 40-45 mg of kelp extract per milliliter of solution. An amount ranging from 2 mL to 6 mL of the solubilized potassium iodide/kelp extract may added.

(25) Citrus oil useful for the present formulation is preferably selected from grapefruit essential oil, lemon essential oil, orange essential oil, and combinations thereof. Preferably the citrus oil will have approximately 500 mg to 1000 mg of essential oil per milliliter. A final concentration range of 0.001% to 1.0% of essential oil may be used in the formulation. More preferably, the final concentration is 0.1% to 0.5% by volume.

(26) Step 4: Addition of Purified Water to Finalize Volume

(27) Purified water is added to the resultant mixture from Step 3 to reach the desired final volume of 750 mL and the mixture is stirred to ensure even distribution of the components throughout the composition.

(28) Purified water useful for the composition may be deionized water, distilled water or water that has been filtered to remove particulates and contaminates and would be considered potable. Preferably deionized water is used.

(29) In one preferred embodiment of the hair loss formulation, 20 grams of the dry component mixture is combined with 60 mL purified water and 60 mL of alcohol-based solvent. When the dry components are fully solubilized, 4 mL of potassium iodide/kelp solution and 2 mL of a citrus essential oil are stirred into the mixture and purified water is added to equal 750 mL.

(30) In another preferred embodiment of the hair loss formulation, 40 grams of the dry component mixture is combined with 120 mL purified water and 120 mL of alcohol-based solvent. When the dry components are fully solubilized, 6 mL of potassium iodide/kelp solution and 2 mL of a citrus essential oil are stirred into the mixture and purified water is added to equal 750 mL.

(31) Optional Components

(32) Additional components suitable for use in a hair spray, such as glycerin, gums, water-soluble polymers, stabilizing agents, or fragrances may be optionally included in the hair loss formulation. Components to stabilize the formulation, improve texture and increase shelf life, or fragrances to make it aesthetically agreeable, may be added to the resultant mixture from Step 2 prior to the addition of purified water in Step 4. Purified water is then added to equal 750 mL of solution.

Exemplary Formulation 2Preparation of Formulation from Solubilized Components

(33) The composition of a preferred hair loss formulation prepared from ionic components provided in a solubilized form is exemplified below. A solubilized composition containing metal and non-metal ions is mixed with a quantity of alcohol-based solvent. The resultant mixture is combined with a quantity of a solution having solubilized iodine and kelp extract. A quantity of citrus oil is then added to the mixture with stirring. Purified water is added to the mixture to reach the final volume desired. Exemplary Formulation 2 will have a final volume of 750 m L.

(34) Step 1: Mixing Solubilized Components with Alcohol-Based Solvent

(35) Metal and nonmetal ions useful for the claimed hair loss composition are provided in a solubilized format comprised of soluble and chelated compounds as characterized in Table II below. The ionic compounds are solubilized in an aqueous base.

(36) TABLE-US-00002 TABLE II Ingredient Total Nitrogen, total 7% Ammoniacal nitrogen 0.4% (as ammonium sulfate) Urea nitrogen 6.6% (as urea) Phosphate, available (as potassium phosphate) 7% Potassium, soluble (as Potash (Potassium oxide) 7% and Potassium chloride) Boron (as Boric acid) 0.02% Copper (Cu), soluble (as Cu-EDTA) 0.05% Iron (Fe), chelated (as Fe-HEEDTA) 0.10% Manganese (Mn), chelated (as Mn-EDTA) 0.08% Zinc (Zn), soluble (as EDTA-Zn) 0.05%

(37) A starting quantity of the solubilized ionic mixture of approximately 500 mL is mixed combined with 60 mL to 120 mL of alcohol-based solvent and stirred until a uniform mixture results. The solubilized ionic mixture is thoroughly mixed prior to measuring the starting and finalizing volumes to ensure uniform distribution of the ionic components.

(38) The preferred alcohol-based solvent is a short chain alcohol that can be safely applied to human skin. The percentage of short chain alcohol in the alcohol-based solvent is preferably 50% to 70% by volume with the remaining volume comprising purified water. The short chain alcohol is selected from ethyl alcohol, isopropyl alcohol and combinations thereof. The ethyl alcohol, isopropyl alcohol, and combinations thereof, may further comprise 0.5% methyl salicylate (wintergreen oil). Preferably, the short chain alcohol is 70% isopropyl alcohol. In a most preferred embodiment, the isopropyl alcohol further comprises 0.5% methyl salicylate (wintergreen oil).

(39) Step 2: Addition of Remaining Active Components

(40) A quantity of a solution having solubilized potassium iodide and kelp extract is added to the mixture prepared in Step 1 with stirring. After the potassium iodide and kelp extract is incorporated into the mixture, a quantity of citrus oil is added with stirring.

(41) A preferred solution containing potassium iodide and kelp extract has approximately 3-4 mg of solubilized potassium iodide and 40-45 mg of kelp extract per mL of solution. An amount ranging from 2 mL to 6 mL of the solubilized potassium iodide/kelp may added to the formulation.

(42) Citrus oil useful for the present formulation is preferably selected from grapefruit essential oil, lemon essential oil, orange essential oil, and combinations thereof. Preferably the citrus oil will have approximately 500 mg to 1000 mg of essential per milliliter. A final concentration range of 0.001% to 1.0% of essential oil may be used in the formulation. More preferably, the final concentration is 0.1% to 0.5% by volume.

(43) Step 3: Addition of Solubilized Components to Finalize Volume

(44) After the additional active components in Step 2 have been fully incorporated into the solubilized starting composition, an additional quantity of solubilized components is added to reach a final volume of 750 mL.

Method of Using Hair Loss Formulation

(45) The method of use for treating hair loss will be the same whether the formulation has been prepared using the dry form or solubilized form of the ionic components. The formulation is best dispersed on the scalp when a non-aerosol spray device is employed. A spray device that produces a fine mist is preferred to ensure even distribution to the scalp and to prevent run-off of the formulation from the scalp. A small spray bottle with a 4 to 8 ounce volume capacity is preferred for ease of use. Alternatively, the formulation can be applied to the treatment area with another application means, such as a sponge.

(46) Treatment Step 1: Cleanse Scalp Area

(47) Prior to applying the hair loss formulation, the scalp area should be thoroughly cleansed and then rinsed to remove any soap residue. Hair should be dried prior to application of the formulation. Users should not apply any hair products to the scalp, such as hair spray, gels, mousse or other products as these products may leave a reside on the scalp possibly inhibiting the hair loss formulation from contacting the hair follicles in the treatment area.

(48) Treatment Step 2: Application of Formulation to Scalp

(49) The scalp area is lightly sprayed with the hair loss formulation and the formulation is allowed to dry on the scalp. Care should be taken not to over-spray the treatment area to prevent the formulation from running off the scalp. Once the first spray of the formulation has dried on the scalp, the formulation can be applied to the scalp a second time in a similar manner and allowed to dry. After the second application has dried, the formulation can be applied a third time to the scalp and allowed to dry.

(50) Application of the hair loss formulation according to the above method may be repeated one to two additional times throughout the day. It is not necessary to wash the scalp prior to subsequent treatment applications in a single day.

(51) Application of the hair loss formulation according to the above method should be continued for at least several months to determine individual efficacy and use may be continued long term to maintain hair growth benefit.

Example 1: User #1

(52) A male (User #1) with pronounced hair loss on the crown area of the scalp and moderate hair loss on the frontal area of the scalp applied the hair spray formulation to the entire scalp area two to three times per day for 2 years. The user noticed a marked increase in hair growth on the frontal and crown areas of the scalp.

(53) FIG. 1 shows the crown area of the scalp of User #1 after 2 years of daily use of the formulation. User #1 found that hair around the balding area on the crown was fuller than prior to using the treatment, the diameter of the balding area had decreased, and growth of new hair was evident in the center portion of the balding area on the crown.

(54) FIG. 2 shows the frontal area of the scalp of User #1 after 2 years of daily use of the formulation. User #1 found that hair growth had filled in along the forehead edges where hair had been receding along hairline and hair on the frontal area of the scalp was fuller than prior to using the treatment.

Example 2: User #2

(55) A male (User #2) with substantial hair loss on the frontal, hairline and crown areas of the scalp applied the hair spray formulation to the entire scalp area daily for 6 months. After six months of daily use of the formulation, User #2 found that new hair growth was evident over the balding area in the crown area and saw significant new hair growth on the frontal and forehead portions of the scalp.