COMPOSITION AND METHODS FOR TISSUE REGENERATION

Abstract

Described herein are topical compositions containing an effective amount of propylene glycol, as a sole active ingredient or a principal active ingredient, and a pharmaceutically acceptable medium. Also described herein are methods of promoting the growth of or the regeneration of a tissue such as nail, hair, gum and skin in humans by topically administering the topical compositions to a human in need thereof.

Claims

1. A topical composition for reducing or preventing the gum recession or promoting the gum growth or regenerating new gum in a human comprising: a gum-growth-promoting agent consisting of from about 1% to about 99% by weight of propylene glycol and a pharmaceutically acceptable medium; wherein the topical composition is to be applied to the gum area as a uniform layer or to be injected topically into various gum areas, wherein the composition is selected from the group consisting of a liquid solution, liquid mixture, suspension, lotion, paste, gel, cream, foam, spray, dressing and an emulsion.

2. The composition of claim 1, wherein the concentration of propylene glycol ranges from about 3% to about 95% by weight or about 10% to about 95% by weight.

3. The composition of claim 1, wherein the concentration of propylene glycol ranges from about 20% to about 95% by weight or about 40% to about 95% by weight.

4. The composition of claim 1, wherein the concentration of propylene glycol ranges from about 30% to about 95% by weight.

5. The composition of claim 1, wherein the pharmaceutically acceptable medium contains an ingredient selected from the group consisting of water, glycerin, dimethyl sulfoxide, other solvent, an electrolyte, a pH modifier, a surfactant, an absorption enhancer, an emulsifier, a thickener, a fragrance, a color, a preservative, and combinations thereof.

6. A method for reducing or preventing the gum recession or promoting the gum growth or regenerating new gum in a human comprising: administering to the gum of the human in need thereof an effective amount of the composition of claim 1.

7. A method for enhancing the growth of and/or for regenerating of a topical tissue in a human, said method comprised of applying to the human in need thereof a composition comprising: an effective concentration of propylene glycol and a pharmaceutically acceptable medium containing an ingredient selected from the group consisting of water, glycerin, dimethyl sulfoxide, a solvent, electrolyte, pH modifier, surfactant, absorption enhancer, emulsifier, thickener, fragrance, preservative, salicylic acid, sodium salicylate, an emulsifier and combinations thereof, and, and optionally, a cell-growth promoter; wherein the composition is selected from the group consisting of a liquid solution, liquid mixture, suspension, lotion, paste, gel, cream, foam, spray, dressing and an emulsion; and wherein the dosage form is applied topically to the tissue of the human to be treated.

8. The method of claim 7, wherein the topical tissue is a scalp.

9. The method of claim 7, wherein the topical tissue is an eyebrow, an eyelash, a skin or a wounded skin.

10. The method of claim 7, wherein the topical tissue is a burned skin.

11. The method of claim 7, wherein the topical tissue is a nail.

12. The method of claim 7, wherein the composition contains the cell-growth promoter in an amount that ranges from about 0.001% to about 30% by weight, wherein the cell-growth promoter is selected from the group consisting of biotin, one or more other water-soluble vitamins, aloe vera powder, aloe vera gel, arginine, arginine hydrochloride, dimethyl sulfoxide, sodium chloride, zinc chloride, magnesium chloride, magnesium sulfate, salicylic acid, sodium salicylate, and combinations thereof.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0017] A first embodiment is directed to a topical composition for reducing or preventing the gum recession or promoting the gum growth or regenerating new gum in a human comprising: a gum-growth-promoting agent consisting of from about 1% to about 99% by weight of propylene glycol and a pharmaceutically acceptable medium; wherein the topical composition is to be applied to the gum area as a uniform layer, preferably at least once a day before bedtime, or to be injected topically into various gum areas at an appropriate time interval, wherein the composition is selected from the group consisting of a liquid solution, liquid mixture, suspension, lotion, paste, gel, cream, foam, spray, dressing and an emulsion.

[0018] In a first aspect of the first embodiment, the concentration of propylene glycol in the composition ranges from about 3% to about 95% by weight or about 10% to about 95% by weight.

[0019] In a second aspect of the first embodiment, the concentration of propylene glycol in the composition ranges from about 20% to about 95% by weight or about 30% to about 95% by weight.

[0020] In a third aspect of the first embodiment, the concentration of propylene glycol in the composition ranges from about 40% to about 95% by weight.

[0021] In a fourth aspect of the first embodiment, the pharmaceutically acceptable medium contains an ingredient selected from the group consisting of water, glycerin, dimethyl sulfoxide, other solvent, an electrolyte, a pH modifier, a surfactant, an absorption enhancer, an emulsifier, a thickener, a fragrance, a color, a preservative, and combinations thereof.

[0022] A fifth aspect of the first embodiment is directed to a method for reducing or preventing the gum recession or promoting the gum growth or regenerating new gum in a human comprising: administering to the gum of the human in need thereof an effective amount of the composition of the first embodiment.

[0023] As related to the fifth aspect of the first embodiment, the administering may occur on an as needed basis. Alternatively, the administering may occur once per day or at least once per day. When administered on a daily basis, the administering may occur once per day, twice per day, three times per day, four times a day, or combinations thereof over an extended period of time so as to achieve the desired result of either reducing or preventing the gum recession or promoting the gum growth or new gum regeneration.

[0024] A second embodiment is directed to a method for enhancing the growth of and/or for regenerating of a topical tissue in a human, said method comprised of applying to the human in need thereof a composition comprising: an effective concentration of propylene glycol and a pharmaceutically acceptable medium containing an ingredient selected from the group consisting of water, glycerin, dimethyl sulfoxide a solvent, electrolyte, pH modifier, surfactant, absorption enhancer, emulsifier, thickener, fragrance, preservative, salicylic acid, sodium salicylate, an emulsifier and combination thereof, and, optionally, a cell-growth promoter; wherein the composition is selected from the group consisting of a liquid solution, liquid mixture, suspension, lotion, paste, gel, cream, foam, spray, dressing and an emulsion; and wherein the dosage form is applied topically to the tissue of the human to be treated.

[0025] As related to the second embodiment, the applying may occur on an as needed basis. Alternatively, the applying may occur once per day or at least once per day. When applied topically on a daily basis, the applying may occur once per day, twice per day, three times per day, four times a day, or combinations thereof over an extended period of time so as to achieve the desired result of either enhancing the growth of and/or for regenerating of a topical tissue in a human.

[0026] In a first aspect of the second embodiment, wherein the topical tissue is a scalp.

[0027] In a second aspect of the second embodiment, the topical tissue is an eyebrow, an eyelash, or a skin or a wounded skin.

[0028] In a third aspect of the second embodiment, the topical tissue is a burned skin.

[0029] In a fourth aspect of the second embodiment, the topical tissue is a nail.

[0030] In a fifth aspect of the second embodiment, the composition contains the cell-growth promoter in an amount that ranges from about 0.001% to about 30% by weight, wherein the cell-growth promoter is selected from the group consisting of biotin, one or more other water-soluble vitamins, aloe vera powder, aloe vera gel, arginine, arginine hydrochloride, dimethyl sulfoxide, sodium chloride, zinc chloride, magnesium chloride, magnesium sulfate, salicylic acid, sodium salicylate, and combinations thereof.

[0031] One of ordinary skill will appreciate that water-soluble vitamins, include, for example, Riboflavin, Pyridoxin, Biotin, Sodium Ascorbate and Thiamine.

[0032] The expression by weight or (w/w) is based on the total weight of the composition.

[0033] The compositions and methods described herein are illustrated by the following examples. The examples should not be used to limit the scope of the claims presented herein.

EXAMPLE 1

[0034] Dramatic Regeneration of New Healthy Toenails after Nail Injuries by a composition containing 80% of PG, 10% of Glycerin, 0.5% of Sodium Salicylate, 0.1% of Sodium Chloride, 0.05% of Magnesium Sulfate, 0.01% of Arginine, 0.01% of Aloe Vera Powder, 0.0001% of Biotin (w/w), and Water (q.s.) in Humans.

[0035] The above solution was applied as a uniform layer to darkened, non-growing injured toenails twice a day in one adult (one big toenail affected) and about 4 times a day in the other adult (one big toenail and two other small toenails affected). Healthy new nails were grown out in about 4 months. Two new healthy toenails were also quickly regenerated in one adult after about 5 months of daily applications of the solution. The above results are believed to be the first of its kind ever reported. All concentrations used in this application are based on weight.

EXAMPLE 2

[0036] Acceleration of Nail Growth by a Solution Described in Example 1 or by a Gel Prepared with an Addition of 1% of Xanthan Gum, a gelling agent.

[0037] To serve as a base line a commercial red nail polish was applied as a thin layer to the cuticle area of the two big toenails of an adult. The above gel was then applied to the left big toenail 2 to 4 times a day. After about 2 months the nail was found to grow about 50% faster from the treated nail compared with the untreated nail. This was repeated about 8 months later with the left toenail serving a control. The right toenail was found to grow about 41% faster compared with the control nail. This kind of enhanced growth of toenail was also found in several other adults using the solution preparation.

[0038] Much lower concentrations of PG such as 10% or 20% or 30% may also be used. On the other hand, a preparation containing 95% of PG and 5% of glycerin may also be employed to safely and effectively regenerate new nails.

EXAMPLE 3

[0039] A Gel Containing 20% of PG, 5% of Arginine, 0.001% of Biotin, 1% of Xanthan Gum and Water (q.s.) for Nail Regeneration or Acceleration of Nail Growth in Humans.

EXAMPLE 4

[0040] Promotion of Hair Growth in Men by an Aqueous Solution Containing 70% of PG, 10% of Glycerin, 3% of Sodium Salicylate, 0.01% of Magnesium Sulfate, 3% of Sodium Chloride and Water (q.s.)

[0041] The above solution was applied twice daily from a spray bottle to the scalp of two adults who were losing their hair. New healthy, thicker, dark hair was found to start to grow in about one week. The length of new hair was about two centimeters in about one month. The rapidity of hair growth in this preliminary study seemed quite encouraging compared with much slower (probably 6 to 12 months) growth rate of some commercial FDA-approved products.

EXAMPLE 5

[0042] Hair Regeneration in a Man with Male Baldness Pattern Following Daily Topical Applications of an Aqueous Solution Containing 60% of PG, 10% of Glycerin, 10% of dimethyl Sulfoxide, 2% of Sodium Salicylate, 4% of Sodium Chloride, 0.7% of N-acetylcysteine, 0.3% of Sodium Phosphate Monobasic, 0.05% of Magnesium Sulfate, 1.5% of Arginine HCl, 1% of Arginine, 0.2% of Glutathion, 0.001% of Biotin and Water (q.s.)

[0043] A male at age 79 (Applicant) applied the above solution twice daily to the right side of his scalp. In about one month new black hair was found to start growing in the applied right side while the controlled left side did not show visible growth of new hair. The above study is still on-going at the time of preparation of this patent application. It is noted that old hair was largely gray and most new hair is dark.

EXAMPLE 6

[0044] Hair Wash Gel Containing 10% of PG, 10% of Glycerin, 1% of Xanthan Gum, 0.9% of Sodium Chloride, Traces of Water-Soluble Vitamins (such as Riboflavin, Pyridoxin, Biotin, Sodium Ascorbate and Thiamine) and Water (q.s.).

EXAMPLE 7

Compositions and Method for Treating Burned or wounded Skin

[0045] An aqueous solution containing 45% of PG, 35% of glycerin, 1% of sodium salicylate, 0.9% of sodium chloride, 0.5% of Arginine, 0.1% of magnesium sulfate, 0.1% of ascorbic acid and 17.4% of water is prepared. This solution can be applied as a thin layer from a soft brush or spray bottle to the burned or wounded skin surface followed by coverage of a proper dressing. This may be repeated twice a day for several days. Healing or re-growth of skin is then expected probably without scarring. An alternative formula will contain only 25% of PG.

[0046] A gel containing 80% of PG, 10% of glycerin, 2% of sodium salicylate, 1% of Xanthan Gum and Water (q.s.). was applied to a superficial wounded skin, about 0.25 cm in size, on the forearm of an adult once a day for three days. The wound was healed later without infection.

EXAMPLE 8

[0047] Dramatic Gum Regeneration and Stabilization of a Loose Tooth by a Gel Containing 70% of PG, 10% of Glycerin, 0.5% of Aloe Vera Powder, 1% of Xanthan Gum and Water (q.s.) in an Adult.

[0048] About a teaspoon of the above gel was applied into the mouth of a male senior with a severe gum loss and with one loose tooth each night after teeth cleaning before bed-time. This was followed by a swirling motion for about one minute in order to mix the gel with the saliva and to have the mixture reach various gum areas. The study lasted about two months. Gum pictures taken before and after treatment in a local dental office revealed surprising healthy growth of new gum. Most importantly, the test subject felt that the earlier loose tooth became much steadier and stronger. No irritation or discomfort was reported. The dentist was so impressed with the gum regeneration and offered to become a volunteer to test the gel because of her receding gum problem.

EXAMPLE 9

[0049] A Gel Containing 50% of PG, 10% of Glycerin, 10% of Dimethyl Sulfoxide, 0.5% of Sodium Chloride, 0.5% of Aloe Vera Gel, 0.5% of Sodium Ascorbate, 0.001% of Biotin and Water (q.s.) for Regeneration of Gum in Humans

EXAMPLE 10

[0050] A Toothpaste Formula for Promoting Gum Growth: 15% of PG, '10% of Glycerin, 3% of Titanium Dioxide, 0.9% of Sodium Chloride, 0.00001% of Riboflavin, 0.1% of Arginine, 0.3% of Sodium Stearate, 0.05% of Magnesium Sulfate, 0.001% of Peppermint, 2% of Xanthan Gum and Water (q.s.)

[0051] It is to be noted that 3, 5, 10, or 25% of PG can also be used in the above formula.

EXAMPLE 11

[0052] A Mouth Wash Solution Containing 20% of PG, 10% of Glycerin, 0.3% of Sodium Chloride, 0.1% of Magnesium Chloride, Trace of Fragrance (Such as Peppermint) and Water (q.s.) for Promotion of Gum Growth in the mouth.

EXAMPLE 12

[0053] A Solution Containing 60% of PG, 10% of Glycerin, 0.9% Sodium Chloride and Water (q.s.) for Microinjection into Various Parts of Anesthetized Gum by a Dentist at an Appropriate Interval.

[0054] It is possible that high concentrations of glycerin such as 80% with 10% of PG and 10% of normal saline may also be injected directly to gums for promoting gum regeneration.

[0055] The above examples are intended to be illustrative, and not restrictive. One skilled in the art will be able to ascertain, without any more routine experimentation, many references to specific embodiments described herein. These equivalents are intended to be encompassed by the following claims.