Formulation for treatment of acne

Abstract

A vitamin, mineral, herbal, and micronutrient treatment for acne via support of the physiologic processes in the body which cause acne is disclosed. It is a targeted formula, designed specifically to address the causes of acne. This specific, unique formulation preferably in a gummy substrate for ease of administration, to induce a willingness on the part of the target population to take it, and to increase the bioavailability of the active ingredients. Other types of confection or edible vehicle can be used.

Description

DESCRIPTION OF PREFERRED EMBODIMENTS

1. In particular, this disclosure covers a unique nutritional vitamin, mineral, herbal formulation for the therapeutic purpose of strengthening the body's defenses against the internal processes which cause acne. The formula preferably includes full-spectrum B vitamins, not a selection of the B's, since an excess of one B can result in a deficiency of another. The formula also includes Vitamin C for its anti-inflammatory, anti-viral and anti-oxidant characteristics. The formula also includes zinc for its skin-healing properties, and includes Vitamin E for its hormone regulation properties.

In particular invention encompasses formula ranges as cited below (under Brief Manufacturing Description).

The invention further encompasses all edible forms of each component, when combined with the others, e.g. zinc as zinc sulfate or zinc acetate.

It is well known that the vitamin B complex components interact with each other, so that a surfeit of one will diminish another (72,73,74,75,76). As a result it is desirable to include substantially the full range of B vitamins in the formula, so as not to cause such a depletion. This invention is believed to provide the minimum amount of each vitamin, mineral and micronutrient necessary to be an effective amount (see minimums in the table below), assuming two pills, tablets or candies are taken daily. The table below provides, also, what an approximate maximum amount of the formula would be if administered in a pill or capsule form (two per day). It is the combination of these elements which gives the resulting efficacy against the disequilibria which cause acne. In some cases components preferably are included to broaden the application of the formulation, since there are apparently five or more different causes of acne for different individuals. Certain vitamins and minerals are effective against certain acne causes, but inclusion of components to treat several of the causes makes the formulation effective for more individuals. Thus this invention encompasses the formula ranges as described, well within the normal administration levels of each component, separately.

2. Original use of an edible formulation in a gummy vitamin format for strengthening the body's defenses against acne.

3. Use of a gummy vitamin format targeted for a therapeutic purpose to a particular malady or condition.

4. Easy-to-use and pleasant-tasting delivery system, which encourages the administration of the vitamin, mineral and herbal therapeutic formulation to control acne.

5. The deliberate maintenance of a slight vitamin, mineral, herbal, micronutrients aftertaste to inform the palate that although the product is in a candy substrate, the product has a therapeutic purpose.

6. Packaging in a fun, multi-colored, designed container to attract the target cohort of ages 12 to 24. The presentation of the formula in a fun package, with a non-medicinal face, for greater acceptability of the product, in the target cohort of 12 to 24 year olds.

7. Enhanced bioavailability of vitamins, minerals, herbs and micronutrients via mastication of a chewable gummy substrate rather than relying on the gastro-intestinal tract's ability to break down the substrate, which it does inefficiently, to treat a particular condition.

8. The avoidance of sugar as a recipe component, which would have the effect of diminishing and neutralizing the therapeutic impact of several of the active ingredients, and so be counter-productive.

9. A preferred combination is Vitamin E, in any of its various forms in the range of about 13 to 100 i.u., biotin in the range of about 3 mcg to 100 mcg, folic acid in the range of about 13 mcg to 100 mcg, niacin in any of its forms in the range of about 3 mg to 100 mg, PABA from about 3 mg to 100 mg, pantothenic acid from about 3 mg to 100 mg, Vitamin B1 from about 3 mg to 100 mg, Vitamin B12 from about 3 mcg to 50 mcg, Vitamin B2 (riboflavin) from about 3 mg to 100 mg, Vitamin B6 (Pyridoxine) from about 3 mg to 100 mg, Vitamin C (ascorbic acid) in its various forms from about 25 mg to 1000 mg, zinc in its various bioavailable forms from about 1.67 mg to 75 mg, choline from about 3 mg to 100 mg, inositol from about 3.33 mg to 100 mg.

10. Another combination would be Vitamin E, in any of its various forms in the range of about 13 to 100 i.u., folic acid in the range of about 13 mcg to 100 mcg, niacin in any of its forms in the range of about 3 mg to 100 mg, PABA from about 3 mg to 100 mg, pantothenic acid from about 3 mg to 100 mg, Vitamin B1 from about 3 mg to 100 mg, Vitamin B12 from about 3 mcg to 50 mcg, Vitamin B2 (riboflavin) from about 3 mg to 100 mg, Vitamin B6 (Pyridoxine) from about 3 mg to 100 mg, Vitamin C (ascorbic acid) in its various forms from about 25 mg to 1000 mg, zinc in its various bioavailable forms from about 1.67 mg to 75 mg, choline from about 3 mg to 100 mg, inositol from about 3.33 mg to 100 mg.

11. Another combination would be Vitamin E, in any of its various forms in the range of about 13 to 100 i.u., biotin in the range of about 3 mcg to 100 mcg, niacin in any of its forms of in the range of about 3 mg to 100 mg, PABA from about 3 mg to 100 mg, pantothenic acid from about 3 mg to 100 mg, Vitamin B1 from about 3 mg to 100 mg, Vitamin B12 from about 3 mcg to 50 mcg, Vitamin B2 (riboflavin) from about 3 mg to 100 mg, Vitamin B6 (Pyridoxine) from about 3 mg to 100 mg, Vitamin C (ascorbic acid) in its various forms from about 25 mg to 1000 mg, zinc in its various bioavailable forms from about 1.67 mg to 75 mg, choline from about 3 mg to 100 mg, inositol from about 3.33 mg to 100 mg.

12. Another combination would be Vitamin E, in any of its various forms in the range of about 13 to 100 i.u., biotin in the range of about 3 mcg to 100 mcg, folic acid in the range of about 13 mcg to 100 mcg, PABA from about 3 mg to 100 mg, pantothenic acid from about 3 mg to 100 mg, Vitamin B1 from about 3 mg to 100 mg, Vitamin B12 from about 3 mcg to 50 mcg, Vitamin B2 (riboflavin) from about 3 mg to 100 mg, Vitamin B6 (Pyridoxine) from about 3 mg to 100 mg, Vitamin C (ascorbic acid) in its various forms from about 25 mg to 1000 mg, zinc in its various bioavailable forms from about 1.67 mg to 75 mg, choline from about 3 mg to 100 mg, inositol from about 3.33 mg to 100 mg.

13. Another combination would be Vitamin E, in any of its various forms in the range of about 13 to 100 i.u., biotin in the range of about 3 mcg to 100 mcg, folic acid in the range of about 13 mcg to 100 mcg, niacin in any of its forms in the range of about 3 mg to 100 mg, pantothenic acid from about 3 mg to 100 mg, Vitamin B1 from about 3 mg to 100 mg, Vitamin B12 from about 3 mcg to 50 mcg, Vitamin B2 (riboflavin) from about 3 mg to 100 mg, Vitamin B6 (Pyridoxine) from about 3 mg to 100 mg, Vitamin C (ascorbic acid) in its various forms from about 25 mg to 1000 mg, zinc in its various bioavailable forms from about 1.67 mg to 75 mg, choline from about 3 mg to 100 mg, inositol from about 3.33 mg to 100 mg.

14. Another combination would be Vitamin E, in any of its various forms in the range of about 13 to 100 i.u., biotin in the range of about 3 mcg to 100 mcg, folic acid in the range of about 13 mcg to 100 mcg, niacin in any of its forms in the range of about 3 mg to 100 mg, PABA from about 3 mg to 100 mg, Vitamin B1 from about 3 mg to 100 mg, Vitamin B12 from about 3 mcg to 50 mcg, Vitamin B2 (riboflavin) from about 3 mg to 100 mg, Vitamin B6 (Pyridoxine) from about 3 mg to 100 mg, Vitamin C (ascorbic acid) in its various forms from 25 mg to 1000 mg, zinc in its various bioavailable forms from about 1.67 mg to 75 mg, choline from about 3 mg to 100 mg, inositol from about 3.33 mg to 100 mg.

15. Another combination would be 11, above without the B12.

16. Another combination would be 11, above without the B2.

17. Another combination would be 11, above without the B6.

18. Another combination would be 11, above without the choline.

19. Another combination would be 11, above without the choline or inositol.

20. Another combination would be 19 without the biotin.

21. Another combination would be 19 without the folic acid.

22. Another combination would be 19 without the niacin.

23. Another combination above would be 19 without the PABA.

24. Another combination would be 19 without the pantothenic acid.

25. Another combination would be 19 without the B12.

26. Another combination would be 19 without B2.

27. Another combination would be 19 without B6.

28. Another combination would be 19 without biotin or folic acid.

29. Another combination would be 28 without niacin.

30. Another combination would be 28 without PABA.

31. Another combination would be 28 without pantothenic acid.

32. Another combination would be 28 without B12.

33. Another combination would be 28 without B2.

34. Another combination would be 28 without B6.

35. As a further variation, alpha lipoic acid, about 50 to 100 mg, and/or selenium, about 200 to 400 mcg, can be included in any of the above formulations. Each of them has been found effective against certain types of infection which would also pertain to acne.

36. Any of the above formulations, further including oregano and parsley aquaresin as in the chart below.

It is important to note that the above variations reflect the fact that there are different causes of acne in different persons, and the different causes respond to some extent to different vitamin and mineral treatments. Many of the different individual components could be eliminated while still resulting in a composition that proves an effective treatment for much of the population of acne patients.

Test Results

A total of 200 test candidates, ages 13 to 54, were tested with the formulation. They were asked to take two per day and to report whether there were any changes in their skin. As acne manifests itself differently, from mild to moderate to extensive, depending on the person and his condition at any given time, the candidates were simply asked to describe the change, if any was observed, in their skin. Two candidates with cystic acne were simultaneously treated with Accutane, which rendered their results confusing, at best. The Accutane-taking candidates had quite ruddy skin tones, looking like a rash both at the beginning and end of their trial. We do not therefore have an opinion as to whether the formulation is efficacious in the cystic acne population.

The test population was comprised of 200 people ages 13 to 54. Of all test candidates, 73.84% showed efficacy. Ages 13 to 17 had an efficacy rate of 74.6%, ages 18 and over an efficacy rate of 73.39%. Test subjects were not considered valid if they failed to take the product for the requisite time period. 26.16% of all test candidates reported no efficacy, 25.40% of 13 to 17 year olds and 26.61% of ages 18 and over. Observations included the description of preliminary results within a 12 hour period, manifesting as a reduction in the size of the acne break-outs and a general calming down of the outbreaks. Additional observations include the prevention of outbreaks proceeding through their normal course, from outset and rather, instead, being stopped.

Many test candidates have continued to ask for additional and/or ongoing supplies of product, a further indication of their positive finding.

On the following pages are preferred ranges for the formulation. The testing described above utilized the lowest amounts in the table, as the objective was to find the minimum amount necessary to achieve the desired result, and the test candidates took two per day, thus twice the minimum each day for each component.

Brief Manufacturing Description

Manufacturing the product in a preferred gummy-candy embodiment will follow normal manufacturing process of gummy jelly candies, excluding sugar.

A solution of gelatin is prepared by soaking dried gelatin granules in water and heated at a temperature to sufficiently melt and solubilize the gelatin. A solution of sugar alcohols is heated to about 93% soluble solids and then cooled to below the boiling temperature of water. The solubilized gelatin is blended with the blend of vitamins and minerals until homogeneous. The gelatin solution is added to the sugar alcohol syrup and blended together along with flavors, colors and acidulants. The syrup solids at this point will be about 78-79% soluble solids. The blended syrup is deposited into starch mold impressions and allowed to solidify. The starch mold will draw excess moisture from the gelatin-based gel. Typical time to achieve desired level of moisture is 24 hours. The finished solids of the product will be about 82% soluble solids. The set candies are removed from the starch and the candies are lightly coated with fat and wax based film to keep the finished candies separate. The product is then transferred for packaging.

Ranges of Composition of Vitamin Blend Per 150 mg
(Target for 1 Unit)
Component                        Weight Range
Vitamin E (as acetate, USP-FCC)  13.33 IU–100 IU
Biotin (FCC)                     3.33 mcg–100 mcg
Folic Acid (USP-FCC)             13.33 mcg–100 mcg
Niacin (as Niacinamide, USP)     3.33 mg–100 mg
PABA (USP)                       3.33 mg–100 mg
Pantothenic Acid (as D-Calcium   3.33 mg–100 mg
Pantothenate, USP)
Vitamin B1 (as Thiamin Mononitrate, USP-FCC) 3.33 mg–100 mg
Vitamin B12 (as Cyanocobalamin, USP) 3.33 mcg–50 mcg
Vitamin B2 (as Riboflavin, USP-FCC) 3.33 mg–100 mg
Vitamin B6 (as Pyridoxine HCl, USP-FCC) 3.33 mg–100 mg
Vitamin C (as Ascorbic Acid, USP-FCC) 25 mg–1000 mg
Zinc (as Zinc Acetate)           1.67 mg–75 mg
Choline (as Choline Bitartate, USP) 3.33 mg–100 mg
Inositol (FCC)                   3.33 mg–100 mg
Maltodextrin (as Maltrin-100)    Quantity sufficient
(as a binding agent, not an active to hold together
ingredient)
Oregano & Parsley Aquaresin Solution 0.01 g

The invention further encompasses all edible forms of each component, when combined with the others, e.g. zinc as zinc sulfate rather than zinc acetate.

In another preferred form of the invention the above formulation further includes alpha-lipoic acid and selenium, in the ranges of about 10-100 mg, and about 400 mcg, respectively.

As noted above, gummy candies are one preferred embodiment, and the invention includes the incorporation of the formulation in other candy or confection, including candy bars, jelly beans, and other candy, preferably without sugar.

Some variations from the above table are possible while still gaining the principal benefits of the invention. Basically, the invention in broad terms encompasses a daily oral dose of a formulation that includes the combination of vitamin B (in a range of B vitamins), vitamin C, zinc, and vitamin E. A broad spectrum of the B vitamins, as listed in the above table, is preferred but is not absolutely necessary. Fewer than all of these B vitamins can be included in the formulation. The minimum quantities per day are approximately twice the amounts in the table, i.e. the table amount, taken twice per day.

Note that the above list of components and ranges includes four of the B vitamins (as well as pantothenic acid, which is sometimes identified as vitamin B5). It is preferred, but not absolutely necessary, that all or substantially all the B vitamins be included because, as explained above, the vitamin B complex components interact with each other. An excess of one or several of the B vitamins will diminish another, or several others. It should be understood that omission of several of the B vitamins, or even many of the B vitamins, may still provide an effective treatment against acne, but this may cause deficiencies in other respects, which can possible lead to other problems.

The above described preferred embodiments are intended to illustrate the principles of the invention, but not to limit its scope. Other embodiments and variations to these preferred embodiments will be apparent to those skilled in the art and may be made without departing from the spirit and scope of the invention as defined in the following claims.

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Claims

1. A method for treating acne, comprising: taking orally a daily dosage of at least the following vitamins and minerals: a range of B vitamins, including vitamin B1, at least about 7 mg, vitamin B12, at least about 7 mcg, vitamin B2, at least about 7 mg and vitamin B6, at least about 7 mg; vitamin C, at least about 50 mg; vitamin E, at least about 27 IU; and zinc, at least about 3 mg.

2. The method of claim 1, wherein the vitamins and minerals are taken as a combined formulation, in amounts half of those listed in claim 1, taken twice daily.

3. The method of claim 1, wherein the vitamins and minerals are taken as a combined formulation in the form of a gummy candy.

4. The method of claim 3, wherein the gummy candy formulation is without sugar.

5. The method of claim 1, wherein the vitamins and minerals further include pantothenic acid, at least about 7 mg.

6. The method of claim 1, wherein the vitamins and minerals include choline, at least about 7 mg.

7. The method of claim 1, wherein the vitamins and minerals include inositol, at least about 7 mg.

8. The method of claim 1, wherein the vitamins and minerals include biotin, at least about 7 mcg.

9. The method of claim 1, wherein the vitamins and minerals include folic acid, at least about 27 mcg.

10. The method of claim 1, wherein the vitamins and minerals include niacin, at least about 7 mg.

11. The method of claim 1, wherein the vitamins and minerals include PABA, at least about 7 mg.

12. The method of claim 1, wherein the range of B vitamins includes all B vitamins.

13. The method of claim 1, wherein the range of B vitamins includes substantially all B vitamins.

14. The method of claim 1, wherein the vitamins and minerals are taken in a combined formulation in the form of a gummy candy, and the formulation including maltodextrin.

15. The method of claim 14, wherein the formulation is without sugar.

16. The method of claim 1, wherein the vitamins and minerals are taken in a combined formulation that further includes oregano and parsley aquaresin solution, at least about 10 mg.

17. The method of claim 1, wherein the vitamins and minerals include alpha lipoic acid, at least about 50 mg.

18. The method of claim 1, wherein the vitamins and minerals include selenium, at least about 200 mcg.

19. A formulation for the treatment and prevention of acne, comprising: a gummy candy substrate, without sugar, andvitamins and minerals contained in the gummy candy substrate, including at least the following: a range of substantially all B vitamins each in an effective amount, in combination with remaining components listed herein, to treat acne with two doses of the formulation taken orally daily; vitamin E, at least about 13.33 IU; biotin, at least about 3.33 mcg; folic acid, at least about 13.33 mcg; niacin, at least about 3.33 mg; PABA, at least about 3.33 mg; pantothenic acid, at least about 3.33 mg; vitamin C, at least about 25 mg; zinc, at least about 1.67 mg; choline, at least about 3.33 mg; and inositol, at least about 3.33 mg.

20. An edible formulation for the treatment and prevention of acne, comprising: a sugar-free candy substrate, andvitamins and minerals contained in the candy substrate, including at least the following: a spectrum of substantially all B vitamins, vitamin E, biotin, folic acid, niacin, PABA, pantothenic acid, vitamin C, and zinc, all in effective amounts in combination to treat acne with two doses of the formulation taken orally daily.

21. The method of claim 1, wherein the vitamins and minerals include inositol, biotin, folic acid, niacin and PABA.

22. The method of claim 1, wherein the vitamins and minerals include at least some of the following: inositol, biotin, folic acid, niacin and PABA.

23. The method of claim 1, wherein the vitamins and minerals include at least some of the following: inositol, at least about 7 mg; biotin, at least about 7 mcg; folic acid, at least about 27 mcg; niacin, at least about 7 mg; and PABA, at least about 7 mg.

24. The method of claim 23, wherein the vitamins and minerals include selenium, at least about 200 mcg, and wherein the vitamins and minerals are taken in a combined formulation that further includes oregano and parsley aquaresin solution, at least about 10 mg.