Patent Application: US-48323406-A

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:
1 . in particular , this disclosure covers a unique nutritional vitamin , mineral , herbal formulation for the therapeutic purpose of strengthening the body &# 39 ; s defenses against the internal processes which cause acne . the formula preferably includes full - spectrum b vitamins , not a selection of the b &# 39 ; 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 &# 39 ; 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 &# 39 ; 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 . 19 . another combination would be 11 , above without the choline or inositol . 28 . another combination would be 19 without biotin or folic acid . 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 . 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 . 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 . 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 . 1 . aamodt r l , rumble w f , johnston g s et al . absorption of orally administrated 65zn ( zinc ) by normal human subjects . am j clin nutr 1981 ; 34 : 2648 - 2652 . 2 . abdel , k . m ., el mofty , a ., ismail , a ., bassili , f . glucose tolerance in blood and skin of patients with acne vulgaris . ind j derm 1977 ; 22 : 139 - 149 3 . { dot over ( a )} gren m s . studies on zinc in wound healing . acta derm venereol suppl 1990 ; 154 : 1 - 36 [ review ]. 4 , { dot over ( a )} gren ms . zinc in wound repair . 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