| CPC A61K 47/20 (2013.01) [A61K 9/0014 (2013.01); A61K 31/122 (2013.01); A61K 31/197 (2013.01); A61K 31/205 (2013.01); A61K 31/4166 (2013.01); A61K 31/4415 (2013.01); A61K 31/522 (2013.01); A61K 31/593 (2013.01); A61K 47/42 (2013.01); A61P 29/02 (2018.01)] | 18 Claims |
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1. A method for alleviating pain from a diabetic neuropathy by topical administration to a patient in need thereof a pharmaceutically effective amount of a composition consisting of:
a) a plurality of solvents consisting of a combination of water, dimethylsulfoxide (DMSO) and methylsulfonylmethane (MSM), wherein:
i) the composition is at least 45 volume percent water;
ii) the composition is at least 10 volume percent DMSO; and
iii) the ratio of DMSO:MSM is between 4:1 and 50:1, inclusive;
b) at least one natural polyamide selected from the group consisting of proteins and peptides, wherein the natural polyamide is selected from the group consisting of a mulberry silk protein, a peptide derived from a mulberry silk protein, a nonmulberry silk protein, a peptide derived from a non-mulberry silk protein, a glycine-rich protein from a plant, and a peptide derived from a glycine-rich protein (GRP) from a plant:
c) at least one compound characteristic of L-carnitine biosynthesis, wherein the compound is selected from the group consisting of: lysine, 6-N-trimethyllysine; hydroxytrimethyllysine (HTML), 4-trimethylaminobutyraldehyde (TMABA), gamma-butyrobetaine, L-carnitine, and acetyl-L-carnitine;
d) at least one compound characteristic of carnosine biosynthesis, wherein the compound is selected from the group consisting of: cytosine, uracil, beta alanine, and carnosine;
e) at least one compound selected from the group consisting of vitamin D3 and vitamin D3 metabolites, wherein the group consists of: cholecalciferol, calcifediol, and calcitriol;
f) coenzyme Q10 (coQ10), wherein the coQ10 is present in one or more redox states selected from the group consisting of: fully oxidized (ubiquinone), semiquinone (ubisemiquinone), and fully reduced (ubiquinol);
g) at least two compounds selected from the group consisting of purine compounds and purine decomposition compounds, wherein:
i) at least one compound is a purine compound selected from the group consisting of purine, adenine, adenosine, guanine, guanosine, isoguanine, inosine, hypoxanthine, xanthine, theobromine, and caffeine;
ii) at least one compound is a purine decomposition compound selected from the group consisting of uric acid and allantoin; and
iii) the ratio of purine decomposition compound(s):purine compound(s) is between 10:1 and 100:1, inclusive;
h) two B vitamins selected from the group consisting of:
i) a B5 compound selected from the group consisting of vitamin B5, provitamin B5 and salts of vitamin B5;
ii) a vitamin B6 compound; and
iii) the ratio of the B5 compound:vitamin B6 compound is between 1:30 and 30:1, inclusive; and
i) the topical composition having:
i) 0.5 to 1.5 weight percent in the aggregate of the at least one natural polyamide;
ii) 0.25 to 1.0 weight percent in the aggregate of the at least one compound characteristic of L-carnitine biosynthesis;
iii) 0.15 to 2.0 weight percent in the aggregate of the at least one compound characteristic of carnosine biosynthesis;
iv) 0.15 to 1.5 weight percent in the aggregate of the at least one compound selected from the group consisting of vitamin D3 and vitamin D3 metabolites;
v) 0.25 to 1.5 weight percent in the aggregate of the coQ10 that is present in one or more redox states;
vi) 0.15 to 0.75 weight percent in the aggregate of the at least one purine decomposition compound(s);
vii) 0.0025 to 0.25 weight percent in the aggregate of the at least one purine compound(s);
viii) 0.05 to 5.0 weight percent in the aggregate of the B5 compound(s); and
ix) 0.05 to 5.0 weight percent in the aggregate of the vitamin B6 compound(s);
j) Irish Moss carrageen, and
k) optionally polysorbate 80, caprylic capric triglycerides, tocopheryl acetate, mixed tocopherols, gluconolactone, sodium benzoate, benzethonium chloride, modified starch, maltodextrin, butylated hydroxytoluene, vegetable oil, menthol, and Argania spinozo oil,
wherein the only vitamins in the composition are a B5 compound, a vitamin B6 compound, vitamin D3 or a vitamin D3 metabolite, and optionally vitamin E.
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