Mineral salt-sulfonic acid compositions and methods of use

Abstract

The present disclosure generally relates to the medical use of compositions comprising a mineral salt and a sulfonic acid for prevention and/or treatment of one or more mucosal diseases, disorders, or conditions or one or more dermal diseases, disorders, or conditions.

1 . A method for treating a mucosal disorder or a dermal disorder in a subject comprising administering to the subject a physiologically acceptable composition that comprises a mineral salt and a sulfonic acid. 
     
     
         2 . The method according to  claim 1  wherein the mucosal disorder comprises mucositis. 
     
     
         3 . The method according to  claim 2  wherein mucositis comprises inflammation of mucosa of the gastrointestinal tract, bladder, esophagus, vagina, rectum, lung, a nasal cavity, an ear, or ocular mucosa. 
     
     
         4 . The method according to  claim 1  wherein the mucosal disorder comprises (a) oral stomatitis, oral mucositis, an oral ulceration, Crohn's disease, periodontitis, interstitial cystitis, or a wound; or (b) vaginal dryness, vaginal burning, vaginal ulceration, dyspareunia, leukorrhea, vulvar pruritus, vulvar burning, or atrophic vaginitis. 
     
     
         5 . (canceled) 
     
     
         6 . The method according to  claim 1 , wherein the mucosal disorder is consequent to any one or more of hormone insufficiency, bone marrow transplant, chemotherapy, radiation therapy, viral infection, fungal infection, and bacterial infection. 
     
     
         7 . (canceled) 
     
     
         8 . (canceled) 
     
     
         9 . The method according to  claim 1  wherein the dermal disorder comprises diaper rash, skin dryness, dermatitis, eczema, psoriasis, erythema, acne, xerosis, and radical oxygen species-induced skin damage. 
     
     
         10 . The method according to  claim 1  wherein the mineral salt comprises (a) a mineral moiety selected from zinc, calcium, iron, copper, magnesium, manganese, cobalt, chromium, selenium, and vanadium and (b) a salt moiety selected from gluconate, acetate, ascorbate, and sulfate. 
     
     
         11 . The method according to  claim 10 , wherein the mineral salt is zinc gluconate, and the composition comprises from between 0.25% (w/w) to 5.5% (w/w) zinc gluconate. 
     
     
         12 . The method according to  claim 1 , wherein the sulfonic acid is taurine and the composition comprises from between 0.25% (w/w) to 30% (w/w) taurine; or comprises from between 0.5% (w/w) and 8.0% (w/w) taurine. 
     
     
         13 . The method according to  claim 1 , (a) wherein the mineral salt is zinc gluconate, and the composition comprises from between 0.25% (w/w) to 5.5% (w/w) zinc gluconate, and wherein the sulfonic acid is taurine and the composition comprises from between 0.25% (w/w) to 30% (w/w) taurine; or (b) wherein the mineral salt is zinc gluconate, and the composition comprises from between 0.25% (w/w) to 5.5% (w/w) zinc gluconate, and wherein the sulfonic acid is taurine and the composition comprises from between 0.5% (w/w) and 8.0% (w/w) taurine; or (c) wherein the composition comprises (i) 0.5% (w/w) zinc gluconate and 1.0% (w/w) taurine, or (ii) 2.5% (w/w) zinc gluconate and 5.0% (w/w) taurine. 
     
     
         14 . (canceled) 
     
     
         15 . (canceled) 
     
     
         16 . The method according to  claim 1 , wherein the composition further comprises one or more of a flavoring agent, a mucoadhesive agent, a pH adjusting agent, a solubilizing agent, a viscosity modulating agent, and a stabilizing agent. 
     
     
         17 . (canceled) 
     
     
         18 . (canceled) 
     
     
         19 . The method according to  claim 1 , wherein the composition further comprises a lactoferrin. 
     
     
         20 . (canceled) 
     
     
         21 . (canceled) 
     
     
         22 . The method according to  claim 1 , wherein the composition has a pH between 3.0 and 8.5. 
     
     
         23 . The method according to  claim 22  wherein the pH is between 3.5 and 4.5. 
     
     
         24 . The method according to  claim 23 , wherein the mucosal disorder is atrophic vaginitis. 
     
     
         25 . The method according to  claim 22  wherein the pH is between 5.5 and 7.5. 
     
     
         26 . The method according to  claim 25  wherein the mucosal disorder is oral mucositis. 
     
     
         27 .- 29 . (canceled) 
     
     
         30 . The method according to  claim 1 , wherein the method further comprises orally administering a second physiologically acceptable composition, wherein the second composition comprises a lactoferrin. 
     
     
         31 . A method of treating a mucosal disorder in a subject who is receiving or who will receive chemotherapy or radiation therapy for treatment of a malignancy, said method comprising administering to the subject a therapeutically effective amount of a physiologically acceptable composition that comprises a mineral salt and a sulfonic acid. 
     
     
         32 . The method according to  claim 31 , wherein the mineral salt is zinc gluconate and the sulfonic acid is taurine. 
     
     
         33 . A composition comprising from between 0.25-5.5% (w/w) zinc gluconate; from between 0.5%-8% (w/w) taurine; and at least one of (a) from between 0.05%-3.0% (w/w) glycyrrhetinic acid; (b) from between 0.04%-15% (w/w) polyvinylpyrrolidone (PVP); (c) from between 0.01%-5.0% (w/w) hyaluronic acid; and (d) from between 0.05%-5.0% (w/w) glycerin. 
     
     
         34 . The composition according to  claim 33 , comprising from between 0.25-5.5% (w/w) zinc gluconate; from between 0.5%-8% (w/w) taurine; and from between 0.04-15% (w/w) PVP. 
     
     
         35 . The composition according to  claim 33  wherein the pH is adjusted to between 3.5 and 4.5 or is adjusted to between 5.5 and 7.5. 
     
     
         36 . The composition of  claim 33  further comprising lactoferrin. 
     
     
         37 . A method for supplementing a mineral deficiency in a subject, said method comprising administering a composition comprising a mineral salt, a sulfonic acid, and one or more of from between 0.05% to 3.0% (w/w) glycyrrhetinic acid; from between 0.04% to 15% (w/w) polyvinylpyrrolidone (PVP); from between 0.01% to 5.0% (w/w) hyaluronic acid; and from between 0.05% to 5.0% (w/w) glycerin. 
     
     
         38 . The method according to  claim 37 , wherein the mineral salt comprises (a) a mineral moiety selected from zinc, calcium, iron, copper, magnesium, manganese, cobalt, chromium, selenium, and vanadium and (b) a salt moiety selected from gluconate, acetate, ascorbate, and sulfate. 
     
     
         39 . The method according to  claim 38  wherein the mineral moiety is zinc and the salt moiety is gluconate. 
     
     
         40 . The method according to  claim 37  wherein the sulfonic acid is taurine. 
     
     
         41 . The method according to  claim 37  wherein the mineral salt is from between 0.25% (w/w) to 5.5% (w/w) zinc gluconate and wherein the sulfonic acid is from between 0.25% (w/w) to 30% (w/w) taurine. 
     
     
         42 . A method for inhibiting disruption of intercellular junctions between adjacent cells, comprising contacting the cells with a composition comprising a physiologically acceptable composition that comprises a mineral salt and a sulfonic acid. 
     
     
         43 . The method according to  claim 42 , wherein the cells are epithelial cells or endothelial cells. 
     
     
         44 . The method according to  claim 42 , wherein the cells are present in a subject who has or who is at risk for developing a mucosal disorder or a dermal disorder. 
     
     
         45 . The method of  claim 44 , wherein the mucosal disorder comprises mucositis. 
     
     
         46 . The method of  claim 44 , wherein the mucosal disorder is selected from:
 (a) oral stomatitis, oral mucositis, an oral ulceration, Crohn's disease, periodontitis, interstitial cystitis, and a wound;   (b) vaginal dryness, vaginal burning, vaginal ulceration, dyspareunia, leukorrhea, vulvar pruritus, vulvar burning, and atrophic vaginitis;   (c) a mucosal disorder that is consequent to any one or more of hormone insufficiency, bone marrow transplant, chemotherapy, radiation therapy, viral infection, fungal infection, and bacterial infection; and   (d) a mucosal disorder that is consequent to one or both of chemotherapy and radiation therapy administered to the subject for treatment of a head and neck tumor, a leukemia, breast cancer, prostate cancer, pancreatic cancer, ovarian cancer, melanoma, liver cancer, lung cancer, urinary cancer, colon cancer, or HIV/AIDS.   
     
     
         47 . The method of  claim 44 , wherein the dermal disorder comprises diaper rash, skin dryness, dermatitis, eczema, psoriasis, erythema, acne, xerosis, or radical oxygen species-induced skin damage. 
     
     
         48 . The method of  claim 42 , wherein the mineral salt comprises (a) a mineral moiety selected from zinc, calcium, iron, copper, magnesium, manganese, cobalt, chromium, selenium, and vanadium and (b) a salt moiety selected from gluconate, acetate, ascorbate, and sulfate. 
     
     
         49 . The method according to  claim 48 , wherein the mineral salt is zinc gluconate, and the composition comprises from between 0.25% (w/w) to 5.5% (w/w) zinc gluconate. 
     
     
         50 . The method according to  claim 48 , wherein the sulfonic acid is taurine and the composition comprises from between 0.25% (w/w) to 30% (w/w) taurine or from between 0.5% (w/w) and 8.0% (w/w) taurine. 
     
     
         51 . The method according to  claim 42 , wherein the mineral salt is zinc gluconate, and the composition comprises (a) from between 0.25% (w/w) to 5.5% (w/w) zinc gluconate, and wherein the sulfonic acid is taurine and the composition comprises from between 0.25% (w/w) to 30% (w/w) taurine; or (b) from between 0.2% (w/w) to 5.5% (w/w) zinc gluconate, and wherein the composition comprises from between 0.5% (w/w) and 8.0% (w/w) taurine. 
     
     
         52 . (canceled) 
     
     
         53 . (canceled) 
     
     
         54 . The method according to  claim 42 , wherein the composition further comprises a lactoferrin. 
     
     
         55 . (canceled) 
     
     
         56 . (canceled)