Novel formulations and uses for curcuma extracts

Abstract

Formulations and uses of extracts of Curcuma longa L. plants for safe use topically, orally, rectally, or vaginally, for example, are provided. A sunscreen containing an extract of Curcuma longa L. is provided, the sunscreen having an absorption that spans the UVA and UVB ranges in a manner that meets updated FDA recommendations without requiring the addition of titanium dioxide. A process of producing the extract is also provided, using an extraction solvent that is at least substantially non-toxic and useful also as a pharmaceutically acceptable carrier in liquid dosage forms. The extraction process also produces a significantly higher yield from a single extraction than the state-of-the-art. Liquid dosage forms can be produced directly from the extraction process without requiring removal of the extraction solvent, reducing complexity and cost of processing over the state-of-the-art. Microemulsions and nanoemulsions are also provided to enhance the bioavailability and stability of the extracts.

1 . A pharmaceutically acceptable composition comprising a purified liquid extract from the roots of a  Curcuma longa  L. plant, the purified liquid extract comprising:
 curcumin;   demethoxycurcumin;   bisdemethoxycurcumin; and,   an at least substantially non-toxic extraction solvent that
 removes the extract from the roots of a  Curcuma longa  L. plant in an extraction process; and, 
 functions as a pharmaceutically acceptable carrier having (i) an acute oral toxicity with an LD50 of at least 49,700 mg/kg or (ii) an acute dermal toxicity of at least 5000 mg/kg; 
 wherein, the extraction solvent was (iii) used in the extraction process that removed the extract from the roots of the  Curcuma longa  L. plant and (iv) chosen to remain as a component of the pharmaceutically acceptable composition. 
   
     
     
         2 . The composition of  claim 1 , wherein the extraction solvent comprises polyoxyethylene (20) sorbitan monooleate (TWEEN 80 HP), polyethylene glycol, isopropyl myristate, or a combination thereof. 
     
     
         3 . The composition of  claim 1 , wherein the extraction solvent comprises a combination of TWEEN 80 HP and isopropyl myristate. 
     
     
         4 . The composition of  claim 1 , wherein the extraction solvent comprises a ratio of TWEEN 80 HP:isopropyl myristate ranging from about 20:80 to about 50:50. 
     
     
         5 . The composition of  claim 1 , wherein the composition comprises a pharmaceutically acceptable oil selected from the group consisting of an animal oil, a fish oil, a vegetable oil, or a mineral oil. 
     
     
         6 . The composition of  claim 5 , wherein the pharmaceutically acceptable oil comprises an edible oil selected from the group consisting of olive oil, sunflower oil, sesame oil, almond oil, corn oil, orange oil, lime oil, black pepper oil, nutmeg oil, basil oil, rosemary oil, clove oil, grapefruit oil, fennel oil, coriander oil, bergamot oil, cinnamon oil, lemon oil, peppermint oil, garlic oil, thyme oil, marjoram oil, lemongrass oil, ginger oil, and  cardamon  oil, liquid paraffin, cotton seed oil, peanut oil, nut oil, soy, rapeseed oil, vitamin E oil, Vitamin E TPGS oil, fish oil, tallow-derived oil, silicone oil, castor oil, squalene oil, or a mixture thereof. 
     
     
         7 . The composition of  claim 5 , wherein the pharmaceutically acceptable oil comprises sesame oil. 
     
     
         8 . The composition of  claim 5 , wherein the pharmaceutically acceptable oil comprises cotton seed oil. 
     
     
         9 . The composition of  claim 1 , wherein the composition is in a dosage form for administration topically. 
     
     
         10 . (canceled) 
     
     
         11 . The composition of  claim 1 , wherein the composition is in a dosage form for administration orally. 
     
     
         12 . An oral dosage form comprising the composition of  claim 1 , the dosage form consisting of a capsule or tablet. 
     
     
         13 . A dietary supplement comprising the composition of  claim 1 , wherein the dietary supplement functions as an antioxidant in a subject consuming the dietary supplement. 
     
     
         14 . A pharmaceutically acceptable emulsion comprising a purified liquid extract from the roots of a  Curcuma longa  L. plant, the emulsion comprising:
 curcumin;   demethoxycurcumin;   bisdemethoxycurcumin;   an at least substantially non-toxic extraction solvent that
 removes the extract from the roots of a  Curcuma longa  L. plant in an extraction process; and, 
 functions as a pharmaceutically acceptable carrier having (i) an acute oral toxicity with an LD50 of at least 49,700 mg/kg or (ii) an acute dermal toxicity of at least 5000 mg/kg; 
 wherein, the extraction solvent was (iii) used in the extraction process that removed the extract from the roots of the  Curcuma longa  L. plant and (iv) chosen to remain as a component of the pharmaceutically acceptable composition; 
   a pharmaceutically acceptable oil; and,   an emulgent.   
     
     
         15 . The emulsion of  claim 14 , wherein the emulsion is an aqueous emulsion. 
     
     
         16 . The emulsion of  claim 14 , wherein the extraction solvent comprises TWEEN 80 HP. 
     
     
         17 . The emulsion of  claim 14 , wherein the extraction solvent comprises isopropyl myristate. 
     
     
         18 . The emulsion of  claim 14 , wherein the pharmaceutically acceptable oil includes an edible oil selected from the group consisting of olive oil, sunflower oil, sesame oil, almond oil, corn oil, orange oil, lime oil, black pepper oil, nutmeg oil, basil oil, rosemary oil, clove oil, grapefruit oil, fennel oil, coriander oil, bergamot oil, cinnamon oil, lemon oil, peppermint oil, garlic oil, thyme oil, marjoram oil, lemongrass oil, ginger oil, and  cardamon  oil, liquid paraffin, cotton seed oil, peanut oil, nut oil, soy oil, rapeseed oil, vitamin E oil, fish oil, tallow-derived oil, silicone oil, castor oil, squalene oil, or a mixture thereof. 
     
     
         19 . The emulsion of  claim 14 , wherein the pharmaceutically acceptable oil comprises sesame oil. 
     
     
         20 . The emulsion of  claim 14 , wherein the pharmaceutically acceptable oil comprises cotton seed oil. 
     
     
         21 . (canceled) 
     
     
         22 . (canceled) 
     
     
         23 . (canceled) 
     
     
         24 . (canceled) 
     
     
         25 . (canceled) 
     
     
         26 . (canceled) 
     
     
         27 . (canceled) 
     
     
         28 . (canceled) 
     
     
         29 . (canceled) 
     
     
         30 . A composition for use as a sunscreen, the composition comprising an extract of a  Curcuma longa  L. root. 
     
     
         31 . A kit for protecting a dermal tissue from UVA and UVB exposure, the kit comprising:
 the composition of  claim 1  in an oral dosage form;   an extract of a  Curcuma longa  L. root in a topical dosage form; and,   instructions for administration of the topical dosage form, the oral dosage form, or a combination of the topical and oral dosage forms.   
     
     
         32 . A method of treating a skin to prevent or inhibit exposure of the skin to UVA and UVB, the method comprising topically administering an effective amount of the composition of  claim 1  to a dermal tissue of a subject. 
     
     
         33 . The method of  claim 32 , further comprising oral administration of an effective amount of an oral dosage form of the composition of  claim 1  to the subject in combination with the topical administration. 
     
     
         34 . A method of treating an inflammation of a tissue of a subject, the method comprising administering an effective amount of the composition of  claim 1  to a tissue of the subject. 
     
     
         35 . The method of  claim 34 , wherein the tissue is a dermal tissue. 
     
     
         36 . The method of  claim 34 , wherein the tissue is a mucosal tissue. 
     
     
         37 . The method of  claim 34 , wherein the tissue is gastrointestinal tissue. 
     
     
         38 . A method of treating a wounded tissue of a subject, the method comprising administering an effective amount of the composition of  claim 1  to the wounded tissue of the subject. 
     
     
         39 . The method of  claim 38 , wherein the tissue is a dermal tissue. 
     
     
         40 . The method of  claim 38 , wherein the tissue is a mucosal tissue. 
     
     
         41 . The method of  claim 38 , wherein the tissue is gastrointestinal tissue. 
     
     
         42 . A method of treating a subject with an antioxidant, the method comprising administering an effective amount of the composition of  claim 1  to the subject as the antioxidant.