Patches and Methods for the Transdermal Delivery of a Therapeutically Effective Amount of Iron

Abstract

Embodiments of the invention provide patches for the transdermal delivery of iron-containing compositions to an individual suffering from an iron deficiency. Many embodiments provide an iontophoretic patch for the transdermal delivery of a therapeutically effective amount of iron. The patch comprises an electrode and a reservoir containing a composition comprising ionic iron for the delivery of the therapeutically effective amount of iron. Various embodiments provide methods of using embodiments of the iontophoretic patch for delivering a therapeutically effective amount of iron to an individual suffering from one more forms of iron deficiency including iron deficiency anemia. Such methods can be used for treating and/or preventing the iron deficiency. The amount of delivered iron can be adjusted depending upon various treatment parameters such as patient weight and type and amount of iron deficiency.

1 . An iontophoretic patch for the transdermal delivery of a therapeutically effective amount of iron, the patch comprising
 an electrode; and   a reservoir electrically coupled to the electrode, the reservoir containing a composition comprising ionic iron for the transdermal delivery of the therapeutically effective amount of iron, the electrode configured and positioned to apply an electromotive driving force to the ionic iron in the reservoir to drive the therapeutically effective amount of iron out of the reservoir and into the skin of a patient.   
     
     
         2 - 22 . (canceled) 
     
     
         23 . An iontophoretic patch for the transdermal delivery of a therapeutically effective amount of iron and a vitamin or mineral, the patch comprising:
 an electrode; and   a reservoir electrically coupled to the electrode, the reservoir containing a composition comprising ionic iron for the delivery of the therapeutically effective amount of iron, the composition further comprising a vitamin supplement or a mineral.   
     
     
         24 . The patch of  claim 23 , wherein the vitamin supplement or mineral is selected from the group consisting of folic acid, vitamin A, vitamin B, vitamin C, vitamin D, vitamin E, vitamin K, calcium, and magnesium. 
     
     
         25 . The patch of  claim 24 , wherein the vitamin B is selected from the group consisting of thiamin (vitamin B1), riboflavin (vitamin B2), niacin (vitamin B3), pantothenic acid (vitamin B5), pyridoxine (vitamin B6), biotin, folic acid, the cobalamins (vitamin B12), and choline. 
     
     
         26 . The patch of  claim 24 , wherein the vitamin C is selected from the group consisting of ascorbate and L threonate. 
     
     
         27 . The patch of  claim 24 , wherein the vitamin D is selected from the group consisting of cholecalciferol (vitamin D3) and ergocalciferol (vitamin D2). 
     
     
         28 . The patch of  claim 24 , wherein the vitamin E is selected from the group consisting of alpha-tocopherol, D-alpha-tocopherol, D-alpha-tocopheryl succinate, D-alpha-tocopheryl acetate, DL-alpha-tocopherol, DL-alpha-tocopheryl acetate, DL-alpha-tocopheryl succinate, gamma tocopherol, mixed tocopherols, and DL-alpha tocopherol nicotinate. 
     
     
         29 . The patch of  claim 24 , wherein the calcium is selected from the group consisting of calcium carbonate, calcium phosphate, calcium lactate, calcium gluconate, calcium citrate and a combination thereof. 
     
     
         30 . The patch of  claim 24 , wherein the magnesium is selected from the group consisting of magnesium oxide, magnesium chloride, magnesium lactate, magnesium sulfate and magnesium gluconate. 
     
     
         31 . The patch of  claim 24 , wherein the vitamin supplement or mineral is selected from the group consisting of vitamin A, thiamin (vitamin B1), riboflavin (vitamin B2), niacin (vitamin B3), pantothenic acid (vitamin B5), pyridoxine (vitamin B6), biotin, folic acid, the cobalamins (vitamin B12), choline, ascorbate, L threonate, cholecalciferol (vitamin D3) ergocalciferol (vitamin D2), alpha-tocopherol, D-alpha-tocopherol, D-alpha-tocopheryl succinate, D-alpha-tocopheryl acetate, DL-alpha-tocopherol, DL-alpha-tocopheryl acetate, DL-alpha-tocopheryl succinate, gamma tocopherol, mixed tocopherols, DL-alpha tocopherol nicotinate, vitamin K, calcium carbonate, calcium phosphate, calcium lactate, calcium gluconate, calcium citrate, magnesium oxide, magnesium chloride, magnesium lactate, magnesium sulfate and magnesium gluconate. 
     
     
         32 . The patch of  claim 23 , wherein the composition comprises at least two vitamin supplements. 
     
     
         33 . The patch of  claim 23 , wherein the composition comprises at least two minerals. 
     
     
         34 . The patch of  claim 23 , wherein the composition comprises a vitamin supplement and a mineral. 
     
     
         35 . The patch of  claim 23 , wherein the reservoir comprises a layer of the patch. 
     
     
         36 . The patch of  claim 23 , wherein the reservoir comprises a compartment. 
     
     
         37 . The patch of  claim 23 , wherein the reservoir comprises substantially the entire patch. 
     
     
         38 . The patch of  claim 23 , wherein the ionic iron is in the form of at least one ferrous salt. 
     
     
         39 . The patch of  claim 38 , wherein the at least one ferrous salt is selected from the group consisting of: ferrous gluconate, ferrous chloride, ferrous sulfate, and ferrous fumarate. 
     
     
         40 . The patch of  claim 23 , wherein the composition further comprises at least one transdermal permeabilizing agent. 
     
     
         41 . The patch of  claim 40 , wherein the at least one transdermal permeabilizing agent comprises a cyclodextrin. 
     
     
         42 . The patch of  claim 23 , wherein the composition comprises an amount of elemental iron in a range from about 10 mg to about 50 mg. 
     
     
         43 . The patch of  claim 23 , wherein the composition comprises an amount of elemental iron in a range from about 1 mg to about 100 mg. 
     
     
         44 . The patch of  claim 23 , wherein the composition comprises an amount of elemental iron in a range from about 1 mg to about 75 mg. 
     
     
         45 . The patch of  claim 23 , wherein the composition comprises an amount of elemental iron in a range from about 1 mg to about 50 mg. 
     
     
         46 . The patch of  claim 23  wherein the composition comprises an amount of elemental iron in a range from about 1 mg to about 10 mg. 
     
     
         47 . The patch of  claim 23 , wherein the patch includes at least one needle configured to penetrate a selected depth into a stratum layer of the skin to enhance delivery of the composition while minimizing perceptible pain from the penetration. 
     
     
         48 . The patch of  claim 47 , wherein the at least one needle includes an array of needles. 
     
     
         49 . The patch of  claim 48 , wherein the at least one needle has a length in the range of about 100 to about 150 μm. 
     
     
         50 . The patch of  claim 23 , further comprising
 a rate controlling member positioned between the reservoir and a tissue contacting side of the patch, the rate controlling member configured to control the rate at which iron migrates from the reservoir to the tissue contacting side.   
     
     
         51 . An iontophoretic system for the transdermal delivery of a therapeutically effective amount of iron, the system comprising the patch of  claim 23 ; and
 a second patch, the patch having a skin contacting layer comprising a plurality of needles, the plurality of needles arranged in an arrayed pattern, the plurality of needles having a length wherein when the second patch is pressed against the skin the needles penetrate a selected depth into the skin to create channels in a stratum corneum layer of the skin for enhanced delivery of the composition while minimizing perceptible pain from the penetration.   
     
     
         52 . The system of  claim 51 , wherein the needles have a length in the range of about 100 to about 150 μm. 
     
     
         53 . The system of  claim 51 , wherein the array of needles are configured to create the channels in the stratum corneum with an application force to the second patch of no more than about 10 newtons.