Patches and method for the transdermal delivery of a therapeutically effective amount of iron
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. A method for the transdermal iontophoretic delivery of a composition comprising ionic iron to an individual in need thereof, comprising:
contacting the individual with a patch comprising an active electrode and a reservoir including a composition comprising ionic iron, the reservoir and composition being separate from the electrode; and
applying current from the active electrode to the reservoir to cause transdermal iontophoretic delivery of a therapeutically effective amount of ionic iron from the reservoir to the individual, wherein the composition does not include heme iron or heme iron polypeptide.
2. The method of claim 1 , wherein the ionic iron is in the form of one or more ferrous salts.
3. The method of claim 2 , wherein the one or more ferrous salts are selected from the group consisting of: ferrous gluconate, ferrous chloride, ferrous sulfate, and ferrous fumarate.
4. The method of claim 1 , wherein the composition comprises at least one agent selected from the group consisting of: a vitamin supplement, erythropoietin, and an erythropoietin stimulating agent.
5. The method of claim 4 , wherein the vitamin supplement is selected from the group consisting of thiamine, riboflavin, niacin, pantothenic acid, pyroxidine, biotin, folic acid, and cobalamin.
6. The method of claim 1 , wherein the therapeutically effective amount of delivered ionic iron is in a range from about 1 mg to about 50 mg of elemental iron.
7. The method of claim 1 , wherein the therapeutically effective amount of delivered ionic iron is in a range from about 1 mg to about 40 mg of elemental iron.
8. The method of claim 1 , wherein the therapeutically effective amount of delivered ionic iron is in a range from about 1 mg to about 30 mg of elemental iron.
9. The method of claim 1 , further comprising adjusting the therapeutically effective amount of ionic delivered iron to the individual based on a treatment parameter.
10. The method of claim 9 , wherein the treatment parameter is a patient characteristic, patient weight, type of iron deficiency being treated or selected therapeutic outcome.
11. The method of claim 1 , wherein the ionic iron composition is delivered substantially continuously.
12. The method of claim 1 , wherein the ionic iron composition is delivered over a period of about one day to about one month.
13. The method of claim 1 , wherein the ionic iron composition is delivered over a period of about one day to about one week.
14. The method of claim 13 , wherein the ionic iron composition is delivered over a period of about one day to about three days.
15. The method of claim 14 , wherein the ionic iron composition is delivered over a period of about one day.
16. The method of claim 15 , wherein the therapeutically effective amount of delivered ionic iron is in a range from about 1 mg to about 50 mg of elemental iron.
17. The method of claim 1 , further comprising: delivering sufficient iron to prevent and/or treat an iron deficiency in an individual.
18. The method of claim 17 , further comprising administering a parental therapeutically effective amount of iron.
19. The method of claim 18 , wherein the parental administration is done prior to transdermal delivery.
20. The method of claim 18 , wherein the parental administration is intravenous or subcutaneous.
21. The method of claim 18 , wherein at least one of the parental administration and the transdermal delivery are adjusted relative to the other.
22. The method of claim 21 , wherein the adjustment is in at least one of a rate or amount of iron delivery.
23. The method of claim 17 , further comprising administering an oral therapeutically effective amount of iron.
24. The method of claim 23 , wherein the oral administration is done prior to the transdermal delivery.
25. The method of claim 17 , further comprising administering an intravenous bolus of iron to the individual prior transdermal delivery wherein the bolus contains about 500 mg to 1 gram of iron.
26. The method of claim 17 , wherein the individual has an iron deficiency without anemia.
27. The method of claim 26 , wherein the iron deficiency is being treated in order to prevent growth retardation, cognitive disabilities, and/or mental retardation.
28. The method of claim 26 , wherein the iron deficiency, is caused by chronic alcoholism; poor nutrition; decreased consumption of animal protein and absorbic acid; increased iron demands of pregnancy, infancy, or adolescence; malabsorption syndromes; and foods or drugs that reduce the gastrointestinal absorption of iron.
29. The method of claim 17 , wherein the individual has an iron deficiency anemia.
30. The method of claim 29 , wherein the individual has an iron deficiency characterized by microcytosis of red blood cells, a hemoglobin iron binding capacity of less than 20%, ferritin levels less than about 10 μg/L, or transferrin iron saturation levels less than 20%.
31. The method of claim 17 , wherein the individual has a functional iron deficiency with ferritin levels less than 100 μg/L.
32. The method of claim 17 , wherein the individual is selected from the group consisting of a child, infant, and neonate.
33. The method of claim 17 , wherein the therapeutically effective amount of delivered ionic iron is in a range from about 0.5 mg to about 40 mg of elemental iron.
34. The method of claim 17 , wherein the therapeutically effective amount of delivered ionic iron is in a range from about 0.5 mg to about 20 mg of elemental iron.
35. The method of claim 17 , wherein the therapeutically effective amount of delivered ionic iron is adjusted based on an anthropomorphic parameter or an indicator of iron deficiency.
36. The method of claim 17 , wherein the ionic iron composition is delivered over a period of about one day to about one week.
37. The method of claim 1 , further comprising: creating a plurality of micro channels in the stratum corneum to enhance transdermal delivery of the ionic iron.
38. The method of claim 37 , wherein the plurality of micro-channels are created mechanically.
39. The method of claim 38 , wherein the plurality of micro-channels are created using a plurality of needles.
40. The method of claim 38 , wherein the plurality of micro-channels are created using an electrical discharge on or into the skin.
41. The method of claim 40 , wherein the discharge is created using a plurality of conductive microfilaments.
42. A method for the transdermal iontophoretic delivery of a composition comprising ionic iron to an individual in need thereof, the method comprising:
contacting the individual with a patch comprising an active electrode and a reservoir including a pharmaceutical composition comprising ionic iron, wherein the composition is uniformly distributed within the reservoir, the reservoir and composition being separate from the electrode; and
applying current from the active electrode to the reservoir to cause transdermal iontophoretic delivery of a therapeutically effective amount of ionic iron from the reservoir to the individual wherein the composition does not include heme iron or heme iron polypeptide.