Patches and methods for the transdermal delivery of a therapeutically effective amount of iron

• US 9,913,806 B2
• Filed: 06/25/2009
• Issued: 03/13/2018
• Est. Priority Date: 06/25/2008
• Status: Active Grant

• Current Assignee: FE3 Medical Incorporated
• Original Assignee: FE3 Medical Incorporated
• Inventors: Berenson, Ronald J.
• Primary Examiner(s): Bosques, Edelmira
• Application Number:
  US12/459,186
• Publication Number:
  US 20100130912A1
• Time in Patent Office: 3,183 Days
• Field of Search: 604 20, 604501, 6048911
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/295 Iron group metal compounds
• CPC Class Codes: A61K 33/26 Iron; Compounds thereof
• CPC Class Codes: A61K 38/1816 Erythropoietin [EPO]
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 9/0009 involving or responsive to electricity, magnetism or acoustic waves; Galenical aspects of sonophoresis, iontophoresis, electroporation or electroosmosis microelectromechanical systems A61K9/0097
• CPC Class Codes: A61K 9/0021 Intradermal administration, e.g. through microneedle arrays, needleless injectors mechanical aspects A61M
• CPC Class Codes: A61K 9/7023 Transdermal patches and similar drug-containing composite devices, e.g. cataplasms galenical aspects of iontophoretic devices A61K9/0009; microneedle arrays A61K9/0021; buccal patches A61K9/006
• CPC Class Codes: A61K 9/703 characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
• CPC Class Codes: A61N 1/0444 Membrane
• CPC Class Codes: A61N 1/0448 Drug reservoir
• CPC Class Codes: A61N 1/303 Constructional details electrodes for external use A61N1/0428
• CPC Class Codes: A61P 15/08 for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
• CPC Class Codes: A61P 25/28 for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
• CPC Class Codes: A61P 25/32 Alcohol-abuse
• CPC Class Codes: A61P 3/00 Drugs for disorders of the metabolism of the blood or the extracellular fluid A61P7/00
• CPC Class Codes: A61P 3/02 Nutrients, e.g. vitamins, minerals
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 7/06 Antianaemics

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.

Claims

1. An iontophoretic patch for the transdermal delivery of a therapeutically effective amount of iron, the patch comprising an electrode and a reservoir containing a composition comprising an effective amount of an ionic iron in a chelated iron complex comprising ferric pyrophosphate for the delivery of the therapeutically effective amount of iron, wherein the patch does not comprise a polyolefin material in contact with the composition, and wherein the composition does not include heme iron or heme iron polypeptide, and the reservoir contains an amount of the composition to continuously deliver a therapeutically effective amount of iron for a period of at least 3 days.

2. The patch of claim 1, wherein the reservoir comprises a layer of the patch.

3. The patch of claim 1, wherein the reservoir comprises a compartment.

4. The patch of claim 1, wherein the reservoir comprises substantially the entire patch.

5. The patch of claim 1, wherein the composition further comprises at least one agent selected from the group consisting of:

a vitamin supplement, erythropoietin, and an erythropoietin stimulating agent.

6. The patch of claim 1, wherein the composition further comprises at least one transdermal permeabilizing agent.

7. The patch of claim 6, wherein the at least one transdermal permeabilizing agent comprises a cyclodextrin.

8. The patch of claim 1, wherein the composition comprises an amount of elemental iron in a range from about 10 mg to about 50 mg.

9. The patch of claim 1, wherein the composition comprises an amount of elemental iron in a range from about 1 mg to about 100 mg.

10. The patch of claim 1, wherein the composition comprises an amount of elemental iron in a range from about 1 mg to about 75 mg.

11. The patch of claim 1, wherein the composition comprises an amount of elemental iron in a range from about 1 mg to about 50 mg.

12. The patch of claim 1 wherein the composition comprises an amount of elemental iron in a range from about 1 mg to about 10 mg.

13. The patch of claim 1, wherein the patch includes at least one needle configured to penetrate a selected depth into a stratum layer of skin to enhance delivery of the composition while minimizing perceptible pain from the penetration.

14. The patch of claim 13, wherein the at least one needle includes an array of needles.

15. The patch of claim 14, wherein the at least one needle has a length in the range of about 100 to about 150 μ

m.

16. The patch of claim 1, 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 a rate at which iron migrates from the reservoir to the tissue contacting side.

17. An iontophoretic system for the transdermal delivery of a therapeutically effective amount of iron, the system comprising the patch of claim 1;

and

a second patch, the second patch having a skin contacting layer comprising a plurality of needles, the plurality of needles arranged in an arrayed pattern and having a length of from about 10 μ

m to about 150 μ

m.

18. The system of claim 17, wherein the needles have a length in the range of about 100 to about 150 μ

m.

19. The system of claim 17, wherein the arrayed pattern of needles is configured to create channels in the stratum corneum with an application force to the second patch of no more than about 10 newtons.

20. An iontophoretic patch for the transdermal delivery of a therapeutically effective amount of iron, the patch comprising an electrode and a reservoir containing a composition comprising an effective amount of an ionic iron in a chelated iron complex for the delivery of the therapeutically effective amount of iron, wherein the patch does not comprise a polyolefin material in contact with the composition, and wherein the composition does not include heme iron or heme iron polypeptide, and the reservoir contains an amount of the composition to continuously deliver a therapeutically effective amount of iron for a period of at least 3 days, and wherein the chelated iron complex comprises ionic iron selected from the group consisting of ferric gluconate, ferric ammonium sulfate, ferric ammonium oxalate, ferric potassium oxalate, ferric sodium oxalate, ferric trisglycinate, ferric bisglycinate, ferric aspartate, ferric citrate, ferric ammonium citrate, ferric choline citrate, ferric manganese citrate, ferric quinine citrate and ferric sodium citrate.