Claims for Patent: 7,558,625

Summary for Patent: 7,558,625

Title:	Combined micro-channel generation and iontophoresis for transdermal delivery of pharmaceutical agents
Abstract:	The present invention relates to methods of transdermal delivery of pharmaceutical agents. In particular, the present invention relates to a method for transdermal delivery by generating micro-channels on the skin of a subject and delivering iontophoretically a pharmaceutical agent through the micro-channels. The method provides synergistic transdermal delivery of such pharmaceutical agents.
Inventor(s):	Levin; Galit (Nordiya, IL), Gershonowitz; Amikam (Modi\'in, IL), Stern; Meir (Rehovot, IL), Sherman; Amir (Gedera, IL)
Assignee:	TransPharma Medical Ltd. (Lod, IL)
Application Number:	11/749,814
Patent Claims:	1. A method for transdermal delivery of a pharmaceutical agent to a subject, which comprises: generating a plurality of micro-channels in a first region of the skin of a subject, wherein generating the plurality of micro-channels is performed by a micro-channel generating apparatus comprising: (i) an electrode cartridge comprising a plurality of electrodes; and (ii) a main unit comprising a control unit which is adapted to apply electrical energy between the plurality of electrodes of (i) when said plurality of electrodes are in vicinity of a first region of the skin, enabling ablation of stratum corneum in the first region of the skin beneath the plurality of electrodes, thereby generating a plurality of micro-channels; placing a first electrode assembly on said first region of the skin of the subject where the plurality of micro-channels are present, the first electrode assembly comprising a first electrode and an agent reservoir comprising a pharmaceutical agent, the agent reservoir being electrically connected to the first electrode; placing a second electrode assembly on a second region of the skin of the subject, the second electrode assembly comprising a second electrode and an electrolyte reservoir, with the first and second electrodes electrically connected to a power supply; and applying electric energy between the power supply and the first and second electrodes, thereby delivering iontophoretically the pharmaceutical agent through the plurality of micro-channels into the skin of the subject. 2. The method according to claim 1, wherein the electrodes having a diameter of about 30 microns to about 150 microns. 3. The method according to claim 2, wherein the electrodes having a diameter of about 40 microns to about 100 microns. 4. The method according to claim 3, wherein the electrodes having a diameter of about 80 microns. 5. The method according to claim 1, wherein the electrical energy is radio frequency energy. 6. The method according to claim 1, wherein the control unit generates current flow or one or more sparks. 7. The method according to claim 1, wherein the micro-channels have a density of about 75 to about 450 micro-channels/cm.sup.2. 8. The method according to claim 7, wherein the micro-channels have a density of about 75 to about 300 micro-channels/cm.sup.2. 9. The method according to claim 8, wherein the micro-channels have a density of about 150 micro-channels/cm.sup.2. 10. The method according to claim 1, wherein the pharmaceutical agent is selected from the group consisting of anti-infectives, analgesics, anesthetics, antiarthritics, antiasthmatic agents, anticonvulsants, anti-depressants, anti-diabetic agents, anti-diarrhea agents, anti-histamines, anti-inflammatory agents, anti-migraine agents, anti-motion sickness preparations, anti-neoplastics, anti-parkinsonism drugs, anti-pruritics, anti-psychotics, antipyretics, anti-spasmodics, anticholinergics, sympathomimetics, xanthine derivatives, cardiovascular preparations, calcium channel blockers, beta-blockers, anti-arryhthmics, anti-hypertensives, diuretics, vasodilators, central nervous system stimulants, cough suppressants, cold suppressants, decongestants, diagnostics, hormones, hypnotics, immunosuppressives, muscle relaxants, parasympathomimetics, peptides, polypeptides, proteins, psychostimulants, sedatives and tranquilizers. 11. The method according to claim 10, wherein the pharmaceutical agent is a peptide, polypeptide or protein selected from the group consisting of insulin, proinsulin, follicle stimulating hormone, insulin like growth factor-1, insulin like growth factor-2, platelet derived growth factor, epidermal growth factor, fibroblast growth factors, nerve growth factor, transforming growth factors, tumor necrosis factor, calcitonin, parathyroid hormone, growth hormone, bone morphogenic protein, erythropoietin, hemopoietic growth factors, luteinizing hormone, calcitonin, glucagons, clotting factors, anti-clotting factors, bombesin, thrombin, enkephalinase, collagen, collagen domain, mullerian-inhibiting agent, relaxin A-chain, relaxin B-chain, prorelaxin, inhibin, activin, vascular endothelial growth factors, receptors for hormones, receptors for growth factors, integrin, protein A, protein D, rheumatoid factors, neurotrophic factors, CD proteins, osteoinductive factors, immunotoxins, interferons, colony stimulating factors, interleukins, superoxide dismutase, surface membrane proteins, decay accelerating factor, viral antigens, transport proteins; addressins, regulatory proteins, antibodies, and analogs, fragments and pharmaceutically acceptable salts thereof. 12. The method according to claim 11, wherein the pharmaceutical agent is selected from the group consisting of human insulin and human growth hormone. 13. The method according to claim 1, wherein the pharmaceutical agent reservoir further comprises at least one of the components selected from the group consisting of polymeric materials, electrolytes, preservatives, solubilizing agents, absorption promoters, and enzyme inhibitors.

Details for Patent 7,558,625

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Eli Lilly And Company	HUMULIN R U-100	insulin human	Injection	018780	10/28/1982		2024-11-18
Eli Lilly And Company	HUMULIN R U-500	insulin human	Injection	018780	12/29/2015		2024-11-18
Eli Lilly And Company	HUMULIN R U-100	insulin human	Injection	018780	08/06/1998		2024-11-18