Active transdermal drug delivery system and the method thereof

• US 9,327,105 B2
• Filed: 03/21/2011
• Issued: 05/03/2016
• Est. Priority Date: 03/26/2010
• Status: Active Grant

• Current Assignee: iTrace Biomedical Inc.
• Original Assignee: iTrace Biomedical Inc.
• Inventors: Ramdas, Radhakrishnan, Karri, Kartik, Sharma, Chidella Venkata Krishna Mohan
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): CARPENTER, WILLIAM R
• Application Number:
  US13/064,334
• Publication Number:
  US 20110264028A1
• Time in Patent Office: 1,870 Days
• Field of Search: 604/20, 604/49, 607/2, 424/449
• US Class Current: 1/1
• 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: A61M 2037/0007 having means for enhancing the permeation of substances through the epidermis, e.g. using suction or depression, electric or magnetic fields, sound waves or chemical agents
• CPC Class Codes: A61M 35/006 using sponges, foams, absorbent pads or swabs as spreading means
• CPC Class Codes: A61M 37/00 Other apparatus for introducing media into the body for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30; Percutany, i.e. introducing medicines into the body by diffusion through the skin salt baths A61H33/04
• CPC Class Codes: A61M 37/0092 using ultrasonic, sonic or infrasonic vibrations, e.g. phonophoresis
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61N 1/0428 Specially adapted for iontophoresis, e.g. AC, DC or including drug reservoirs
• CPC Class Codes: A61N 1/0492 Patch electrodes A61N1/0412, A61N1/0428 take precedence
• CPC Class Codes: A61N 1/325 for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body electrodes for external use A61N1/0428

Abstract

The present invention relates to an active transdermal drug delivery system performing transdermal drug delivery comprising of a patch capable of being attachable to the skin of the subject; at least one electrical energy power input; a plurality of converters/energy transducers configured for converting the electrical energy to different forms of energy; and a controller including a programmable microprocessor configured for providing the intensity, sequence, nature, and timing information for the different energies supplied and thereby providing activating signals to the said converters for the transdermal drug delivery by the said patch, and a method for performing transdermal drug delivery using said electronic patch.

Claims

1. An active transdermal drug delivery system for transdermally delivering a drug to a subject, wherein the system comprises:

a patch configured to be attached to a skin of a subject, wherein the patch comprises;

a thermal transducer;

an ultrasonic transducer; and

an electromotive force transducer; and

a layer configured to retain a drug for delivery to the subject;

a controller operatively connected to the transducers, wherein the controller comprises a programmable microprocessor configured to simultaneously pulse heat in the range of from about 30°

C. to about 60°

C., ultrasonic vibrations, and an electromotive force to the skin of the subject to transdermally deliver the drug to the subject, wherein a pulse comprises a duration of one second or more.

2. An active transdermal drug delivery system as claimed in claim 1, wherein the layer comprises a reservoir, a coating, or a combination thereof.

3. An active transdermal drug delivery system as claimed in claim 2, wherein the coating comprises multiple layers.

4. An active transdermal drug delivery system as claimed in claim 2, wherein the reservoir comprises multiple micro-reservoirs.

5. An active transdermal drug delivery system as claimed in claim 2, wherein the coating comprises a gel, a cream, an ointment, a dispersion, a liquid or a combination of any of the foregoing.

6. An active transdermal drug delivery system as claimed in claim 1, wherein the patch comprises a removable protective liner or a coating or a seal.

7. An active transdermal drug delivery system as claimed in claim 1, wherein the patch comprises a support material.

8. An active transdermal drug delivery system as claimed in claim 1, comprising an input power source operatively coupled to the transducers, wherein the input power source is configured to provide altering current (AC) or direct current (DC).

9. An active transdermal drug delivery system as claimed in claim 8, wherein the input power source is a battery, a capacitor, or a combination thereof.

10. An active transdermal drug delivery system as claimed in claim 8, wherein the input power source is configured to deliver steady current in a range of 0.001 mA-20 mA.

11. An active transdermal drug delivery system as claimed in claim 8, wherein the input power source is configured to deliver steady potential in a range of 0-1500V.

12. An active transdermal drug delivery system as claimed in claim 1, wherein the thermal transducer comprises high resistance and conductive patterns, coating, or material for converting the electrical energy into heat.

13. An active transdermal drug delivery system as claimed in claim 1, wherein the ultrasonic transducer comprises a piezoelectric device.

14. An active transdermal drug delivery system as claimed in claim 1, wherein the ultrasonic transducer comprises a piezoelectric device configured to deliver ultrasonic vibrations in a range of 20 KHz-100 KHz.

15. An active transdermal drug delivery system as claimed in claim 1, wherein the electromotive transducer comprises conductive patterns or resistive patterns.

16. An active transdermal drug delivery system as claimed in claim 1, wherein,

the patch comprises a support material, wherein the support material comprises a thin flexible sheet made of polymer, or rubber, or resin, or textile, or a thin metal acceptable for medical applications;

at least a part of the support material comprises an

adhesive; and

at least a part of the support material is perforated.

17. An active transdermal drug delivery system as claimed in claim 1, wherein the patch comprises a plurality of sensors configured to determine and to provide patient status information operatively coupled to the controller.

18. An active transdermal drug delivery system as claimed in claim 1, wherein the drug-containing layer comprises a reservoir or a coating formulation comprising polymeric binders, excipients, an adhesive matrix, a membrane matrix or a combination of any of the foregoing.

19. An active transdermal drug delivery system as claimed in claim 18, wherein the patch comprises at least two drug-containing layers.

20. An active transdermal drug delivery system as claimed in claim 1, comprising electronic interconnections operably connecting the controller and the patch.

21. An active transdermal drug delivery system as claimed in claim 1, wherein the controller and the patch comprise wireless connections.

22. An active transdermal drug delivery system as claimed in claim 1, wherein the controller comprises a memory configured to store drug delivery profiles.

23. An active transdermal drug delivery system as claimed in claim 22, wherein the drug delivery profiles are based on disease, doses, time, skin permeability, medicament, environment characteristics and the subject.

24. An active transdermal drug delivery system as claimed in claim 1, wherein the system is configured for local drug delivery or for systemic drug delivery.

25. An active transdermal drug delivery system as claimed in claim 1, wherein the layer further comprises a vitamin, a mineral, a cosmetic, a nutraceutical, or a combination of any of the foregoing.

26. An active transdermal drug delivery system as claimed in claim 1, wherein the drug is selected from the group consisting of analgesic agents, anti-arthritic agents, anti-arrhythmic agents, anti-asthmatic agents, anesthetics, anticonvulsants, antidepressants, anti-anxiety drug, antibiotics, anticancer agents, antidiabetic agents, anticholinergic antagonists antidotes, antiviral agents, anti-inflammatory agent, antiglaucoma agents, antiemetics, antihistamines, antipanic agents, anti-infective agents, antineoplastics, antiparkisonian drugs, antirheumatic agents, antipsychotics, appetite stimulants and suppressants, attention deficit disorder (ADD) and attention deficit hyperactivity disorder (ADHD) drugs, cholesterol-lowering agents, anxiolytics, blood modifiers, cardiovascular agents, central nervous system stimulants, drug for Alzheimer'"'"'s disease management, drugs for cystic fibrosis management, diagnostic agents, dietary supplements, drugs for erectile dysfunction, gastrointestinal agents, hormones, drugs for treatment of alcoholism, drugs for treatment of addiction, immunosuppressives, mast cell stabilizers, migraine preparations, motion sickness products, drugs for multiple sclerosis management, muscle relaxants, nonsteroidal anti-inflammatories, opioids, other analgesics and stimulants, ophthalmic preparations, osteoporosis preparations, prostaglandins, respiratory agents, sedatives and hypnotics, skin and mucous membrane agents, smoking cessation aids, Tourette'"'"'s syndrome agents, urinary tract agents, vertigo agents, vaccines, polynucleotides, ribozymes, herbal remedies, nutritional agents, or combinations thereof.

27. An active transdermal drug delivery system as claimed in claim 1, wherein the layer further comprises a cosmetic selected from collagen, Botulinum toxin (bottox) alpha hydroxyacids, alpha ketoacids, polymeric hydroxyacids, moisturizers, marine extract, and antioxidants including ascorbic acid (vitamin C), tocopherol (Vitamin E), and retinol (vitamin A), and/or cosmetically acceptable salts, esters, amides, or a material capable of improving oxygen supply in the skin.

28. A method for performing transdermal drug delivery using the transdermal drug delivery system as claim 1, comprising the steps of:

attaching the patch to the skin of the subject;

inputting electrical energy from a power source to the transducers;

controlling the electrical energy power input to the transducers using the controller to simultaneously pulse heat, ultrasonic vibration, and electromotive force to the layer and to the skin of the subject.