BIOSYNCHRONOUS TRANSDERMAL DRUG DELIVERY

• US 20060062838A1
• Filed: 09/13/2005
• Published: 03/23/2006
• Est. Priority Date: 09/13/2004
• Status: Active Grant

• Current Assignee: Morningside Venture Investments Ltd. (Morningside Group Ltd.)
• Original Assignee: Chrono Therapeutics Inc.
• Inventors: Giannos, Steven A., DiPierro, Guy
• Granted Patent: US 7,780,981 B2
• Time in Patent Office: Days
• US Class Current: 424/449
• CPC Class Codes: A61K 31/00 Medicinal preparations containing organic active ingredients
• CPC Class Codes: A61K 31/04 Nitro compounds
• CPC Class Codes: A61K 31/137 Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
• CPC Class Codes: A61K 31/465 Nicotine; Derivatives thereof
• 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 9/0014 Skin, i.e. galenical aspects of topical compositions non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00
• 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: 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 2037/0023 Drug applicators using microneedles
• CPC Class Codes: A61M 2037/0061 Methods for using microneedles
• CPC Class Codes: A61M 2205/0266 Shape memory materials
• CPC Class Codes: A61M 2205/3337 Controlling, regulating pressure or flow by means of a valve by-passing a pump
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• 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 37/0015 by using microneedles
• CPC Class Codes: A61M 37/0092 using ultrasonic, sonic or infrasonic vibrations, e.g. phonophoresis
• CPC Class Codes: A61M 39/22 Valves or arrangement of valves A61M39/02, A61M39/0247, A61M39/16 take precedence; regulating valves in infusion systems A61M5/16881; in devices worn by the patient for the reception of urine, faeces, catamenial or other discharge, or in colostomy devices A61F5/4405
• CPC Class Codes: A61N 1/30 Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis

Abstract

Systems and methods for treating diseases, addictions and disorders in humans and animals involving synchronizing and tailoring the administration of drug compounds with the body'"'"'s natural circadian rhythms, in order to counteract symptoms when they are likely to be at their worst. Automated and pre programmable transdermal drug administration system are used. This system can also utilize a pump or pressurized reservoir, and/or a system for removing depleted carrier solution, or other modulated dispensing actuator, in conjunction with micro-fabricated structures commonly referred to as Micro-needles, or heat, or iontophoresis, sonophoresis, or a wide range of chemical permeation enhancers.

Claims

1. A method for delivering a bioactive agent to a human or animal comprising:

providing a trans dermal drug delivery device coupled to the human or animal, the delivery device having a source of the bioactive agent, a programmable timing mechanism, and a mechanism for causing the bioactive agent to be delivered transdermally in response to the timing mechanism; and

timing routines implemented by the timing mechanism, wherein the timing routines are selected to deliver the bioactive agent at a time, rate, sequence and/or cycle that is synchronized with a biological rhythm of the human or animal.

2. The method of claim 1 whereby permeation through the skin is assisted using one or more from the group comprising:

micro-fabricated structures commonly referred to as Micro-needles, heat, iontophoresis, sonophoresis, and a chemical permeation enhancer.

3. The method of claim 1 wherein the bioactive agent comprises a stimulant and the timing routines are selected to deliver the stimulant immediately before the human or animal wakes up.

4. The method of claim 1 wherein the bioactive agent comprises nicotine and the timing routines are selected to deliver the nicotine at times that are associated with nicotine cravings.

5. The method of claim 3 wherein at least one of the selected times corresponds to a time at which the human or animal experiences a morning nicotine craving.

6. The method of claim 1 wherein the bioactive agent comprises an antihistamine and the timing routines are selected to deliver the antihistamine while the human or animal sleeps.

7. The method of claim 1 wherein the bioactive agent comprises a stimulant and the timing routines are selected to deliver the stimulant immediately before the human or animal wakes up.

8. A method for treating a symptom, condition, and/or disease comprising:

identifying a drug suitable for treating a particular symptom, condition and/or disease;

identifying a biologically superior time for modulating the administration of the a drug;

programming a time-programmable transdermal drug delivery system with a schedule selected to synchronize with the identified biologically superior time for modulating; and

causing the time-programmable transdermal drug delivery system to deliver the active ingredient according to the programmed schedule.

9. A programmable transdermal drug delivery device comprising:

an interface for coupling to the skin of a host;

a reservoir storing a quantity of an active composition;

a delivery mechanism for modulating the quantity of the active composition supplied from the reservoir to the interface in response to a control signal; and

a timing mechanism coupled to the delivery mechanism and configured to generate the control signal according to a programmed administration schedule.

10. The device of claim 9 wherein the valve mechanism controls a rate at which the active composition is supplied in response to the control signal.

11. The device of claim 9 further comprising a mechanism for removing the active composition from the interface in response to the control signal.

12. The device of claim 9 further comprising a mechanism for removing carrier materials from the interface.

13. A method for delivering a drug to a human or animal comprising:

providing a transdermal drug delivery device coupled to the human or animal, the delivery device having a source of the drug, a programmable timing mechanism, and a mechanism for causing the drug to be delivered transdermally in response to the timing mechanism; and

timing routines implemented by the timing mechanism, wherein the timing routines are selected to deliver the drug at a time when the human or animal is expected to be asleep.

14. The method of claim 13 wherein the timing routines terminate drug delivery at a time when the human or animal is expected to be asleep.

15. The method of claim 13 wherein the timing routines increase the dosage of drug delivered at a time when the human or animal is expected to be asleep.

16. The method of claim 13 wherein the timing routines decrease the dosage of drug delivered at a time when the human or animal is expected to be asleep.