BIOSYNCHRONOUS TRANSDERMAL DRUG DELIVERY

• US 20100280432A1
• Filed: 07/13/2010
• Published: 11/04/2010
• Est. Priority Date: 09/13/2004
• Status: Abandoned Application

• Current Assignee: Morningside Venture Investments Ltd. (Morningside Group Ltd.)
• Original Assignee: Chrono Therapeutics Inc.
• Inventors: Giannos, Steven A., DiPierro, Guy
• Application Number:
  US12/835,693
• Publication Number:
  US 20100280432A1
• Time in Patent Office: Days
• US Class Current: 604/20
• 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 transdermal drug delivery device coupled to the human or animal, the delivery device comprising

(a) a source of the bioactive agent,

(b) a programmable timing mechanism which implements timing routines, 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;

and

(c) a mechanism for causing the bioactive agent to be delivered transdermally in response to the timing mechanism.

2. The method of claim 1, whereby permeation through the skin is assisted using one or more from the group comprising 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 4, 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. A method for treating a symptom, condition, and/or disease comprising:

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

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

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

(d) causing the time-programmable transdermal drug delivery system to deliver the active ingredient according to the programmed schedule,

wherein the drug delivery system comprises;

(i) an interface for coupling to the skin of a host;

(ii) a reservoir storing a quantity of an active composition;

(iii) a delivery mechanism configured to cause the bioactive agent to be delivered from the reservoir to the skin of the host, wherein the bioactive agent is delivered transdermally to the host, and wherein the quantity of the active composition supplied from the reservoir to the interface is modulated in response to a control signal; and

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

8. A programmable transdermal drug delivery device comprising:

(a) an interface for coupling to the skin of a host;

(b) a reservoir storing a quantity of an active composition;

(c) a delivery mechanism configured to cause the bioactive agent to be delivered from the reservoir to the skin of the host, wherein the bioactive agent is delivered transdermally to the host, and wherein the quantity of the active composition supplied from the reservoir to the interface is modulated in response to a control signal; and

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

9. The device of claim 8, wherein a valve mechanism controls a rate at which the active composition is supplied in response to the control signal.

10. The device of claim 8, further comprising:

(a) a mechanism for removing the active composition from the interface in response to the control signal;

(b) a mechanism for removing carrier materials from the interface;

or

(c) a combination thereof.

11. The device of claim 10, wherein the removal mechanism comprises a waste reservoir.

12. The device of claim 11, wherein the waste reservoir is an expandable waste reservoir and comprises at least one desiccant and at least one hydrophilic substance.

13. The device of claim 11, wherein a portion of the active composition is removed from the interface via evaporation into the waste reservoir.

14. The device of claim 10, wherein the removal system is configured to control discontinuance of transdermal delivery of the bioactive agent by removing at least a portion of the bioactive agent and/or a carrier solution from the skin of the host, wherein the device is maintained coupled to the host during removal of the portion of the bioactive agent and/or carrier solution.

15. The device of claim 10, further comprising a membrane in contact with the skin of the host, wherein the bioactive agent is delivered from the reservoir to the membrane and from the membrane to the skin of the host, and further wherein the removal system is configured to remove the portion of the bioactive agent and/or carrier solution from the membrane.

16. The device of claim 15, wherein the bioactive agent is delivered from the membrane into the skin of the host by passive transdermal diffusion.

17. The device of claim 15, wherein the delivery mechanism comprises a pump configured to cause the bioactive agent to be delivered from the reservoir to the membrane.

18. The device of claim 17, wherein the reservoir is a collapsible reservoir.

19. The device of claim 18, wherein the reservoir is a pressurized reservoir and the delivery mechanism comprises a valve configured to control release of the bioactive agent from the pressurized reservoir.

20. The device of claim 8, further comprising an electronic programmable timing mechanism, wherein the delivery mechanism is responsive to the timing mechanism to cause the bioactive agent to be delivered from the reservoir to the skin of the host.

21. The device of claim 20, further comprising timing routines implemented by the timing mechanism, wherein the timing routines are configured to deliver the bioactive agent at a time, rate, sequence and/or cycle that is synchronized with a biological rhythm of the host.

22. The device of claim 21, wherein the bioactive agent comprises nicotine and the timing routines are configured to deliver the nicotine at times that are associated with nicotine cravings.