Biosynchronous transdermal drug delivery

• US 9,555,227 B2
• Filed: 06/22/2015
• Issued: 01/31/2017
• Est. Priority Date: 09/13/2004
• Status: Active Grant

• Current Assignee: Morningside Venture Investments Ltd. (Morningside Group Ltd.)
• Original Assignee: Chrono Therapeutics Inc.
• Inventors: Dipierro, Guy
• Primary Examiner(s): GHALI, ISIS A D
• Application Number:
  US14/746,704
• Publication Number:
  US 20150283367A1
• Time in Patent Office: 589 Days
• Field of Search: None
• US Class Current: 1/1
• 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 synchronizing the administration of compounds with the human body'"'"'s natural circadian rhythms and addiction rhythms to counteract symptoms when they are likely to be at their worst by using an automated and pre programmable transdermal or other drug administration system.

Claims

1. A method for delivering an active substance to a user, the method comprising:

placing a delivery device in contact with the user'"'"'s skin, the dispensing device comprising a reservoir, a skin interface, a programmable dosage controller configured to control the time and dosage of the active substance according to a dosage profile corresponding to a circadian rhythm of the user, and a solvent recovery element;

dispensing a first portion of the active substance and solvent from the reservoir to the skin interlace according to the dosage profile;

delivering the active substance through the skin interface to the skin; and

removing a portion of the solvent from the skin interface and trapping the solvent within the solvent recovery element to control active substance delivery according to the dosage profile.

2. The method of claim 1, wherein the skin interlace comprises a highly permeable membrane.

3. The method of claim 2, further comprising diffusing the active substance across a surface, area of the highly permeable membrane.

4. The method of claim 3, wherein delivering the active substance through the skin interface includes delivering the active substance across a surface area of the highly permeable membrane to the skin.

5. The method of claim 1, wherein the programmable dosage controller is configured to control a valve in fluid communication with the reservoir.

6. The method of claim 1, wherein the delivery device is adhesively attached to the skin.

7. The method of claim 1, wherein the programmable dosage controller comprises timing routines corresponding to the circadian rhythm.

8. The method of claim 7, wherein the timing routines are selected to deliver the active substance at a time, rate, sequence and/or cycle corresponding to the circadian rhythm.

9. The method of claim 1, wherein the active substance comprises nicotine and the dosage profile is configured to deliver the nicotine at times that are associated with nicotine cravings.

10. The method of claim 9, wherein at least one of the times corresponds to a time at which the user experiences a morning nicotine craving.

11. The method of claim 1, Further comprising:

removing the delivery device after contacting the skin for greater than 24 hours.

12. The method of claim 1, further comprising:

removing the delivery device after contacting the skin for greater than 72 hours.

13. The method of claim 1, wherein the reservoir contains the active substance and solvent.

14. The method of claim 13, further comprising:

replacing the reservoir with a second reservoir containing an active substance and a solvent.

15. The method of claim 14, further comprising:

using the delivery device with the second reservoir for greater than 72 hours.

16. The method of claim 1, wherein the solvent recovery element is a waste reservoir.

17. The method of claim 1, wherein the active substance comprises a stimulant and the dosage profile is configured to deliver the stimulant during a 1-2 hour pre-wake-up period.

18. The method of claim 1, wherein the active substance comprises cold medicine and the dosage profile is configured to deliver the cold medicine while the user sleeps.

19. The method of claim 18, further comprising dispensing vitamins and/or minerals to the skin interface while the user sleeps.

20. The method of claim 1, wherein the active substance comprises nitroglycerine and the dosage profile is configured to deliver the nitroglycerine while the user sleeps in first amount in a first time period and in a second amount higher than the first amount in a second time period.

21. The method of claim 1, wherein the active substance is an asthma drug and the dosage profile is configured to deliver the asthma drug while the user sleeps.

22. The method of claim 1, wherein the active substance is a hypertension drug and the dosage profile is configured to deliver the hypertension drug while the user sleeps.

23. The method of claim 1, wherein the active substance is selegiline and the dosage profile is configured to deliver the selegiline while the user sleeps.

24. A method for delivering an active substance to a user, the method comprising:

placing a delivery device in contact with the user'"'"'s skin, the dispensing device comprising a reservoir, a skin interface, a programmable dosage controller configured to control the time and dosage of the active substance according to a dosage profile and a solvent recovery element;

dispensing a first portion of the active substance and solvent from the reservoir to the skin interface according to the dosage profile;

removing a portion of the solvent from the skin interface into the solvent recovery element to control active substance concentration and to control active substance delivery according to the dosage profile; and

delivering the active substance through the skin interface to the skin in discreet doses over a 24 hour period to ensure consistent bioavailability.

25. A method for delivering an active substance and to a user, the method comprising:

placing a delivery device in contact with the user'"'"'s skin, the dispensing device comprising a reservoir, a skin interface, a programmable dosage controller configured to control the time and dosage of the active substance according to a dosage profile and a solvent recovery element;

dispensing a first portion of the active substance and solvent from the reservoir to the skin interface according to the dosage profile;

removing a portion of the solvent from the skin interface into the solvent recovery element to control active substance concentration and to control active substance delivery according to the dosage profile; and

delivering the active substance through the skin interface to the skin in greater amounts upon wake up and at meal times to assist with weight loss.