Methods and formulations for photodynamic therapy

• US 7,094,228 B2
• Filed: 07/30/2002
• Issued: 08/22/2006
• Est. Priority Date: 07/31/2001
• Status: Expired due to Fees

• Current Assignee: Nuvo Research AG (Searchlight Pharma, Inc.)
• Original Assignee: Zars, Inc.
• Inventors: Hull, Wade, Zhang, Jie, Rigby, Larry
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US10/208,662
• Publication Number:
  US 20030093057A1
• Time in Patent Office: 1,484 Days
• Field of Search: 604 20- 22, 604/19, 604/890, 604/1, 604/289, 604/291, 604/304
• US Class Current: 604/500
• 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 2205/36 related to heating or cooling
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50
• CPC Class Codes: A61N 5/062 Photodynamic therapy, i.e. excitation of an agent

Abstract

An apparatus to rapidly deliver a drug to a patient, the invention comprising the method of locating a drug beneath a patient'"'"'s skin in a drug depot site, placing a heating component near the drug depot site and generating heat in and near the drug depot site. A control component connected to the heating component is used to control the magnitude and duration of heat generated by the heating component.

Claims

1. A method for rapidly delivery of a drug to a patient comprising:

administering dermally a photosensitizer formulation;

applying immediately a pH modifying permeation enhancer to the photosensitizer formulation;

applying a heating component to the skin of the user over the photosensitizer delivery site to heat underlying tissues at the site; and

moderating a control component capable of controlling the magnitude and duration of heat generated by the heating component, to control the speed and depth of penetration of said formulation.

2. The method of claim 1, wherein a portion of the formulation is stored in skin and sub-skin tissues.

3. The method of claim 2, wherein said storage of said drug creates a depot site.

4. The method of claim 2, wherein said drug is in controlled release formulation.

5. The method of claim 2, wherein the drug is disposed in the skin tissues.

6. The method of claim 2, wherein the formulation is disposed in the sub-skin tissues.

7. The method of claim 2, wherein the formulation in the drug depot site is injected into the skin.

8. The method of claim 2, wherein the step of administering comprises implanting the formulation into the skin.

9. The method of claim 3, wherein the heating component is capable of generating heat when supplied with electric current.

10. The method of claim 9, wherein the control component receives a temperature signal from a temperature sensor proximate to the skin.

11. The method of claim 10, wherein the control component adjusts the electric current to the heating component according to the temperature sensor.

12. The method of claim 9, wherein the control component also has a mechanism to lockout a length of time in which the device generates no heating during formulation administration.

13. The method of claim 9, wherein the control component is a mechanism that allows the patient to trigger delivery of a pre-determined amount of bolus formulation from the depot site.

14. The method of claim 9, wherein the control component is pre-programmed to send an electric current with predetermined magnitude through a wire to the heating component for a pre-determined length of time.

15. The method of claim 14, wherein the magnitude and the pre-determined length of time of the current produce a temperature increase at the skin for a pre-determined length of time that releases a pre-determined amount of the formulation from the depot site.

16. The method of claim 14, wherein the magnitude of the current is designed to produce several heating temperature vs. time profiles to accommodate different needs.

17. The method of claim 1 further comprising a microprocessor in conjunction with the electric heating component.

18. The method of claim 1, wherein the heating component has a temperature sensor that measures the temperature at the drug patch and transmits the measured temperature to the control component to regulate the heating temperature.

19. The method of claim 1, wherein the heating component has a layer of thermal insulating material on the side not in contact with the skin for minimizing heat loss.

20. The method of claim 1, wherein an anesthetic is delivered concurrently with the permeation enhancer into the skin from a transdermal drug patch.

21. The method of claim 20, further comprising means for releasably affixing the heating component to the drug patch.

22. The method of claim 21, wherein the heating component and the drug patch have areas with corresponding loop and hook fasteners.

23. The method of claim 1, wherein said heating component is an exothermic oxidation heating patch.

24. The method of claim 23, wherein the heating component is a disposable heating component.

25. The method of claim 1, wherein the drug is selected from the group consisting of analgesics, anti-arthritis drugs, anti-inflammatory drugs, anti-migraine drugs, cardiovascularly active drugs, smoke cessation drugs, hormones, androgen, estrogen, non-steroidal anti-inflammatory agents, anti-hypertensive agents, analgesic agents, anti-depressants, antibiotics, anti-cancer agents, local anesthetics, antiemetics, anti-infectants, contraceptives, anti-diabetic agents, steroids, anti-allergy agents, anti-migraine agents, agents for smoking cessation, anti-obesity agents, nicotine, testosterone, estradiol nitroglycerin, clonidine, dexamethasone, wintergreen oil, tetacaine, lidocaine, fentanyl, sufentanil, alfentanil and other potent mu-receptor agonists, progesterone, insulin, vitamin A., vitamin C, vitamin E, prilocaine, bupivacine, sumatriptan, scopolamine, dihydroegotamine, and combination thereof.