Transcorneal drug-release system

• US 6,132,755 A
• Filed: 06/16/1998
• Issued: 10/17/2000
• Est. Priority Date: 07/14/1995
• Status: Expired due to Term

• Current Assignee: Boehringer Ingelheim Promeco SA de CV (C.H. Boehringer Sohn AG & Co. KG)
• Original Assignee: Boehringer Ingelheim Promeco SA de CV (C.H. Boehringer Sohn AG & Co. KG)
• Inventors: Eicher, Joachim, Zierenberg, Bernd
• Primary Examiner(s): Azpuru, Carlos A.
• Application Number:
  US08/983,197
• Time in Patent Office: 854 Days
• Field of Search: 424/427
• US Class Current: 424/427
• 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 2037/003 having a lumen
• 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: A61M 37/0015 by using microneedles

Abstract

The invention refers to a transcorneal system for the actively controlled transcorneal delivery of a medicament into a subject comprising an active substance reservoir and a device provided with a plurality of micro-pins or micro-blades adapted in use to penetrate the stratum corneum of the subject and connected with reservoir via a liquid conveying connection and thereby allow active substance to pass from the reservoir through capillary openings of the micro-pins or along the micro-blades into the subject.

Claims

1. A transcorneal system for controlled transcorneal delivery of a medicament into a warm-blooded animal comprising:

a) an active substance reservoir comprising a drug -containing liquid ;

b) a device, which device is provided with micro-blades which are capable of penetrating the stratum corneum of the animal and which device is also provided with a liquid-conveying means, whereby the device is connected to the reservoir via its liquid-conveying means to allow drug-containing liquid to pass from the reservoir to the micro-blades; and

c) a means for actively controlling the passing of drug-containing liquid from the reservoir to the micro-blades, wherein the means for actively controlling the passing of drug-containing liquid from the reservoir to the micro-blades is an integrated pump with integrated electronic controls.

7. The transcorneal system as recited in claim 1, wherein the integrated pump is an electrically driven piezo-electric membrane performing a pump movement.

9. The transcorneal system as recited in claim 1, wherein the reservoir has at least one movable or flexible boundary surface.

11. The transcorneal system as recited in claim 9, wherein the moveable boundary surface is a piston within a cylinder.

13. The transcorneal system as recited in claim 9, wherein the flexible boundary surface is a membrane.

15. The transcorneal system as recited in claim 9, wherein the flexible boundary surface is a concertina.

17. The transcorneal system as recited in claim 1, wherein the micro-blades have a length of at least about 10 μ

m.

18. The transcorneal system as recited in claim 1, wherein the micro-pins have a length of at least about 10 μ

m.

19. The transcorneal system as recited in claim 1, wherein the micro-blades are made of a thermoplastic material.

2. A transcorneal system for controlled transcorneal delivery of a medicament into a warm-blooded animal comprising:

a) an active substance reservoir comprising a drug-containing liquid;

b) a device, which device is provided with a plurality of micro-pins which are capable of penetrating the stratum corneum and which micro-pins have capillary openings at both ends and hollow spaces within the micro-pins and which device is connected to the reservoir via the capillary opening at one end of each of the micro-pins and is adjacent the stratum corneum at the opposite end of each of the micro-pins; and

c) a means for actively discharging the drug-containing liquid from the reservoir through the micro-pins, wherein the means for actively discharging the drug-containing liquid is an integrated pump with integrated electronic controls.

3. The transcorneal system as recited in claim 2, further comprising microvalves between the reservoir and the capillary openings of the micro-pins.

4. The transcorneal system as recited in claim 2, wherein each micro-pins is provided with capillary openings that have a round cross-section.

5. The transcorneal system as recited in claim 2, wherein each micro-pin is provided with capillary openings that are slit-like.

6. The transcorneal system as recited in claim 2, wherein each micro-pin is made of a micro-porous material that is previous to the drug-containing liquid in the reservoir.

8. The transcorneal system as recited in claim 2, wherein the integrated pump is an electrically driven piezo-electric membrane performing a pump movement.

10. The transcorneal system as recited in claim 2, wherein the reservoir has at least one movable or flexible boundary surface.

12. The transcorneal system as recited in claim 10, wherein the moveable boundary surface is a piston within a cylinder.

14. The transcorneal system as recited in claim 10, wherein the flexible boundary surface is a membrane.

16. The transcorneal system as recited in claim 10, wherein the flexible boundary surface is a concertina.

20. The transcorneal system as recited in claim 2, wherein the micro-pins are made of a thermoplastic material.

21. The transcorneal system as recited in claim 2, wherein each micro-pin has a tip with a radius of curvature of less than about 10 μ

m.