Solid solution perforator for drug delivery and other applications

• US 6,945,952 B2
• Filed: 06/25/2002
• Issued: 09/20/2005
• Est. Priority Date: 06/25/2002
• Status: Expired due to Term

• Current Assignee: TheraJect, Inc.
• Original Assignee: TheraJect, Inc.
• Inventors: Kwon, Sung-Yun
• Primary Examiner(s): Lucchesi, Nicholas D.
• Assistant Examiner(s): WILLIAMS, CATHERINE SERKE
• Application Number:
  US10/179,749
• Publication Number:
  US 20040087893A1
• Time in Patent Office: 1,183 Days
• Field of Search: 604/46, 604/60, 604/890.1, 604/47, 604/506, 604/93.01, 604/117, 604/180, 604131-147, 604173-174, 604181-182, 604/185, 604/187, 604/218, 604/239, 604272-274, 424/426, 424/449, 424/448, 424/423
• US Class Current: 604/46
• CPC Class Codes: A61B 17/205 Vaccinating by means of needles or other puncturing devices
• CPC Class Codes: A61B 2017/00345 Micromachines, nanomachines, microsystems
• CPC Class Codes: A61K 2039/54 characterised by the route of administration
• CPC Class Codes: A61K 9/0021 Intradermal administration, e.g. through microneedle arrays, needleless injectors mechanical aspects A61M
• CPC Class Codes: A61K 9/7084 Transdermal patches having a drug layer or reservoir, and one or more separate drug-free skin-adhesive layers, e.g. between drug reservoir and skin, or surrounding the drug reservoir; Liquid-filled reservoir patches
• CPC Class Codes: A61M 2037/0023 Drug applicators using microneedles
• CPC Class Codes: A61M 31/007 Injectors for solid bodies, e.g. suppositories
• CPC Class Codes: A61M 37/0015 by using microneedles

Abstract

A solid drug solution perforator (SSP) system and an associated drug reservoir are provided for delivering therapeutic, prophylactic and/or cosmetic compounds, for nutrient delivery and for drug targeting. For drug delivery, the SSP system includes an active drug ingredient and a matrix of perforator material that biodegrades or dissolves quickly upon contact with a patient'"'"'s body. The SSP system provides a skin barrier perforator and a controller for prompt initiation and cut-off drug delivery. In a preferred method of transdermal drug delivery, an SSP system containing a selected drug penetrates into an epidermis or dermis, and the drug is promptly released from the (dissolving) SSP system perforator. An additional drug is optionally delivered from a patch reservoir through skin pores created by insertion of the perforator. Formulation and fabrication procedures for the SSP and associated reservoir are also provided. An SSP system can be fabricated with variety of shapes and dimensions.

Claims

1. A system for controlled delivery of one or more drugs to a patient'"'"'s body, the system comprising:

an array of one or more dissolvable, substantially solid, drug solution delivery perforators, with each perforator having a first end with at least one point or blade adapted for penetrating skin and for providing a skin aperture on a patient'"'"'s body, with at least one of the perforators including a matrix material that is dissolvable, the at least one perforator dissolving over a time interval of between a few tens of seconds and a few hours after the perforator has been inserted into the patient'"'"'s body, and including a first selected drug distributed within the matrix, where the perforator array can be positioned adjacent to a selected region of the patient'"'"'s skin; and

an activatable pressure mechanism, associated with the at least one perforator, configured to cause the at least one perforator to penetrate the patient'"'"'s skin at the selected region, in response to activation of the pressure mechanism, wherein upon activation said pressure mechanism adjusts the skin penetration depth of said at least one perforator.

2. The system of claim 1, wherein said at least one perforator comprises a matrix material that is at least one or more of a polymer, a carbohydrate derivative, a water-soluble glass, a water-soluble halide, a non-ionic hydrophilic surfactant, an ionic surfactant and a lipophilic additive.

3. The system of claim 1, wherein said at least one perforator comprises a matrix material that is 100 percent drug.

4. The system of claim 1, wherein said at least one perforator comprises a solid matrix material having at least one selected drug distributed within the matrix, where the drug is at least one of a protein, a peptide, a DNA component, a gene, a polysaccharide, a vaccine, a synthetic organic compound and a synthetic non-organic compound.

5. The system of claim 1, wherein said at least one perforator is positioned to penetrate said skin to an epidermal layer of said skin.

6. The system of claim 1, wherein said at least one perforator is positioned to penetrate said skin to a dermal layer of said skin.

7. The system of claim 1, wherein said pressure mechanism is adapted to withdraw said at least one perforator from said patient'"'"'s skin, after said at least one perforator has penetrated said patient'"'"'s skin.

8. The system of claim 1, wherein said pressure mechanism is drawn from a group of skin penetration mechanisms consisting of an activatable spring, a screw driven by an activatable screw motor, a gas pressure-driven device and a manually operated perforator.

9. The system of claim 1, wherein said pressure mechanism, when activated, drives said at least one perforator into said patient'"'"'s skin a selected distance in a range of 10-1000 μ

m.

10. The system of claim 1, wherein said first end of said at least one perforator is a needle having a cross-sectional shape that is polygonal.

11. The system of claim 1, wherein said first end of said at least one perforator is a needle having a cross-sectional shape that is cusp-like.

12. The system of claim 1, wherein said first end of said at least one perforator is a blade.

13. The system of claim 1, wherein said at least one perforator has an outer diameter near said first end in a range of 10-100 μ

m.

14. The system of claim 1, further comprising a fluid reservoir, in fluid communication with said skin aperture and having a fluid container adapted for receiving and holding a selected amount of a second selected drug.

15. The system of claim 14, wherein said reservoir comprises a patch reservoir that receives and holds said second drug, and said first and second drugs are substantially the same.

16. The system of claim 14, wherein said reservoir comprises a patch reservoir that receives and holds said second drug, and said first and second drugs are different from each other.

17. The system of claim 14, wherein said reservoir comprises a patch reservoir having an annular region of adhesive that surrounds and contacts said selected region on said patient'"'"'s skin.

18. The system of claim 17, wherein said adhesive comprises a substance that is anti-bacterial.

19. The system of claim 15, further comprising a second array of perforators, located adjacent to said first array of perforators, with at least one perforator in the second array having a first end with at least one point or blade and being oriented so that the at least one perforator in the second array and said fluid container can be moved relative to each other to provide at least one aperture in said fluid container.

20. The system of claim 14, wherein said reservoir contains a fluid comprising a chemical enhancer drawn from a group consisting of a fatty alcohol, an acid, an ester, a surfactant, a macrocyclis, a terpene, a phospholipid, a pyrrolidone, an amide and an amino acid.

21. The system of claim 1, wherein said array of perforators includes at least 20 of said perforators in a region having an area no more than 1 cm².

22. The system of claim 1, further comprising at least a second of said perforators that includes a second matrix material that is dissolvable, swellable or biodegradable within a selected second time interval, when positioned within said patient'"'"'s body, and substantially no drug is distributed within the second matrix material.

24. The system of claim 1, further comprising a fluid reservoir, in fluid communication with said skin aperture and having a fluid container adapted for receiving and holding a selected amount of a solvent for dissolving said perforator.

25. The system of claim 14, wherein diffusion channels are created by dissolution of said perforators and said second selected drug diffuses through said diffusion channels.

26. A method of delivering one or more drugs to a patient, said method comprising contacting the system of claim 1 with a patient'"'"'s skin;

and activating said activatable pressure mechanism, to deliver one or more drugs to the patient.

27. A method of delivering one or more drugs to a patient, said method comprising contacting the system of claim 25 with a patient'"'"'s skin;

and activating said activatable pressure mechanism, to deliver one or more drugs to the patient.

23. A system for diagnosis of a selected body fluid in a patient'"'"'s body, the system comprising:

an array of one or more solid perforators, with each perforator having a first end with at least one point or blade adapted for penetrating skin and for providing a skin aperture on a patient'"'"'s body, with at least one of the perforators including a matrix material that is dissolvable, swellable or biodegradable within a selected time interval when the perforator is positioned within the patient'"'"'s body, where no drug is distributed within the matrix and where the perforator array can be positioned adjacent to a selected region of the patient'"'"'s skin; and

an activatable pressure mechanism, associated with the at least one perforator, for causing the at least one perforator to penetrate the patient'"'"'s skin at the selected region, in response to activation of the pressure mechanism.