Solid solution perforator for drug delivery and other applications

• US 20060074376A1
• Filed: 11/21/2005
• Published: 04/06/2006
• Est. Priority Date: 06/25/2002
• Status: Active Grant

• Current Assignee: TheraJect, Inc.
• Original Assignee: TheraJect, Inc.
• Inventors: Kwon, Sung-Yun
• Granted Patent: US 7,182,747 B2
• Time in Patent Office: Days
• 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 of 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. An array comprising a plurality of dissolvable, substantially solid, drug solution delivery perforators, wherein each perforator comprises 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, and further wherein at least one of the perforators is formed from a matrix material that is dissolvable and includes a first selected drug distributed within the matrix, the perforators dissolving over a time interval of between a few tens of seconds and a few hours after the perforator has been inserted into a patient'"'"'s body.

2. The array of claim 1, wherein said matrix material 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 array of claim 1, wherein the matrix material is 100 percent drug.

4. The array of claim 1, wherein the matrix material is a solid matrix material having at least one selected drug distributed within the matrix, wherein 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 array of claim 1, wherein said first end of said perforator is a needle having a cross-sectional shape that is cusp-like.

6. The array of claim 1, wherein said perforator has an outer diameter near said first end in a range of 10-100 μ

m.

7. The array 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.

8. The array of claim 7, wherein said reservoir comprises a patch reservoir that receives and holds said second drug, and said first and second drugs are substantially the same.

9. The array of claim 7, 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.

10. The array of claim 7, wherein said reservoir comprises a patch reservoir having an annular region of adhesive that surrounds and contacts a selected region on said patient'"'"'s skin.

11. The array of claim 10, wherein said adhesive comprises a substance that is anti-bacterial.

12. The array of claim 7, wherein said reservoir contains a fluid comprising a chemical enhancer selected from the group consisting of a fatty alcohol, an acid, an ester, a surfactant, a macrocyclis, a terpene, a phospholipid, apyrrolidone, an amide and an amino acid.

13. The array of claim 1, wherein said array comprises at least 20 of said dissolvable perforators in a region having an area no more than 1 cm2.

14. The array 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.

15. The array of claim 7, wherein diffusion channels are created by dissolution of said perforators and said second selected drug diffuses through said diffusion channels.

16. A method of delivering one or more drugs to a patient, said method comprising:

(a) contacting the array of claim 1 with a patient'"'"'s skin; and

(b) causing at least one perforator in the array to penetrate the patient'"'"'s skin, to deliver one or more drugs to the patient.

17. The method of claim 16, wherein said at least one perforator in the array is caused to penetrate the patient'"'"'s skin by manual pressure.

18. The method of claim 16, wherein said at least one perforator is positioned to penetrate said skin to an epidermal layer of said skin.

19. The method of claim 16, wherein said at least one perforator is positioned to penetrate said skin to a dermal layer of said skin.

20. The method of claim 16, wherein said at least one perforator penetrates said patient'"'"'s skin to a distance in a range of 10-1000 μ

m.