Solid solution perforator for drug delivery and other applications

• US 7,211,062 B2
• Filed: 01/28/2004
• Issued: 05/01/2007
• 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): WILLIAMS, CATHERINE SERKE
• Application Number:
  US10/767,359
• Publication Number:
  US 20040199103A1
• Time in Patent Office: 1,189 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, 604/48, 604 82- 85, 424/426, 424/449, 424/448, 424/423, 424/400, 424/422
• 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 perforator (SSP) system and an associated drug reservoir are provided for delivering theraputic, 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. A system for delivering a substance into tissue comprising:

a patch including

a basal layer having a first side and a second side, and

a plurality of micro-perforators projecting from the first side of the basal layer and formed from a solid matrix material without channels or passageways that are dissolved by a solvent in the tissue to form channels for delivering a substance into the tissue by diffusion, wherein the matrix material comprises a polymer or a carbohydrate derivative; and

a reservoir, including the solvent that dissolves the solid matrix material upon contact with the solvent over a time interval of between a few tens of seconds and a few hours after the micro-perforators have been inserted into a patient'"'"'s body, wherein the reservoir can be attached to the second side of the basal layer.

2. The system of claim 1 wherein the matrix material comprises the substance.

3. The system of claim 1 wherein the reservoir further includes the substance.

4. The system of claim 3 wherein the matrix material comprises a second substance.

5. The system of claim 1 wherein the substance is a drug.

6. The system of claim 1 wherein the matrix material comprises a polymer.

7. The system of claim 1 wherein the matrix material comprises a carbohydrate derivative.

8. The system of claim 1 wherein the matrix material is water-soluble.

9. The system of claim 1 wherein the reservoir is integrally attached to the second side of the basal layer.

10. A method for delivering a substance into tissue comprising:

forming a plurality of channels into the tissue by

affixing a patch including a basal layer having a first side and a second side, and a plurality of micro-perforators projecting from the first side of the basal layer and formed of a solid matrix material without channels or passageways into the tissue, wherein the matrix material comprises a polymer or a carbohydrate derivative, and

dissolving the solid matrix material to form the plurality of channels, wherein the matrix material dissolves over a time interval of between a few tens of seconds and a few hours after the micro-perforators have been inserted into a patient'"'"'s body, wherein dissolving the matrix material comprises attaching to the patch a reservoir of a solvent effective to dissolve the matrix material upon contact with the solvent, and delivering the solvent from the reservoir to the micro-perforators; and

delivering the substance through the plurality of channels by diffusion.

11. The method of claim 10 wherein dissolving the matrix material is effective to deliver a second substance into the tissue.

12. The method of claim 10 wherein the method further comprises removing the basal layer from the tissue after the micro-perforators have dissolved.

13. The method of claim 10 that further comprises activating a perforation activation mechanism that is effective to insert the plurality of micro-perforators to a predetermined distance into the tissue.