Tip-loaded microneedle arrays for transdermal insertion

• US 9,944,019 B2
• Filed: 05/01/2013
• Issued: 04/17/2018
• Est. Priority Date: 05/01/2012
• Status: Active Grant

• Current Assignee: Carnegie Mellon University, University of Pittsburgh of The Commonwealth System of Higher Education
• Original Assignee: Carnegie Mellon University, University of Pittsburgh of The Commonwealth System of Higher Education
• Inventors: Falo, Jr., Louis D., Erdos, Geza, Ozdoganlar, O. Burak
• Primary Examiner(s): VU, QUYNH-NHU HOANG
• Application Number:
  US14/398,375
• Publication Number:
  US 20150126923A1
• Time in Patent Office: 1,812 Days
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61K 9/0021 Intradermal administration, e.g. through microneedle arrays, needleless injectors mechanical aspects A61M
• CPC Class Codes: A61L 2300/802 Additives, excipients, e.g. cyclodextrins, fatty acids, surfactants
• CPC Class Codes: A61L 2400/18 Modification of implant surfaces in order to improve biocompatibility, cell growth, fixation of biomolecules, e.g. plasma treatment
• CPC Class Codes: A61L 31/042 Polysaccharides
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61M 2037/0023 Drug applicators using microneedles
• CPC Class Codes: A61M 2037/0046 Solid microneedles
• CPC Class Codes: A61M 2037/0053 Methods for producing microneedles
• CPC Class Codes: A61M 2037/0061 Methods for using microneedles
• CPC Class Codes: A61M 37/0015 by using microneedles
• CPC Class Codes: B23C 3/20 for shaping dies
• CPC Class Codes: B29C 67/00 Shaping techniques not covered by groups B29C39/00 - B29C65/00, B29C70/00 or B29C73/00
• CPC Class Codes: B29L 2031/7544 Injection needles, syringes

Abstract

A method of forming a microneedle array can include forming a microneedle array that has one or more bioactive component. The microneedle array can include a base portion and plurality of microneedles extending from the base portion, and the one or more bioactive components are present in a higher concentration in the plurality of microneedles than in the base portion.

Claims

1. A dissolvable microneedle array for transdermal insertion into a patient comprising:

one or more bioactive components;

a base portion; and

a plurality of microneedles extending from the base portion, the plurality of microneedles comprising a top half and a bottom half

wherein the one or more bioactive components are concentrated in the top half of the microneedles,

wherein the base portion and the plurality of microneedles comprise a plurality of layers of dissoluble biocompatible material,

wherein the dissoluble biocompatible material define a shape of the plurality of microneedles, the one or more bioactive components are contained in the plurality of layers, and at least some of the plurality of layers that contain the one or more bioactive components are spatially separated from others of the plurality of layers that contain the one or more bioactive components.

2. The dissolvable microneedle array of claim 1, wherein the base portion is substantially formed without any bioactive components contained therein.

3. The dissolvable microneedle array of claim 2, wherein the plurality of microneedles have a first cross-sectional dimension at an area of a top portion, a second cross-sectional dimension at an area of a bottom portion, and a third cross-sectional dimension at an area of an intermediate portion, wherein the third cross-sectional dimension is greater than the first and second cross-sectional dimensions.

4. The dissolvable microneedle array of claim 3, wherein each microneedle generally tapers to a point above the intermediate portion and each microneedle generally tapers to a smaller cross-sectional dimension below the intermediate portion.

5. The dissolvable microneedle array of claim 1, wherein the dissoluble biocompatible material is carboxymethylcellulose.

6. The dissolvable microneedle array of claim 2, wherein the one or more bioactive component comprises at least two different bioactive components.

7. The dissolvable microneedle array of claim 6, wherein the at least two different bioactive components are selected from the group consisting of a chemotherapeutic agent, an adjuvant, and a chemo attractant for a cancer chemo immunotherapy application.

8. The dissolvable microneedle array of claim 6, wherein the one or more bioactive component comprises an antigen and an adjuvant for a vaccine application.

9. The dissolvable microneedle array of claim 2, wherein the one or more bioactive component comprises at least one viral vector.

10. The dissolvable microneedle array of claim 9, wherein the at least one viral vector comprises an adenovector.

11. The dissolvable microneedle array of claim 1, wherein the one or more bioactive component comprises doxorubicin.

12. The dissolvable microneedle array of claim 1, wherein the spatially separated layers of the one or more bioactive components comprise different active components.

13. The dissolvable microneedle array of claim 1, wherein the spatially separated layers of the one or more bioactive components comprise different amounts of the same bioactive component.

14. The dissolvable microneedle array of claim 1, wherein the spatially separated layers of the one or more bioactive components comprise different concentrations of the same bioactive component.