Patch production

• US 8,734,697 B2
• Filed: 12/17/2009
• Issued: 05/27/2014
• Est. Priority Date: 12/22/2008
• Status: Active Grant

• Current Assignee: Vaxxas Pty Ltd.
• Original Assignee: The University of Queensland
• Inventors: Chen, Xianfeng, Kendall, Mark Anthony Fernance, Prow, Tarl, Raphael, Anthony Paul
• Primary Examiner(s): Soroush, Ali
• Application Number:
  US13/141,667
• Publication Number:
  US 20120027810A1
• Time in Patent Office: 1,622 Days
• Field of Search: 264/219, 264/220
• US Class Current: 264/219
• 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 37/0015 by using microneedles

Abstract

A method for use in producing a patch having a number of projections thereon. The method includes providing a distribution member and filling material on a mold surface, the mold including a number of cavities extending from the mold surface for defining the patch projections, filling the cavities with filling material, at least in part by urging filling material from the distribution member into the cavities, causing the filling material to solidify and separating the solidified filling material and the mold to thereby form the patch.

Claims

1. A method for use in producing a patch having a number of projections thereon, the method including:

a) providing a distribution member and filling material on a mold surface of a mold, the mold including a number of cavities extending from the mold surface for defining the patch projections, wherein the distribution member evenly disperses filling material across the mold surface so that the filling material evenly fills the mold;

b) filling the cavities with filling material, at least in part by urging filling material from the distribution member into the cavities;

c) causing the filling material to solidify; and

d) separating the solidified filling material and the mold to thereby form the patch.

2. The method according to claim 1, wherein the method includes causing filling material on the mold surface to solidify, thereby forming a patch base.

3. The method according to claim 1, wherein the step of providing a distribution member and filling material on the mold surface includes:

a) providing the distribution member on the mold surface; and

b) applying the filling material to the distribution member.

4. The method according to claim 1, wherein the distribution member is at least one of:

a) a diffusion filter; and

b) a membrane.

5. The method according to claim 1, wherein the method of solidifying the filling material includes at least one of:

a) exposure to vacuum;

b) temperature control;

c) humidity control;

d) using a gas flow; and

e) exposing the filling material to a reagent;

f) exposing the filling material to UV light; and

g) exposing the filling material to radiation.

6. The method according to claim 1, wherein the method of urging the filling material into the cavities includes using a centrifuge.

7. The method according to claim 1, wherein the step of filling the cavities with filling material includes:

a) calculating a volume of filling material required to at least partially fill the cavities; and

b) filling the cavities using the calculated volume of filling material.

8. The method according to claim 1, wherein the method includes forming the projections with at least two layers of filling material.

9. The method according to claim 1, wherein resulting projections include at least two layers.

10. The method according to claim 1, wherein the step of filling the cavities with filling material includes:

a) partially filling the cavities with a first filling material; and

b) filling a cavity using at least a second filling material.

11. The method according to claim 10, wherein the method includes filling the cavity using at least a third filling material.

12. The method according to claim 11, wherein the third filling material forms a patch base.

13. The method according to claim 10, wherein the step of partially filling the cavities with the first filling material includes:

a) determining a layer depth;

b) calculating a volume of first fluid material in accordance with the layer depth; and

c) partially filling the cavities using the calculated volume of first filling material.

14. The method according to claim 1, wherein the step of filling the cavities with filling material includes:

a) urging a first filling material from a first distribution member into the cavities, to thereby partially fill the cavities;

b) causing the first filling material to solidify;

c) urging a second filling material from a second distribution member into the cavities, to thereby fill the cavities; and

d) causing the second filling material to solidify.

15. The method according to claim 14, wherein the step of filling the cavities with filling material further includes:

a) urging a third filling material from a third distribution member into the cavities, to thereby fill the cavities; and

b) causing the third filling material to solidify.

16. The method according to claim 14, wherein the method includes replacing the first distribution member with the second distribution member prior to providing the second filling material.

17. The method according to claim 1, wherein the method includes:

a) prior to providing the filling material on the mold surface, determining mold properties; and

b) selecting filling material properties at least partially in accordance with the mold properties.

18. The method according to claim 17, wherein the mold properties include at least one of:

a) cavity size;

b) cavity shape;

c) cavity spacing;

d) cavity surface properties; and

e) mold materials.

19. The method according to claim 17, wherein the filling material properties include at least one of:

a) a surface tension; and

b) a viscosity.

20. The method according to claim 17, wherein the method includes forming a filling material having selected filling material properties, the filling material including at least one of:

a) a viscosity enhancer;

b) a detergent;

c) a surfactant; and

d) an adjuvant.

21. The method according to claim 1, wherein the filling material is dissolvable on contact with fluid in a subject.

22. The method according to claim 1, wherein the filling material includes a material for delivery to a subject in use.

23. The method according to claim 22, wherein the material is at least one of:

a) a biological agent; and

b) a therapeutic agent.

24. The method according to claim 22, wherein the material is at least one of:

a) nanoparticles;

b) a nucleic acid or protein;

c) an antigen, allergen, or adjuvant;

d) parasites, bacteria, viruses, or virus-like particles;

e) quantum dots, SERS tags, raman tags or other nanobiosensors;

f) metals or metallic compounds;

g) molecules, elements or compounds;

h) DNA;

i) protein;

j) RNA, siRNA, sfRNA, iRNA;

k) synthetic biological materials;

l) polymers; and

,

m) drugs.

25. The method according to claim 1, wherein the method includes:

a) forming the mold prior to providing the distribution member and filling material on the mold surface by creating a male mold having a number of projections; and

b) using the male mold to thereby form the mold.

26. The method according to claim 25, wherein the method includes creating the male mold using an etching process.

27. The method according to claim 25, wherein the method includes etching a silicon substrate to thereby form the male mold.

28. A method for use in producing a patch having a number of projections thereon, the method including:

a) providing a first filling material on a mold surface of a mold, the mold including a number of cavities extending from the mold surface for defining the patch projections;

b) partially filling the cavities with first filling material;

c) causing the first filling material to solidify;

d) providing a second filling material on the mold surface;

e) filling the cavities with second filling material;

f) causing the second filling material to solidify; and

g) separating the solidified filling material and the mold to thereby form the patch.

29. The method according to claim 28, wherein the method includes:

a) providing a first distribution member on the mold surface with the first filling material;

b) partially filling the cavities with the first filling material, at least in part by urging the first filling material from the first distribution member into the cavities;

c) providing a second distribution member on the mold surface with the second material; and

d) filling the cavities with the second filling material, at least in part by urging the second filling material from the second distribution member into the cavities.