Solid Solution Perforator Containing Drug Particle and/or Drug-Adsorbed Particles

• US 20090035446A1
• Filed: 09/05/2006
• Published: 02/05/2009
• Est. Priority Date: 09/06/2005
• Status: Abandoned Application

• Current Assignee: TheraJect, Inc.
• Original Assignee: TheraJect, Inc.
• Inventors: Kwon, Sung-Yun
• Application Number:
  US11/991,682
• Publication Number:
  US 20090035446A1
• Time in Patent Office: Days
• US Class Current: 427/2.100
• CPC Class Codes: A61K 2039/54 characterised by the route of administration
• CPC Class Codes: A61K 2039/55555 Liposomes; Vesicles, e.g. nanoparticles; Spheres, e.g. nanospheres; Polymers
• CPC Class Codes: A61K 9/0021 Intradermal administration, e.g. through microneedle arrays, needleless injectors mechanical aspects A61M
• 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 solid drug solution perforator containing drug particles and/or drug-adsorbed or loaded particles with an associated drug reservoir (SSPP system) are provided for delivering therapeutic, prophylactic and/or cosmetic compounds, diagnostics, and for nutrient delivery and drug targeting. For drug delivery, the SSPP system includes an active drug ingredient in particulate form or drug adsorbed on the particle surface in a matrix material that dissolves upon contact with a patient'"'"'s body. In a preferred method of transdermal drug delivery, an SSPP system containing a drug-adsorbed microparticle penetrates into the epidermis or dermis, and the drug is released from the (dissolving) SSPP system perforator and desorbed from the particles. 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 SSPP and associated reservoir are also provided. An SSPP system can be fabricated with variety of shapes and dimensions.

Claims

1. A method of producing a microneedle with a selected drug concentrated in the tip or on the tip surface, said method comprising:

(a) providing a particulate component selected from the group consisting of a particulate drug, and an inert particle with a drug adsorbed thereto;

(b) combining said particulate component with a soluble matrix material to form a suspension solution comprising said particulate component;

(c) casting said suspension solution into a microneedle mold;

(d) centrifuging said cast microneedle mold under conditions that move the particulate component into the microneedle tip or tip surface; and

(e) drying and separating the cast microneedle from the mold.

2. The method of claim 1, wherein the particulate component is a particulate drug.

3. The method of claim 1, wherein the particulate component is an inert particle with a drug adsorbed thereto.

4. The method of claim 3, wherein the drug is a vaccine.

5. The method of claim 4, wherein the inert particle is poly (lactic-co-glycolic acid) (PLGA) or aluminum hydroxide and aluminum phosphate (alum).

6. The method of claim 1, wherein the drug is a protein.

7. The method of claim 1, wherein the matrix material is a hydrogel.

8. The method of claim 7, wherein the matrix material comprises sodium carboxymethyl cellulose.

9. A method of producing a microneedle with a selected drug concentrated in the tip or on the tip surface, said method comprising:

(a) combining a selected drug, a soluble matrix material and an inert particle in solution to form a suspension solution comprising the inert particle with said drug and matrix adsorbed thereto;

(b) casting said suspension solution into a microneedle mold;

(c) centrifuging said cast microneedle mold under conditions that move the drug-adsorbed inert particle into the microneedle tip or surface of the microneedle; and

(d) drying and separating the cast microneedle from the mold.

10. The method of claim 9, wherein the drug is a vaccine.

11. The method of claim 10, wherein the inert particle is poly (lactic-co-glycolic acid) (PLGA) or aluminum hydroxide and aluminum phosphate (alum).

12. The method of claim 9, wherein the drug is a protein.

13. The method of claim 9, wherein the matrix material is a hydrogel.

14. The method of claim 13, wherein the matrix material comprises sodium carboxymethyl cellulose.

15. A method of producing a microneedle with a selected drug concentrated in the tip or on the tip surface, said method comprising:

(a) providing a particulate component selected from the group consisting of a dried particulate drug, and a dried inert particle with a drug adsorbed thereto;

(b) adding said particulate component into the tip portion of a microneedle mold;

(c) packing a powdered matrix onto the particulate component to fill the microneedle mold;

(d) applying a compressive force to the packed microneedle mold to solidify the microneedle; and

(e) drying and separating the cast microneedle from the mold.

16. The method of claim 15, wherein the particulate component is a particulate drug.

17. The method of claim 15, wherein the particulate component is an inert particle with a drug adsorbed thereto.

18. The method of claim 17, wherein the drug is a vaccine.

19. The method of claim 18, wherein the inert particle is poly (lactic-co-glycolic acid) (PLGA) or aluminum hydroxide and aluminum phosphate (alum).

20. The method of claim 15, wherein the drug is a protein.

21. The method of claim 15, wherein the matrix material is a hydrogel.

22. The method of claim 21, wherein the matrix material comprises sodium carboxymethyl cellulose.