Microneedles with improved open channel cross-sectional geometries

• US 9,795,775 B2
• Filed: 05/20/2014
• Issued: 10/24/2017
• Est. Priority Date: 05/23/2013
• Status: Active Grant

• Current Assignee: Sorrento Therapeutics Inc.
• Original Assignee: Kimberly-Clark Worldwide Incorporated (Kimberly-Clark Corporation)
• Inventors: Baker, Andrew, Ross, Russell F., Ranganathan, Sridhar
• Primary Examiner(s): GRAY, PHILLIP A
• Application Number:
  US14/787,044
• Publication Number:
  US 20160106965A1
• Time in Patent Office: 1,253 Days
• Field of Search: 604173, 604117
• CPC Class Codes: A61M 2037/0023 Drug applicators using microneedles
• CPC Class Codes: A61M 2037/003 having a lumen
• CPC Class Codes: A61M 2037/0038 having a channel at the side surface
• CPC Class Codes: A61M 37/0015 by using microneedles

Abstract

In one aspect a drug delivery device may include a reservoir containing a liquid drug formulation and a microneedle assembly in fluid communication with the reservoir. The microneedle assembly may include a plurality of microneedles, with each microneedle defining an open channel for receiving a drug formulation. The open channel may have a normalized hydraulic radius ranging from about 0.1 to about 0.8. The open channel may also have a liquid-to-solid interfacial energy and a liquid-to-vapor interfacial energy when a fixed volume of the drug formulation is received therein. In addition, the drug formulation and a cross-sectional geometry of the open channel may be selected and configured such that the liquid-to-solid energy exceeds the liquid-to-vapor energy as the length of the fixed volume of drug formulation is increased within the open channel.

Claims

1. A drug delivery device, comprising:

a reservoir containing a liquid drug formulation; and

a microneedle assembly in fluid communication with the reservoir, the microneedle assembly including a support defining an upper surface and a lower surface, the microneedle assembly further including a plurality of microneedles extending from the lower surface, each microneedle defining an open channel for receiving the drug formulation, the open channel having a normalized hydraulic radius ranging from 0.1 to 0.8, the open channel further having a liquid-to-solid interfacial energy and a liquid-to-vapor interfacial energy when a fixed volume of the drug formulation is received therein,

wherein the drug formulation and a cross-sectional geometry of the open channel is selected and configured based on an interaction between the drug formulation and the open channel such that the liquid-to-solid interfacial energy exceeds the liquid-to-vapor interfacial energy as a fluid length of the fixed volume of drug formulation is increased within the open channel.

2. The drug delivery device as in claim 1, wherein the liquid-to-solid interfacial energy is determined according to the following equation:

E_LS=−

L*L_g*γ

*Cos(θ

)

wherein, E_LS corresponds to the liquid-to-solid interfacial energy, L corresponds to the fluid length, L_g corresponds to a liquid/solid interface length of the drug formulation within the open channel, γ

corresponds to a liquid surface tension of the drug formulation within the open channel and θ

corresponds to a contact angle defined between the drug formulation and the open channel.

3. The drug delivery device as in claim 1, wherein the liquid-to-vapor interfacial energy is determined according to the following equation:

E_LV=L*L_S*γ

wherein, E_LV corresponds to the liquid-to-vapor interfacial energy, L corresponds to the fluid length, L_S corresponds to a liquid/vapor interface length of the drug formulation within the open channel and γ

corresponds to a liquid surface tension of the drug formulation within the open channel.

4. The drug delivery device as in claim 1, wherein the drug formulation and the cross-sectional geometry of the open channel is selected and configured such that the following constraint is satisfied:

5. The drug delivery device as in claim 4, wherein the open channel defines a substantially parabolic shaped cross-section.

6. The drug delivery device as in claim 5, wherein the drug formulation and the cross-sectional geometry of the open channel is selected and configured such that at least one of the following constraints is satisfied:

7. The drug delivery device as in claim 4, wherein the open channel defines a substantially trapezoidal shaped cross-section.

8. The drug delivery device as in claim 7, wherein the drug formulation and the cross-sectional geometry of the open channel is selected and configured such that at least one of the following constraints is satisfied:

9. The drug delivery device as in claim 1, wherein the open channel defines a substantially parabolic shaped cross-section, wherein a distance from a vertex of the cross-sectional shape to a focal point of the cross-sectional shape is equal to or less than 50% of a depth of the open channel.

10. The drug delivery device as in claim 1, wherein each microneedle has a skin contact area ranging from about 1,500 um² to about 262,500 um².

29. The drug delivery device as in claim 1, wherein the drug formulation and the cross-sectional geometry of the open channel is selected and configured such that the open channel is self-draining.

11. A drug delivery device, comprising:

a reservoir configured to initially retain a drug formulation; and

a microneedle assembly in fluid communication with the reservoir, the microneedle assembly being configured such that a passive fluid flow of the drug formulation is directed through the microneedle assembly, the microneedle assembly including a support defining an upper surface and a lower surface, the microneedle assembly further including a plurality of microneedles extending from the lower surface, each microneedle defining an open channel for receiving the drug formulation, the open channel having a normalized hydraulic radius ranging from 0.1 to 0.8, the open channel further having a liquid-to-solid interfacial energy and a liquid-to-vapor interfacial energy when a fixed volume of the drug formulation is received therein,

wherein the drug formulation and a cross-sectional geometry of the open channel is selected and configured based on an interaction between the drug formulation and the open channel such that the liquid-to-solid interfacial energy exceeds the liquid-to-vapor interfacial energy as a fluid length of the fixed volume of drug formulation is increased within the open channel.

12. The drug delivery device as in claim 11, wherein the passive fluid flow of the drug formulation through the microneedle assembly derives from the forces associated with at least one of a relative surface tension of the drug formulation, a surface energy of a material forming each microneedle or bodily absorption.

13. The drug delivery device as in claim 11, wherein the reservoir includes a top surface and a bottom surface, the reservoir defining a plurality of passages extending between the top and bottom surfaces, the passages being configured such that the drug formulation is retained within the passages against gravity until a negative pressure is generated within the microneedle assembly that draws the drug formulations out of the reservoir and into the open channel of each microneedle.

14. The drug delivery device as in claim 11, further comprising a spreading membrane disposed between the microneedle assembly and the reservoir, the spreading membrane being configured to distribute the drug formulation along a bottom surface of the reservoir.

15. The drug delivery device as in claim 11, wherein the liquid-to-solid interfacial energy is determined according to the following equation:

E_LS=−

L*L_g*γ

*Cos(θ

)

wherein, E_LS corresponds to the liquid-to-solid interfacial energy, L corresponds to the fluid length, L_g corresponds to a liquid/solid interface length of the drug formulation within the open channel, γ

corresponds to a liquid surface tension of the drug formulation within the open channel and θ

corresponds to a contact angle defined between the drug formulation and the open channel.

16. The drug delivery device as in claim 11, wherein the liquid-to-vapor interfacial energy is determined according to the following equation:

E_LV=L*L_S*γ

wherein, E_LV corresponds to the liquid-to-vapor interfacial energy, L corresponds to the fluid length, L_S corresponds to a liquid/vapor interface length of the drug formulation within the open channel and γ

corresponds to a liquid surface tension of the drug formulation within the open channel.

17. The drug delivery device as in claim 11, wherein the drug formulation and the cross-sectional geometry of the open channel is selected and configured such that the following constraint is satisfied:

18. The drug delivery device as in claim 17, wherein the open channel defines a substantially parabolic shaped cross-section.

19. The drug delivery device as in claim 18, wherein the drug formulation and the cross-sectional geometry of the open channel is selected and configured such that at least one the following constraints is satisfied:

20. The drug delivery device as in claim 17, wherein the open channel defines a substantially trapezoidal shaped cross-section.

21. The drug delivery device as in claim 20, wherein the drug formulation and the cross-sectional geometry of the open channel is selected and configured such that at least one of the following constraints is satisfied:

22. The drug delivery device as in claim 11, wherein the open channel defines a substantially parabolic shaped cross-section, wherein a distance from a vertex of the cross-sectional shape to a focal point of the cross-sectional shape is equal to or less than 50% of a depth of the open channel.

23. The drug delivery device as in claim 11, wherein each microneedle has a skin contact area ranging from about 1,500 um² to about 262,500 um².

30. The drug delivery device as in claim 11, wherein the drug formulation and the cross-sectional geometry of the open channel is selected and configured such that the open channel is self-draining.

24. A drug delivery device, comprising:

a reservoir containing a liquid drug formulation; and

a microneedle assembly in fluid communication with the reservoir, the microneedle assembly including a support defining an upper surface and a lower surface, the microneedle assembly further including a plurality of microneedles extending from the lower surface, each microneedle defining an open channel for receiving the drug formulation and having a skin contact area ranging from about 1,500 um² to about 262,500 um², the open channel having a liquid-to-solid interfacial energy and a liquid-to-vapor interfacial energy when a fixed volume of the drug formulation is received therein,

wherein a relationship between a cross-sectional geometry of the open channel and a contact angle defined between the open channel and the drug formulation is selected and configured such that the liquid-to-solid interfacial energy exceeds the liquid-to-vapor interfacial energy as a fluid length of the fixed volume of drug formulation is increased within the open channel.

25. The drug delivery device as in claim 24, wherein the open channel has a normalized hydraulic radius ranging from 0.1 to 0.8.

26. The drug delivery device as in claim 24, wherein the drug formulation and the cross-sectional geometry of the open channel is selected and configured such that the following constraint is satisfied:

27. The drug delivery device as in claim 26, wherein the open channel defines a substantially parabolic shaped cross-section.

28. The drug delivery device as in claim 26, wherein the open channel defines a substantially trapezoidal shaped cross-section.