Method and device for controlling drug pharmacokinetics

• US 20040023844A1
• Filed: 05/06/2003
• Published: 02/05/2004
• Est. Priority Date: 05/06/2002
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Pettis, Ronald J., Ginsberg, Barry, Harvey, Noel
• Granted Patent: US 7,722,595 B2
• Time in Patent Office: Days
• US Class Current: 514/1
• CPC Class Codes: A61M 2037/0023 Drug applicators using microneedles
• CPC Class Codes: A61M 2037/0061 Methods for using microneedles
• CPC Class Codes: A61M 37/0015 by using microneedles
• CPC Class Codes: A61M 5/3291 Shafts with additional lateral openings

Abstract

Methods and devices for administration of substances into at least two compartments of skin for systemic absorption and improved pharmacokinetics, based on biphasic or bimodel kinetic profiling.

Claims

1. A method for delivering a therapeutic substance to a subject comprising delivering the substance within or beneath the skin at least into the intradermal space to access at least two compartments, which compartments afford the substance different pharmacokinetics, which enhance the effectiveness of the substance in terms of a resultant composite pharmacokinetics compared to delivery to a single compartment.

2. The method of claim 1 wherein the substance is delivered to multiple sites that each include at least two compartments.

3. The method of claim 1 wherein the delivery of the substance is by a needle or cannula.

4. The method of claim 3 wherein a single needle or cannula is inserted into the intradermal space.

5. The method of claim 3 wherein multiple needles or needle arrays are inserted into the intradermal space.

6. The method of claim 5 wherein the multiple needles have different lengths.

7. The method of claim 3 wherein the needle or cannula is about 300 μ

m to about 5 mm long.

8. The method of claim 7 wherein the needle or cannula is about 500 μ

m to about 1 mm long.

9. The method of claim 3 wherein the needle or cannula has an outlet placed at a depth of about 250 μ

m to about 2 mm when it is inserted into the intradermal space.

10. The method of claim 9 wherein the outlet is at a depth of about 750 μ

m to about 1.5 mm when the needle or cannula is inserted.

11. The method of claim 10 wherein the outlet has an exposed height of about 0 to about 1 mm.

12. The method of claim 11 wherein the outlet has an exposed height of about 0 to about 300 μ

m.

13. The method of claim 1 wherein the delivery of the substance is by a needle selected from the group consisting of microneedles, catheter needles, and injection needles.

14. The method of claim 1 further comprising controlling the delivery rate or volume delivered of the substance to the intradermal space.

15. The method of claim 1 wherein said delivery is controlled pursuant to an algorithm having logic components which include physiologic models, rules based models or moving average methods, therapy pharmacokinetic models, monitoring signal processing algorithms, predictive control models, or combinations thereof.

16. The method of claim 1 wherein the multiple compartments are intradermal and subcutaneous tissue compartments.

17. The method of claim 1 wherein access of the two or more compartments is by at least one needle that targets the ID compartment and at least another one needle that targets SC compartment.

18. The method of claim 1 wherein access of the two or more compartments is by at least one needle which essentially simultaneously targets the ID compartment and SC compartment.

19. The method of claim 18 wherein the needle or needles targets the SC compartment by overloading the ID compartment.

20. The method of claim 1 wherein access of the two or more compartments is by at least one needle which sequentially targets the ID compartment and SC compartment.

21. The method of claim 1 wherein delivery to multiple compartments is by at least one needle that targets the interface of the ID and SC compartments.

22. The method of claim 1 wherein a portion of said therapeutic substance is absorbed more rapidly into an intradermal tissue space, and the remaining portion is absorbed less rapidly into a subcutaneous tissue space.

23. The method of claim 1 wherein the enhanced effectiveness is a decrease in T_max.

24. The method of claim 1 wherein the enhanced effectiveness is an increase in C_max.

25. The method of claim 1 wherein the enhanced effectiveness is a decrease in T_lag.

26. The method of claim 1 wherein the enhanced effectiveness is enhanced absorption rate.

27. The method of claim 1 wherein the enhanced effectiveness is improved bioavailability.