Method for altering drug pharmacokinetics based on medical delivery platform

• US 20040175360A1
• Filed: 03/17/2004
• Published: 09/09/2004
• Est. Priority Date: 06/29/2000
• Status: Abandoned Application

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Down, James, Pettis, Ronald J., Alchas, Paul G., Harvey, Noel G.
• Application Number:
  US10/803,735
• Publication Number:
  US 20040175360A1
• Time in Patent Office: Days
• US Class Current: 424/85.4
• CPC Class Codes: A61K 38/193 Colony stimulating factors [CSF]
• CPC Class Codes: A61K 38/21 Interferons [IFN]
• CPC Class Codes: A61K 38/28 Insulins
• CPC Class Codes: A61M 2202/0445 Proteins
• CPC Class Codes: A61M 37/0015 by using microneedles
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• CPC Class Codes: A61M 5/282 by compression of deformable ampoule or carpule wall
• CPC Class Codes: A61M 5/3202 Devices for protection of the needle before use, e.g. caps A61M5/50 takes precedence; for infusion spikes A61M5/1626; protectors for sharps A61B50/3001
• CPC Class Codes: A61M 5/3278 Apparatus for destroying used needles or syringes needle resheathing means destroying the needle A61M5/321
• CPC Class Codes: A61M 5/46 having means for controlling depth of insertion

Abstract

The present invention relates to methods and devices for administration of substances into the intradermal layer of skin.

Claims

1. A method for delivering interferon into an intradermal space within mammalian skin comprising administering the interferon through at least one small gauge hollow needle having an outlet with an exposed height between 0 and 1 mm, said outlet being inserted into the skin to a depth of between 0.3 mm and 2 mm, such that administration occurs at a depth between 0.3 mm and 2 mm.

2. The method of claim 1, wherein the delivery of interferon to the intradermal space produces improved pharmacokinetics compared to pharmacokinetics after subcutaneous injection.

3. The method of claim 2, wherein the improved pharmacokinetics is increased bioavailability, a decrease in T_max, an increase in C_max, a decrease in T_lag, or an enhanced absorption rate of interferon.

4. The method of claim 1, wherein interferon is administered through at least one small gauge needle.

5. The method of claim 1, wherein the needle has an outlet with an exposed height between 0 and 1 mm.

6. The method of claim 1, wherein the delivery of interferon comprises inserting the needle to a depth which delivers the interferon at least about 0.3 mm and no more than about 2 mm.

7. The method of claim 1, wherein interferon is administered over a time period of not more than 10 minutes.

8. The method of claim 1, wherein interferon is administered over a time period greater than 10 minutes.

9. The method of claim 1, wherein interferon is administered at a rate between 1 nL/min and 200 mL/min.

10. The method of claim 1, wherein the needle(s) are inserted substantially perpendicularly to the skin.

11. A method of administering interferon comprising injecting or infusing the interferon intradermally through one or more microneedles having a length and an outlet, so that the interferon is selectively delivered into the dermis.

12. The method of claim 11, wherein administration of interferon into the dermis produces improved systemic pharmacokinetics compared to subcutaneous administration.

13. The method of claim 12, wherein the improved pharmacokinetics is increased bioavailability of interferon, a decrease in T_max, an increase in C_max, a decrease in T_lag, or an enhanced absorption rate of interferon.

14. The method of claim 11, wherein the length of the microneedle is from about 0.5 mm to about 1.7 mm.

15. The method of claim 11, wherein the microneedle is a 30 to 34 gauge needle.

16. The method of claim 11, wherein the microneedle has an outlet of from 0 to 1 mm.

17. The method of claim 11, wherein the microneedle is configured in a delivery device which positions the microneedle perpendicular to the skin.

18. The method of claim 11, wherein the microneedle is contained in an array of microneedles.

19. The method of claim 18, wherein the array comprises 3 microneedles.

20. The method of claim 18, wherein the array comprises 6 microneedles.

21. A method for delivering interferon to a subject comprising contacting the skin of the subject with a device having a dermal access means for accurately targeting the dermal space of the subject, wherein a clinically efficacious amount of interferon is delivered.