Method and device for controlling drug pharmacokinetics

• US 7,722,595 B2
• Filed: 05/06/2003
• Issued: 05/25/2010
• 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
• Primary Examiner(s): Sirmons; Kevin C
• Assistant Examiner(s): Witczak; Catherine N
• Application Number:
  US10/429,973
• Publication Number:
  US 20040023844A1
• Time in Patent Office: 2,576 Days
• Field of Search: 604/500, 604/173, 604/22, 604/20, 604/27, 604/28, 604/239
• US Class Current: 604/500
• 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

The invention pertains to methods and devices for controlling the pharmacokinetics of administered substances, particularly therapeutic substances by combining advantages of delivery to two or more compartments within the skin. The invention provides methods and devices for delivering substances to subcutaneous and intradermal compartments of the skin to achieve a hybrid pharmacokinetic profile that has a portion similar to that achieved by intradermal delivery, e.g., rapid and high peak onset levels of the substance, and a portion similar to that achieved by subcutaneous delivery, e.g., longer circulating levels of the substance.

Claims

1. A method for delivering insulin to a subject comprising utilizing at least one delivery device to deliver insulin to the subject, wherein the delivery device comprises a first needle that delivers insulin to the intradermal compartment and a second needle that delivers insulin to the subcutaneous compartment, wherein the first needle inserts into the subject'"'"'s skin at a depth less than 2.5 mm, and wherein the second needle inserts into the subject'"'"'s skin at a depth greater than 2.5 mm and less than 5.0 mm.

2. The method of claim 1, wherein delivery of insulin into the intradermal and subcutaneous compartments is essentially simultaneous.

3. The method of claim 1, wherein delivery of insulin into the intradermal and subcutaneous compartments is sequential.

4. The method of claim 1, wherein the first needle inserts into the subject'"'"'s skin at a depth of at least about 1.0 mm to about 2.0 mm.

5. The method of claim 4, wherein the first needle inserts into the subject'"'"'s skin at a depth of at least about 1.0 mm to about 1.7 mm.

6. The method of claim 1, wherein the second needle inserts into the subject'"'"'s skin at a depth greater than 2.5 mm to about 3.0 mm.

7. The method of claim 1, wherein the first needle inserts into the subject'"'"'s skin at a depth of about 1 mm and the second needle inserts into the subject'"'"'s skin at a depth of about 3 mm.