Method and device for controlling drug pharmacokinetics

• US 9,192,750 B2
• Filed: 04/07/2010
• Issued: 11/24/2015
• Est. Priority Date: 05/06/2002
• Status: Expired due to Term

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Pettis, Ronald J., Harvey, Noel, Ginsberg, Barry
• Primary Examiner(s): Bosques, Edelmira
• Assistant Examiner(s): Thomas, Jr., Bradley G
• Application Number:
  US12/755,540
• Publication Number:
  US 20100262120A1
• Time in Patent Office: 2,057 Days
• Field of Search: 604/500, 604/173, 604/22, 604/20, 604/27, 604/28, 604/239, 604/117, 604/506, 604/522, 604/141, 604/180, 604/272
• US Class Current: 1/1
• 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 insulin to a subject comprising utilizing at least one delivery device to deliver insulin to the subject, wherein insulin is delivered to both the intradermal and the subcutaneous compartments, wherein the delivery device comprises a single needle or cannula, wherein the single needle or cannula comprises a side port that delivers insulin into the intradermal compartment, and wherein the single needle or cannula further comprises an end port that delivers insulin into the subcutaneous compartment, wherein the end port inserts into the subject'"'"'s skin at a depth of at least about 2.0 mm to about 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 using algorithms having logic components that include physiologic models, rules based models or moving average methods, therapy pharmacokinetic models, monitoring signal processing algorithms, predictive control models, or combinations thereof.

4. The method of claim 1, wherein delivery of insulin into the intradermal and subcutaneous compartments is by a bolus injection.

5. The method of claim 1, wherein delivery of insulin into the intradermal and subcutaneous compartments is by a metered bolus injection.

6. The method of claim 1, wherein delivery of insulin into the intradermal and subcutaneous compartments is by an infusion.

7. The method of claim 1, wherein delivery of insulin into the intradermal and subcutaneous compartments is at a dose of 100-200μ

l.