Method of controlling pharmacokinetics of immunomodulatory compounds

• US 20070134719A1
• Filed: 02/09/2007
• Published: 06/14/2007
• Est. Priority Date: 08/30/2002
• Status: Abandoned Application

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Pettis, Ronald
• Application Number:
  US11/704,574
• Publication Number:
  US 20070134719A1
• Time in Patent Office: Days
• US Class Current: 435/6
• CPC Class Codes: A61K 38/00 Medicinal preparations containing peptides peptides containing beta-lactam rings A61K31/00; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, A61K31/00; ergot alkaloids of the cyclic peptide type A61K31/48; containing macromolecular compounds having statistically distributed amino acid units A61K31/74; medicinal preparations containing antigens or antibodies A61K39/00; medicinal preparations characterised by the non-active ingredients, e.g. peptides as drug carriers, A61K47/00
• CPC Class Codes: A61K 38/212 IFN-alpha
• CPC Class Codes: A61P 37/02 Immunomodulators

Abstract

The present invention relates to a method of administering a-interferon into the intradermal compartment of a subject'"'"'s skin, whereby absorption in the dermis produces improved systemic pharmacokinetics compared to subcutaneous administration. The present invention provides an improved method of delivery in that it provides, among other benefits, rapid systemic distribution of a-interferon, rapid onset of the effects of a-interferon, improved bioavailability of a-interferon, and improved maximum concentrations of a-interferon. Methods of the invention are particularly useful in removal of the physical or kinetic barriers invoked when drugs pass through and become trapped in cutaneous tissue compartments prior to systemic absorption.

Claims

1. A method of administering α

-interferon comprising delivering α

-interferon intradermally through one or more microneedles having a length and outlet suitable for selectively delivering α

-interferon into the dermis to obtain delivery of α

-interferon in the dermis, wherein delivery of α

-interferon to the dermis produces improved systemic pharmacokinetics as compared to subcutaneous administration of α

-interferon.

2. The method of claim 1 wherein the improved pharmacokinetics is increased bioavailability.

3. The method of claim 1 wherein the improved pharmacokinetics is decreased T_max.

4. The method of claim 1 wherein the improved pharmacokinetics is an increase in C_max.

5. The method of claim 1 wherein the improved pharmacokinetics is a decrease in T_lag.

6. The method of claim 1 wherein the improved pharmacokinetics is an enhanced absorption rate.

7. The method of claim 1 wherein the length of the microneedle is from about 0.5 mm to about 1.7 mm.

8. The method of claim 1 wherein the microneedle is 30 gauge or narrower.

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

10. The method of claim 1 wherein the microneedle is configured in a delivery device which positions the microneedle perpendicular to skin surface.

11. The method of claim 1 wherein the microneedle needle is contained in an array of microneedles needles.

12. The method of claim 11 wherein the array comprises 3 microneedles.

13. The method of claim 111 wherein the array comprises 6 microneedles.