METHOD FOR ALTERING DRUG PHARMACOKINETICS BASED ON MEDICAL DELIVERY PLATFORM

• US 20110190725A1
• Filed: 03/28/2011
• Published: 08/04/2011
• Est. Priority Date: 06/29/2000
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Harvey, Noel G., Down, James A., Pettis, Ronald J.
• Granted Patent: US 8,708,994 B2
• Time in Patent Office: Days
• US Class Current: 604/506
• CPC Class Codes: A61K 38/28 Insulins
• CPC Class Codes: A61K 38/29 Parathyroid hormone, i.e. parathormone; Parathyroid hormone-related peptides
• CPC Class Codes: A61M 2037/0038 having a channel at the side surface
• CPC Class Codes: A61M 2037/0061 Methods for using microneedles
• 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 5/32 Needles; Details of needles pertaining to their connection with syringe or hub infusion needles A61M5/158; Accessories for bringing the needle into, or holding the needle on, the body A61M5/42, A61M5/46 take precedence; guide needles for catheters A61M25/065; Devices for protection of needles apparatus specially adapted for cleaning or sterilising needles A61M5/001
• CPC Class Codes: A61M 5/3286 Needle tip design, e.g. for improved penetration
• CPC Class Codes: A61M 5/3291 Shafts with additional lateral openings
• CPC Class Codes: A61M 5/3295 Multiple needle devices, e.g. a plurality of needles arranged coaxially or in parallel
• CPC Class Codes: A61M 5/46 having means for controlling depth of insertion
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics

Abstract

A method for directly delivering whereby a substance is introduced into an intradermal space within mammalian skin which involves administering the substance through at least one small gauge hollow needle having an outlet with an exposed height between 0 and 1 mm. The outlet is inserted into the skin to a depth of between 0.3 mm and 2 mm such that the delivery of the substance occurs at a depth between 0.3 mm and 2 mm.

Claims

1. A method for administration of a substance to the intradermal space of a mammal, the method comprising injecting the substance into the intradermal space of the mammal through at least one hollow needle comprising a needle outlet at a depth of about 0.3 mm to about 2.5 mm, wherein the outlet has an exposed height from 0 mm to about 1 mm, and wherein improved systemic absorption is produced relative to absorption produced upon injecting the substance subcutaneously.

2. The method of claim 1, wherein the substance is administered as a bolus.

3. The method of claim 1, wherein the substance is administered by infusion.

4. The method of claim 1, wherein the substance comprises a monoclonal antibody.

5. The method of claim 1, wherein the substance comprises a pegylated antibody.

6. The method of claim 1, wherein the substance comprises insulin.

7. The method of claim 1, wherein the substance comprises a vaccine.

8. The method of claim 7, wherein the substance further comprises a carrier or adjuvant.

9. The method of claim 1, wherein the substance is in the form of nanoparticles.

10. The method of claim 1, wherein the at least one hollow needle comprises an array of microneedles.

11. The method of claim 1, wherein the exposed height of the needle outlet is 0 mm.

12. The method of claim 1, wherein the needle outlet is formed by a bevel.

13. The method of claim 1, wherein the needle outlet is formed by an opening in the side of the needle.

14. A method for administration of a drug to a human subject, comprising delivering the drug through the lumen of a hollow needle into an intradermal compartment of the human subject'"'"'s skin, which method comprises

(a) inserting the needle into the subject'"'"'s skin so that the needle penetrates the intradermal compartment, and the needle'"'"'s outlet depth and exposed height of the outlet are located within the intradermal compartment, wherein the outlet has an exposed height of 0 to about 1 mm;

and

(b) delivering the drug through the lumen of the needle with the application of pressure in an amount effective to control the rate of delivery of the drug, so that the drug is delivered through the lumen of the needle into the intradermal compartment and distributed systemically exhibiting a higher maximum plasma concentration and a higher bioavailability as compared to subcutaneous delivery of the drug.

15. The method of claim 14, wherein the needle is selected from the group consisting of microneedles, catheter needles, and injection needles.

16. The method of claim 14, wherein a single needle is inserted.

17. The method of claim 14, wherein multiple needles are inserted.

18. The method of claim 14, wherein the substance is a liquid delivered by pressure directly on the liquid.

19. The method of claim 14, wherein a hormone is delivered.

20. The method of claim 19, wherein the hormone is insulin or PTH.

21. The method of claim 14, wherein the needle has a length from about 0.5 to about 1.7 mm.

22. The method of claim 14, wherein the needle'"'"'s outlet depth is between about 0.3 mm to 2 mm when the needle is inserted.

23. The method of claim 14, wherein the outlet has an exposed height of 0 mm.

24. The method of claim 14, wherein the delivery rate or volume is controlled by spacing of multiple needles.