# US 8,465,468 B1 · Intradermal delivery of substances > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 8,465,468 B1 - Document ID: US8465468B1 - Status: Granted - Kind: B1 - Application number: 09/606,909 - Filed: 2000-06-29 - Granted: 2013-06-18 - Earliest claimed: 2000-06-29 - Assignees: Becton, Dickinson and Company - Applicants: Ronald J. Pettis; James A. Down; Noel G. Harvey - Inventors: Ronald J. Pettis; James A. Down; Noel G. Harvey - Web page: https://patentgrep.com/patent/US8465468B1 ## CPC - A61M 5/46: having means for controlling depth of insertion - A61K 38/28: Insulins - A61K 38/29: Parathyroid hormone, i.e. parathormone; Parathyroid hormone-related peptides - A61M 5/158: Needles {for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body} - 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; Devices for protection of needles - A61M 5/3286: {Needle tip design, e.g. for improved penetration} - A61M 5/3291: {Shafts with additional lateral openings} - A61M 5/3295: {Multiple needle devices, e.g. a plurality of needles arranged coaxially or in parallel} - A61M 37/0015: {by using microneedles} - A61P 3/10: for hyperglycaemia, e.g. antidiabetics - A61M 2037/0038: {having a channel at the side surface} - A61M 2037/0061: {Methods for using microneedles} - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS ## Abstract The present invention provides improved methods for ID delivery of drugs and other substances to humans or animals. The methods employ small gauge needles, especially microneedles, placed in the intradermal space to deliver the substance to the intradermal space as a bolus or by infusion. It has been discovered that the placement of the needle outlet within the skin and the exposed height of the needle outlet are critical for efficacious delivery of active substances via small gauge needles to prevent leakage of the substance out of the skin and to improve absorption within the intradermal space. The pharmacokinetics of hormone drugs delivered according to the methods of the invention have been found to be very similar to the pharmacokinetics of conventional SC delivery, indicating that ID administration according to the methods of the invention is likely to produce a similar clinical result (i.e., similar efficacy) with the advantage of reduction or elimination of pain for the patient. Delivery devices which place the needle outlet at an appropriate depth in the intradermal space and control the volume and rate of fluid delivery provide accurate delivery of the substance to the desired location without leakage. ## Claims ### Claim 1 A method for administration of insulin to a human subject, comprising delivering the insulin 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 about 0 to 1 mm; and (b) delivering the insulin through the lumen of the needle with the application of pressure in an amount effective to control the rate of delivery of the insulin, so that the insulin 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. ### Claim 2 (depends on 1) The method of claim 1, wherein the needle is selected from the group consisting of microneedles, catheter needles, and injection needles. ### Claim 3 (depends on 1) The method of claim 1, wherein a single needle is inserted. ### Claim 4 (depends on 1) The method of claim 1, wherein multiple needles are inserted. ### Claim 5 (depends on 1) The method of claim 1, wherein the needle is about 300 μm to 2 mm long. ### Claim 6 (depends on 1) The method of claim 1, wherein the needle is about 500 μm to 1 mm long. ### Claim 7 (depends on 1) The method of claim 1, wherein the outlet is at a depth of about 250 μm to 2 mm when the needle is inserted. ### Claim 8 (depends on 1) The method of claim 1, wherein the outlet is at a depth of about 750 μm to 1.5 mm when the needle is inserted. ### Claim 9 (depends on 1) The method of claim 1, wherein the outlet has an exposed height of about 0 to 300 μm. ### Claim 10 (depends on 1) The method of claim 1, wherein the delivery rate or volume is controlled by spacing of multiple needles, needle diameter or number of needles.