METHODS AND DEVICES FOR ADMINISTRATION OF SUBSTANCES INTO THE INTRADERMAL LAYER OF SKIN FOR SYSTEMIC ABSORPTION

• US 20080118507A1
• Filed: 10/31/2007
• Published: 05/22/2008
• Est. Priority Date: 06/29/2001
• Status: Abandoned Application

• Current Assignee: James A. Down, Noel G. Harvey, Ronald J. Pettis
• Original Assignee: James A. Down, Noel G. Harvey, Ronald J. Pettis
• Inventors: Pettis, Ronald J., Harvey, Noel G., Down, James A.
• Application Number:
  US11/932,272
• Publication Number:
  US 20080118507A1
• Time in Patent Office: Days
• US Class Current: 424/133.1
• CPC Class Codes: A61K 38/193 Colony stimulating factors [CSF]
• CPC Class Codes: A61K 38/21 Interferons [IFN]
• CPC Class Codes: A61K 38/28 Insulins
• CPC Class Codes: A61M 2202/0445 Proteins immunoglobulin A61M2202/0417; beta-2-microglobulin A61M2202/0421; thrombin A61M2202/0425; haemoglobin A61M2202/0433
• 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 5/282 by compression of deformable ampoule or carpule wall
• CPC Class Codes: A61M 5/3202 Devices for protection of the needle before use, e.g. caps A61M5/50 takes precedence; for infusion spikes A61M5/1626; protectors for sharps A61B50/3001
• CPC Class Codes: A61M 5/3278 Apparatus for destroying used needles or syringes needle resheathing means destroying the needle A61M5/321
• CPC Class Codes: A61M 5/46 having means for controlling depth of insertion

Abstract

Methods and devices for administration of substances into the intradermal layer of skin for systemic absorption.

Claims

1-66. -66. (canceled)

67. A method for administering a macromolecular pharmaceutical substance to a patient, the method comprising delivering a bolus of the substance intradermally via a needle inserted into the patient'"'"'s skin so that the needle penetrates the intradermal compartment wherein 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, so that the substance is delivered into the intradermal compartment and distributed systemically exhibiting a higher C_max and a shorter T_max of the substance, by comparison with subcutaneous administration of the substance at an identical dose and rate of delivery, wherein the macromolecular pharmaceutical substance is an antibody or a fragment thereof.

68. The method of claim 67, wherein the antibody is a monoclonal antibody.

69. The method of claim 67, wherein the antibody is a pegylated antibody.

70. The method of claim 67, wherein the antibody is a single chain antibody fragment.

71. The method of claim 67, wherein delivering the substance intradermally comprises injecting the substance intradermally.

72. The method of claim 67, wherein the administering comprises delivering the substance over a period of from about 2 min to about 10 min.

73. The method of claim 67, wherein the administering comprises delivering a bolus of the substance over a period of less than 10 minutes.

74. The method of claim 67, wherein the needle has a length of from about 0.3 mm to about 2.0 mm.

75. The method of claim 67, wherein the needle is a 30 to 50 gauge needle.

76. The method of claim 67, wherein the needle is configured in a delivery device which positions the needle substantially perpendicular to skin surface.

77. The method of claim 67, wherein the needle is in an array of microneedles.

78. The method of claim 77, wherein the array comprises 3 microneedles.

79. The method of claim 77, wherein the array comprises 6 microneedles.

80. The method of claim 67, wherein the substance is administered at a volume rate of from about 2 microliters per minute to about 200 milliliters per minute.

81. The method of claim 80, wherein the substance is administered at a volume rate of from about 2 microliters per minute to about 10 milliliters per minute.

82. The method of claim 80, wherein the substance is administered at a volume rate of from about 10 microliters per minute to about 200 milliliters per minute.

83. The method of claim 67, wherein the macromolecular pharmaceutical substance has a molecular weight of at least 1000 Da.

84. The method of claim 67, wherein the macromolecular pharmaceutical substance has a molecular weight of at least 2000 Da.

85. The method of claim 67, wherein the macromolecular pharmaceutical substance has a molecular weight of at least 4000 Da.

86. The method of claim 67, wherein the macromolecular pharmaceutical substance has a molecular weight of at least 10,000 Da.

87. The method of claim 67, wherein the macromolecular pharmaceutical substance has a molecular weight of greater than 10,000 Da.