Intra-dermal delivery of biologically active agents
First Claim
1. A method for administration of at least one biologically active agent to a human subject, comprising delivering the agent into the intradermal compartment of the human subject'"'"'s skin so that the agent has a higher tissue bioavailability in a particular tissue compared to when the same agent is delivered to a deeper tissue compartment.
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Accused Products
Abstract
The present invention relates to methods and devices for delivering one or more biologically active agents, particularly a diagnostic agent to the intradermal compartment of a subject'"'"'s skin. The present invention provides an improved method of delivery of biologically active agents in that it provides among other benefits, rapid uptake into the local lymphatics, improved targeting to a particular tissue, improved bioavailability, improved tissue bioavailability, improved tissue specific kinetics, improved deposition of a pre-selected volume of the agent to be administered, and rapid biological and pharmacodynamics and biological and pharmacokinetics. This invention provides methods for rapid transport of agents through lymphatic vasculature accessed by intradermal delivery of the agent. Methods of the invention are particularly useful for delivery of diagnostic agents.
184 Citations
61 Claims
- 1. A method for administration of at least one biologically active agent to a human subject, comprising delivering the agent into the intradermal compartment of the human subject'"'"'s skin so that the agent has a higher tissue bioavailability in a particular tissue compared to when the same agent is delivered to a deeper tissue compartment.
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7. A method for administration of at least one diagnostic agent to a human subject, comprising delivering the diagnostic agent into the intradermal compartment of the human subject'"'"'s skin so that the diagnostic agent has a faster onset compared to when the same agent is delivered to the subcutaneous compartment.
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8. A method for administration of at least one diagnostic agent to a particular tissue of a human subject, comprising delivering the diagnostic agent into the intradermal compartment of the human subject'"'"'s skin so that the amount of the pre-selected dose of the diagnostic agent deposited in the particular tissue is increased compared to when the same agent is delivered to the subcutaneous compartment.
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9. A method for administration of at least one diagnostic agent to a human subject, comprising delivering the agent into the intradermal compartment of the human subject'"'"'s skin so that the agent has a higher tissue bioavailability compared to when the same agent is delivered by the ID Mantoux method.
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10. A method for administration of at least one diagnostic agent to a human subject, comprising delivering the agent into the intradermal compartment of the human subject'"'"'s skin so that the agent has a faster onset compared to when the same agent is delivered by the ID Mantoux method.
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11. A method for administration of at least one diagnostic agent to a human subject, comprising delivering the agent into the intradermal compartment of the human subject'"'"'s skin so that the amount of the pre-selected dose of the agent deposited in a particular tissue is increased compared to when the same agent is delivered by the ID Mantoux method.
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12. A method for administration of at least one biologically active agent to a human subject, comprising delivering the agent into the intradermal compartment of the human subject'"'"'s skin so that the agent is deposited in a particular tissue, wherein the agent specifically recognizes a cell which resides in the particular tissue.
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13. A method for administration of a formulation comprising delivering the formulation into the intradermal compartment of the human subject'"'"'s skin so that the formulation is deposited in a particular tissue, wherein the formulation comprises a first targeting agent and a second agent, so that the first targeting agent specifically recognizes a cell which resides in the particular tissue.
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14. A method for administration of at least one diagnostic agent for the detection of a breast tumor to a human subject, comprising delivering the agent into the intradermal compartment of the human subject'"'"'s skin at a controlled rate, volume, and pressure so that the agent is deposited in the intradermal compartment of the subject'"'"'s skin.
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15. A method for administration of at least one diagnostic agent for the detection of a breast tumor to a human subject, comprising delivering the agent into the intradermal compartment of the human subject'"'"'s skin so that more than 75% of the pre-selected volume is deposited into the intradermal compartment, relative to when the same pre-selected volume is delivered to the intradermal compartment by the traditional ID Mantoux method.
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16. A method for administration of at least one diagnostic agent for the detection of a breast tumor to a human subject, comprising delivering the agent into the intradermal compartment of the human subject'"'"'s skin so that the agent is transported to the local lymphatic system.
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17. A method for administration of at least one diagnostic agent for the detection of a breast tumor to a human subject, comprising delivering the agent into the intradermal compartment of the human subject'"'"'s skin so that the agent has a higher tissue bioavailability compared to when the same agent is delivered by the ID Mantoux method.
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18. A method for administration of at least one diagnostic agent for the detection of a breast tumor to a human subject, comprising delivering the agent into the intradermal compartment of the human subject'"'"'s skin so that the agent has a faster onset compared to when the same agent is delivered by the ID Mantoux method.
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19. A method for administration of at least one diagnostic agent for the detection of a breast tumor to a human subject, comprising delivering the agent into the intradermal compartment of the human subject'"'"'s skin so that the amount of the pre-selected dose of the agent deposited in the lymphatic tissue is increased by at least 300% compared to when the same agent is delivered by the ID Mantoux method.
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22. A method for administration of at least one diagnostic agent to a human subject, comprising delivering the agent at a pre-selected volume into the intradermal compartment of the human subject'"'"'s skin so that more than 75% of the pre-selected volume is deposited into the intradermal compartment, relative to when the same pre-selected volume is delivered to the intradermal compartment by the traditional ID Mantoux method.
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23. A method for administration of at least one diagnostic agent to a human subject, comprising delivering the agent into the intradermal compartment of the human subject'"'"'s skin through a needle having a length sufficient to penetrate the intradermal compartment and an outlet at a depth within the intradermal compartment so that the agent is deposited into the intradermal compartment, wherein the needle is not inserted at a 15 degree angle so that at the site of deposition there is no elliptical wheal formation.
- 24. A method for administration of at least one biologically active agent to a particular tissue of a human subject, comprising delivering the agent into an intradermal compartment of the human subject'"'"'s skin, wherein the agent is deposited in the particular tissue and specifically binds a marker of a disease in the particular tissue.
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41. A method for diagnosis of a disease having a specific marker in a human subject comprising
(a) administering a biologically active agent into an intradermal compartment of a human subject'"'"'s skin, wherein the agent is deposited in a particular tissue comprising the marker; -
(b) tracing the agent;
(c) imaging the agent; and
(d) determining whether any specific binding of said agent occurs, wherein the presence of specific binding indicating a probability of said disease. - View Dependent Claims (42, 43, 44, 45, 46, 47, 48, 49)
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- 50. A method for administration of a formulation comprising at least one diagnostic agent to a human subject, comprising delivering the formulation into the intradermal compartment of the human subject'"'"'s skin at a controlled rate, volume, and pressure so that the formulation is deposited in the intradermal compartment of the subject'"'"'s skin
- 59. A method for administration of at least one biologically active agent to a human subject, comprising delivering the agent into the intradermal compartment of the human subject'"'"'s skin so that the agent specifically binds a biological entity.
Specification