FIELD: medicine.
SUBSTANCE: invention refers to medical equipment, namely to a method for delivering one or more agents into one or more lymphatic tissues in a subject. Method involves: (a) use of one or more needles having a plurality of needles in relation to one or more skin regions having a lymphatic vasculature wherein one or more needle arrays provide contact of one or more layers of the epidermis with one or more nanostructured or nanotopographic surfaces that induce reversible increase in the permeability of one or more cells of the barrier layer of the epidermis for at least one or more agents; (b) administering a total amount of the liquid dosage form in the form of a plurality of portions of the dose of one or more agents at a controlled flow rate when administered ranging from 0.01 mcl/h to 100 mcl/h for each of the needles, when the total combined flow rate controlled with the introduction of from 0.02 mcl/h/cm2 to 50,000 ml/h/cm2 in terms of the surface of one or more arrays of needles on a common area, which contact with the skin of the subject, wherein each portion of the dose of one or more agents is independently administered at a plurality of independent depth values in range of 1 mcm to 500 mcm, outside the epidermis most surface layer in the individual, but still within the subject's epidermis, which is characterized by a Gaussian distribution of depth values in epidermis, before any further diffusion or movement of one or more agents in the epidermis; and where after the stage of introduction, one or more agents are moved or diffuse deeper through the epidermis, through the epidermis basal layer and at least into the underlying part of the viable derma with the capture of part of one or more biologically active agents with one or more susceptible plexus of lymphatic capillaries; where introduction into the epidermis provides more capture of one or more biologically active agents in the lymphatic vasculature compared to intravenous, intradermal or subcutaneous delivery of identical one or more agents; and where after introduction, the permeability of one or more cells of the barrier layer is returned to the state before bringing the epidermis into contact with one or more nanostructured or nanotopographic surfaces.
EFFECT: methods of delivering active agents into the lymphatic system are disclosed.
38 cl, 13 dwg
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Authors
Dates
2020-04-23—Published
2016-07-22—Filed