Iontophoretic device and method for administering immune response-enhancing agents and compositions
An iontophoresis device and method delivers an immune response-enhancing agent, or composition thereof via iontophoresis. The device may include an active electrode assembly having a drug solution holding portion, comprising an immune response-enhancing agent, or composition thereof; and a non-active electrode assembly. An iontophoresis device delivers an immune response-enhancing agent via iontophoresis. The device includes an active electrode assembly and a non-active electrode assembly, wherein the active electrode assembly comprises: a first electrode element operable to provide an electrical potential of a first polarity and a drug solution holding portion arranged on a front surface of the first electrode member.
1 .- 47 . (canceled)
48 . An iontophoresis device for administering an immune response-enhancing agent, or composition thereof, the iontophoresis device comprising:
an active electrode assembly having a drug solution holding portion, comprising an immune response-enhancing agent, or composition thereof;
an active electrode element operable to apply an electrical potential of a first polarity to drive at least a portion of the immune response-enhancing agent, or composition thereof, from the iontophoresis device
a non-active electrode assembly having a non-active electrode element operable to apply an electrical potential of a second polarity.
49 . The device of claim 48 wherein the immune response-enhancing agent is an adjuvant.
50 . The device of claim 49 wherein the adjuvant is lipid A or an analog of lipid A; an agonist of a toll-like receptor; a saponin or a derivative thereof; CpG; imiquimod; resiquimod; or dSLIM.
51 . The device of claim 50 wherein the analog of lipid A is selected from monophosphoryl lipid A (MPL), 3-O-deacylated monophosphoryl lipid A, or aminoalkylglucosaminide 4-phosphate.
52 . The device of claim 50 wherein the toll-like receptor is selected from TLR-2, TLR-4, TLR-5, TLR-7, or TLR-9.
53 . The device of claim 50 wherein the saponin is QS-21.
54 . The device of any one of claims 48 to 53 wherein the drug solution holding portion further comprises a vaccine or antigen.
55 . The device of claim 54 wherein the vaccine or antigen comprises at least one antigen selected from viral antigens; bacterial antigens including bacterial endotoxin; protozoal antigens; parasite antigens; hepatitis antigens including hepatitis A, hepatitis B, and hepatitis C; hepatitis B surface antigen (HBsAg); mutants of hepatitis B surface antigen; influenza antigens; Bordetella pertussis (pertussis) antigens; Corynebacterium diphtheriae (diphtheria) antigens; Chlostridium tetani (tetanus) antigens; influenza B viral antigens; polio virus antigens; or cancer antigens.
56 . The device of claim 55 wherein the parasite antigen is selected from leishmania antigens or malaria antigens.
57 . The device of claim 55 wherein the cancer antigen is selected from melanoma antigens; basal cell carcinoma antigens; breast cancer antigens; prostate cancer antigens; lung cancer antigens; or ovarian cancer antigens.
58 . The device of claim 54 wherein the vaccine or antigen comprises an antigen mixture selected from mixtures of DTP (diphtheria, tetanus, pertussis) and HBsAg (hepatitis B surface antigen); mixtures of Hib ( haemophilus influenzae type b) and HBsAg; mixtures of DTP, HBsAg, and Hib; or mixtures of IPV (inactivated polio vaccine), DTP, HBsAg, and Hib.
59 . The device of any one of claims 48 to 53 wherein the drug solution holding portion further comprises an allergen.
60 . The device of claim 59 wherein the allergen is selected from insect venoms; plant pollens; house dust mites; animal dander; ragweed; or endotoxin.
61 . The device of claim 48 wherein the active electrode assembly further comprises:
a first ion exchange membrane arranged on a front surface of the drug solution holding portion; and
wherein the non-active electrode assembly further comprises:
a first electrolyte solution holding portion arranged on a front surface of the non-active electrode element.
62 . The device of claim 61 wherein the active electrode assembly further comprises:
a second electrolyte solution holding portion arranged on a front surface of the active electrode element; and
a second ion exchange membrane interposed between the second electrolyte solution holding portion and the drug solution holding portion.
63 . The device of claim 62 wherein the non-active electrode assembly further comprises:
a third ion exchange membrane arranged on a front surface of the first electrolyte solution holding portion.
64 . The device of claim 63 wherein the non-active electrode assembly further comprises:
a third electrolyte solution holding portion arranged on a front surface of the third ion exchange membrane; and
a fourth ion-exchange membrane arranged on a front surface of the third electrolyte solution holding portion.
65 . The device of claim 64 wherein the first polarity is a negative polarity; the second polarity is a positive polarity; the first ion exchange membrane and the fourth ion exchange membrane are anion exchange membranes; the second ion exchange membrane and third ion exchange membrane are cation exchange membranes; and the immune response-enhancing agent is lipid A or a lipid A analog.
66 . The device of claim 65 wherein the lipid A analog is selected from monophosphoryl lipid A (MPL); 3-O-deacylated monophosphoryl lipid A; or aminoalkylglucosaminide 4-phosphate.
67 . A method for administering an immune response-enhancing agent, or composition thereof, using an iontophoresis device, comprising an active electrode assembly having a drug solution holding portion, comprising an immune response-enhancing agent, or composition thereof; and a non-active electrode assembly; the method comprising:
electrically coupling the active electrode assembly and the non-active assembly to poles of a power source; and
applying a voltage or current to the active electrode assembly and the non-active electrode assembly for a period of time;
wherein the active electrode assembly and the non-active electrode assembly are brought into contact with a skin of a mammal.
68 . The method of claim 67 wherein the immune response-enhancing agent is an adjuvant.
69 . The method of claim 68 wherein the adjuvant is lipid A or an analog of lipid A; an agonist of a toll-like receptor; a saponin or a derivative thereof; CpG; imiquimod; resiquimod; or dSLIM.
70 . The method of claim 69 wherein the analog of lipid A is selected from monophosphoryl lipid A (MPL); 3-O-deacylated monophosphoryl lipid A; or aminoalkylglucosaminide 4-phosphate.
71 . The method of claim 69 wherein the toll-like receptor is selected from TLR-2; TLR-4; TLR-5; TLR-7; or TLR-9.
72 . The method of claim 69 wherein the saponin is QS-21.
73 . The method of any one of claims 67 to 72 wherein the drug solution holding portion further comprises a vaccine or antigen.
74 . The method of claim 73 wherein the vaccine or antigen comprises at least one antigen selected from viral antigens; bacterial antigens including bacterial endotoxin; protozoal antigens; parasite antigens; hepatitis antigens including hepatitis A, hepatitis B, and hepatitis C; hepatitis B surface antigen (HBsAg); mutants of hepatitis B surface antigen; influenza antigens; Bordetella pertussis (pertussis) antigens; Corynebacterium diphtheriae (diphtheria) antigens; Chlostridium tetani (tetanus) antigens; influenza B viral antigens; polio virus antigens; or cancer antigens.
75 . The method of claim 74 wherein the parasite antigen is selected from leishmania antigens or malaria antigens.
76 . The method of claim 74 wherein the cancer antigen is selected from melanoma antigens; basal cell carcinoma antigens; breast cancer antigens; prostate cancer antigens; lung cancer antigens; or ovarian cancer antigens.
77 . The method of claim 73 wherein the vaccine or antigen comprises an antigen mixture selected from mixtures of DTP (diphtheria, tetanus, pertussis) and HBsAg (hepatitis B surface antigen); mixtures of Hib ( haemophilus influenzae type b) and HBsAg; mixtures of DTP, HBsAg, and Hib; or mixtures of IPV (inactivated polio vaccine), DTP, HBsAg, and Hib.
78 . The method of any one of claims 67 to 72 wherein the drug solution holding portion further comprises an allergen.
79 . The method of claim 78 wherein the allergen is selected from insect venoms; plant pollens; house dust mites; animal dander; ragweed; or endotoxin.