Iontophoretic device and method for administering immune response-enhancing agents and compositions

• US 20060135906A1
• Filed: 11/16/2005
• Published: 06/22/2006
• Est. Priority Date: 11/16/2004
• Status: Abandoned Application

• Current Assignee: TTI Ellebeau, Inc. (Ease Asset Management Ltd.)
• Original Assignee: TTI Ellebeau, Inc. (Ease Asset Management Ltd.)
• Inventors: Matsumura, Akihiko, Reed, Steven G.
• Application Number:
  US11/280,805
• Publication Number:
  US 20060135906A1
• Time in Patent Office: Days
• US Class Current: 604/20
• CPC Class Codes: A61K 2039/54 characterised by the route of administration
• CPC Class Codes: A61K 2039/55572 Lipopolysaccharides; Lipid A; Monophosphoryl lipid A
• CPC Class Codes: A61K 39/04 Mycobacterium, e.g. Mycobacterium tuberculosis
• CPC Class Codes: A61K 39/39 characterised by the immunostimulating additives, e.g. chemical adjuvants
• CPC Class Codes: A61N 1/0436 Material of the electrode
• CPC Class Codes: A61N 1/0444 Membrane
• CPC Class Codes: A61N 1/0448 Drug reservoir
• CPC Class Codes: Y02A 50/30 Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

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.

Claims

1-47. -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.