Iontophoretic delivery of vesicle-encapsulated active agents
An iontophoresis device is provided for the delivery of active agents encapsulated in vesicles such as transferosomes and niosomes to a biological interface such as skin or mucous membranes.
1 . An iontophoresis device for delivering active agents to a biological interface, the iontophoresis device comprising an active electrode assembly and a counter electrode assembly, the active electrode assembly further including:
an active electrode element operable to provide an electrical potential; and
an inner active agent reservoir comprising a plurality of first vesicles, at least some of the first vesicles encapsulating a first active agent.
2 . The iontophoresis device of claim 1 wherein the first vesicle is a transferosome.
3 . The iontophoresis device of claim 2 wherein the transferosome comprises lipids.
4 . The iontophoresis device of claim 3 wherein the transferosome further comprises cholesterol, sodium cholate or a combination thereof.
5 . The iontophoresis device of claim 2 wherein the transferosome carries a net charge on a surface of the transferosome.
6 . The iontophoresis device of claim 1 wherein the first vesicle is a niosome.
7 . The iontophoresis device of claim 6 wherein the niosome carries a net charge on a surface of the niosome.
8 . The iontophoresis device of claim 3 wherein the niosome is electrically neutral.
9 . The iontophoresis device of claim 1 wherein as least 10% of the first vesicles contain first active agent.
10 . The iontophoresis device of claim 1 wherein as least 30% of the first vesicles contain first active agent.
11 . The iontophoresis device of claim 1 wherein as least 60% of the first vesicles contain first active agent.
12 . The iontophoresis device of claim 1 further comprising:
an electrolyte reservoir comprising an electrolyte composition; and
an inner ion selective membrane positioned between said electrolyte reservoir and said inner active agent reservoir.
13 . The iontophoresis device of claim 12 , further comprising:
an outermost ion selective membrane having an outer surface, the outer surface being proximate the biological interface when in use.
14 . The iontophoresis device of claim 12 , further comprising:
a second active agent cached in the outermost ion selective membrane.
15 . The iontophoresis device of claim 14 wherein the second active agent is encapsulated in a second vesicle.
16 . The iontophoresis device of claim 12 , further comprising:
a third active agent deposited on the out surface of the outermost ion selective membrane.
17 . The iontophoresis device of claim 16 wherein the third active agent is encapsulated in a third vesicle.
18 . The iontophoresis device of claim 1 wherein the first active agent has a molecular weight higher than 1,000 Daltons.
19 . The iontophoresis device of claim 1 wherein the first active agent is DNA, insulin-like growth factors (IGF), bone morphogenetic proteins (BMP), heparin-binding fibroblast growth factor (FGF), platelet-derived growth factors (PDGF), TGF-β, parathyroid hormone (PTH), or statins.
20 . A method for transdermal administration of an active agent by iontophoresis, comprising:
positioning an active electrode assembly and a counter electrode assembly of an iontophoresis device on a biological interface of a subject, the active electrode assembly further including an active electrode element operable to provide an electrical potential; and an inner active agent reservoir comprising a plurality of vesicles, at least some of the vesicles encapsulating an active agent; and
applying a sufficient amount of current to administer a therapeutically effective amount of the active agent encapsulated in the vesicles in the subject for a limited period of time.
21 . The method of claim 20 wherein the vesicle is a transferosome.
22 . The method of claim 21 wherein the transferosome comprises lipids.
23 . The method of claim 22 wherein the transferosome further comprises cholesterol, sodium cholate or a combination thereof.
24 . The method of claim 20 wherein the vesicle is a niosome.
25 . The method of claim 20 wherein the vesicle carries a net charge on a surface thereof.
26 . The method of claim 20 wherein the vesicles are electrically neutral.
27 . The method of claim 20 wherein the vesicles remain intact during the transdermal administration.
28 . The method of claim 20 wherein the active agent is DNA, insulin-like growth factors (IGF), bone morphogenetic proteins (BMP), heparin-binding fibroblast growth factor (FGF), platelet-derived growth factors (PDGF), TGF-β, parathyroid hormone (PTH), or statins.