Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Patent
1997-08-18
1999-12-14
Bockelman, Mark
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
604 21, 604514, 607134, 607135, A61N 130
Patent
active
060010886
DESCRIPTION:
BRIEF SUMMARY
FIELD OF THE INVENTION
THIS INVENTION relates to the process of iontophoresis whereby the delivery of topical active agents is enhanced by the application of an electrical potential difference.
Iontophoresis targets active agents to tissues underlying the skin such as the dermis, subcutaneous tissue, fascia or muscle, bypassing the gastrointestinal tract as a site of absorption and hence avoiding first pass degradation of the drug.
BACKGROUND OF THE INVENTION
The skin is the major barrier to the entry of foreign solutes from the environment into the body as well to the loss of heat and moisture from the body. The outermost layer of the epidermis, the stratum corneum, is normally assumed to be the major barrier to drug absorption through the skin. It has also been assumed that the drugs penetrating the epidermis are then removed by the dermal blood supply.
Drugs will not penetrate into deeper tissues after topical application if the stratum corneum barrier is not overcome. Complete removal of this barrier should yield tissue levels equivalent to those observed after dermal application. Singh et al., (1993) referred to in the list of references hereinafter, observed that iontophoresis also yielded tissue concentrations of lignocaine and salicylic acid in vivo, similar to those observed for dermal application.
Iontophoresis is a process which involves the transport of charged substances into body tissue, such as skin, by the passage of an electric current. Transport of solutes by iontophoresis is dependent on many factors, including solute physio chemical factors which includes (ionic charges [Gangarosa et al., 1980; Pikal, 1990; Srinivasan and Higuchi, 1990; Kasting and Keister, 1989; Phipps et al., 1989; Burnette and Ongpipattanakul, 1987; DeNuzzio and Berner, 1990], the presence of extraneous ions [Bellatone et al., 1986], pH of the donor solution [Siddiqui et al., 1985b and 1989; Burnette and Marrero, 1986; Wearley et al., 1989], ionic strength [Lelawongs et al, 100-; Wearley et al., 1989], solute concentration [O'Malley and Oester, 1955; Bellatone et al, 1986; Wearley et al., 1989], buffer constituents, chemical structure of the solute inclusive of conductivity [Siddiqui et al., 1989]); physiological factors (skin region--density of appendages [Roberts et al., 1982; Feldman et al., 1967], age, sex, race, hydration of the skin [Potts et al., 1984], delipidization--ethanol pretreatment [Srinivasan et al., 1989], fluidisation of lipids and permeability of skin [Tregear, 1966; Phipps et al., 1989]) and electrical factors inclusive of current density [Bellatone et al., 1986; DelTerzo et al., 1989], nature of electrodes [Bellatone et al., 1986, Masada et al., 1989], duration of treatment, nature of current [Okabe et al., 1986; Yamamoto and Yamamoto, 1976 and 1978; Chien et al., 1989; Bagniefski and Burnette, 1990; Pikal and Shah, 1991]).
Hitherto there has been described methods and compositions for enhanced skin concentration of iontophoretically delivered active agents. During iontophoresis, charged compounds pass from a reservoir attached to the skin of a person into the tissue underneath. The process is one wherein the rate of delivery is a function of current, active agent concentration and presence of other ions. It is a generally held belief that higher concentrations of active agent, higher levels of current and lower concentrations of other ions result in greater delivery of the active compound. Generally, iontophoretic devices comprise at least two electrodes--both on the surface, an electrical energy source, such as a battery, and at least one reservoir which contains the active agent to be delivered.
Mention can be made to prior art which describes methods and devices involving the internal placement of iontophoretic electrodes into body cavities. Stephen et al., (U.S. Pat. No. 5,222,936) describe a method and apparatus specifically for the placement of an iontophoretic electrode in the form of a tubular catheter into hollow body cavities containing ion-rich physiological fluids, such as the bl
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Cross Sheree Elizabeth
Hirst Lawrence William
Lai Pam Muhtze
Roberts Michael Stephen
Bockelman Mark
The University of Queensland
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