Iontophoretic transdermal system for the administration of at le

Details Iontophoretic transdermal system for the administration of at le Iontophoretic transdermal system for the administration of at le

1997-12-15

2000-02-29

Coggins, Wynn Wood

Surgery

Means for introducing or removing material from body for...

Infrared, visible light, ultraviolet, x-ray or electrical...

A61N 130

Patent

active

060320737

DESCRIPTION:

BRIEF SUMMARY
BACKGROUND OF THE INVENTION

The invention relates to a transdermal system for the administration of at least two substances through the skin with the aid of an electric current.
Transdermal systems are generally used to administer a substance, for example a therapeutically active substance or mixture of substances, through the skin of a living organism without the need for clear penetration of the outer layer of the skin--the stratum corneum--and possibly also underlying layers of skin, by mechanical means using a device such as, for example, an injection needle. Transdermal systems are accordingly normally classed as being non-invasive dosage forms.
The great interest in transdermal systems stems from the fact that that dosage form has distinct advantages over other conventional dosage forms. In the case of oral administration undesired side effects frequently occur as a result of incompatibilities in the gastrointestinal tract or the liver. Also, orally administered substances are frequently decomposed or so modified in the gastrointestinal tract or the liver that the desired therapeutic effect does not occur ("first pass" effect). Other forms of parenteral administration, such as, for example, intravenous, subcutaneous or intramuscular injections, involve penetration of the skin or of layers of the skin and are therefore associated by the patient with a sensation of pain. In addition, local inflammation or infection may occur as a result of the partial damage to the skin. Especially in the case of long-term therapy requiring regular injections of the substance or infusions over prolonged periods--often a plurality of times a day--the patient is frequently subjected to a high level of discomfort. This has, among other things, an adverse effect on the co-operation of the patient in adhering to the medically necessary dosage scheme.
Since transdermal systems are not subject to those limitations they are today, especially in the form of one typical example, that is to say the transdermal patch, numbered among the current dosage forms that enjoy widespread usage. Transdermal systems may be divided roughly into passive and active systems. In passive systems the substance to be administered diffuses from a reservoir through the skin. In active systems an additional force promotes the transport of substance through the skin. Especially preferred for that purpose are electric fields, which generate a flow of current through the skin. The administration of a therapeutically active substance through the skin with the aid of an electric current is generally referred to as iontophoresis.
Typically, the iontophoretic systems used today comprise at least two electrodes, one of which forms a contact with the reservoir containing the substance. The other electrode, often referred to as the neutral electrode, is applied directly to the skin and serves to close the circuit via the body. On connection to a source of electrical energy, a current then flows through the skin and transports the substance into the body. In such active systems this is usually accompanied by a passive transport of substance.
A disadvantage of the passive transdermal systems customary today is that the process of diffusion by way of the natural channels of the skin (sebaceous and sweat glands, inter- and trans-cellular transport paths, hair follicles) proceeds very slowly. It is accordingly difficult using a passive transdermal system to administer a substance through the stratum corneum at a dosage rate that is high enough to achieve the desired therapeutic effect. The dosage rate is the amount of substance administered through the skin per unit of time.
Compared with passive transdermal systems, active systems, especially iontophoretic systems, usually enable higher dosage rates to be achieved. An additional advantage of the latter systems is that with them it is possible in a simple manner to influence and alter the dosage rate in a controlled manner. By regulation of the current as the active control element in the administration it is possib

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