U.S. PHARMACOPEIA

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SYSTEMS
In recent years, a number of dosage forms have been developed using modern technology that allows for the uniform release or targeting of drugs to the body. These products are commonly called delivery systems. The most widely used of these are Transdermal Systems.
Transdermal Systems
Transdermal drug delivery systems are self-contained, discrete dosage forms that, when applied to intact skin, are designed to deliver the drug(s) through the skin to the systemic circulation. Systems typically comprise an outer covering (barrier), a drug reservoir, which may have a rate-controlling membrane, a contact adhesive applied to some or all parts of the system and the system/skin interface, and a protective liner that is removed before applying the system. The activity of these systems is defined in terms of the release rate of the drug(s) from the system. The total duration of drug release from the system and the system surface area may also be stated.
Transdermal drug delivery systems work by diffusion: the drug diffuses from the drug reservoir, directly or through the rate-controlling membrane and/or contact adhesive if present, and then through the skin into the general circulation. Typically, modified-release systems are designed to provide drug delivery at a constant rate, such that a true steady-state blood concentration is achieved and maintained until the system is removed. At that time, blood concentration declines at a rate consistent with the pharmacokinetics of the drug.
Transdermal drug delivery systems are applied to body areas consistent with the labeling for the product(s). As long as drug concentration at the system/skin interface remains constant, the amount of drug in the dosage form does not influence plasma concentrations. The functional lifetime of the system is defined by the initial amount of drug in the reservoir and the release rate from the reservoir.
NOTE—Drugs for local rather than systemic effect are commonly applied to the skin embedded in glue on a cloth or plastic backing. These products are defined traditionally as plasters or tapes.
Ocular System
Another type of system is the ocular system, which is intended for placement in the lower conjunctival fornix from which the drug diffuses through a membrane at a constant rate (e.g., Pilocarpine Ocular System).
Intrauterine System
An intrauterine system, based on a similar principle but intended for release of drug over a much longer period of time, e.g., one year, is also available (e.g., Progesterone Intrauterine Contraceptive System).