Transdermal drug delivery device including an occlusive backing

Abstract

A transdermal drug delivery system for the topical application of one or more active agents contained in one or more polymeric and / or adhesive carrier layers, proximate to a non-drug containing polymeric backing layer which can control the delivery rate and profile of the transdermal drug delivery system by adjusting the moisture vapor transmission rate of the polymeric backing layer.

Description

[0001] This application claims the benefit of provisional application 60 / 616,861 filed Oct. 8, 2004, which is hereby incorporated by reference in its entirety.FIELD OF THE INVENTION [0002] This invention relates generally to transdermal drug delivery systems, and more particularly to pharmaceutically acceptable adhesive matrix compositions. The invention additionally relates to transdermal drug delivery systems providing acceptable drug release profiles for an extended period of time of up to seven days or longer. [0003] In particular, the present invention is directed to a transdermal drug delivery system for the topical application of one or more active agents contained in one or more polymeric and / or adhesive carrier layers, proximate to a non-drug containing polymeric backing layer. The backing layer can be processed or manufactured separately from the polymeric and / or adhesive drug carrier layer(s) to prevent or minimize loss of drug or other system components, and combined pri...

AI Technical Summary

Benefits of technology

The present invention provides a transdermal drug delivery system that allows selective modulation of drug permeation and delivery rates and profiles. The system is simple and inexpensive to manufacture and uses a non-drug containing polymeric backing layer that is designed to provide control of drug delivery, onset, and profile. The system can be applied to the dermis using a pressure-sensitive adhesive composition. The invention also includes methods of controlling drug delivery rates, onset, and profiles by selecting a specific non-drug containing polymeric backing layer with specific physical and / or chemical characteristics. The drug carrier composition can be comprised of acrylic-based polymers, silicone-based polymers, or a combination of both. By selectively tailoring the moisture vapor transmission rate of the backing layer, drug delivery, onset, and profiles can be achieved.

Problems solved by technology

The reservoir-type devices have a number of disadvantages including a non-uniform drug release profile where a high dose of drug is initially released upon application to the user, often described as a “burst effect.” This burst or high initial release of drug then drops off after a period of time to a rate that necessary to achieve a therapeutically effective amount.

The high initial blood level concentration of certain drugs may cause adverse or undesired effects, or create toxicity concerns, thereby limiting the use of transdermal administration.

In other instances, the higher initial blood level concentration may reduce the amount of drug required for treatment to the point of risking under dosing, or the higher initial blood level concentration may make it impractical to increase the duration of the device's application while retaining therapeutic effectiveness.

Low drug concentrations in the adhesive can result in difficulties in achieving an acceptable delivery rate of the medicament, preferably one approximating zero order kinetics.

High drug concentrations, on the other hand, frequently affect the adhesion properties of the adhesives, and tend to promote unwanted crystallization.

However, the use of polyacylates alone as the adhesive is not without its drawbacks as polyacrylate adhesives, for example, may tend to cause skin irritation, especially when the transdermal device is used for extended periods of time.

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