Transdermal drug delivery device including an occlusive backing

a transdermal drug and occlusive backing technology, applied in the direction of anti-inflammatory agents, cardiovascular disorders, drug compositions, etc., can solve the problems of limiting the use of transdermal administration, non-uniform drug release profiles, and impractical to increase the duration of the device's application while retaining therapeutic effectiveness, etc., to achieve convenient and convenient use, convenient use, and convenient use

Inactive Publication Date: 2006-04-13
NOVEN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0021] Another object is to provide a transdermal system, which is simple and inexpensive to manufacture. The present invention provides 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 is manufactured to optimize drug loading while providing desirable adhesion to skin or mucosa as well as providing modulation of the drug delivery and profile. The polymeric backing layer is designed to provide control of permeation rate, onset and profile of the active agent from the system.

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.

Method used

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  • Transdermal drug delivery device including an occlusive backing
  • Transdermal drug delivery device including an occlusive backing

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0418] In Example 1, a backing layer comprising polyester and ethylene vinyl acetate was used. The backing layer is commercially available from 3M as ScotchPak 9732. The backing layer had a moisture vapor transmission rate of 15.5 g / m2 / 24 hours. The maxtix blend which included 7% by weight clonidine, 83% by weight of a non-functional, acrylic-based pressure sensitive adhesive (DuroTak 73-9301) and 10% by weight of a carboxy functional acrylic-based pressure sensitive adhesive (DuroTak 87-2852) was formed over the backing layer. The matrix was identical to that used in Examples 1 and 3. As can be seen in Table 3, the flux of the transdermal delivery device was 1.69 μg / cm2 / hr.

example 2

[0419] In Example 2, a backing layer comprising polyurethane and ethylene vinyl alcohol commercially available from J.P. Stevens Co. of East Hampton, Mass. was used. The backing layer had a moisture vapor transmission rate of 100 g / m2 / 24 hours. The maxtix blend which included 7% by weight clonidine, 83% by weight of a non-functional, acrylic-based pressure sensitive adhesive (DuroTak 73-9301) and 10% by weight of a carboxy functional acrylic-based pressure sensitive adhesive (DuroTak 87-2852) was formed over the backing layer. The matrix was identical to that used in Examples 1 and 3. As can be seen in Table 3, the flux of the transdermal delivery device was 0.93 μg / cm2 / hr.

example 3

[0420] In Example 3, a polyurethane backing layer commercially available from J.P. Stevens Co. of East Hampton, Mass. was used. The backing layer had a moisture vapor transmission rate of 1500 g / m2 / 24 hours. The maxtix blend included 7% by weight clonidine, 83% by weight of a non-functional, acrylic-based pressure sensitive adhesive (DuroTak 73-9301) and 10% by weight of a carboxy functional acrylic-based pressure sensitive adhesive (DuroTak 87-2852) was formed over the backing layer and was identical to that used in Examples 1 and 2. As can be seen in Table 3, the flux of the transdermal delivery device was 0.32 μg / cm2 / hr.

TABLE 3Backing MaterialMVTR (g / m2 / 24 hrs)Flux (μg / cm2 / hr)Example 1PET / EVA15.51.69Example 2PU / EVOH1000.93Example 3PU15000.32

[0421] The results from Examples 1 to 3 are set forth graphically in FIG. 2. As illustrated in the forgoing Examples and in FIG. 2, backing layers having a low water vapor transmission rates increase the flux of clonidine. As such, varying t...

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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...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K9/70
CPCA61K9/7061A61K31/4168A61P23/00A61P25/00A61P29/00A61P9/12A61K47/32A61K47/34A61K9/7053A61K9/7069
Inventor KANIOS, DAVIDMANTELLE, JUAN A.NGUYEN, VIET
Owner NOVEN PHARMA
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