Packaging meterials for transdermal drug delivery systems

Abstract

Compositions and methods for producing laminate materials in packaging a transdermal drug delivery system comprising a rubber modified acrylonitrile methyl acrylate copolymer film, alone or in combination with a polyester film, wherein the active drug incorporated in the transdermal system remains substantially solubilized and stable in the system during storage prior to use. The packaging laminate is preferably translucent to allow visual inspection of its contents, and has sufficient tear resistance to substantially provide child resistant and / or proof properties.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application is a continuation of U.S. patent application Ser. No. 10 / 751,587, filed Jan. 5, 2004, which is a continuation-in-part application of U.S. patent application Ser. No. 09 / 804,926, filed Mar. 13, 2001, which is expressly incorporated by reference in its entirety, and which claims the benefit of U.S. Provisional Application Ser. No. 60 / 189,333 filed Mar. 14, 2000, which is expressly incorporated by reference in its entirety.BACKGROUND OF THE INVENTION [0002] This invention relates generally to packaging materials for transdermal drug delivery systems and, more particularly, to materials and methods of providing transdermal system packaging that improves stability and shelf-life of the drug during storage. [0003] The use of transdermal drug delivery systems or “patches” as a means to topically administer a drug is well known. Such systems incorporate the drug into a carrier composition, such as a polymeric and / or pressure-se...

AI Technical Summary

Benefits of technology

[0019] It is therefore an object of this invention to provide a packaging material for a transdermal drug delivery system that improves stability and shelf-life.

[0020] It is therefore another object of this invention to provide a packaging material for a transdermal system that will not significantly react with or degrade the drug or other components of the system, and further protect the system from degradation by environmental factors such as water, air and / or light, during storage of the system prior to use.

[0021] It is also an object of this invention to provide a packaging material for a transdermal system that improves the stability of chiral drugs and active enantiomers thereof contained in a transdermal system during its storage prior to use.

[0022] It is a further object of this invention to provide a packaging material in the form of a laminate that increases the stability and shelf-life of a transdermal system, and has increased tear resistance such that it can be constructed into a substantially child resistant and / or proof pouch.

[0024] It is additionally an object of this invention to provide a method for making a pouch from laminate materials that provide improved stability and tear resistant properties, and. permit visual inspection of the pouch contents.

Problems solved by technology

However, it has been found that the functionality of these adhesives can significantly affect the drug's solubility in the carrier compositions, thereby altering drug flux upon application to the user.

However, certain enhancers may react with drugs to cause their degradation into by-products that can interfere with drug penetration and delivery.

It is also well known that common environmental factors such as the presence of water (in liquid or vapor form), air and / or light can also adversely affect the stability of some drugs.

Such environmental factors can also affect the solubility of the drug in the carrier composition which in turn can also significantly impact the storage stability or shelf-life of the transdermal system.

U.S. Pat. No. 5,008,110 discloses that certain polyolefin materials used for transdermal devices tend to absorb lipophilic solvents and / or enhancers, which can significantly decrease the drug's solubility in the carrier composition, as well as cause physical failure of the packaging material.

U.S. Pat. No. 4,943,435 discloses that nicotine will adversely affect many common transdermal system component materials such as adhesives, membranes, backings and release liners.

It has been unexpectedly discovered that methylphenidate can be unstable and lost by absorption in the presence of certain types of packaging materials used for transdermal systems.

Furthermore, optical purity is important since certain isomers may actually be deleterious rather than simply inert.

Images