Headspace Packaging Testing Of Transdermal Patches

Transdermal patches are a common method for drug delivery. Transdermal patch delivery of drugs is a $25 billion market (2014) and is on its way to being a $40 billion market by 2018, with some 90 drugs in the pipeline that will utilize patches. The active ingredients are designed to be absorbed through the skin and are often very sensitive to oxidation and transmission out of the package. Small defects could render the active ingredient ineffective with some treatments offering extended hormone or pain treatment.

To defend against oxidation, air is often reduced in the package headspace by applying static charge to both sides of the sachet film, drawing the film closely together and eliminating headspace. This low amount of headspace makes the detection of defects challenging using certain methods. By deploying the VeriPac 410 at very low pressures the minute amount of headspace may be ‘activated’ expanding it to a level that allows for the air to be used for a vacuum decay test. The VeriPac 410 force decay technology affirms no large leaks.

Many transdermal patch manufacturers use a derivation of the blue dye test, and in a way that is very insensitive to defects and often completely ineffective at detection all together. More and more transdermal patch suppliers are recognizing this and opening up to new methodologies. PTI’s VeriPac 410 has succeeded at testing each transdermal format it has encountered.