White Paper | Extractables & Leachables Strategies for Printed Container Closures such as Transdermal Patch Products

Inks, coatings and adhesives are frequently used for construction of multi-layer container closure systems such as transdermal patch products. Potential species migrating from printing inks, coatings and adhesives include UV photo-initiators, mineral oils, and resins. There is no single analytical method that can detect all possible ink or coating components due to their different physicochemical properties and so a strategic approach to extractable studies must be adopted.

In this application note, our expert, Dr Tino Otte, Senior Scientific Consultant, describes a study scheme that meets the requirements of current extractables and leachables guidelines to ensure a safe transdermal delivery product which presents a high risk of migration due to likely interaction between the surfaces and the combination of different functional layers. An example is included of ink-related unexpected leachables from printed container closure system after migration through multiple polymer layers.

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