A transdermal patch or drug delivery system is a medicated adhesive patch placed on the skin to deliver a specific dose of medication through the skin and into the bloodstream. Transdermal patches deliver a wide range of drug products from painkillers and hormone therapy to demetia and angina treatment. The laminated patch structure provides stability on the skin and releases the drug at a pre-determined rate.

Reducing the risk to patient safety 

Whist transdermal delivery is now very common, from a patient safety perspective it poses a number of challenges. Guidance from the FDA for transdermal ointments and patches emphasises a high degree of concern associated with route of administration and a high likelihood of packaging component dosage form interaction. Patch-based products are typically complex and multi-layered; ointment tubes use a variety of materials and components. This puts a high priority on extractables and leachables testing of both primary and secondary packaging for these drug products.

How Smithers can help

  • Materials: Expert support with selection, characterization and compatibility
  • Compliance: Testing to help you demonstrate regulatory with FDA, MHRA, EMA, USP and ISO as well as BPOG and PQRI guidelines.
  • Extractables and Leachables: extensive expertize in controlled extraction studies, identification of extractables and leachable profile assessments.
  • Device Testing: From testing container closure to connection compatibility, we test devices to ensure they perform as designed and meet relevant regulations.
  • Transit studies: Simulated distribution testing to recreate supply chain condition faced by your device.
  • Product simulation studies: Combination of testing studies to simuate real life usage of your device and the impact this might have on patient safety through its lifetime.