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.
Cancel
Show Policy

Latest Resources

See all resources