In recent months, microneedle patches have been making headlines as a potential future in drug delivery systems. Because only cosmetic microneedle patches are currently widely available and are not approved by the FDA, there is little information about the extractable profile of these devices. However, as these patches gain traction in the medical world, FDA regulation will require extractable evaluations on these devices. EKG Labs is ready for the challenge.
What is an extractable profile?
Extractables are substances in a device or product, potentially impacting its safety or efficacy, which can be forced out using certain solvents or stressed conditions. Regulatory bodies often require in-depth analytical investigations into the extractable profile of devices and products in order to get a full profile of the potential hazards associated with a medical product and to ensure patient and consumer safety.
Case Study, Overview:
EKG Labs performed an extractable evaluation on two brands of commercially available microneedle patch cosmetic devices. Brand A claims to hold themselves to FDA standards while Brand B is not sold in the United States but is available to purchase through online retailers. Testing was performed under the general guidance of ISO 10993-12. Patches were extracted at 37°C in both hexane (a nonpolar solvent) and ethanol (a polar solvent) alongside method controls. After extraction times of 24 hours, 48 hours, and 96 hours, sample and control extracts were analyzed via LC/MS and GC/MS. Additional nitric acid digestions were analyzed via ICP/MS. Finally, SEM imaging was performed on the samples.
Case Study, Part 1, SEM imaging:
The needles on these patches were observed via scanning electron microscopy (SEM). Brand A and Brand B had distinct physical characteristics. The needles in Brand A were conical and spaced 1000 µm apart while the Brand B needles were pyramidal, spaced 300 µm apart, and much smaller comparatively.
Brand A, pre-extraction:
Brand B, pre-extraction:
Case Study, Part 2, Heavy Metals:
From an ICP/MS scan of USP <232>/<233> elements of interest, no heavy metals were found above the control extraction levels. Additional elemental analysis was performed, and only zinc in Brand A and iron in Brand B were observed above quantitation limits and above the control extraction levels.
Stay tuned for the final update on this study, with LC/MS and GC/MS analysis.
About EKG Labs
EKG Labs performs thorough extractable and leachable testing for a variety of industries such as combination products, medical devices, pharmaceuticals, and consumer products. If you are experiencing a challenge with impurities or need analytical services to support your product development, please contact us at 810-354-5229 to find out how we can help you.
Our analytical services support regulatory filings, product development, and analytical chemistry investigations. Specialty analytical services include: extractables, leachables, characterization, impurity identification, method development, method validation, deformulation, and other investigational activities.