A research consortium from Bath University, the UK’s National Physical Laboratory (NPL) and Colorado School of Mines has been awarded $1.25 million funding from the US Food and Drug Administration to develop improved techniques to assess the performance of topically applied drug products.
Skin disorders such as eczema, acne and psoriasis are common, long-term conditions that often require frequent application of creams and lotions. And with skin diseases accounting for a third of all childhood disease, there’s an ongoing need for more effective topical drugs.
To develop such drugs requires accurate, reproducible and non-invasive methods for analysing topical drug delivery. Existing approaches, such as skin penetration tests, microdialysis and tape-stripping, can be time-consuming, expensive and technically challenging. Instead, the new project will employ state-of-the art imaging techniques to analyse how drugs interact with the skin in real time.
The five-year project brings together NPL’s specialists in advanced Raman spectroscopy and mass spectrometry imaging with leading experts in topical drug delivery and formulation, dermal pharmacokinetic modelling and skin bioavailability at Bath University and Colorado School of Mines.
“The project aims to develop and validate a novel and non-invasive application of Raman and mass spectroscopic techniques to evaluate the bioavailability of a topically applied drug in the skin,” explains Bath University’s Richard Guy. “The successful attainment of this objective will advance regulatory science and accelerate the route-to-market of new drug products.”
NPL will provide expertise in stimulated Raman spectroscopy – a non-invasive, accurate and sensitive tool used to determine the rate and extent at which a topically administered drug becomes available at its site of action within the skin. The method enables analysis of the drug and quantification of its transport across the skin in real time. One key challenge that the team aim to overcome is distinguishing the signal from the drug in the skin from background signals originating from the skin itself. Alongside, mass spectrometry imaging enables rigorous calibration and validation of the Raman results.
“Coherent Raman-based optical imaging methods enable non-invasive, real-time chemical measurements,” says Natalie Belsey, senior research scientist at NPL. “The mass spectrometry imaging capability at NPL brings major benefits of sensitivity and chemical specificity. In combination, these complementary spectroscopic imaging methods offer a powerful technology tool kit with which to asses and enhance the performance of formulated drug products.”
