Zarmpi, Panagiota; Tsikritsis, D; Watson, A C; Vorng, J-L; Tyagi, V; Belsey, N A; Rantou, E; Ghosh, P; Bunge, A L; Woodman, T J; Delgado-Charro, M B; Guy, R H (2025) Raman spectroscopy as a tool to accelerate development of complex medicinal products. Journal of Controlled Release, 387. 114190 ISSN 01683659

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Abstract

Regulatory approval of complex generic drug products that are applied topically to treat skin disease can be challenging because a standard method to assess cutaneous pharmacokinetics in vivo is not available. As a result, expensive and prolonged clinical trials are often necessary, and this has proved to be a significant disincentive to generic product development and restrictive of patient access to more affordable medicines. Here, Raman spectroscopy is used to quantify the relative spatiotemporal disposition of metronidazole (a drug used to treat rosacea) within the skin and proximal to its site of pharmacological action. Analysis of the data permits pharmacokinetic metrics to be extracted and compared between different gel and solution formulations with the potential to establish bioequivalence and enable more efficient complex generic drug product development.

Item Type:	Article
Keywords:	Raman spectroscopy, Cutaneous pharmacokinetics, Topical drug bioavailability, Topical drug product bioequivalence, Regulatory scienc
Subjects:	Nanoscience > Surface and Nanoanalysis
Divisions:	Chemical & Biological Sciences
Identification number/DOI:	10.1016/j.jconrel.2025.114190
Last Modified:	15 May 2026 12:50
URI:	https://eprintspublications.npl.co.uk/id/eprint/10397