TY - JOUR A1 - Jung, Nathalie A1 - Namjoshi, Sarika A1 - Mohammed, Yousuf A1 - Grice, Jeffrey E. A1 - Benson, Heather A. E. A1 - Raney, Sam G. A1 - Roberts, Michael S. A1 - Windbergs, Maike T1 - Application of Confocal Raman Microscopy for the Characterization of Topical Semisolid Formulations and their Penetration into Human Skin Ex Vivo T2 - Pharmaceutical research N2 - Purpose: The quality testing and approval procedure for most pharmaceutical products is a streamlined process with standardized procedures for the determination of critical quality attributes. However, the evaluation of semisolid dosage forms for topical drug delivery remains a challenging task. The work presented here highlights confocal Raman microscopy (CRM) as a valuable tool for the characterization of such products. Methods: CRM, a laser-based method, combining chemically-selective analysis and high resolution imaging, is used for the evaluation of different commercially available topical acyclovir creams. Results: We show that CRM enables the spatially resolved analysis of microstructural features of semisolid products and provides insights into drug distribution and polymorphic state as well as the composition and arrangement of excipients. Further, we explore how CRM can be used to monitor phase separation and to study skin penetration and the interaction with fresh and cryopreserved excised human skin tissue. Conclusion: This study presents a comprehensive overview and illustration of how CRM can facilitate several types of key analyses of semisolid topical formulations and of their interaction with their biological target site, illustrating that CRM is a useful tool for research, development as well as for quality testing in the pharmaceutical industry. KW - acyclovir KW - bioequivalence KW - confocal Raman microscopy KW - non-invasive imaging KW - skin delivery Y1 - 2022 UR - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/69588 UR - https://nbn-resolving.org/urn:nbn:de:hebis:30:3-695889 SN - 1573-904X N1 - Funding for this project was made possible, in part, by the Food and Drug Administration through grant U01FD005226-01. N1 - Open Access funding enabled and organized by Projekt DEAL. VL - 39 IS - 5 SP - 935 EP - 948 PB - Springer Science + Business Media B.V CY - Dordrecht [u.a.] ER -