Abstract
Considering the recent regulatory requirements, the overall importance of in vitro release testing (IVRT) methods regarding topical product development is undeniable, especially when addressing particulate systems. For each IVRT study, several hundreds of samples are generated. Therefore, developing rapid reversed-phase high-performance liquid chromatography (RP-HPLC) methods, able to provide a real-time drug analysis of IVRT samples, is a priority. In this study, eight topical complex drug products exhibiting distinct physicochemical profiles were considered. RP-HPLC methods were developed and fully validated. Chromatographic separations were achieved on a XBridgeTM C18 (5 µm particle size, 150 mm × 2.1 mm), or alternatively on a LiChrospher® 100 RP-18 (5 µm particle size, 125 mm × 4.6 mm) at 30 °C, under isocratic conditions using UV detection at specific wavelengths. According to the physicochemical characteristics of each drug, different mobile phases were selected. Irrespective of the drug (hydrocortisone, etofenamate, bifonazole, clotrimazole, acyclovir, tioconazole, clobetasol, and diclofenac) and formulation, retention time values did not exceed 6.5 min. All methods were linear, specific, precise, and accurate at the intraday and interday levels, robust, and stable. These were successfully applied to establish product-specific IVRT profiles, thus providing a key database useful for topical pharmaceutical manufacturers.
Highlights
The market of skin drug delivery is projected to expand over the five years [1,2]
Semisolid dosage forms intended for topical application enable prolonged in situ release, and for this reason are the preferred therapeutic vehicles when addressing topical conditions [3]
The present study aims to create a fully validated library of reversed-phase high-performance liquid chromatography (RP-HPLC) methods, directed to the real-time drug analysis of eight blockbuster topical drug products
Summary
The market of skin drug delivery is projected to expand over the five years [1,2] Such a trend may certainly be boosted by the increasingly growing relevance of nanotechnology-based products. A complete microstructure characterization in such circumstances should include pH, rheological profile, polymorphism, active pharmaceutical ingredients, and globule size determination, together with a detailed understanding of both release kinetics and permeation behavior. In this context, even though semisolid preparations are one of Processes 2020, 8, 397; doi:10.3390/pr8040397 www.mdpi.com/journal/processes
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