Investigation of the Photoprotective Effects of Various Pigments Against Laser-Marking of Pharmaceutical Tablets

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Abstract
Background/Objectives: With the increasing incidence of drug counterfeiting and the emergence of personalized medicine, the need for unique marking of solid dosage forms, e.g., tablets, has attracted considerable interest in the current research and development landscape. Besides traditional printing methods, laser marking offers several advantages, as it eliminates the need for organic solvents and enables the generation of precise patterns. However, laser exposure may raise safety concerns regarding the stability of photosensitive drugs in the irradiated dosage forms. Therefore, the aim of the present study was to test the photoprotective effect of titanium dioxide (TiO2) and its various alternatives, e.g., talc, calcium carbonate (CaCO3), zinc oxide (ZnO), and black iron oxide (Fe3O4), alongside a ready-to-use reference formulation, Opadry® Brown, which contains TiO2 (titanium-containing, TC) on nifedipine, a light-sensitive model drug. Methods: Laser marking or short-term laser ablation at different wavelengths (193 nm, 248 nm, 532 nm, and 781 nm) was applied to different coating formulations. As a positive control, prolonged exposure to daylight was applied. The properties and photostability of these formulations were evaluated using several analytical methods (i.e., surface profilometry, Raman spectroscopy, and high-performance liquid chromatography (HPLC)). Results: The TiO2, ZnO, Fe3O4, and Opadry® TC Brown coatings maintained their color during the long-term study under all conditions. Furthermore, the prepared formulations exhibited different ablation depths and morphological changes depending on the coating and laser type. HPLC measurements confirmed significant differences in the protective ability of various pigments against sunlight and different types of lasers. Nevertheless, the obtained Raman spectra were not in complete agreement with HPLC results, which can be attributed to spectral overlap between key nifedipine degradation markers and excipient signals in the tablet core. Conclusions: Overall, laser treatment of tablets containing photosensitive drugs may induce API decomposition; however, this effect can be minimized or avoided by careful selection of the appropriate combination of laser type and photoprotective pigment. Under the applied experimental conditions, Ti:Sa laser treatment was associated with the lowest degree of nifedipine degradation among all formulations, while ZnO-containing coatings demonstrated the most consistent photoprotective performance against the majority of the tested laser types, while Fe3O4-containing coatings provided superior protection during prolonged sunlight exposure and Nd:YAG laser irradiation.
Funding Information
  • Ministry of Culture and Innovation of Hungary from the National Research, Development and Innovation Fund (TKP2021-EGA)
  • University of Szeged OA Fund (8760)

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