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Abstract
Some drugs cause phototoxicity in humans when exposed to light, thus there is a need for an in vivo phototoxicity test to evaluate them. However, an in vivo phototoxicity test method to evaluate this has not been established. This study aimed to establish an in vivo phototoxicity test method for transdermally administered drugs. For this, we evaluated the phototoxicity using Sprague-Dawley (SD) rats for transdermal administered drugs and we studied the appropriate UVA dose using 8-methoxypsalen, which is a well-known phototoxic drug. We found that a UVA dose of 15 J/cm2 was dose and time dependent response compared to other UVA doses. We performed the Minimum Erythema Dose (MED) test because UVB can cause skin irritation by itself and selected 0.01 J/cm2 as an appropriate dose of UVB. Using the selected UVA and UVB doses, we performed a phototoxicity study of 6 pharmaceutical drugs, which included phototoxic and non-phototoxic drugs. As a result of the phototoxicity test, 100% accuracy was obtained when compared with previous studies. In addition, we performed histopathology to confirm the new findings. We found that histopathology can be used as an additional indicator of phototoxicity test for transdermally administered drugs.
Highlights
Sunlight is comprised of visible light, infrared light, and ultraviolet light, each with a different range of wavelengths
It was confirmed that the dose of irradiation that the phototoxicity is not induced by UVB is 0.01 J/cm2 is the Minimum Erythema Dose (MED) for UVB
This dose was used in the irradiation dose selection test and the phototoxicity test of transdermal administration were used
Summary
Sunlight is comprised of visible light, infrared light, and ultraviolet light, each with a different range of wavelengths. Ultraviolet light has a shorter wavelength than visible light, has high energy, and a strong chemical action. It can cause various phototoxic reactions, including acute reactions such as erythema on the skin, as well as chronic reactions such as photoaging. Phototoxicity is mainly induced by exposure of photoreactive chemicals to ultraviolet rays [1] These compounds are chemically activated by ultraviolet rays and bind to DNA in the cell nucleus, or. Chemicals such as psoralen, quinolonebased antibiotics, anti-inflammatory drugs, and antidepressants among pharmaceuticals are reported to induce phototoxicity. The demand for evaluation of the phototoxicity evaluation of drugs is increasing, and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has established the Photosafety Evaluation of Pharmaceuticals (ICH S10), which presents general
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