Photostability and toxicity of finasteride, diclofenac and naproxen under simulating sunlight exposure: evaluation of the toxicity trend and of the packaging photoprotection

摘要

Background Drugs photostability plays two different opposite roles; a real advantage arises considering the longer expiration time of the drugs while the consequent persistence in the environment involves an obvious negative effect bound to their harmfulness. On this basis we tested the photostability and toxicity of three pharmaceutical active principles: Finasteride, Diclofenac and Naproxen. The pure active principles, as well as commercial drugs containing them, were considered; for the last, the protective effect of the packaging was also evaluated. Samples were irradiated according to the ICH Guidelines for photostability testing (The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use); a simulating sunlight source (a mercury-vapor lamp coupled to a tungsten filament one) was used to cover the wavelength range 300–2000 nm; Temperature, Relative Humidity, Irradiance and Illuminance were maintained constant during the photodegradation. The concentrations of the pharmaceutical active principles during the photodegradation were monitored by HPLC with UV/Vis detector. Toxicity tests were performed by means of an amperometric biosensor based on suspended yeast cells. Since the products obtained by the photodegradation process can result as toxic or more toxic than the original molecules, tests were performed first and after the photodegadation. Results After 90 hours of exposure the concentration resulted lowered by 42.9%, 88.4% and 91% for Finasteride, Naproxen and Diclofenac respectively. Toxicity of the pure active principles follows the same order of the photostability. After photodegradation a contribute of the reaction products was evidenced. Conclusions The simple and cheap analytical procedure here proposed, allowed to obtain not only data on photostability and toxicity of the pure active principles but, even if roughly, also useful information on the reactions kinetic and toxicity of the photodegradation products.