Dataset Information

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

ABSTRACT:

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.

SUBMITTER: Sammartino MP

PROVIDER: S-EPMC3881013 | biostudies-literature | 2013 Dec

REPOSITORIES: biostudies-literature

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Publications

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

Sammartino Maria Pia MP Castrucci Mauro M Ruiu Daniele D Visco Giovanni G Campanella Luigi L

Chemistry Central journal 20131210 1

<h4>Background</h4>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 th ...[more]

PMID: 24325844

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Project description:Drugs incorporated into hair are exposed to the environment, and cosmetic and chemical treatments, with possible decreases in their content. Knowledge concerning the effect of sunlight on drug content in hair can be helpful to forensic toxicologists, in particular, when investigating drug concentrations above or below pre-determined cut-offs. Twenty authentic positive hair samples were selected which had previously tested positive for amphetamines and/or ketamine. Washed hair were divided into two identical strands, with the former exposed at 765 W/m² (300?800 nm spectrum of irradiance) for 48 h in a solar simulator, and the latter kept in the dark. Hair samples were extracted and analyzed by liquid chromatography high-resolution mass spectrometry detection. The percentage of photodegradation was calculated for each analyte (i.e., amphetamine, methamphetamine, methylendioxyamphetamine, ketamine, and norketamine). In parallel, photodegradation processes of standard molecules dissolved in aqueous and organic solutions were studied. In 20 hair samples positive for the targeted analytes, exposure to artificial sunlight induced an appreciable decrease in drug concentrations. The concentration ranges in the non-irradiated hair samples were 0.01?24 ng/mg, and 65% of samples exhibited a decrease in post-irradiation samples, with reduction from 3% to 100%. When more drugs were present in the same hair sample (i.e., MDMA and ketamine) the degradation yields were compound dependent. A degradation product induced by irradiation of ketamine in aqueous and methanol solutions was identified; it was also found to be present in a true positive hair sample after irradiation. Ketamine, amphetamines, and their metabolites incorporated in the hair of drug users undergo degradation when irradiated by artificial sunlight. Only for ketamine was a photoproduct identified in irradiated standard solutions and in true positive irradiated hair. When decisional cut-offs are applied to hair analysis, photodegradation must be taken into account since sunlight may produce false negative results. Moreover, new markers could be investigated as evidence of illicit drug use.

Dataset Information

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

Background

Results

Conclusions

Publications

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

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