Diffusion of counterfeit drugs in developing countries and stability of galenics stored for months under different conditions of temperature and relative humidity.
AIM: To investigate the diffusion of counterfeit medicines in developing countries and to verify the stability of galenic dosage forms to determine the stability of galenics prepared and stored in developing countries. METHODS: We purchased 221 pharmaceutical samples belonging to different therapeutic classes both in authorized and illegal pharmacies and subjected them to European Pharmacopoeia, 7th ed. quality tests. An UV-visible spectrophotometric assay was used to determine the galenics stability under different conditions of temperature (T) and relative humidity (RH). RESULTS: A substantial percentage of samples was substandard (52%) and thus had to be considered as counterfeit. Stability tests for galenics showed that the tested dosage forms were stable for 24 months under "standard" (t=25+/-2 degrees C, RH=50+/-5%) conditions. Under "accelerated" (t=40+/-2 degrees C, RH=50+/-5%) conditions, samples were stable for 3 months provided that they were stored in glass containers. Stability results of samples stored in "accelerated" conditions were similar to those obtained by on site in tropical countries and could so supply precious information on the expected stability of galenics in tropical countries. CONCLUSION: This study gives useful information about the presence of counterfeit medicinal products in the pharmacies of many developing countries. This should serve as an alarm bell and an input for the production of galenics. We recommend setting up of galenic laboratories in developing countries around the globe. (+info)
Determination of local anesthetics in illegal products using HPLC method with amperometric detection.
An HPLC method with amperometric detection was developed for analysis of two local anesthetics (lidocaine and benzocaine) in products for delaying ejaculation illegally marketed in Polish sex shops. Chromatographic elution on an RP column C18 with mobile phase composed of acetate buffer with acetonitrile, provides an optimal separation not only of active substances but also electroactive preservatives which are occasionally added to cosmetic creams (methylparaben and propylparaben). Application of glassy carbon electrode as a working electrode and a procedure with pulsed potential waveforms enables a sensitive, accurate measurement within a relatively short analysis time (250 s). This method has been successfully employed for the determination of local anesthetics in products under investigation. The obtained results show that most samples contained therapeutic concentrations of lidocaine or benzocaine. According to European law, a sale of products containing lidocaine or benzocaine outside the pharmacy sector is forbidden. (+info)