Diffusion of counterfeit drugs in developing countries and stability of galenics stored for months under different conditions of temperature and relative humidity

摘要

Aim To investigate the diffusion of counterfeit medicinesin developing countries and to verify the stability of galenicdosage forms to determine the stability of galenicsprepared and stored in developing countries.Methods We purchased 221 pharmaceutical samples belongingto different therapeutic classes both in authorizedand illegal pharmacies and subjected them to EuropeanPharmacopoeia, 7th ed. quality tests. An UV-visible spectrophotometricassay was used to determine the galenicsstability under different conditions of temperature (T) andrelative 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 testeddosage forms were stable for 24 months under “standard”(t = 25 ± 2°C, RH = 50 ± 5%) conditions. Under “accelerated”(t = 40 ± 2°C, RH = 50 ± 5%) conditions, samples were stablefor 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 intropical countries and could so supply precious informationon the expected stability of galenics in tropical countries.Conclusion This study gives useful information about thepresence of counterfeit medicinal products in the pharmaciesof many developing countries. This should serve as analarm bell and an input for the production of galenics. Werecommend setting up of galenic laboratories in developingcountries around the globe