Izvorni znanstveni članak
Diffusion of counterfeit drugs in developing countries and stability of galenics stored for months under different conditions of temperature and relative humidity
Francesca Baratta
; Department of Science and Technology of Drug, Pharmacy Faculty, University of Turin, Torino Italy
Antonio Germano
; Aid Progress Pharmacist Agreement, San Gillio, Italy
Paola Brusa
; Department of Science and Technology of Drug, Pharmacy Faculty, University of Turin, Torino Italy
Sažetak
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°C, RH = 50 ± 5%) conditions. Under “accelerated”
(t = 40 ± 2°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
Ključne riječi
Hrčak ID:
83881
URI
Datum izdavanja:
15.4.2012.
Posjeta: 1.435 *