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

نویسندگان

  • Francesca Baratta
  • Antonio Germano
  • Paola Brusa
چکیده

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.

برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید

ثبت نام

اگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید

منابع مشابه

Accelerated Stability and Chemical Kinetics of Ethanol Extracts of Fruit of Piper sarmentosum Using High Performance Liquid Chromatography

The extracts of Piper sarmentosum, a medicinal plant, are being used to prepare phytopharmaceuticals while the information about chemical kinetics of constituents of the extract is unavailable to assign precise shelf life (t90) and find optimum storage conditions of the product for patient safety, and to avoid economic repercussions of launching an unstable product. The extract was exposed to t...

متن کامل

Accelerated Stability and Chemical Kinetics of Ethanol Extracts of Fruit of Piper sarmentosum Using High Performance Liquid Chromatography

The extracts of Piper sarmentosum, a medicinal plant, are being used to prepare phytopharmaceuticals while the information about chemical kinetics of constituents of the extract is unavailable to assign precise shelf life (t90) and find optimum storage conditions of the product for patient safety, and to avoid economic repercussions of launching an unstable product. The extract was exposed to t...

متن کامل

EVALUATION OF PEG 4000 SOLUTION STABILITY IN DIFFERENT TEMPERATURES AND ENVIRONMENTAL CONDITIONS OVER THE TWELVE MONTHS

Background & Aims: Polyethylene glycol (PEG) solution is used as a laxative for the treatment of constipation in children. Due to the preparation of this solution as a compounding ingredient and solution instability as well as unavailability of the exact expiration date of compounding ingredients, it is necessary and important to investigate the stability of PEG solution. Materials & Methods: ...

متن کامل

تغییرات میزان گلیکوآلکالوییدکل و آلفاسولانین در سیب‌زمینی در طول نگه‌داری و فرایند حرارتی

Three potato cultivars (Solanum tuberosum L.), spring Marfona, autumn Cosima and Marfona, obtained from Isfahan Province, were stored under different conditions: 4oC, darkness 12oC, fluorescent light room temperature, darkness and room temperature, daylight. Relative humidity of the above stores was 85 to 90%. Analyses were carried out to determine total glycoalkaloids, α-solanine, specific gra...

متن کامل

تغییرات میزان گلیکوآلکالوییدکل و آلفاسولانین در سیب‌زمینی در طول نگه‌داری و فرایند حرارتی

Three potato cultivars (Solanum tuberosum L.), spring Marfona, autumn Cosima and Marfona, obtained from Isfahan Province, were stored under different conditions: 4oC, darkness 12oC, fluorescent light room temperature, darkness and room temperature, daylight. Relative humidity of the above stores was 85 to 90%. Analyses were carried out to determine total glycoalkaloids, α-solanine, specific gra...

متن کامل

ذخیره در منابع من


  با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید

برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید

ثبت نام

اگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید

عنوان ژورنال:

دوره 53  شماره 

صفحات  -

تاریخ انتشار 2012