B. Prasad, V. Kumar, H. Bhutani
Oct 1, 2008
Citations
1
Influential Citations
3
Citations
Journal
The Indian journal of tuberculosis
Abstract
BACKGROUND The present study was carried out to screen various ethambutol dihydrochloride (EB2HCI) bulk drug samples and anti-tuberculosis (anti-TB) products for the presence of less active (R,S)-EB2HCl. METHODOLOGY Samples of pure EB2HCl were received gratis from various companies and the formulations were procured from local market, and also from a Directly Observed Treatment Short-course (DOTS) centre. Some products available in the institute from Global Drug Facility were also included in the study. In total, 5 API samples and 35 formulations containing EB2HCI were investigated. These were subjected to evaluation for the presence of (R,S)-EB2HCl using a previously published differential scanning calorimetric method. The thermograms were recorded between 25 degrees C and 250 degrees C at a rate of 10 degrees C/min. RESULTS 1 API sample and 12 formulations were found to contain (R,S)-EB2HCI up to an extent of 30-100%. One of the DOTS centres supply was also found to contain approximately 97% of the less active isomer. CONCLUSION The presence of therapeutically inactive form of the EB2HCl from 30-100% in approximately 30% of the products in the local market is an alarming finding, which means low quality anti-TB products are in circulation. The same may be contributory to the developing resistance of the drugs against the mycobacterium.