A SURVEY ON QUALITIES OF DRUGS COMMERCIALLY AVILABLE IN THAILAND

Abstract

In our programme on quality evaluation of generic drug products, over ten items of those commercially produced by local manufacturers were investigated for their in vitro qualities as compared to those of innovator’s using pharmacopeial methods.  On the basis of pharmacopeial specification, substandard qualities were found in 14 items out of 17.  For each generic drug, there is a great variation in qualities among different manufacturers.  All tested samples of all products pass the pharmacopeial standard with regard to weight variation and content uniformity.  Failure to meet the percent labelled amount limit was observed for spironolactone and ranitidine tablets.  An achievement in disintegration test was generally shown, though in the recent pharmacopeia, no requirement on disintegration was specified.  Failure to pass the dissolution specification was demonstrated in tablets of paracetamol, cimetidine, ranitidine, ibuprofen, spironolactone, naproxensodium, danazol, hydroxyzine, terfenadine, ketotifen, metronidazole, alprazolam, cotrimoxazole and ampicillin.  For drugs locally manufactured, their qualities on the basis of pharmacopeial requirement, still need improvement, particularly to enhance the dissolution property.