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Clarithromycin (CAM) dry syrup is widely used for pediatric infections and nine generic versions of this product are now available on the Japanese market.The purpose of this study was to compare the pharmaceutical quality and palatability of the original CAM dry syrup with the nine generic versions.The quality evaluation included assessments of uniformity based on particle size and dividing methods.The particles of each product were divided into four groups on the basis of particle size and the mean CAM content of each group was determined.With the original product,the content was almost 100% for every particle size group,but for several of the generic products,the content was not uniform between particle size groups.Uniformity was lower for products divided by hand than those divided by machine and for many of the generic products,content uniformity exceeded the evaluation standard (JP XV),especially in the case that they were divided by hand.In the evaluation of palatability which included the parameters of bitterness intensity (gustatory sensation test),ease of suspension and dispersion,and precipitation characteristics,for some generic products,the bitterness intensity increased over time.It was possible to achieve uniform suspension and dispersion for the original product but not for several of the generic products.As for precipitation characteristics,one of the generic products exhibited separation over time.

Quality Evaluation of Original Product and Generic Versions of Clarithromycin Dry Syrup