Assessment of Drug Loss and Variation in Divided Weight after Dispensing a Pediatric Dose of E Keppra_® Dry Syrup 50%

Abstract

Adsorption of the new generation antiepileptic drug E Keppra_® dry syrup containing 50% levetiracetam to an automated dividing and packing machine was observed after dispensing by using the machine. We examined drug loss and variation in divided weight after dispensing a pediatric dose of the dry syrup. When 1.4 g of E Keppra_® dry syrup 50% was divided into 14 packs using an automated dividing and packing machine, the drug loss per pack was 10% - 27%. The high drug loss was observed during an early stage of packaging the dry syrup. Conversely, drug loss per pack was less than 10% when 7.0 g of the dry syrup was divided into 14 packs. The variation in divided weight in 1.4 g of the dry syrup was 2.3%, which was larger than the variation in 7.0 g of the dry syrup. The drug loss and variation in divided weight were observed under the following conditions: the dry syrup particles were less than the average particle diameter of 150 μm and the humidity was less than 50%. The drug loss during division was prevented by addition of a vehicle, such as lactose, to the dry syrup. These results indicate that using the machine to divide the E Keppra_® dry syrup 50% into low doses recommended for children gives rise to inaccurate dosing.