29. Jan 2016
Spray-dried lactose is widely used as filler and binder in the pharmaceutical industry, but many adults are not able to digest lactose. Therefore, it is indispensable to provide alternatives to lactose-containing drugs in order to make them suitable for lactose intolerant patients. EMDEX® is a promising substitute for spray-dried lactose as it has similar powder and tableting properties. The aim of this study was to test a lactose-free reformulation of cetirizine tablets. EMDEX® was used successfully as a lactose substitute in cetirizine tablets resulting in comparable tablet properties in terms of crushing strength, disintegration time and dissolution profile. Furthermore, the EMDEX® formulation was characterized by an excellent powder flow and low ejection forces during the tableting process.