The Use of EMDEX® in a Lactose-free Reformulation of Cetirizine Tablets

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.

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