Evaluation of Lactose Excipients in the Standard Formulation for Direct Tableting Processes

Abstract

Direct tableting is the easiest method of pharmaceutical compacting processes. The standard formulation, defined in the lactose/corn starch in a 7/3 mixture with 20% binder, was adopted in this process. Four direct compression lactose powders, DCL11, DCL14, Lactopress Spray-dried, Dilactose S, were examined as a lactose in this formulation. Acetaminophen (drug content 1%) was used as a model drug.
The bulk density of lactose powders were higher than that of mixtures with other excipients. On the other hand, the tap density of mixtures was much higher than that of lactose. The four lactose mixtures showed the same level of flowability in spite of the differences in flowability of the bulk lactose powders. The shearing property of these powders was also measured in order to evaluate the flowability. The tablets from these mixtures had a low friability (<0.5%), a high hardness (>90N) and a short disintegration time (<220s).