The evaluation of dynamic compaction analysis as a QbD tool for paediatric orodispersible mini tablet formulation

The formulation of orodispersible minitablets (ODMTs) usually targets the disintegration time and mechanical strength, but should also consider a series of technological issues related to powder flow and compression behaviour. In this regard, the present study aimed to evaluate the contribution of dynamic compaction analysis as Quality by Design (QbD) tool in ODMTs’ formulation. Placebo tablets were prepared by direct compression following a design of experiments (DoE). Each powder blend was subjected to dynamic compaction analysis; the work of compression, the elastic recovery, the detachment stress, the ejection stress as well as the disintegration time and crushing strength were determined.

The effects of input variables on the responses were quantified as regression models and two sets of constraints were applied for Design Space (DS) development: one regarding tablet characteristics and the second one including compression performance parameters. The DS was validated and the robust point and negative control were used to prepare ODMTs. Their characteristics confirmed the benefits of including the compression parameters into the early formulation stages of ODMTs.