In the present study, the performance of PROSOLV® EASYtab SP was tested in four DC formulations with different model APIs. Each of the selected APIs presented a particular challenge in terms of producing tablets with suitable hardness, weight uniformity, content uniformity and/or reliable dissolution profiles. PROSOLV® EASYtab SP was shown to perform considerably better than the corresponding physical mixture of its components for all formu- lations tested.
PROSOLV® EASYtab SP is a ready-to-use tablet excipient composite, comprised of microcrystalline cellulose as filler/binder, colloidal silicon dioxide as flow aid, sodium starch glycolate as disintegrant and sodium stearyl fumarate as lubricant. PROSOLV® EASYtab SP is specifically designed for use in direct compression. In direct compression formulations, the active ingredient can of- ten present challenges in terms of achieving powder blends with decent flowability, compactability and homogeneity. These problems can cause insufficient tablet hardness, poor weight and/or content uniformity and inconsistent drug release. The impact of adverse API properties grows with increasing concentration in the formu- lation. For the purpose of this study, four medium-dose formula- tions of APIs were selected, each of which presented its individual morphological challenge. (See overview in Table 1)