The Performance of PROSOLV® EASYtab SP in Four Medium-Dose, Direct Compression Formulations with Morphologically Challenging Model APIs

In the present study, the performance of PROSOLV® EASYt ab 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 formulations
tested.

Introduction

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 often 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 formulation.

For the purpose of this study, four medium-dose formulations of APIs were selected, each of which presented its individual morphological challenge. (See overview in Table 1)

Table 1: Properties of selected model APIs

In each case, the functional performance of the PROSOLV® EASYtab SP formulations were compared to simple dry blends of the individual components. Parameters measured in this study were: Compaction force, ejection force, tablet disintegration time, content and weight uniformity as well as API dissolution. PROSOLV® EASYtab SP formulations
were simply blended with the API for 18 minutes. For the physical blends, the API was blended with microcrystalline cellulose, sodium starch glycolate, and silicon dioxide for 15 minutes. Sodium stearyl fumarate was then added and blended for an additional three minutes.

See the study results in the PROSOLV^® EASYtab SP technical information:

Download the full technical information on PROSOLV EASYtab SP with a click on the picture or here: Technical_Info_The_Performance_of_PROSOLV_EASYtab_SP__