Spray-dried composite particles of erythritol and porous silica for orally disintegrating tablets prepared by direct tableting

• Spray-dried fine composite particles show strong binding force in tablets.
• Addition of composite particles increased tensile strength of untreated erythritol.
• Erythritol/porous silica (2/1) was best in enhancing the tensile strength of tablets.
• Sufficient orally disintegrating tablet was obtained with composite particle.

This study investigated the preparation of orally disintegrating tablets (ODTs), which were prepared from spray-dried composite particles (CPs) of erythritol and porous silica (Sylysia 350) by direct tableting. Powder X-ray diffraction and differential scanning calorimetry indicated that erythritol was embedded in silica pores and remained in the crystalline state. CPs containing erythritol/porous silica ratios of 1:1, 2:1, and 3:1 showed excellent compactability resulting from strong binding properties. Although erythritol powder has poor compactability and caused problems during tableting, adding a small amount of CPs to erythritol improved tablet hardness. CPs containing an erythritol:porous silica ratio of 2:1 most effectively improved erythritol compactability. Erythritol powder containing CPs showed higher deformability than that of physical mixtures, and CPs inhibited elastic recovery after compression because of strong interparticulate bonding. Furthermore, CPs retained function as dry binders when stored under humid conditions. Placebo ODTs prepared with CPs (erythritol:porous silica ratios of 1:1, 2:1, and 3:1) and crospovidone (Kollidon® CL) as a disintegrant showed both excellent tablet hardness and rapid disintegration. We confirmed that the use of CPs improved manufacturing of ODTs containing active pharmaceutical ingredients using an appropriate compression pressure.

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