Properties of Fujicalin®, a New Modified Anhydrous Dibasic Calcium Phosphate for Direct Compression: Comparison with Dicalcium Phosphate Dihydrate

Abstract

The novel, commercially available, free-flowing spherically granulated dicalcium phosphate anhydrous (SGDCPA) Fujicalin for direct tableting was compared with directly compressible dicalcium phosphate dihydrate (DCPD), the properties of which are well known. The two excipients were investigated and compared with regard to their physical and powder properties, compressibility, and compactibility. As a consequence of the spherical shape of its particles, SGDCPA shows the same good flowability and even better compactibility. In contrast to DCPD, SGDCPA shows significant uptake of moisture when exposed to relative humidities (RHs) exceeding 70%. For both excipients, the main deformation mechanism is fragmentation, with SGDCPA yielding significantly stronger tablets.

Key Words:

• Dicalcium phosphate dihydrate
• Fujicalin
• Powder properties
• Spherically granulated dicalcium phosphate anhydrous
• Tablets