Fujicalin® - Unique Spray Dried Carrier for Liquisolid Systems and Probiotic Tablets that Last 3 Years Introduction

Introduction Since the late 1950s and early 60’s, conventional calcium hydrogen phosphate has been widely used as the excipient for direct compression tabletting. However, the fi rst generation of calcium phosphates were hard and rough pillar-like crystals with crystal water, which often caused abrasiveness of punches and dies in tabletting. In addition, the crystal water could possibly be released during processing, and chemically interact with hydrolysable APIs, affecting their stabilities. With the advent of second generation dibasic calcium phosphate anhydrous (DCPA), the problem of abrasiveness of punches and dies reduced remarkably. However, conventional DCPAs and dibasic calcium phosphate dihydrates (DCPDs) do not provide much of advantages over other directly compressible excipients such as microcrystalline cellulose, mannitol, lactose, sucrose, maltose, and starch. Fujicalin®, a spraydried DCPA developed by Fuji Chemical Industry Co., Ltd. (Fuji) based in Toyama, Japan (www.fujichemical. co.jp/english), offers a new grade of DCPA with unique properties. Fujicalin® is produced by combining the restricted crystal growth synthesis technique to reduce crystal size and spray-drying granulation to make a spherical shape, which remarkably improves fl owability and compressibility in comparison to conventional DCPAs and DCPDs (Fig.1-2) [1-2]. Fujicalin® is an excellent carrier for liquisolid systems (up to 12% of Tocopherol acetate load) according to new studies conducted at the University of Hamburg. Other striking commercial application of Fujicalin® includes probiotic tablets that can be stored at room temperature for 3 years with normal bottle packaging.