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NUTRA_32A-32L_Nutra 12/30/13 2:11 PM Page 32C January 2014 32C Tablets & Capsules tabletting Overcoming manufacturing challenges of nutraceutical tablets Rob Blanchard and Trevor Higgins I Holland Mass production of dietary supplements on a tablet press can pose manufacturing challenges unique to nutraceutical products. This article examines these special challenges and offers some tips to address them. N utraceuticals, vitamins, minerals, and other dietary supplements in tablet form may closely resemble their pharmaceutical counterparts, but manufacturing these products on a modern, high-speed tablet press can present some distinct challenges. Consider that the typical drug product contains one to four active pharmaceutical ingredients (APIs) and five or six excipients. Meanwhile, common multivitamin formulas contain up to 50 actives and two to eight excipients. Taking into account the size of tablet that can be comfortably swallowed, the sheer bulk of actives in a multivitamin limits the amount of excipients that can be used. Whereas a pharmaceutical tablet may consist of 10 to 30 percent API and 70 to 90 percent excipients, a nutra formulation comprising 70 to 90 percent actives allows little room for excipients. Multiple actives can introduce complications related to particle size, flow, compressibility, moisture sensitivity, ingredient interaction, and quality control (QC) testing. For example, some actives may consist of coarse granules, while others are fine powders; some may be hydrophilic and others hydrophobic. The ingredient blend may thus contain many different particle sizes and ingredients with diverse characteristics. In such cases, segregation and flow problems may arise, resulting in capping, sticking, mottling, and basic content uniformity problems. Furthermore, many natural ingredients tend to be unrefined, abrasive, corrosive, and/or hard (Figure 1). This can prematurely wear process equipment, especially the punches and dies that contact these aggressive mixtures. Since dietary supplements tend to be bulkier than drug products, they often require high compaction forces to bind the ingredients into a robust tablet, and the tabletting equipment is usually run at high speeds for long periods to satisfy industry demands for high output and low cost. This obviously compounds the stress and wear on tooling. Tooling remedies There are several ways to reduce the risk of damage to punches and dies from abrasion, corrosion, and impregnation by hard granules. The first step is to choose tooling