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Tablets & Capsules March 2018 37 requirements of a defined population group and when the combination has a proven advantage over single compounds administered separately in therapeutic effect, safety, or compliance. FDCs provide greater convenience and can increase patient compliance because they require patients to take fewer doses [1]. FDCs can be particularly beneficial when used to treat life-threatening diseases such as HIV/AIDS, diabetes, or cardiovascular disease, where a single drug targeting a specific receptor is not considered optimal. For instance, in the case of cardiovascular disease, a combination of antihypertensive and antihyperlipidemic drugs is more beneficial for patients than taking the individual drugs separately because it reduces multiple risk factors without increasing the risk of adverse effects [2]. Similarly, in the case of HIV, an FDC prevents viral drug resistance by decreasing the level of viral replication and raising the barrier to resistance development [3]. An FDC can also improve an API's bioavailability by combining the API with a drug-metabolizing enzyme inhibitor. The FDA has encouraged FDC development, as evidenced by the number of FDC products the agency has approved. From 1990 through 2013, the FDA approved 131 FDC products (an average of 5.7 per year). The largest number of these targeted indications related to cardiovascular disease, followed by endocrinology and infectious diseases. Of the 131 approved FDCs, 98 were oral dosage forms. Between 2010 and the end of 2015, 63 of the 655 new drug applications (NDAs) approved by the FDA were for FDCs [4]. This represents nearly 10 percent of the NDAs approved during that 5-year period—an average of 12.6 new FDC products per year. Photo 1: The granular or powder material making up the two layers in a bilayer tablet should have similar physical properties, including particle size distribution, bulk density, and flow characteristics. Aside from the approval status of the APIs to be combined, the primary consideration when developing an FDC is the development strategy. Allendale, New Jersey Óä£ÈÓnÓääÊUÊÜÜÜ°À>iiÀÕðV `Ài°*iÌÀVJÀ>iiÀÕðV For 35 YEARS the pharmaceutical industry has relied upon ÀBiÀ to de-dust, de-burr and convey tablets with the highest efficiency. To learn more about how to *,"6 the EFFICIENCY of your tableting lines contact Kraemer U.S. Tablet de-dusting solutions from the Global Leader