Issue link: https://www.e-digitaleditions.com/i/316458
B 22 May 2014 Tablets & Capsules multi-layer tablets The challenges of producing bi-layer tablets Robert Sedlock SMI The functions of single- and bi-layer tablet presses are similar, but bi-layer presses pose unique challenges. If you don't address them, you risk wasting material and extending formulation development and manufacturing times. This article describes some of the techniques and tools you can use to increase product yields, identify setup issues, and improve the process to get your product to market. i-layer tablets have become popular in the pharma- ceutical, dietary-supplement, and other industries. Advantages include their ability to control release, com- bine otherwise incompatible APIs and excipients, and dif- ferentiate brands. In controlled-release applications, for- mulators use novel techniques that take advantage of the functional properties of one layer to control the release of the other layer. Osmotic release is one example. Bi-layer tablets can also improve patient compliance by reducing the number of daily doses required and sim- plifying regimens. In fact, as the population skews older, more people will need more medicine so the future of bi- layer tablets grows brighter. But with the many advantages of multi-layered tablets comes the challenge of successfully producing them on the tablet press. While the principles of making bi-layers are similar to those of single-layer tablets, the operation requires more attention to detail. Examples of these chal- lenges include using the appropriate instrumentation to monitor and control force, keeping the APIs separated to avoid cross-contamination, and preventing excessive waste of material due to incorrect press setup. In many cases, a tablet press that produces bi-layers can be converted to produce single-layer tablets, which extends the return on your investment in the equipment. You can also set up the tablet press to produce bi-layers that comprise the same formulation, which enables you to achieve a higher-weight tablet than would be possible using a single-layer setup. A bi-layer tablet press g-Sedlockart_22-27_Masters 5/14/14 10:16 AM Page 22