Issue link: https://www.e-digitaleditions.com/i/492796
I 18 April 2015 Tablets & Capsules coating Layering an API onto tablets using a perforated-drum coater: A case study Vasant Shetty, Sameer Borate, Anuprita Landge, and Shweta Suman ACG Pharma Technologies Controlling weight gain is an important factor when applying any coating, but it becomes absolutely critical when the coating contains an API. This article presents a case study that identi- fies the critical process parameters for developing a consistent and robust coating process that provides in-range results. low-dose drug products, although manufacturing high- dose products is simpler because content uniformity across the batch is less of an issue. In the case of low-dose products, process optimization becomes critical to ensure quality and consistency. The two major factors are machine design and controlling the process parameters that most influence the quality of the finished product. Key aspects of machine design Baffle design, mixing pattern, spray pattern, spray con- sistency, drying efficiency, turbulence in the coating zone, temperature consistency, airflow, and differential pressure are among the factors that affect the quality of the finished product. But baffle design, spray pattern, and airflow pattern are three that have a major effect on the coating process. Baffles. Many types of baffles are available, including tubular, ploughshare, rabbit ear, shark fin, spiral, and nnovators continue to seek drug products that can deliver multiple active pharmaceutical ingredients (APIs) in a single tablet or capsule. Among the approaches used are biphasic tablets, multi-particulate tablets, and con- trolled-release matrix systems. Applying an API in layers over placebo tablets or over tablets that include an API are other approaches. The latter method—which can employ an aqueous or non-aqueous coating—enables formulators to combine incompatible APIs into a single dosage form [1, 2]. API layering can also be used to overcome patent restrictions and is suitable for manufacturing high- and