Issue link: https://www.e-digitaleditions.com/i/845331
T 18 July 2017 Tablets & Capsules formulation Control strategy considerations during formulation and process development Robert J. Timko RhoTau Pharma Services Control strategy is a key element of drug product development. For tablets and capsules, it involves understanding the product and process development and the relationships among the mate- rials, equipment, process, and facility attributes. While creating a design space may be optional, a control strategy is required regardless of whether you undertake a traditional or Quality- by-Design approach to development. ablets and capsules have long been the primary plat- forms for reliable delivery of safe, efficacious pharmaceu- tical products. Compressed tablets originated in England in the early 1840s, and the use of capsules can be traced back to the early 18th century. Given that history, one would expect that the scientists who develop these solid dosage forms and specify how to manufacture them would have a good understanding of the important qual- ity attributes that are required to ensure a commercially viable product.