Issue link: https://www.e-digitaleditions.com/i/1218534
26 March 2020 Tablets & Capsules issues proper attention early in the program, downstream problems that were unapparent during early development can materialize during scale-up, potentially requiring a reformulation and undoubtedly causing costly delays. Pay attention to these well-known challenges and remain focused on mitigation strategies throughout development. Challenges during scale-up Consider the supply chain for the API and excipients as well as process scale-up early in the drug development process. Make sure to: 1. Design formulations and processes in the lab that are scalable beyond a few hundred grams. 2. Design processes and formulations during R&D with larger-scale equipment in mind for ease of scale-up. For example, if you prepare a binder solution by heating with a magnetic stirrer during development, determine how you will heat, safely handle, and stir 100 to 200 kilo- grams of solution at commercial scale. 3. Plan for the transition from R&D to commercial production by using equipment trains during develop- ment that match the equipment trains you'll be using for the larger-scale batches at the production facility. This will allow you to avoid performing tech transfers from one facility to another, which affects costs and timelines. Knowledge and broad experience can ensure that your process is feasible, safe, and cost-effective at a com- mercial scale. A CDMO with the knowledge, expertise, and equipment to successfully formulate and process a variety of complex and challenging APIs into immediate- or modified-release dosage forms can help successfully guide your program from R&D through regulatory filing and commercialization. T&C References 1. Sandeep Kalepu and Vijaykumar Nekkanti, "Insol- uble drug delivery strategies: Review of recent advances and business prospects," Acta Pharmaceutica Sinica B, 2015, Vol. 5, No. 5, pages 442-453. Neha Shah, PhD, is a scientist at Recro Gainesville, Gaines- ville, GA (770 531 8800, www.recrogainesville.com). The company provides oral solid dosage form development, clini- cal and commercial manufacturing, and packaging and logistics services to the global pharmaceutical market, spe- cializing in extended-release solid dosage forms and DEA-controlled substances.