Issue link: https://www.e-digitaleditions.com/i/276262
P 18 March 2014 Tablets & Capsules formulation QbD and co-processed excipients: A low-risk alternative to API-in-capsule for expediting first-in-human studies Adam Lambert CoreRx Pharmaceutical companies are struggling to do more with less, and as resources diminish, patents expire, and competition increases, companies are striving to reach critical drug develop- ment milestones faster despite the chemical and physical chal- lenges of the active pharmaceutical ingredient (API) candidate. This article outlines why opting to fill capsules with neat API to speed development of clinical supplies may not, in fact, be the most expeditious approach. lacing neat API in a capsule is a common approach to manufacturing Phase I supplies. In some cases, API-in- capsule shortens overall development by as much as 6 months because it reduces or eliminates time spent on formulation, analytical development, and stability testing. Developing placebos is also simple, and many pharma- ceutical companies see it as a quick-fix option for meeting aggressive Phase I start dates. But there are trade-offs. While the API-in-capsule approach may save time and get your candidate API into clinical studies sooner, it doesn't eliminate the need to develop a formulation or optimize the manufacturing process. It is therefore critical to weigh the impact of API-in-capsule on your overall development plan— including its timeline and cost—versus using a formulated product in early studies. Table 1 lists the advantages and disadvantages of the API-in-capsule approach. Table 1 Pros and cons of the neat API-in-capsule approach Advantages Disadvantages Short manufacturing time Higher overall drug development costs Minimal need to characterize API Longer overall development time Suitable when API is scarce Need to develop matching placebo Taste-masking unnecessary Unsuitable for all APIs Minimal need for analytical development Possible incompatibility with capsule material d-Lambertart_18-21_Masters 3/5/14 10:06 AM Page 18