Issue link: https://www.e-digitaleditions.com/i/1000772
12 July 2018 Tablets & Capsules S The question almost always comes up when my clients are investigating small-molecule APIs, because some individuals, such as financial backers, often believe that using API powder in a bottle or capsule can reduce the amount of time required to complete clinical Phase I human studies. The perceived advantage of using API powder in a bottle or capsule is speed. Time is money, and you can very quickly prepare the few hundred bottles or capsules to cover supplies for clinical Phase I and the necessary supporting stability studies. You might save three or four months for a Biopharmaceutical Classification System (BCS) I drug candidate. But how many modern drug This article discusses the risks associated with dosing active pharmaceutical ingredient (API) powder in a bottle or capsule for clinical Phase I studies. ometimes simple dosing with API powder in a bottle or capsule for a clinical Phase I study can be acceptable, and it may be quicker to use API powder in either a capsule or a bottle than to develop a formulation. However, use of such an approach is not always appropriate and may not be quicker in the long run. If you get it wrong, you can cause considerable delay to your project, which most often means that it is dead in the water. Using API powder in a bottle or capsule for clinical Phase I studies Chris Moreton FinnBrit Consulting formulation