API In Capsule Vs. The Lost Art Of Formulation DevelopmentSource: CoreRX, Inc.
By Todd Daviau, Ph.D
Very few businesses have as specialized a set of needs as those in the pharmaceutical sector. The combination of huge product development costs, large amounts of data and intense regulatory control makes it critical for companies to have needed information as soon as possible in order to meet a varied and closely monitored set of business processes.
Time is money – a fact well understood by those in the pharmaceutical industry, where developing a new product can take almost a decade and cost hundreds of millions of dollars. Avoidance of costly and time-consuming product development is, therefore, quite desirable for drug companies in the race to bring products to the marketplace before competition. API in capsule might then offer an appealing pathway alternative.
This route permits companies to obtain critical clinical trial data before the added expense of formulation development and in particular, excipient compatibility and process optimization experiments are performed.