White Paper: Recent Options For Phase I Formulation Development And Clinical Trial Material Supply

By Balaji V. Kadri, Xcelience

Pharmaceutical companies are challenged with choosing a dosage form that will reach clinical studies quickly and that can be made using a cost-effective process. To meet the demands of early-stage development, contract research organizations can evaluate various dosage-form options. The author examines various methods of capsule filling, including binary blends.

Large and small pharmaceutical companies as well as emerging companies that may operate as virtual companies strive to shorten drug-development times. The ability to hasten drug development is particularly important for virtual pharmaceutical companies, which focus on drug discovery and development but rely heavily on outsourced services to perform the functions necessary to move a drug through development to commercial manufacture. The ability of these companies to stay competitive depends on transforming new chemical entities into clinical products. The increase in the number of virtual companies has resulted in enormous investments in investigational new drugs. The active pharmaceutical ingredients (APIs) coming out of synthesis are challenging formulators’ abilities to develop dosage forms.