Recent Options for Phase 1 Formulation Development and Clinical Trial Material Supply - Pharmaceutical Technology

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Recent Options for Phase 1 Formulation Development and Clinical Trial Material Supply
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.

Pharmaceutical Technology


The methods of active pharmaceutical ingredient in a capsule, drug in a bottle, liquid in a capsule, or multiple binary blends provide options for getting drug product into the clinic in a short period of time. Although not all the options are capable of reaching commercial scale, they are all capable of supporting early clinical studies and may be used as a path to an eventual commercial dosage form.


The author is thankful to Paul Skultety, director of pharmaceutical development services at Xcelience for final review.

Balaji V. Kadri is a manager of the preformulation and formulation-development department at Xcelience, 5415 West Laurel St., Tampa, FL 33647, tel. 813.286.0404, fax 813.286.1105,


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