The choice of suitable excipients is a base requirement in pharmaceutical manufacturing. For solid dosage forms, such excipients, as well as API, are powders that rarely show adequate properties for a direct employment in manufacturing. Therefore, powder processing is generally required. The long experience in powder processing has led to well-established techniques, such as milling, blending, drying, and filling, that however require continuous improvement to comply with the fast-growing automation and in-process control technologies. Moreover, standards and regulations have to evolve to keep pace with the technological progress. The future development of new manufacturing concepts will demand rethinking of traditional methods and particle engineering approaches.

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Powder and Particle-Dependent Traditional Manufacturing Processes (Unit Operations)

  • Anthony J. Hickey,
  • Stefano Giovagnoli

摘要

The choice of suitable excipients is a base requirement in pharmaceutical manufacturing. For solid dosage forms, such excipients, as well as API, are powders that rarely show adequate properties for a direct employment in manufacturing. Therefore, powder processing is generally required. The long experience in powder processing has led to well-established techniques, such as milling, blending, drying, and filling, that however require continuous improvement to comply with the fast-growing automation and in-process control technologies. Moreover, standards and regulations have to evolve to keep pace with the technological progress. The future development of new manufacturing concepts will demand rethinking of traditional methods and particle engineering approaches.