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Building Quality into the Manufacture of Powder Inhalation Systems

Rantanen J, Savolainen M.

RDD Europe 2009. Volume 1, 2009: 63-72.

Abstract:

The advent of Quality by Design (QbD) and the Process Analytical Technology (PAT) initiative has provided an opportunity for the pharmaceutical industry to re-evaluate manufacturing science. High throughput screening of new chemical entities and related increased demand for more cost-effective manufacturing necessitates the need for robust processing solutions. Efficient processing is achieved through the utilization of existing knowledge, a well-defined risk management strategy, and in-house expertise in design of experiments. This will form the basis for ensuring the selection of robust process monitoring and control solutions. The solid-state composition of a powder inhalation formulation is considered to be one of the critical quality attributes. The balance between the amorphous and crystalline nature of the powder mixture can determine the overall performance of this dosage form. Unit operations related to manufacturing of powder inhalation systems involve mechanical stress and heat, and for this reason, there is the risk for processing-induced transition in the solid-state composition. Spectroscopic techniques, such as near infrared (NIR) and Raman spectroscopy, can be used noninvasively to determine the amount of amorphous and crystalline content of these materials, and by this means, provide an ideal tool for real-time quality assurance and process control of these complex formulations.