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Smart Specification Setting for Dry Powder Inhalation Carriers.

Pauline H M Janssen1, Marly Bastiaansen2, Lisa B Buijvoets2

  • 1DFE Pharma, Klever Str. 187, 47574 Goch, Germany; Department of Pharmaceutical Technology and Biopharmacy, University of Groningen, Antonius Deusinglaan 1, 9713 AV Groningen, the Netherlands.

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Summary

Setting particle size specifications for inhalation excipients using quality-by-design principles can lead to broader ranges. This approach ensures drug product efficacy, safety, and manufacturing without compromise, improving risk management.

Keywords:
ExcipientsFormulationInhalationInteractive mixturesLung drug deliveryParticle sizePhysical characterizationPulmonary drug delivery

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Area of Science:

  • Pharmaceutical Manufacturing
  • Drug Delivery Systems
  • Materials Science

Background:

  • Excipient specifications are critical for robust pharmaceutical manufacturing throughout a drug product's lifecycle.
  • Particle size specifications are particularly important for dry powder inhalation excipients, requiring agreement between users and suppliers.

Purpose of the Study:

  • To evaluate two development strategies for setting particle size specifications for pharmaceutical excipients.
  • To demonstrate how quality-by-design principles can be applied to specification setting.

Main Methods:

  • Evaluation of two distinct strategies for developing particle size specifications.
  • Application of quality-by-design (QbD) principles to the process of setting specifications.

Main Results:

  • The application of quality-by-design principles can result in broader particle size specifications.
  • Broader specifications do not negatively impact the efficacy, safety, or manufacturability of the drug product.

Conclusions:

  • Quality-by-design enables the establishment of robust and potentially wider particle size specifications for inhalation excipients.
  • Wider specifications offer benefits such as improved risk mitigation and potentially streamlined regulatory processes.