Quality by Design for Orally Inhaled Drug Products - PQRI

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Formulation Considerations• Formulations of the currently approved DPIs– Micronized drug attached to larger carrierparticles (i.e., lactose) or– Micronized drug particles agglomerated into softpellets12
Formulation Considerations• Physicochemical properties of drug andexcipient(s) particles– Particle size and shape– Density– Surface properties– Solid (polymorphic) form• Particle interactions– Drug-drug interactions– Excipient-excipient Interactions– Drug-excipient Interactions13
Page 1 and 2: Quality by Design for Orally Inhale
Page 3 and 4: What is Pharmaceutical Quality?•
Page 5 and 6: What Constitutes QbD?Labeled UseSaf
Page 7 and 8: Dry Powder Inhalers• Contain micr
Page 9 and 10: Quality Target Product Profile• A
Page 11: Quality Target Product Profile for
Page 15 and 16: Device Considerations• Device mat
Page 17 and 18: Process Development• Understand i
Page 19 and 20: Design Space• Design Space- The m
Page 21 and 22: IPAC-RS (1998-2003)• Nonparametri
Page 23 and 24: 2005 FDA ACPS Meeting Outcome• FD
Page 25 and 26: Control StrategiesLevel 1: Extensiv
Page 27 and 28: Level 2 ControlWDS = Within Design
Page 29 and 30: Control Variability• There is unc

Quality by Design for Orally Inhaled Drug Products - PQRI

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