Quality by Design for Orally Inhaled Drug Products - PQRI

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Orally Inhaled Drug Products• Propellant driven metered dose inhalers(MDIs)• Dry powder inhalers (DPIs)• NebulizersMDIDPI (Advair Diskus)Nebulizer6
Dry Powder Inhalers• Contain micronized drug attached to largercarrier particles (i.e., lactose) or micronized drugparticles agglomerated into soft pellets• Employ the patient’s inspiratory effort to provideenergy for drug delivery (passive DPI system)Pre-metered SingleDose UnitPre-meteredMultiple Dose UnitDrug ReservoirHandihaler Diskus Twisthaler7
Page 1 and 2: Quality by Design for Orally Inhale
Page 3 and 4: What is Pharmaceutical Quality?•
Page 5: What Constitutes QbD?Labeled UseSaf
Page 9 and 10: Quality Target Product Profile• A
Page 11 and 12: Quality Target Product Profile for
Page 13 and 14: Formulation Considerations• Physi
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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