Quality by Design for Orally Inhaled Drug Products - PQRI

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Why is QbD More Significant toOrally Inhaled Drug Products?• Inhalation manufacturing often exhibits lowprocess capability• Product is a device in association with aformulation• Product handling may affect received dose• Environmental effects may influence productmanufacture and use• Low testing efficiency of aerodynamic particleassessment methods• Lack of clear in vitro - in vivo correlationsN. Bowles et al. Drug Delivery to the Lungs 18, The Aerosol Society, Edinburgh, UK, 2007:75-78 8
Quality Target Product Profile• A prospective summary of the qualitycharacteristics of a drug product that will bestensure the desired safety and efficacy.• Guide to establish formulation strategy and keepthe formulation effort focused and efficient9
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: Dry Powder Inhalers• Contain micr
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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