Good Cascade Impactor Practices, AIM and EDA for Orally Inhaled Products

• Συγγραφή απο Οργανισμό/Αρχή: SpringerLink (Online service)
• Άλλοι συγγραφείς: Tougas, Terrence P. (Επιμελητής έκδοσης), Mitchell, Jolyon P. (Επιμελητής έκδοσης), Lyapustina, Svetlana A. (Επιμελητής έκδοσης)
• Μορφή: Ηλεκτρονική πηγή Ηλ. βιβλίο
• Γλώσσα: English
• Έκδοση: Boston, MA : Springer US : Imprint: Springer, 2013.
• Θέματα: Medicine.; Pharmaceutical technology.; Biomedicine.; Pharmaceutical Sciences/Technology.; Biomedicine general.

Aerodynamic particle size characteristics of orally inhaled products (OIPs) are critical to their performance.  Testing based on cascade impaction has been the primary tool used to characterize this critical quality attribute and is a regulatory expectation for Quality Control purposes.  In recent y...

Πίνακας περιεχομένων:

• Introduction
• Current Approaches To APSD Measurement of OIPs Based on Inertial Impaction
• Physical Causes of APSD Changes in Aerosols From OIPs and their Impact on Cascade Impactor Measurements
• Good Cascade Impactor Practices
• The AIM and EDA Concepts: Why they are Needed
• Product Lifecycle Approach to Cascade Impaction Measurements
• Theoretical Basis for the EDA Concept
• Performance Characterization of EDA and its Potential to Improve Decision Making in Product Batch Release
• Verification of the EDA Concept through an Assessment of Theoretical Failure Modes, Failure Mode Analysis and Case Studies with Real Data
• Validating AIM-Based Instrumentation and Associated Measurement Techniques
• The Regulatory and Compendial Acceptance Pathways for AIM and EDA
• Applying the AIM Concept in Support of Developing Improved In Vitro-In Vivo Relationships for OIPs
• Future Directions for the AIM and EDA Concepts
• Conclusions.