Good cascade impactor practices, AIM and EDA for orally inhaled products / / Svetlana A. Lyapustina

• Record Nr.: UNINA9910437620503321
• Autore: Lyapustina Svetlana A
• Pubbl/distr/stampa: New York, : Springer, 2013
• ISBN: 1-4614-6296-7
• Edizione: [1st ed. 2013.]
• Descrizione fisica: 1 online resource (442 p.)
• Disciplina: 615.19
• Soggetti: Pharmaceutical chemistry; Drugs - Dosage
• Lingua di pubblicazione: Inglese
• Formato: Materiale a stampa
• Livello bibliografico: Monografia
• Note generali: Description based upon print version of record.
• Nota di bibliografia: Includes index.
• Nota di contenuto: 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.
• Sommario/riassunto: 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 years, there have been substantial efforts directed at improving aerodynamic particle size determinations. Good Cascade Impactor Practices, AIM and EDA for Orally Inhaled Products brings together for the first time a review of best practices for performing ; cascade impactor testing with a thorough discussion of the recently introduced concepts of abbreviated impactor measurements (AIM) and efficient data analysis (EDA). Topics covered include: · Review of pharmacopeial methods (US and European) for assessment of aerodynamic particle size distribution (APSD) of OIPs. · Physical processes that underlie aerosol formation from OIPs and the mechanisms that affect the APSD. · Good cascade impactor practice (GCIP) related to either full resolution or abbreviated impactor measurements. · Introduction of the AIM and EDA concepts. · Selection of the type of testing through the development lifecycle of an OIP. · Theoretical basis for EDA. · Performance evaluation of EDA as a quality control element. · Case studies related to the application of EDA. · Experimental studies validating the AIM concept conducted by European Pharmaceutical Aerosol Group (EPAG) and the Cascade Impaction Working Group of the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS). · Regulatory and compendial pathways to adoption of AIM and EDA. · Exploration and extension of AIM as a potential approach to measures that could be more predictive of particle deposition in the human respiratory tract. This comprehensive volume was written by a group of prominent international experts in aerosol testing led by members of the Cascade Impaction Working Group of IPAC-RS. IPAC-RS is an international association of pharmaceutical companies committed to advancing consensus-based, scientifically driven standards and regulations for orally inhaled and nasal drug products.