AAPS Connection
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48th Annual AAPS Arden Conference: Pharmaceutical Materials Science and Engineering—Mechanical Characterization and Predictive Tools for Rapid Drug Product Development March 4–6, 2013 USP Meetings Center Rockville, MD Overview Over the last decade, pharmaceutical materials science has established itself as the foundation for Quality-byDesign (QBD) product development, and significant advances in the application of materials science have been made to understand the functionality of excipients and active pharmaceutical ingredients and how they influence the performance of formulations. Mathematical modeling can lend considerable insight and predictive ability to aid in development of difficult formulations, e.g., high drug loading, complex tablet shapes, or multilayer tablets. Both qualitative insight as well as quantitative modeling and prediction are possible when accurate material properties are known and their combined influence in a multicomponent formulation can be understood theoretically and empirically. The implementation of QbD in pharmaceutical tablet product development has been largely relying on statistical approach, i.e., design of experiments (DOE). Although useful in identifying a design space, DOE typically is resource intensive and does not provide mechanistic understanding of the performance of a formulation. A seamless integration
between materials science and DOE is key for truly achieving QbD in product development. In this conference, key materials science and engineering principles applicable to tablet design will be covered, e.g., relationship between mechanical properties and compaction behavior, crystal and particle engineering for superior tableting performance, powder flow measurement. This conference will provide formulation scientists with both basic knowledge in materials science and advanced techniques that can be used to facilitate the design of tablet product.
Goals and Objectives & & &
Review fundamental mechanical properties of pharmaceutical solids and the methods to measure them. Review theoretical modeling of particle mixing and simulation tools of powder compaction. Apply mechanical properties in drug product development following a QbD approach.
For more information visit www.aaps.org/Arden.
AAPS Workshop on Drug Transporters in ADME: From the Bench to the Bedside March 17–20, 2013 Bethesda North Marriott Conference Center Bethesda, MD
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Background
Summary/Description
Drug transporter-related research has grown exponentially in the last few years driven particularly by the emergence of the U.S. Food and Drug Administration (FDA) critical path transporter white paper and subsequent draft guidance from the FDA, European Medicines Agency, and Prescription Drug Marketing Act. Although considerable progress has been made over the past 15 years, the field of drug transport continues to evolve, particularly with respect to clinical translation of in vitro/preclinical data (Nat Rev Drug Discovery, 2010), understanding of systemic/tissue drug exposure implications, toxicity
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