Titlebook: Amorphous Solid Dispersions; Theory and Practice Navnit Shah,Harpreet Sandhu,A. Waseem Malick Book 2014 Controlled Release Society 2014 amo

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MBP Technology: Process Development and Scale-Upecipitate with (ionic) polymers to increase the bioavailability of poorly soluble drugs. This chapter focuses on process development, scale-up, and its challenges for manufacturing of MBP on commercial scale. A preliminary formulation is established based on the physicochemical properties of API, sm

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Pharmaceutical Development of MBP Solid Dispersions: Case Studies technology has been applied to a number of poorly soluble compounds to enhance their biopharmaceutical performance in preclinical, toxicology, and clinical studies. MBP technology demonstrated its utility and versatility in preparing amorphous solid dispersions in various situations. Among the seve

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Structural Characterization of Amorphous Solid Dispersionspted that the physical stability, downstream processability, and performance of an ASD largely inherits its physical structure. The . and multi-methodological characterization of ASD microstructure require a range of analytical techniques working on diverse principles. This chapter presents a broad

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Overview of Amorphous Solid Dispersion Technologies 1960s, the application of solid dispersion concept to solve solubility challenges in real world was limited and this was partly due to the lack of commercially viable processing technologies. However, in the past two decades this area has seen remarkable progress as the science and understanding of

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Spray Drying: Scale-Up and Manufacturingd dispersion process for a late-stage candidate. The spray drying process was developed under a quality by design (QbD) approach at a large commercial-scale unit. The goal of this section is to highlight some important stages of the methodology (risk assessment, statistical and mechanistic modeling,