Zecevic, Damir E. published the artcileRational development of solid dispersions via hot-melt extrusion using screening, material characterization, and numeric simulation tools, HPLC of Formula: 64519-82-0, the main research area is drug solid dispersion extrusion.
Effective and predictive small-scale selection tools are inevitable during the development of a solubility enhanced drug product. For hot-melt extrusion, this selection process can start with a microscale performance evaluation on a hot-stage microscope (HSM). A batch size of 400 mg can provide sufficient materials to assess the drug product attributes such as solid-state properties, solubility enhancement, and phys. stability as well as process related attributes such as processing temperature in a twin-screw extruder (TSE). Prototype formulations will then be fed into a 5 mm TSE (∼1-2 g) to confirm performance from the HSM under addnl. shear stress. Small stress stability testing might be performed with these samples or a larger batch (20-40 g) made by 9 or 12 mm TSE. Simultaneously, numeric process simulations are performed using process data as well as rheol. and thermal properties of the formulations. Further scale up work to 16 and 18 mm TSE confirmed and refined the simulation model. Thus, at the end of the laboratory-scale development, not only the clin. trial supply could be manufactured, but also one can form a sound risk assessment to support further scale up even without decades of process experience. © 2013 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci.
Journal of Pharmaceutical Sciences published new progress about Decomposition. 64519-82-0 belongs to class alcohols-buliding-blocks, name is (3R,4R,5R)-6-(((2S,3R,4S,5S,6R)-3,4,5-Trihydroxy-6-(hydroxymethyl)tetrahydro-2H-pyran-2-yl)oxy)hexane-1,2,3,4,5-pentaol, and the molecular formula is C12H24O11, HPLC of Formula: 64519-82-0.
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