Microprecipitation of nanoparticulate pharmaceutical agents

Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Particulate form

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424488, 424490, 424 94, 424 95, A61K 914

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active

055609325

ABSTRACT:
This invention describes the preparation of nanoparticulate pharmaceutical agent dispersion via a process that comprises the dissolution of the said pharmaceutical agent in an alkaline solution and then neutralizing the said solution with an acid in the presence of a suitable surface-modifying, surface-active agent to form a fine particle dispersion of the said pharmaceutical agent. This can be preferably followed by steps of diafiltration clean-up of the dispersion and then concentration of it to a desired level. This process of dispersion preparation leads to microcrystalline particles of Z-average diameters smaller than 400 nm as measured by photon correlation spectroscopy. Various modification of precipitation schemes are described, many of which are suitable for large-scale manufacture of these agent dispersions.

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