Microprecipitation of nanoparticulate pharmaceutical agents usin

Details Microprecipitation of nanoparticulate pharmaceutical agents usin Microprecipitation of nanoparticulate pharmaceutical agents usin

1995-01-10

1998-02-10

Page, Thurman K.

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Particulate form

424490, 424 91, 424 94, A61K 914

Patent

active

057166420

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 suitable surface-modifying, surface-active agents to form a fine particle dispersion of the said pharmaceutical agent. A combination of surface active surface modifying agents comprising a nonionic surface active substance and an anionic surface active material having a chemical structure which is at least on a molecular basis 75% similar to the pharmaceutical agent is used. This process is 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 modifications of precipitation schemes are described, many of which are suitable for large-scale manufacture of these agent dispersions.

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