Drug – bio-affecting and body treating compositions – In vivo diagnosis or in vivo testing – X-ray contrast imaging agent
Patent
1995-01-10
1997-09-09
Hollinden, Gary E.
Drug, bio-affecting and body treating compositions
In vivo diagnosis or in vivo testing
X-ray contrast imaging agent
424 94, 424489, 424490, 424488, 424 129, A61K 4904, A61K 914
Patent
active
056653310
ABSTRACT:
This invention describes the coprecipitation of nanoparticulate pharmaceutical agent dispersion via a process that comprises the dissolution of the said pharmaceutical agent in combination with a crystal growth modifier (CGM) in an alkaline solution and then neutralizing the said solution with an acid in the presence of suitable surface-modifying surface-active agent or agents to form a fine particle dispersion of the said pharmaceutical agent, 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. It has been discovered that coprecipitation with CGM leads to smaller particle size compared to a case where precipitation is carried out using the pharmaceutical agent alone. Thus, this dispersion of instant invention is expected to have greater bioavailability. The CGM compound is a compound that has at least about 75% of its chemical structure identical to that of the pharmaceutical agent.
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Bagchi Pranab
Bosch H. William
Scaringe Raymond P.
Hartley Michael G.
Hollinden Gary E.
NanoSystems L.L.C.
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