Pharmaceutical composition containing high drug load and method for preparing same
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United States of America Patent
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-
Sep 17, 1991
Issued Date -
N/A
app pub date -
Mar 15, 1989
filing date -
Sep 11, 1987
priority date (Note) -
Expired
status (Latency Note)
Importance
Abstract
A pharmaceutical composition in the form of beads prepared by an extrusion-spheronization technique and containing more than 80% by weight drug, less than 15% by weight non-lipophilic binder-plasticizer, such as microcrystalline cellulose to achieve required plasticity for processing, a starch-based excipient such as sodium starch glycolate or pregelatinized starch to control water/fluid distribution and thereby inhibit agglomeration during processing, and water-soluble binder such as hydrolyzed gelatin to make the final beads less friable. During processing a granulating agent such as ethanol/water is added to improve blend properties and control during spheronization. A method for preparing the above beads is also provided.
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