Pharmaceutical composition containing high drug load and...

A - Human Necessities – 61 – K

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167/168, 167/185

A61K 9/14 (2006.01) A61K 9/16 (2006.01) A61K 9/50 (2006.01) A61K 31/40 (2006.01) A61K 31/66 (2006.01)

Patent

CA 1334074

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.

577021

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