Pharmaceutical compositions in the form of beadlets and method

A - Human Necessities – 61 – K

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A61K 9/16 (2006.01) A61K 9/26 (2006.01) A61K 9/50 (2006.01) A61K 31/40 (2006.01) A61K 31/55 (2006.01) A61K 47/38 (2006.01)

Patent

CA 1323833

Abstract NEW PHARMACEUTICAL COMPOSITIONS IN THE FORM OF BEADLETS AND METHOD A pharmaceutical composition is provided which is in the form of a plurality of beadlets, adapted to be filled into pharmaceutical hard shell capsules, or compressed into tablets, which beadlets are formed of a pharmaceutical such as an ACE inhibitor, for example, captopril, a beta-blocker such as nadolol, propranolol or atenolol, a calcium channel blocker such as diltiazem or nifedipine or other pharmaceuticals including combinations thereof, binder such as microcrystalline cellulose, and at least 5% by weight of an acid processing aid, such as citric acid, which imparts plasticity to the wet mass needed for efficient extrusion and spheronization. A method for forming beadlets is also provided which includes the steps of extruding a composition as described above, and subjecting the resulting extrudate to a spheronization step wherein an acid processing aid such as citric acid is employed to improve processing and form improved beadlets.

559971

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