| CPC A61K 9/2893 (2013.01) [A61K 9/2054 (2013.01); A61K 31/196 (2013.01)] | 12 Claims |
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1. A method of producing a coatable core for a modified release drug formulation for oral administration, the coatable core having a high drug load of at least 70 wt % based on a total weight of the coatable core, wherein the drug is present in the core in an amount of more than 1200 mg, the method comprising:
granulating a composition comprising a drug and at least one binder to form granules;
blending the granules with a pharmacologically acceptable disintegrant and optionally, one or more additional pharmacologically acceptable excipients, to form a compression blend, wherein the disintegrant is present in an amount from about 0.5 wt % to about 5 wt %, based on the total weight of the coatable core; and
compressing the compression blend using an external lubrication compression method, to form a coatable core.
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