Patent ID: 8940329
Filing Date: 2015-01-27
Classification: A61K,A61P

Abstract:
1. Pharmaceutical granules consisting of (i) 75 wt % or more of ibuprofen, (ii) in the range of about 0.5 to about 10 wt % of sodium starch glycolate, (iii) in the range of about 2 to about 14.5 wt % of at least one pharmaceutically-acceptable binder, which binder is different from sodium starch glycolate, (iv) in the range of about 0.01 to about 2.0 wt % of at least one pharmaceutically-acceptable wetting agent, and optionally (v) in the range of about 0.01 to about 0.5 wt % of at least one pharmaceutically-acceptable glidant, and (vi) a moisture content that is less than 5 wt %, wherein sodium starch glycolate is substantially uniformly dispersed in the granules, wherein said granules are devoid of non-crosslinked polyvinylpyrrolidone, wherein said wetting agent remains on the outer surface of said granules, wherein the foregoing percentages of (i), (ii), (iii), (iv), and (v) are based on the dry weight of said granules, and the weight of (vi) is based on the weight of the granules, and wherein said granules are formed by spraying an aqueous solution, dispersion, or suspension of (iii), followed by spraying an aqueous solution, dispersion, or suspension of (iv), onto a fluidized mixture of (i) and (ii).