Patent ID: 9180104
Filing Date: 2015-11-10
Classification: A61K

Abstract:
1. A modified release solid oral composition comprising (a) a homogenous solid dispersion comprising (i) an adsorbate powder comprising benzonatate adsorbed onto an amorphous adsorbent selected from one or more of silica, silicon dioxide or silicate and (ii) at least one pharmaceutically acceptable modified release pH-independent, hydrophilic or hydrophobic matrix-forming substance in an amount effective to provide a modified release profile to the benzonatate, and (b) a reverse enteric coating over the homogenous solid dispersion of (a), wherein there is substantially no benzonatate release from the composition in the buccal cavity or esophagus following oral ingestion of the tablet, wherein said composition provides a pharmacokinetic profile for benzonatate in which the Cmax (arithmetic mean) is about 30 ng/mL, to about 35 ngmL and the AUCinf (arithmetic mean) is about 180 ng-h/mL to about 185 ng-h/mL, based on an equivalent of a single dose of about 300 mg benzonatate administered at 12 hour intervals in a 24 hour period.