CPC A61K 31/245 (2013.01) [A61K 9/0053 (2013.01); A61K 9/2009 (2013.01); A61K 9/209 (2013.01); A61K 9/2054 (2013.01); A61K 9/2077 (2013.01); A61K 9/2081 (2013.01); A61K 9/2846 (2013.01); A61K 9/2866 (2013.01); A61K 9/2886 (2013.01); A61K 31/09 (2013.01); A61K 31/25 (2013.01); A61K 45/06 (2013.01); A61K 9/2013 (2013.01); A61K 9/5084 (2013.01)] | 20 Claims |
1. An anti-tussive modified release solid oral composition comprising (a) benzonatate in a matrix, wherein said matrix is a homogenous solid dispersion comprising (i) a benzonatate component, 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 benzonatate in a matrix (a), wherein there is no more than about 55% of the benzonatate released from the composition within 1 hour as determined in an in vitro dissolution test and substantially no benzonatate release from the composition in the buccal cavity.
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