Benzonatate modified release solid tablets and capsules
AssigneeTris Pharma, Inc.
InventorsAndrea Nelson, Quin-Zene Chen, Harsh Mehta, Yu-Hsing Tu
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Abstract
A modified release benzonatate solid tablet or capsule is described which comprises a benzonatate adsorbate in a matrix with a sufficient amount of one or more pharmaceutically acceptable modified release pH-independent, substances to provide a modified release profile to the benzonatate, wherein there is substantially no benzonatate release from the tablet or capsule in the buccal cavity and no more than about 25% release of the benzonatate within 1 hour as determined in an in vitro dissolution assay.
Claims20
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.
A method for treating a patient with cough symptoms, said method comprising administering an effective oral dose of 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.
Dependencies are inferred from the claim text.