The patent badge is an abbreviated version of the USPTO patent document. The patent badge does contain a link to the full patent document.

The patent badge is an abbreviated version of the USPTO patent document. The patent badge covers the following: Patent number, Date patent was issued, Date patent was filed, Title of the patent, Applicant, Inventor, Assignee, Attorney firm, Primary examiner, Assistant examiner, CPCs, and Abstract. The patent badge does contain a link to the full patent document (in Adobe Acrobat format, aka pdf). To download or print any patent click here.

Date of Patent:
Nov. 10, 2015

Filed:

May. 20, 2014
Applicant:

Tris Pharma Inc., Monmouth Junction, NJ (US);

Inventors:

Andrea Nelson, Edison, NJ (US);

Quin-Zene Chen, Belle Mead, NJ (US);

Harsh Mehta, Monroe Township, NJ (US);

Yu-Hsing Tu, West Windsor, NJ (US);

Assignee:

Tris Pharma, Inc., Monmouth Junction, NJ (US);

Attorneys:
Primary Examiner:
Assistant Examiner:
Int. Cl.
CPC ...
A61K 9/22 (2006.01); A61K 31/09 (2006.01); A61K 31/245 (2006.01); A61K 9/24 (2006.01); A61K 9/28 (2006.01); A61K 45/06 (2006.01); A61K 9/20 (2006.01); A61K 9/50 (2006.01);
U.S. Cl.
CPC ...
A61K 31/09 (2013.01); A61K 9/209 (2013.01); A61K 9/2077 (2013.01); A61K 9/2081 (2013.01); A61K 9/2846 (2013.01); A61K 9/2886 (2013.01); A61K 31/245 (2013.01); A61K 45/06 (2013.01); A61K 9/2013 (2013.01); A61K 9/2054 (2013.01); A61K 9/5084 (2013.01);
Abstract

A 12-hour anti-tussive modified release solid tablet or capsule is described which comprises a benzonatate in a matrix with a sufficient amount of one or more pharmaceutically acceptable modified release pH-independent, substances to provide a 12-hour 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. The modified release may be provided by (a) a high melt temperature, water-insoluble wax or waxy substance, (b) a low viscosity hydrophilic polymer such a hydroxypropyl methylcellulose, (c) a reverse enteric coating, or combinations thereof. The benzonatate may be in an adsorbate with a silico or silicate or in a complex with a weak acidic ion exchange resin complex.


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