US 11,890,267 B2
Benzonatate modified release solid tablets and capsules
Andrea Nelson, Belle Mead, NJ (US); Quin-Zene Chen, Belle Mead, NJ (US); Harsh Mehta, Monroe Township, NJ (US); and Yu-Hsing Tu, West Windsor, NJ (US)
Assigned to TRIS PHARMA INC, Monmouth Junction, NJ (US)
Filed by Tris Pharma Inc., Monmouth Junction, NJ (US)
Filed on Jan. 11, 2022, as Appl. No. 17/573,333.
Application 17/573,333 is a continuation of application No. 16/668,479, filed on Oct. 30, 2019, granted, now 11,241,411.
Application 16/668,479 is a continuation of application No. 15/841,785, filed on Dec. 14, 2017, abandoned.
Application 15/841,785 is a continuation of application No. 15/075,697, filed on Mar. 21, 2016, granted, now 9,867,797.
Application 15/075,697 is a continuation of application No. 14/863,784, filed on Sep. 24, 2015, granted, now 9,408,823, issued on Aug. 9, 2016.
Application 14/863,784 is a continuation of application No. 14/282,058, filed on May 20, 2014, granted, now 9,180,104, issued on Nov. 10, 2015.
Application 14/282,058 is a continuation of application No. PCT/US2014/023106, filed on Mar. 11, 2014.
Claims priority of provisional application 61/872,019, filed on Aug. 30, 2013.
Claims priority of provisional application 61/780,689, filed on Mar. 13, 2013.
Prior Publication US 2022/0202762 A1, Jun. 30, 2022
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 9/20 (2006.01); A61K 31/245 (2006.01); A61K 9/00 (2006.01); A61K 9/24 (2006.01); A61K 9/28 (2006.01); A61K 31/09 (2006.01); A61K 31/25 (2006.01); A61K 45/06 (2006.01); A61K 9/50 (2006.01)
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.