US 12,257,218 B2
Pharmaceutical formulation
Raghu Cavatur, Parsippany, NJ (US); Kevin Chen, Parsippany, NJ (US); Matthew Kaser, Parsippany, NJ (US); Hongchun Qiu, Parsippany, NJ (US); Ernest Joseph Woodhouse, Slough (GB); Josef Borovicka, Slough (GB); and Elliot Wilkinson, Slough (GB)
Assigned to RB HEALTH (US) LLC, Parsippany, NJ (US)
Filed by RB HEALTH (US) LLC, Parsippany, NJ (US)
Filed on Feb. 9, 2022, as Appl. No. 17/667,746.
Application 17/667,746 is a continuation of application No. 15/291,061, filed on Oct. 11, 2016, granted, now 11,278,506.
Claims priority of provisional application 62/239,775, filed on Oct. 9, 2015.
Claims priority of provisional application 62/239,780, filed on Oct. 9, 2015.
Prior Publication US 2023/0062872 A1, Mar. 2, 2023
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/192 (2006.01); A61K 9/20 (2006.01); A61K 9/24 (2006.01); A61K 9/48 (2006.01); A61K 31/09 (2006.01); A61K 31/485 (2006.01)
CPC A61K 31/192 (2013.01) [A61K 9/2009 (2013.01); A61K 9/2013 (2013.01); A61K 9/2031 (2013.01); A61K 9/2054 (2013.01); A61K 9/209 (2013.01); A61K 9/4808 (2013.01); A61K 9/4858 (2013.01); A61K 9/4866 (2013.01); A61K 31/09 (2013.01); A61K 31/485 (2013.01)] 8 Claims
OG exemplary drawing
 
1. A pharmaceutical composition comprising:
(a) about 600 mg of guaifenesin;
(b) about 30 mg of dextromethorphan or a pharmaceutically acceptable salt thereof;
(c) about 110 mg of naproxen or a pharmaceutically acceptable salt thereof;
(d) about 18 to 28 mg of hypromellose; and
(e) about 8 to 14 mg of hydroxyethyl cellulose;
wherein the pharmaceutical composition provides a therapeutic effect in respect of each of guaifenesin, naproxen, and dextromethorphan for 12 hours,
wherein substantially all of naproxen dissolves within 30 minutes in a pH 6.8 phosphate buffer, and
wherein the pharmaceutical composition is a bilayer tablet comprising an immediate release layer containing substantially all of the naproxen and at least about 100 mg of the guaifenesin and at least about 8 mg of the dextromethorphan, wherein the immediate release layer contains none of the hypromellose, and wherein the immediate release layer contains none of the hydroxyethyl cellulose.