US 9,808,431 B2
Immediate release oral guaifenesin solution
Paul Hafey, Keller, TX (US)
Assigned to Sovereign Pharmaceuticals, LLC, Fort Worth, TX (US)
Filed on Jan. 9, 2017, as Appl. No. 15/401,318.
Application 15/401,318 is a continuation of application No. 14/940,455, filed on Nov. 13, 2015, granted, now 9,549,907.
Prior Publication US 2017/0135965 A1, May 18, 2017
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/09 (2006.01); A61K 9/00 (2006.01); A61K 45/06 (2006.01); A61K 47/10 (2017.01); A61K 31/137 (2006.01)
CPC A61K 31/09 (2013.01) [A61K 9/0053 (2013.01); A61K 31/137 (2013.01); A61K 45/06 (2013.01); A61K 47/10 (2013.01)] 20 Claims
1. An immediate release solution for oral administration of guaifenesin and one or more additional drugs, wherein the one or more additional drugs comprise at least one of an antitussive, a decongestant, an antihistamine or an analgesic and the solution comprises as solvents water and a total of from 48% to 72% by weight, relative to a total weight of the solution, of propylene glycol and glycerol, and wherein the solution, when orally administered to an adult human subject as a single dose in an amount which affords 200 mg of guaifenesin, provides (i) a Cmax of at least 3600 ng/mL of guaifenesin and/or an AUC(0-inf) of guaifenesin of at least 3700 ng·hr/mL and (ii) a therapeutically effective plasma concentration of guaifenesin for at least 4 hours.