Claims for Patent: 10,105,324

Summary for Patent: 10,105,324

Title:	Immediate release oral guaifenesin solution
Abstract:	Disclosed is a method of treating or ameliorating a condition which can be treated or ameliorated by the administration of guaifenesin, which method comprises orally administering to a subject in need thereof an effective amount of an immediate release solution for oral administration of guaifenesin and at least one additional drug. In addition to water the solution comprises as solvents propylene glycol and glycerol in a concentration which significantly increases the bioavailability of guaifenesin in the human body.
Inventor(s):	Hafey; Paul (Keller, TX)
Assignee:	SOVEREIGN PHARMACEUTICALS, LLC (Fort Worth, TX)
Application Number:	15/796,938
Patent Claims:	1. A method of treating or ameliorating cough or cold, wherein the method comprises orally administering to a subject in need thereof an effective amount of an immediate release solution for oral administration of guaifenesin and one or more additional drugs which comprise at least one of an antitussive, a decongestant, an antihistsamine or an analgesic, which 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, when orally administered to an adult human subject as a single dose in an amount which affords 200 mg of guaifenesin, provides (i) a C.sub.max of at least 3600 ng/mL of guaifenesin and/or an AUC.sub.(0-inf) of guaifenesin of at least 3700 nghr/mL and (ii) a therapeutically effective plasma concentration of guaifenesin for at least 4 hours. 2. The method of claim 1, wherein the solution comprises a total of from 54% to 66% by weight of propylene glycol and glycerol. 3. The method of claim 1, wherein a weight ratio of glycerol to propylene glycol is from 1.7:1 to 2.5:1. 4. The method of claim 1, wherein the solution comprises from 15% to 23% by of propylene glycol. 5. The method of claim 1, wherein the solution comprises from 33% to 49% by weight of glycerol. 6. The method of claim 1, wherein the solution provides a C.sub.max of at least 3800 ng/mL of guaifenesin. 7. The method of claim 1, wherein the solution provides a C.sub.max of at least 4000 ng/mL of guaifenesin. 8. The method of claim 6, wherein the solution provides an AUC.sub.(0-inf) of guaifenesin of at least 3900 nghr/mL. 9. The method of claim 7, wherein the solution further provides an AUC.sub.(0-inf) of guaifenesin of at least 4100 nghr/mL. 10. The method of claim 1, wherein the one or more additional drugs comprise a decongestant. 11. The method of claim 10, wherein the decongestant comprises at least one of pseudoephedrine and a pharmaceutically acceptable salt thereof. 12. The method of claim 10, wherein the decongestant comprises at least one of phenylephrine and a pharmaceutically acceptable salt thereof. 13. The method of claim 1, wherein the one or more additional drugs comprise an antihistamine. 14. The method of claim 1, wherein the one or more additional drugs comprise an analgesic. 15. The method of claim 1, wherein the one or more additional drugs comprise an antitussive. 16. A method of treating or ameliorating cough or cold, wherein the method comprises orally administering to a subject in need thereof an effective amount of an immediate release solution for oral administration of guaifenesin and one or more additional drugs which comprise at least one of an antitussive, a decongestant, an antihistsamine or an analgesic, which solution comprises as solvents water and additionally propylene glycol and glycerol in a concentration which, when the solution is orally administered to an adult human subject as a single dose in an amount which affords 200 mg of guaifenesin, provides (i) a C.sub.max of guaifenesin which is higher than the C.sub.max of guaifenesin provided by an aqueous solution without propylene glycol and glycerol that comprises the same concentrations of guaifenesin and the at least one additional drug by a factor of at least 1.5 and/or an AUC.sub.(0-inf) of guaifenesin which is higher than the AUC.sub.(0-inf) of guaifenesin provided by the aqueous solution by a factor of at least 1.4 and (ii) a therapeutically effective plasma concentration of guaifenesin for at least 4 hours. 17. The method of claim 16, wherein the solution provides a C.sub.max of guaifenesin which is higher than the C.sub.max of guaifenesin provided by an aqueous solution by a factor of at least 1.6 and an AUC.sub.(0-inf) of guaifenesin which is higher than the AUC.sub.(0-inf) of guaifenesin provided by the aqueous solution by a factor of at least 1.5. 18. The method of claim 17, wherein the solution comprises a total of from 48% to 72% by weight of propylene glycol and glycerol, based on a total weight of the solution. 19. The method of claim 16, wherein the one or more additional drugs comprise a decongestant. 20. The method of claim 16, wherein the one or more additional drugs comprise an antihistamine and/or an antitussive.