Immediate release oral guaifenesin solution
AssigneeSovereign Pharmaceuticals, Ltd.
InventorPaul Hafey
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Abstract
Disclosed is 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.
Claims20
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.
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 additionally propylene glycol and glycerol in a concentration which, when orally administered to an adult human subject as a single dose in an amount which affords 200 mg of guaifenesin, provides in (i) a Cmax of guaifenesin which is higher than the Cmax 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(0-inf) of guaifenesin which is higher than the AUC(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.
Dependencies are inferred from the claim text.