Patent ID: 7838032

Claim:
A drug product comprising guaifenesin and having two portions, wherein a first portion comprises guaifenesin in an immediate release form, which releases guaifenesin in a human's stomach, and a second portion comprises guaifenesin in a sustained release form, wherein the drug product contains 1200 mg of guaifenesin and provides a mean C max and at least one of a mean AUC inf and a mean AUC 0-12 for guaifenesin under fasted conditions based on single-dose administration that are from 80% to 125% of the mean C max and at least one of the mean AUC inf and the mean AUC 0-12 for guaifenesin provided by a bi-layer tablet containing 1200 mg of guaifenesin and having an immediate release layer consisting essentially of about 210.5 mg of guaifenesin dc, about 117.5 mg of microcrystalline cellulose, about 30 mg of sodium starch glycolate, and about 1 mg of magnesium stearate, and a sustained release layer consisting essentially of about 1052.7 mg of guaifenesin dc, about 25 mg of hydroxypropyl methyl cellulose, about 12.5 mg of carbomer 934P, about 5.7 mg of magnesium stearate, and a colorant, and wherein guaifenesin is absorbed into bloodstream such that the drug product can be appropriately dosed once in a 12-hour period.