The invention relates to a novel pharmaceutical sustained release formulation of
guaifenesin and at least one additional
drug ingredient. The formulation may comprise a hydrophilic
polymer, preferably a hydroxypropyl methylcellulose, and a water-insoluble
polymer, preferably an
acrylic resin, in a ratio range of about one-to-one (1:1) to about nine-to-one (9:1), more preferably a range of about three-to-two (3:2) to about six-to-one (6:1), and most preferably in a range of about two-to-one (2:1) to about four-to-one (4:1) by weight. This formulation capable of providing therapeutically effective
bioavailability of
guaifenesin for at least twelve hours after dosing in a human subject. The invention also relates to a modified release product which has two portions: a first portion having an
immediate release formulation of
guaifenesin and a second portion having a sustained release formulation of guaifenesin, wherein one or both portions has at least one additional
drug ingredient. The modified release product has a maximum guaifenesin
serum concentration equivalent to that of an
immediate release guaifenesin tablet, and is capable of providing therapeutically effective
bioavailability of guaifenesin for at least twelve hours after dosing in a human subject.