DAVIS, ROBERT D.,BLUME, RALPH W.,KEYSER, DONALD JEFFREY
申请号：
CA2481739
公开号：
CA2481739C
申请日:
2003.04.15
申请国别(地区):
CA
年份:
2012
代理人:
摘要：
The invention relates to a novel pharmaceutical modified release formulationof guaifenesin and optionally a second drug which is preferably selected fromdextromethorphan and pseudoephedrine. The formulation may comprise ahydrophilic polymer, preferably a hydroxypropyl methylcellulose, and awater~insoluble polymer, preferably an acrylic resin, in a ratio range ofabout one-to-one (1:1) to about nine-to-one (9:1), more preferably a range ofabout three-to-two (3:2) to about six-to-one (6:1), and most preferably in arange of about two-to-one (2:1) to about four-to-one (4:1) by weight. Thisformulation capable of providing therapeutically effective bioavailability ofguaifenesin for at least twelve hours after dosing in a human subject. Theinvention also relates to a modified release product which has two portions: afirst portion having an immediate release formulation of guaifenesin and asecond portion having a sustained release formulation of guaifenesin, whereinone or both portions further comprises dextromethorphan. The modified releaseproduct has a maximum guaifenesin serum concentration equivalent to that of animmediate release guaifenesin tablet, and is capable of providingtherapeutically effective bioavailability of guaifenesin for at least twelvehours after dosing in a human subject.
