US 6,955,821 B2
Sustained release formulations of guaifenesin and additional drug ingredientsGeneral
US 6,955,821 B2
Sustained release formulations of guaifenesin and additional drug ingredients
Tech Center:
1600 Biotechnology and Organic Chemistry
Examiner:
Thurman K. Page
Art Unit:
1615 Organic Compounds: Bio-affecting, Body Treating, Drug Delivery, Steroids, Herbicides, Pesticides, Cosmetics, and Drugs
Agent:
Inventors:
Robert D. Davis; Ralph W. Blume; Donald Jeffrey Keyser
Assignee:
Priority:
04/28/00
Filed:
04/15/02
Granted:
10/18/05
Expiration:
05/19/20
Abstract
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.
Cooperative Patent Classification (CPC)
A61A61K2300/00A61P11/10A61K