Title of Invention

SUSTAINED RELEASE OF GUAIFENESIN COMBINATION DRUGS

Abstract The invention relates to a novel pharmaceutical modified release formulation of guaifenesin and optionally a second drug which is preferably selected from dextromethorphan and pseudoephedrine. The formulation may comprise a hydrophilic polymer, preferably a hydroxypropyl methylcellulose, and a waterinsoluble 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 further comprises dextromethorphan. 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.
Full Text

Documents:

1599-KOLNP-2004-(13-10-2011)-ASSIGNMENT.pdf

1599-KOLNP-2004-(13-10-2011)-CERTIFIED COPIES(OTHER COUNTRIES).pdf

1599-KOLNP-2004-(13-10-2011)-CORRESPONDENCE.pdf

1599-KOLNP-2004-(13-10-2011)-FORM 13-1.1.pdf

1599-KOLNP-2004-(13-10-2011)-FORM 13.pdf

1599-KOLNP-2004-(13-10-2011)-FORM 16-1.1.pdf

1599-KOLNP-2004-(13-10-2011)-FORM 16-1.2.pdf

1599-KOLNP-2004-(13-10-2011)-FORM 16.pdf

1599-KOLNP-2004-(13-10-2011)-OTHERS.pdf

1599-KOLNP-2004-(13-10-2011)-PA.pdf

1599-KOLNP-2004-(13-10-2011)-PETION UNDER RULE 137-1.1.pdf

1599-KOLNP-2004-(13-10-2011)-PETION UNDER RULE 137.pdf

1599-KOLNP-2004-CORRESPONDENCE-1.1.pdf

1599-KOLNP-2004-CORRESPONDENCE.pdf

1599-KOLNP-2004-FORM 27.pdf

1599-KOLNP-2004-FORM-27.pdf

1599-kolnp-2004-granted-abstract.pdf

1599-kolnp-2004-granted-assignment.pdf

1599-kolnp-2004-granted-claims.pdf

1599-kolnp-2004-granted-correspondence.pdf

1599-kolnp-2004-granted-description (complete).pdf

1599-kolnp-2004-granted-drawings.pdf

1599-kolnp-2004-granted-examination report.pdf

1599-kolnp-2004-granted-form 1.pdf

1599-kolnp-2004-granted-form 18.pdf

1599-kolnp-2004-granted-form 3.pdf

1599-kolnp-2004-granted-form 5.pdf

1599-kolnp-2004-granted-gpa.pdf

1599-kolnp-2004-granted-letter patent.pdf

1599-kolnp-2004-granted-reply to examination report.pdf

1599-kolnp-2004-granted-specification.pdf

1599-KOLNP-2004-PA.pdf


Patent Number 221152
Indian Patent Application Number 1599/KOLNP/2004
PG Journal Number 23/2008
Publication Date 20-Jun-2008
Grant Date 18-Jun-2008
Date of Filing 25-Oct-2004
Name of Patentee ADAMS LABORATORIES, INC.
Applicant Address 14801 SOVEREIGN ROAD, FORT WORTH, TX 76155-2645
Inventors:
# Inventor's Name Inventor's Address
1 DAVIS ROBERT D 1600 RIDGE HAVEN DRIVE, APT. 208. ARLINGTON, TX 76011
2 BLUME RALPH W 6709 WELCH AVENUE, FORT WORTH TX 76133
3 KEYSER DONALD JEFFREY 1216 WYNDHAM HILL LANE, SOUTHLAKE, TX 76092
PCT International Classification Number A61K 9/20
PCT International Application Number PCT/US03/11500
PCT International Filing date 2003-04-15
PCT Conventions:
# PCT Application Number Date of Convention Priority Country
1 10/121,706 2002-04-15 U.S.A.
2 10/406,574 2003-04-04 U.S.A.
3 10/406,557 2003-04-04 U.S.A.