EP 1503739 A4 20060621 - SUSTAINED RELEASE OF GUAIFENESIN COMBINATION DRUGS

Title (en)

SUSTAINED RELEASE OF GUAIFENESIN COMBINATION DRUGS

Title (de)

VERZÖGERTE FREISETZUNG VON GUAIFENESIN-KOMBINATIONSPRODUKTEN

Title (fr)

LIBERATION REGULIERE DE MEDICAMENTS COMBINES DE GUAIFENESIN

Publication

EP 1503739 A4 20060621 (EN)

Application

EP 03736462 A 20030415

Priority

US 0311500 W 20030415
US 12170602 A 20020415
US 40655703 A 20030404
US 40657403 A 20030404

Abstract (en)

[origin: WO03088952A1] 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.

IPC 1-7

A61K 9/20

IPC 8 full level

A61K 9/48 (2006.01); A61K 9/24 (2006.01); A61K 31/09 (2006.01); A61K 31/137 (2006.01); A61K 31/485 (2006.01); A61K 31/495 (2006.01); A61K 47/12 (2006.01); A61K 47/32 (2006.01); A61K 47/36 (2006.01); A61K 47/38 (2006.01); A61P 11/02 (2006.01); A61P 11/10 (2006.01)

CPC (source: EP)

A61K 9/209 (2013.01); A61K 31/09 (2013.01); A61K 31/137 (2013.01); A61K 31/485 (2013.01); A61K 31/495 (2013.01); A61P 11/02 (2017.12); A61P 11/10 (2017.12)

C-Set (source: EP)

Citation (search report)

[A] EP 0384514 A2 19900829 - NORWICH EATON PHARMA [US]
[A] US 4552899 A 19851112 - SUNSHINE ABRAHAM [US], et al
[A] US 2002022058 A1 20020221 - LOVERCHECK DALE R [US]
[A] WO 0033818 A1 20000615 - NOSTRUM PHARMACEUTICALS INC [US]
[A] WO 0119901 A2 20010322 - SMITHKLINE BEECHAM CORP [US], et al
See references of WO 03088952A1

Designated contracting state (EPC)

AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HU IE IT LI LU MC NL PT RO SE SI SK TR

DOCDB simple family (publication)

WO 03088952 A1 20031030; AU 2003237807 A1 20031103; AU 2003237807 B2 20081023; CA 2481739 A1 20031030; CA 2481739 C 20121002; CN 1655766 A 20050817; CN 1655766 B 20120530; EA 007156 B1 20060825; EA 200401369 A1 20050630; EP 1503739 A1 20050209; EP 1503739 A4 20060621; IL 164438 A0 20051218; JP 2005528402 A 20050922; JP 5466346 B2 20140409; MX PA04010225 A 20050705; ZA 200409171 B 20050727

DOCDB simple family (application)

US 0311500 W 20030415; AU 2003237807 A 20030415; CA 2481739 A 20030415; CN 03812511 A 20030415; EA 200401369 A 20030415; EP 03736462 A 20030415; IL 16443803 A 20030415; JP 2003585704 A 20030415; MX PA04010225 A 20030415; ZA 200409171 A 20041111