: MODIFIED RELEASE FORMULATIONS OF AT LEAST ONE FORM OF TRAMADOL

Application 1187/KOLNP/2004 published 2006-05-12, filed 2004-08-17
The present invention provides for a modified release pharmaceutical composition comprising at least one form of tramadol selected from the group consisting of tramadol, enantiomers thereof, pharmaceutically acceptable salts thereof and combinations thereof, the composition exhibiting an in vitro dissolution profile (measured using the USP Basket Method at 75 rpm in 900 ml 0.1 N HCl at 37 °C) such that after 2 hours, from about 0 % up to about 30 % (by weight) of the at least one form of tramadol is released, after 4 hours, from about 5 % to about 22 % (by weight) of the at least one form of tramadol is released, after 6 hours, from about 15 % to about 38 % (by weight) of the at least one form of tramadol is released, after 8 hours, more than about 40 % (by weight) of the at least one form of tramadol is released. (FIG. NIL)

Applicant

BIOVAIL LABORATORIES INC.
Chelston Park, Building 1, Ground Floor, Collymore Rock, St. Michael, West Indies BARBADOS.

Inventor

1. SETH, Pawan, 2. MAES, Paul, J.

International Info

Classification: A61K 9/22, 9/32, 9/36
Publication Number: WO 03/072025
Application Date: 2003-02-21

Priority Information

60/357,851 U.S.A. 2002-02-21