To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: ACCP: Rapidly Absorbed Ibuprofen Extrudate Provides Quicker Pain Relief Than Currently Available Tablet Forms URL: http://www.pslgroup.com/dg/2451EA.htm Doctor's Guide October 6, 2004
By Linda J. Little PHOENIX, AZ -- October 6, 2004 -- A novel form of ibuprofen – ibuprofen extrudate – speeds up pain relief compared to the currently available tablet forms, report researchers. Presenting findings of a study that compared the new extrudate formulation to an existing lysinate formulation already on the market in Europe and the normal formulation for bioequivalency, Dr. Matthias Klueglich, a researcher with Boehringer Ingelheim, Germany said, "The new formulation is rapidly absorbed, similar to the lysinate formation, but quicker than the normal formulation" He pointed out that the new formulation "is fast dissolving and provides quicker pain relief." Dr. Klueglich spoke here at the 33rd Annual Meeting of the American College of Clinical Pharmacology. This new form of ibuprofen is a solid dispersion that is distributed in a hydrophilic polymer matrix, which facilitates and speeds release. The ibuprofen already is in a soluble form, ready for absorption as soon as the formulation has disintegrated. While it is not yet available in Europe nor the United States, the drug is expected to enter the European market in the ensuing months. The researchers also determined the effect of food on the three 400-mg formulations, which are all non-steroidal anti-inflammatory drugs (NSAIDs). The open label trial was 12 sequence, 4-period crossover that involved 38 healthy men and women. The volunteers received dosages of all 3 formulations on an empty stomach, as well as after eating a high-fat, high calorie breakfast. All treatments were well tolerated. Bioequivalence of the 400 mg ibuprofen extrudate and lysinate tablets was confirmed in the fasted state. Rate of absorption in the fasted state was 20% faster after administration of the extrudate and lysinate tablets compared to normal ibuprofen. The food effect could be demonstrated in all 3 formations, but to a lesser degree with the extrudate formulation. All 3 ibuprofen formulations were slower to reached maximum potency if taken after eating a high calorie breakfast. When taking the extrudate on an empty stomach, the median time to full effect was 45 minutes, as was the lysinate ibuprofen. However, after eating, it took 75 minutes for the extrudate and 90 minutes for the lysinate to take full effect. For those taking the normal formation of ibuprofen, the full effect took 83 minutes on an empty stomach and 98 minutes after eating. However, the extent of overall absorption among the different formulations was not different. Dr. Klueglich said, "The new formulation – the extrudate – is a rapidly dissolving formulation." He concluded, "It is faster acting than the normal ibuprofen and is at least equal to the lysinate." [Presentation title: Ibuprofen Extrudate, A Novel, Rapidly Dissolving Ibuprofen: Relative Bioavailability Compared to Lysinate and Normal Ibuprofen, and Good Effect" Poster number 34] --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.