alexa Urinary Excretion Levels of MMX-Mesalazine as a Tool to Assess Non- Adherence
ISSN : 2153-2435

Pharmaceutica Analytica Acta
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Research Article

Urinary Excretion Levels of MMX-Mesalazine as a Tool to Assess Non- Adherence

Tessa EH Romkens1,2*, Jody Salomon1, Wilbert HM Peters1, David M Burger3, Frank Hoentjen1 and Joost PH Drenth1

1Department of Gastroenterology and Hepatology, Radboud university medical center, Nijmegen, The Netherlands

2Department of Gastroenterology and Hepatology, Jeroen Bosch Hospital, ‘s-Hertogenbosch, The Netherlands

3Department of Pharmacy and Radboud Institute for Health Sciences, Radboud university medical center, Nijmegen, The Netherlands

*Corresponding Author:
Tessa Romkens
Radboud university medical center
Department of Gastroenterology and Hepatology
P.O. Box 9101, 6500 HB Nijmegen, The Netherlands
Tel: +31 243614760
Fax: +31 243540103
E-mail: [email protected]

Received Date: October 31, 2015 Accepted Date: November 26, 2015 Published Date: November 28, 2015

Citation Date: Romkens TEH, Salomon J, Peters WHM, Burger DM, Hoentjen F, et al. (2015) Urinary Excretion Levels of MMX-Mesalazine as a Tool to Assess Non-Adherence. Pharm Anal Acta 6:443. doi: 10.4172/2153-2435.1000443

Copyright: © 2015 Romkens T, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

 

Abstract

Objective: 5-Amino salicylicacid (5-ASA) is the cornerstone of ulcerative colitis treatment, with (assessment of) non-adherence as a challenge. Multi-matrix release (MMX)-mesalazine has the advantage of once-daily (OD) dosing. Primarily we assessed urinary (NAc-) 5-ASA excretion, as measured by High-Performance Liquid Chromatography (HPLC), in order to monitor nonadherence, in healthy volunteers taking MMX-mesalazine. Secondly, we established urinary (NAc-)5-ASA cut-off levels for (partial) nonadherence. Method: We studied 25 healthy adult volunteers who used MMX-mesalazine 2400 mg OD (days 1-4), followed by 1200 mg twice daily (BID) (days 8-11), separated by a drug-free interval of 3 days. Daily morning urine spot samples were collected. The cut-off level for adherence was set at the lowest steady state (NAc-)5-ASA urinary concentration level. Results: Stability of urinary 5-ASA and NAc-5-ASA, stored at room temperature during 24 hours was 96.4 ± 8.3% and 96.4 ± 4.1%. Recovery of urinary 5-ASA and NAc-5-ASA was 114.3 ± 10.4% and 107.5 ± 6.4%. The limit of detection and quantification were 1.1 ug/ml and 3.5 ug/ml for NAc-5-ASA and 0.4 ug/ml and 1.3 ug/ml for 5-ASA. The maximal 5-ASA within-run and between-run relative SD were 10.4% and 12.5%. The cut-off level for non-adherence was determined at 9.67 (OD) and at 15.39 (BID) mg/mmol (NAc-) 5-ASA per mmol creatinine. Conclusion: HPLC is a feasible, sensitive and reproducible method to measure urinary (NAc-) 5-ASA excretion in volunteers taking MMX-mesalazine. This study establishes urinary (NAc-) 5-ASA cut-off levels for MMX-mesalazine non-adherence that may be useful in clinical practice and future trials.

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