Development of a novel combination tablet containing trimebutine maleate and mosapride citrate for the treatment of functional dyspepsia

Title
Development of a novel combination tablet containing trimebutine maleate and mosapride citrate for the treatment of functional dyspepsia
Author(s)
용철순조관형[조관형]최영근[최영근]강준혁[강준혁]최한곤[최한곤]박영준[박영준]
Keywords
LIQUID-CHROMATOGRAPHIC DETERMINATION; GASTROINTESTINAL DISORDERS; SOLID DISPERSION; ESTER PRODRUG; BIOAVAILABILITY; ACETAMINOPHEN; STABILITY; FORMULATION; POPULATION; PREVALENCE
Issue Date
201010
Publisher
ELSEVIER SCIENCE BV
Citation
INTERNATIONAL JOURNAL OF PHARMACEUTICS, v.400, no.1-2, pp.145 - 152
Abstract
To develop a novel combination tablet which contained 100 mg trimebutine maleate and 5 mg mosapride citrate (TMCT) for the treatment of functional dyspepsia, the wet granulation method was used to prepare TMCTs with various amounts of diluents and stabilizers. The levels of impurities, the stability and the dissolution of the TMCTs were investigated. The oral bioavailability of drugs in the TMCTs was then evaluated and compared to the simultaneous oral administration of trimebutine maleate-loaded and mosapride citrate-loaded commercial products in the beagle dog. Among the diluents tested, D-mannitol was selected, since the microcrystalline cellulose and lactose did not inhibit the production of drug impurities due to their hygroscopic properties and chemical interactions, respectively. Furthermore, succinic acid was selected as the stabilizer because it gave the lowest level of total drug impurities of the organic acids tested. The combination tablet of trimebutine maleate and mosapride citrate prepared with D-mannitol and succinic acid gave a total drug content higher than 95% and total impurities lower than 0.5% at 25 degrees C/60% RH and 40 degrees C/75% RH during a 6-month period, indicating that the tablets were stable for at least 6 months. Furthermore, this combination tablet showed a similar dissolution to the trimebutine maleate-loaded and mosapride citrate-loaded commercial products and gave insignificantly different absorption compared to these commercial products in beagle dogs. Thus, the combination tablet of trimebutine maleate and mosapride citrate prepared with D-mannitol and succinic acid would be a stable and effective oral pharmaceutical product for the treatment of functional dyspepsia. Crown Copyright (C) 2010 Published by Elsevier B.V. All rights reserved.
URI
http://hdl.handle.net/YU.REPOSITORY/23511http://dx.doi.org/10.1016/j.ijpharm.2010.08.047
ISSN
0378-5173
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약학대학 > 약학부 > Articles
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