Stability study of the gastric floating dosage form of capecitabine View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2014-03

AUTHORS

Ehsan Taghizadeh Davoudi, Mohamed Ibrahim Noordin, Hamid Akbari Javar, Ali Kadivar, Mohsen Ashjari, Siavash Hosseinpour Chermahini

ABSTRACT

Since administration of capecitabine tablets leading to dose limiting makes the unfavorable toxicity, preparation of sustained-release tablets will overcome most of these side effects. The aim of this study was to prepare and study the stability of capecitabine sustained-release tablets. Sustained-release tablets of capecitabine were characterized by differential scanning calorimetry, X-ray diffraction, and infrared and ultraviolet spectroscopy techniques to determine the stability of the tablets. All tests carried out for tablets upon preparation as well as 6 and 12 months after preparation. The gradual decomposition of capecitabine sustained-release tablets stored at accelerated conditions (40 °C in 75 % of relative humidity) was indicated by decreasing values of peak purity and melting temperature, calculated from the Van’t Hoff equation. Except for the occurrence of one sharp peak for long-term stability and some sharp peaks in the accelerated condition, all peaks showed a crystallized nature. But the FTIR and UV results showed that there were no changes between the initial sustained-release tablets and stored tablets. Although the XRD results showed more peaks in the accelerated condition tablets, the crystalline form of capecitabine was maintained. These findings demonstrate that the capecitabine sustained-release tablet has excellent stability in normal and long-term storage conditions, with slight changes in the accelerated condition. More... »

PAGES

2495-2499

References to SciGraph publications

  • 2000-11. Capecitabine in INVESTIGATIONAL NEW DRUGS
  • 2009-10-20. The Role of USP Monographs in Stability Testing in PHARMACEUTICAL STABILITY TESTING TO SUPPORT GLOBAL MARKETS
  • 2011-09. Stability studies of capecitabine in JOURNAL OF THERMAL ANALYSIS AND CALORIMETRY
  • Identifiers

    URI

    http://scigraph.springernature.com/pub.10.1007/s10973-013-3540-2

    DOI

    http://dx.doi.org/10.1007/s10973-013-3540-2

    DIMENSIONS

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