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Stability study of the gastric floating dosage form of capecitabine

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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.

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Abbreviations

μg:

Microgram

ACC:

Accelerated time

API:

Active pharmaceutical ingredient

Cap:

Capecitabine

FDA:

Food and drug administration

Long:

Long term

RH:

Relative humidity

USP:

United States of pharmacopeia

UV:

Ultraviolet

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Acknowledgements

This study was supported by research grants from IPPP, University of Malaya, Malaysia (Grant No.: PS202/2010B). Also, the authors thank Osvah Pharmaceutical Company, Tehran, Iran for their gift of capecitabine and also to Mrs. Fatemeh Allah Bedashti for her friendship and assistance.

Conflict of interest

There is no conflict of interest in this project.

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Authors and Affiliations

  1. Department of Pharmacy, Faculty of Medicine, University of Malaya, 50603, Kuala Lumpur, Malaysia

    Ehsan Taghizadeh Davoudi, Mohamed Ibrahim Noordin & Ali Kadivar

  2. Department of Pharmaceutics, Faculty of Pharmacy, Tehran University of Medical Sciences (TUMS), Tehran, Iran

    Hamid Akbari Javar

  3. Institute of Nanoscience and Nanotechnology, University of Kashan, 8731751167, Kashan, Iran

    Mohsen Ashjari

  4. Department of Bioprocess Engineering, Faculty of Chemical Engineering, University Teknologi Malaysia (UTM), 81310, Johor Baharu, Johor, Malaysia

    Siavash Hosseinpour Chermahini

Authors
  1. Ehsan Taghizadeh Davoudi
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  2. Mohamed Ibrahim Noordin
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  3. Hamid Akbari Javar
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  4. Ali Kadivar
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  5. Mohsen Ashjari
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  6. Siavash Hosseinpour Chermahini
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Correspondence to Hamid Akbari Javar.

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Davoudi, E.T., Noordin, M.I., Javar, H.A. et al. Stability study of the gastric floating dosage form of capecitabine. J Therm Anal Calorim 115, 2495–2499 (2014). https://doi.org/10.1007/s10973-013-3540-2

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  • DOI: https://doi.org/10.1007/s10973-013-3540-2

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