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Assessment of Isomalt for Colon-Specific Delivery and Its Comparison with Lactulose

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Abstract

Lactulose is used as a triggering substance in a unique colon-specific delivery technology called CODESTM. Colonic microflora degrades lactulose and forms short-chain fatty acids to activate the CODESTM system. However, lactulose has been reported to cause a Maillard-type reaction with substances containing primary or secondary amino groups that may produce carcinogenic compounds. Thus, the aim of this study was to look into the possibility to substitute lactulose with isomalt for fabrication of CODESTM. The in vitro degradation of both sugars before incorporating them into the CODESTM system was evaluated with the help of rat caecal microflora. The results showed that isomalt was less efficient with regard to its rate and extent of degradation into short-chain fatty acids by the microflora compared to lactulose. However, the in vitro dissolution study did not show a significant difference in the performance between lactulose and isomalt when they were incorporated separately in CODESTM. A similar result was also obtained in the in vivo study. Based on the above results, isomalt could be used as an alternative to lactulose for colonic delivery system utilizing the principles of CODESTM.

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Acknowledgments

The authors would like to thank Universiti Sains Malaysia for providing Research University grant (1001/PFARMASI/815004) to support this work. The authors also would like to thank all manufacturers/suppliers for providing excipients free of cost for this study. Encouragement and support of Mrs. Fatema Rafiq Zakaria, chairperson, Maulana Azad Educational Trust, India is also greatly acknowledged.

Declarations of Interests

The authors report no declaration of interest.

Author information

Authors and Affiliations

  1. Y.B. Chavan College of Pharmacy, Dr. Rafiq Zakaria Campus, Rauza Bagh, Aurangabad, MS, India

    Mohamed Hassan G. Dehghan & Shaikh Mohammed Asif

  2. Pulla Reddy Institute of Pharmacy, Annaram, Medak, AP, India

    V. Rama Mohan Gupta

  3. Wockhardt Limited, Aurangabad, MS, India

    Shaikh Mohammed Asif & Mohammad Rizwan

  4. School of Pharmaceutical Sciences, Universiti Sains Malaysia, Minden, Penang, Malaysia

    Yusrida Darwis

  5. Department of Pharmaceutics, Faculty of Pharmacy, Jamia Hamdard, Delhi, India

    Mohammad Rizwan

  6. Dr. Reddys Laboratories, Hyderabad, AP, India

    Veenu Piyush Mundada

Authors
  1. Mohamed Hassan G. Dehghan
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  2. V. Rama Mohan Gupta
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  3. Shaikh Mohammed Asif
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  4. Yusrida Darwis
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  5. Mohammad Rizwan
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  6. Veenu Piyush Mundada
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Correspondence to Shaikh Mohammed Asif.

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Dehghan, M.H.G., Gupta, V.R.M., Asif, S.M. et al. Assessment of Isomalt for Colon-Specific Delivery and Its Comparison with Lactulose. AAPS PharmSciTech 14, 53–59 (2013). https://doi.org/10.1208/s12249-012-9886-0

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  • DOI: https://doi.org/10.1208/s12249-012-9886-0

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